Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise today to voice my strong opposition to H.R. 5247, the Right to Try Act of 2018.

This legislation, introduced only last week, is an egregious attempt, in my opinion, by the Goldwater Institute to undermine the gold standard drug approval process at the Food and Drug Administration.

The supporters of this bill claim to be helping desperate patients who are looking for hope.

If this is such a patient-centered bill, then why does every major patient organization overwhelmingly oppose it?

More than 100 patient organizations, including the National Organization for Rare Disorders, the Friends of Cancer Research, and the American Cancer Society have all written in opposition to this legislation.

In a letter to congressional leadership, these 103 patient organizations noted ``that the alternative pathway in the latest version of this legislation is still less safe for our patients than the current expanded access process under the FDA.''

It is not only the patient organizations that are voicing concerns. Four former FDA Commissioners--Drs. Hamburg and Califf, who served under the Obama administration; and Drs. McClellan and Andrew von Eschenbach, who served under the Bush administration--also oppose this legislation. That is two former Republican Commissioners and two former Democratic Commissioners who are opposed to both the House bill and the Senate bill on this same issue.

These four Commissioners explained their opposition by saying: ``There is no evidence that either bill would meaningfully improve access for patients, but both would remove the FDA from the process and create a dangerous precedent that would erode protections for vulnerable patients.''

Mr. Speaker, I think most importantly, I would stress that this legislation is simply not needed. There is already a successful program in place today at the FDA in which seriously ill patients and their doctors can request access to an experimental treatment from a manufacturer. This application process, which takes as little as 45 minutes for a physician to complete, has been overwhelmingly successful.

Last summer, a review by the Government Accountability Office found that the FDA approves 99 percent of the requests submitted to the agency. In fact, of the nearly 1,700 requests the FDA received last year, only 9 were not approved.

Physicians and patients also receive approval quickly. Emergency requests are often granted immediately over the phone and, on average, receive a response within 4 days.

While the FDA approves 99 percent of the treatments it reviews through this expanded access process, as it is called, it also adjusts applications for 11 percent of the patients to improve patient safety protections.

In order to protect patients, this review, in my opinion, should continue. We must protect patients from bad actors or from dangerous treatments that might make their lives worse. Just imagine the health consequences to patients if these 11 percent of applicants had not been adjusted.

This is the very reason that the FDA must be involved in the process. If you eliminate FDA review, as this bill does, you are putting patients at risk.

I want to talk a little bit about the fact that many States now have right-to-try statutes. I fear that some Members--and I heard this last week when the bill was on the suspension list--might support this legislation under the false belief that the State right-to-try laws in their States have provided help to patients. But nothing could be further from the truth.

One example supporters of this legislation like to bring up is Dr. Delpassand from Texas, who claims to have treated patients under the State right to try.

Mr. Speaker, I include in the Record a letter from Mr. Andrew McFadyen of The Isaac Foundation, who dispels this myth.

The Isaac Foundation,

March 20, 2018.

Rep. Greg Walden, Chair,

Rep. Frank Pallone, Ranking Member,

Energy & Commerce Committee.

Dear Mr. Pallone and Mr. Walden: I am writing to you

regarding your upcoming debate on HR 5247, the Right to Try

initiative fronted by the Goldwater Institute. I am the

Executive Director of The Isaac Foundation, an organization

that is dedicated to providing advocacy and support to

patients dealing with a wide range of disorders and needing

access to rare disease treatments. Our work pushes

international boundaries, with the bulk of our efforts taking

place in Canada and the United States. I am also a member of

the NYU Working Group on Compassionate Use and Pre-Approval

Access where we are making a concerted effort to improve and

address the issues around access to experimental medications,

and I'm involved with a non-profit called GE2P2.

I'm proud to say at The Isaac Foundation that we've never

been unsuccessful gaining access to life-saving medications

and treatments for patients in Canada, and our work directly

with pharmaceutical companies is helping countless patients

see similar results in the United States. We have had success

by being collaborative partners with industry, regulatory

authorities, and patients in need.

I watched the discussion last week with growing

consternation that many of our elected officials have not

taken the opportunity to fact-check claims being made by RTT

proponents. Most notably, continued mention of Right to Try

being used by Dr.

Delpassand out of Texas is both egregiously wrong and,

indeed, is the perfect example of why RTT should not be

passed by lawmakers.

In October 2016, I testified during Senator Ron Johnson's

hearing on Right to Try, at which Johnson introduced and

played a video created by the Goldwater Institute of Dr.

Delpassand. During that 3-minute video, Dr. Delpassand

explained that he was using the state RTT law to treat his

patients because the FDA would not allow him to do it through

an Expanded Access Program. Senator Johnson asked me what I

thought about this video--which included few facts, no

context, and was edited by the people fronting the RTT push

themselves. I explained that there must be a reason why Dr.

Delpassand was in the 1% of cases not allowed by the FDA and

vowed I would investigate.

In March of 2017, I received a set of documents from the

FDA under a FOIA request. They show that Dr. Delpassand's

clinic failed inspections during the clinical trial of

Lutathera (lutetium Lu 177 dotatate). Specifically, he failed

inspection due to 3 key and very important reasons:

1. Enrolling subjects into the study during a partial

clinical hold, issued by the Agency.

2. Underreporting of Adverse Events.

3. 1572-protocol noncompliance.

The failed inspections were discovered after complaint from

the CDER Good Clinical Practice Compliance Oversight Branch,

Division of Good Clinical Practice Compliance Evaluation,

Office of Scientific Investigations (OSI). A ``Clinical

Hold'' was placed on the lab and Dr. Delpassand. During a

clinical hold, subjects may not be given an investigational

drug. Dr. Delpassand and his clinic disregarded this clinical

hold and enrolled 6 patients.

Additionally, and just as concerning in terms of patient

safety, Dr. Delpassand's clinic failed to promptly report

significant new adverse events or risks to the FDA. This

failure to report was noted numerous times during the

inspection. The inspection also found numerous other areas of

concern. I have attached the full report for your

consideration.

After these inspections, the FDA would not allow Dr.

Delpassand to open an EAP at his clinic for patients in need,

and rightly so. They FDA did, however, allow 42 different

locations the ability to provide this drug for patients

requiring access, including two sites in Texas. A quick

search on ClinicialTrials.gov shows this information, further

proving that the FDA has been able to provide patients the

required access they need, ensuring the environment that they

are receiving the drug they need is safe.

My understanding of the situation is that the company

running the clinical trial distanced themselves from Dr.

Delpassand after these failed inspections. Without company

support, and without the FDA's permission to open an EAP, Dr.

Delpassand had to use the state legislation to provide drug

to his patients. Questions remain, however, such as how Dr.

Delpassand paid for the product he was giving his patients,

did patients themselves have to pay for that drug supply

(which isn't allowed under the Texas RTT law) and who, if

anyone, was overseeing the program to ensure safety of the

patients, especially after multiple infractions were seen

during the failed FDA inspection.

Most important, it should be noted that the FDA process

here worked exactly how it is supposed to. A lab was

inspected for safety to ensure patients are looked after in

the appropriate fashion. That inspection placed a hold on

further treating of patients due to numerous infractions. The

FDA worked with the company to ensure access for patients

across the USA in 42 different sites, helping to monitor

adverse events while also allowing the product to advance to

approval. That product was approved by the FDA in January

2018.

Also importantly, RTT was used because it was the only way

for Dr. Delpassand to treat patients in his clinic after it

failed inspection. RTT is a loophole designed to allow people

who cannot otherwise follow safety rules set forth by the FDA

that are meant to protect vulnerable patients. It's not being

used--anywhere--to provide patients with hope or access to

life-saving drugs.

One final note, and one that I've not see mentioned

anywhere. HR 5247 includes the name of a young child--a brave

child battling Duchenne Muscular Dystrophy--named Jordan

McLinn. Jordan has been photographed numerous times with Vice

President Pence, and is often used as an example of why Right

to Try is needed. The problem with these optics is that

Jordan has never received any treatment under Right to Try,

even though Right to Try has been available in his state of

Indiana for 3 years. He already has access to the life-saving

treatment he needs--through an FDA approved clinical trial.

He's doing well on that trial drug, as I understand it, and

receives all the benefits of FDA oversite to ensure his

safety on that trial. In essence, the child used to promote

RTT is the perfect example of why the FDA process works and

is needed.

The true reality is that the landscape for access to

medications for dying patients does not change tomorrow if a

Federal Right to Try law is passed today. Very clearly, those

patients in dire need of help today will wake up tomorrow

needing access to the same life-saving treatments, and feel

the same despair because they will not be getting the access

they need through Right to Try.

The barrier to that access here isn't the FDA, and no Right

to Try law enacted by lawmakers in this country is going to

remove the true barrier--pharmaceutical companies. The

gatekeepers to these medications are the pharmaceutical

companies themselves, and we need to be working

collaboratively as a team--Industry, Government, physicians,

and Patients--to craft solutions that will work for everyone,

keeping in mind that we are all on the same side, that we all

want the same thing--broad and expeditious access to life-

saving medications for patients in need.

I understand how difficult this is for patients--I see it

every day, and I feel it every night as I check in on my son

(who is battling his own devastating and very rare disease)

to make sure he is still breathing, to make sure he is still

with us. But I also understand that the change we all need

will not come with Right to Try. It will come through

collaboration with all stakeholders and by providing

companies the safety and assurances they need to make their

medications available to our dying patients.

Lawmakers should be spending their time helping make that

collaboration happen because that is how we are going to save

our dying patients. They should not spin their wheels passing

legislation like Right to Try that looks good, and feels

good, but will do nothing for those in need. If they do, they

are doing a disservice to a large and very vulnerable group

of patients now and in the future, my own son, my own hero

Isaac, included.

Thank you for your time on this matter.

Sincerely,

Andrew McFadyen,

Executive Director, The Isaac Foundation.

Andrew McFadyen said:

Dr. Delpassand claims to have used right to try because FDA

would not allow him to do expanded access. And this was for a

very good reason. FDA placed a clinical hold on a study, due

to the fact that his clinic was not reporting serious,

adverse events, as required; and he continued to enroll

patients, despite the clinic hold.

The work of Dr. Delpassand's study was associated with 40

deaths and 2 hospitalizations. FDA's clinical hold on Dr.

Delpassand's work is a sign to me that FDA's expanded access

pathway was working to prevent bad actors from continuing to

expose vulnerable patients to experimental treatments.

Mr. Speaker, H.R. 5247 is dangerous for our patients. It is an unprecedented attempt to roll back the FDA's oversight of investigational treatments. I urge my colleagues to stand with more than 100 organizations that have come forward to oppose this misguided and, I believe, harmful legislation.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield such time as she may consume to the gentlewoman from Illinois (Ms. Schakowsky), who is the ranking member for the Digital Commerce and Consumer Protection Subcommittee.

Mr. Speaker, I yield such time as she may consume to the gentlewoman from California (Ms. Matsui).

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I want to explain some other reasons why I am very opposed to this bill. I am concerned that H.R. 5247 essentially does nothing to address what may be the true barrier to expanded access, and that is the determination by the manufacturer as to whether or not they will provide access to their product that is under development. And I want to stress, there is nothing in this legislation before us today that would compel a manufacturer to grant access upon request.

Further, I believe that trusted manufacturers like J&J, or Johnson & Johnson, which is headquartered in my district, have already said that any compassionate use request must be subject to FDA review. Now, I have heard my colleagues refer to this as a Hail Mary pass for the terminally ill. I think, in reality, it is offering false hope of a cure to patients and their families when there is no guarantee that any patient will receive access to treatment from a manufacturer.

In fact, H.R. 5247 sets an extremely low threshold for the types of experimental treatments that may be available through this alternative pathway by allowing patients access to investigational treatments that have only completed a phase 1 clinical trial. Patients will be exposed to treatments with no or relatively little data that they are actually effective. These extremely small trials only examine the safety and toxicity of a drug and do not determine the effectiveness or potential side effects. Access at this phase 1 stage in the development could expose patients to untested products and further harm and result in delaying access to a treatment that may be more appropriate and more beneficial for their underlying disease or condition.

Only 1 in 10 products move on from phase 1 clinical trials to FDA approval. Mr. Speaker, the bill does not make any adverse-event reporting to the FDA immediate. It also limits FDA's ability to use clinical outcomes associated with the use of an investigational product when reviewing a product for approval if it could adversely impact its review. It also prevents any entity from being held liable for use of the treatment.

Again, these are some of the many reasons that more than 100 organizations oppose this dangerous bill.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, may I inquire how much time I have remaining?

Mr. Speaker, I yield such time as he may consume to the gentleman from Texas (Mr. Gene Green), the ranking member of the Health Subcommittee.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, there has been a lot of misinformation spread by supporters of this legislation that FDA is a barrier to patients receiving access to these investigational treatments, and I want to be very clear that that is simply not the case.

FDA's expanded access program approves nearly all requests for investigational drugs or biologics it receives. For the past 5 years, FDA's approval rate for expanded access requests has been over 99 percent. In fiscal year 2017, as I previously mentioned, only nine individual requests were denied.

FDA also conducts its review quickly. FDA physicians are available 24 hours a day to approve any emergency expanded access requests the agency receives, typically granting emergency requests immediately, over the phone, and nonemergency requests in a median time of 4 days and, generally, no longer than 30 days.

FDA has also taken actions to streamline the expanded access request process for physicians to make it less burdensome. I think that was mentioned by Mr. Walden, the chairman.

Pharmaceutical companies can choose to deny a patient access to an experimental treatment because, for example, there is not enough of the drug available or they are concerned about dangerous side effects. The fact is, when a patient is denied access to an experimental treatment, it is because the company has said no, not the FDA.

So let's be clear as to what this legislation is. It is an attempt to undermine the authority of the expert public health agency charged with reviewing drugs to ensure their safety and efficacy.

I would urge my colleagues to oppose this grab at FDA's authority. That is really what this legislation is all about.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I said before that I have found that some Members were looking to vote for this bill because they said: Well, we have the right to try in our State by State statute, so what is the difference if we do it on the Federal level?

I just want to stress again that the State right-to-try laws do not give patients a right to try effectively and have done little to expand access to investigational treatments.

There are 37 States and the District of Columbia that have enacted right-to-try laws, and there is no evidence that anyone has obtained an investigational treatment via these laws that couldn't have been obtained through FDA's expanded access program.

Right-to-try laws do not compel companies to provide patients access to investigational treatments; therefore, under these State laws, patients still do not have a right to try, only the

right to request the treatment from the company.

State right-to-try laws do not address the fundamental barriers of cost and company restrictions. Neither the FDA nor States require insurers or pharmaceutical companies to cover the cost or reduce the costs of these often expensive treatments. Instead, these laws put patients at higher risk by prohibiting or weakening FDA's oversight of investigational treatments.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, may I inquire how much time remains and whether the gentleman has additional speakers on his side.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I just want to stress that, as I said before, we have the four previous FDA Commissioners, two Democrats and two Republicans appointed by President Bush, who have raised serious concerns about this legislation because it excludes FDA review and they think could pose serious risks to vulnerable patients.

I just wanted to read, once again, a statement that they made jointly to The Washington Post, where they said: ``There is no evidence that either bill would meaningfully improve access for patients, but both would remove the FDA from the process and create a dangerous precedent that would erode protections for vulnerable patients.''

Mr. Speaker, I just want to stress to my colleagues on both sides of the aisle that my concern is that no one is actually going to be able to get an experimental drug by this bill. In other words, if you are a manufacturer that actually has done something and come up with an experimental drug that you believe will make a difference to someone who is terminally ill, you are likely going to want to go through the FDA expanded access process because then there is a seal of approval that the FDA has actually looked at this and said that it is relatively safe to use.

So my real fear is that the only thing this is going to do is open up to the possibility of some charlatan, fly-by-night snake oil drug company or manufacturer who is going to make all kinds of claims that have not been reviewed by the FDA for any kind of safety, and that then people may say: Okay. Well, I will take that because I am terminally ill and I might as well try something.

But that isn't really what we should be doing here. We should be providing a process, as the FDA does right now, where, if someone is terminally ill and they want to try something, they at least have some certification of approval by the FDA that this is something that may help them, that may make a difference, and that, in the case of about 11 percent of the cases where the application is made to the FDA, some changes are made to make sure that even though there is a certain level of risk, that that level of risk is reduced by the FDA putting on additional safety precautions.

So my real concern here is I don't want people to vote for this legislation thinking that somehow it is going to make a difference. I really don't believe that is true. Otherwise, I wouldn't urge the opposition that I am. But for all these reasons, I do urge strong opposition to this bill and ask that my colleagues vote ``no.''

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, I have a motion to recommit at the desk.

I am opposed to the bill in its current form.

Mr. Speaker, this is an amendment to the bill, or the final amendment to the bill, which will not kill the bill or send it back to committee. If adopted, the bill will immediately proceed to final passage, as amended. And this amendment would offer a more targeted approach to improving the FDA's current expanded access program.

In October, the Energy and Commerce Committee held a hearing on the widely opposed Senate right-to-try legislation. At that hearing, we heard concerns from FDA Commissioner Gottlieb and also from manufacturers, academic experts, and patient groups that S. 204 was legislation that would expose broad numbers of patients to harm, and sought to hamstrung the FDA's ability to oversee or engage in any meaningful way on the use of investigational treatments.

Since that time, my colleagues on the other side of the aisle have drafted new legislation that maintains, in my opinion, the same harmful approach prohibiting FDA review of experimental treatments. The FDA is part of the process for a reason. It protects patients from potentially bad actors or from experimental treatments that might do more harm than good.

So my motion to recommit, Mr. Speaker, abandons this harmful attempt to undermine the FDA's expanded access pathway and, instead, seeks to make two improvements that have been identified as meaningful by both manufacturers and patient groups.

This proposal will also not be any surprise to Chairman Walden or Chairman Burgess because it was the bipartisan proposal our staffs were negotiating prior to the introduction of the current Republican bill.

So I want to stress that, unlike the current bill, H.R. 5247, this proposal is not based on the false premise that FDA approval is a barrier to accessing investigational treatments. Rather, it addresses the two key problems identified by expert witnesses at our hearing: how the FDA will utilize clinical outcomes of investigational treatments and liability protection.

To that end, under this motion to recommit, the FDA is directed to issue guidance to manufacturers specifically on how and when the FDA will consider clinical outcomes, and when a sponsor may request the consideration of such outcomes when it comes time to submit an application for approval for the investigational treatment.

This will provide manufacturers with the clarity they are seeking regarding

how allowing patients access to drugs that are still under development may impact their ability to gain full FDA approval. It will also ensure that there is a public process for such guidance, ensuring that stakeholders will have the opportunity to offer their views on this issue.

Mr. Speaker, the motion to recommit also provides liability protection to manufacturers, physicians, clinical investigators, and hospitals, if they are in compliance with the current law and regulations for expanded access. If you are a manufacturer, a physician, or a hospital that is in compliance with current rules and requirements related to expanded access, you will receive protection for allowing access to the investigational treatment.

Finally, it also provides transparency around the number of expanded access requests the FDA receives and grants, how many requests a manufacturer receives and grants, and if there are any serious adverse events. This transparency, I believe, will provide clear data as to how many patients are making expanded access requests and how often these requests are granted or denied by the FDA and manufacturers.

Mr. Speaker, I believe that these legislative fixes will go a long way to bolstering the existing successful expanded access pathway, while maintaining the critical review and oversight of the agency charged with protecting our public health, that being the FDA.

I just want to say that, last fall, FDA Commissioner Gottlieb testified on right-to-try efforts and told our committee: ``There is a perception that certain products that aren't being offered under FDA expanded access will be offered under right-to-try, and I don't see that.''

That is our current Commissioner Gottlieb, who I respect a great deal.

Rather than creating an unnecessary alternative pathway that threatens our drug approval process and our clinical trial program, I would urge my colleagues to join with Democrats and 103 patient organizations in supporting the current expanded access program.

These targeted improvements under the motion to recommit to the existing program are, I think, a way to achieve a better goal. So I urge my colleagues to support my motion to recommit and oppose this, what I consider, dangerous Republican proposal in the bill before us.

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, on that I demand the yeas and nays.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise today in strong opposition to S. 204, the Federal Right to Try Act. This is dangerous legislation that threatens FDA's authority over ensuring that medical treatments are safe and effective. This bill needlessly exposes vulnerable patients to the risks of unproven medications.

We heard last night in the Rules Committee from my Republican colleagues that we must accept and pass this legislation because the Senate is unable to pass a bill that passed the House earlier this year. That House bill was bad enough, but this Senate bill is much worse. I cannot fathom why my Republican colleagues are surrendering to the Senate and agreeing to pass a more dangerous version of the right- to-try legislation.

The Senate bill, like the House bill, establishes an alternative pathway for experimental treatments that eliminates any review from the Food and Drug Administration and scientific and medical experts of an independent review board. This will provide fly-by-night physicians and clinics the opportunity to peddle false hope and ineffective drugs to desperate patients.

At a hearing before our committee, FDA Commissioner Scott Gottlieb cautioned that S. 204 risked ``exposing people to unwanted side effects from experimental therapies.''

Now, supporters of this bill would have you believe that this legislation is targeted at those with terminal illnesses, but this is simply not the case. S. 204 would, in fact, apply to a much broader range of patients diagnosed with life-threatening diseases or conditions. And the term ``life-threatening disease or condition'' could include chronic and often manageable diseases, such as diabetes or chronic heart failure.

If all patients with diabetes and other chronic but manageable illnesses were eligible, it would greatly expand the scope of the legislation well beyond the scope of most State laws and FDA's expanded access program. This exposes an even greater number of patients to risk and undermines our clinical trial program by diverting patients from trials that could support full approval to the alternate pathway.

Commissioner Gottlieb also cautioned Congress that this legislation risked ``undermining a regulatory process that has been carefully crafted over many years to strike a very careful balance.'' The Commissioner noted that S. 204 would not subject all participants to the alternate pathway to critical regulatory requirements, such as labeling products as investigational, charging limitations, and restrictions on promotion and commercialization of such treatments.

S. 204 could also impede the FDA from taking action against manufacturers and others that violate other provisions of the Federal Food, Drug, and Cosmetic Act. Under this bill, if a bad actor is not in compliance with good manufacturing practices or does not protect against intentional alteration--adulteration, I should say--or allows dishonest or misleading labeling, the FDA will not be able to take any enforcement action.

But, more importantly, Mr. Speaker, this Federal right-to-try bill simply is not necessary, in my opinion. FDA has an expanded access program and has an approval rate of nearly 100 percent.

To be clear, FDA's high approval rate is not just a rubberstamp for these applications. Of the applications FDA receives and approves, it also adjusts applications for 11 percent of patients to improve patient safety protections. This could include modifying the dosing, strengthening informed consent, or improving safety monitoring.

We must protect patients from bad actors or from dangerous treatments that might make their lives worse. Without this critical review, there will not be any oversight to ensure that patients are not being taken advantage of or put in harm's way.

The main reason this bill is being pushed is to chip away at FDA's authority to ensure the safety and effectiveness of our drugs.

FDA oversight of access to experimental treatment exists for a reason: it protects patients from potentially snake oil salesmen or from experimental treatments that might do more harm than good.

By removing the FDA oversight, you are counting on physicians and manufacturers to serve as the gatekeeper and protector of our patients. I simply don't buy that that is going to work.

Supporters of this bill want to blindly believe that there are no bad actors out there, but imagine someone like Martin Shkreli promising a dying patient a cure that could save their life. Under this bill, FDA would play no role in determining whether or not Martin Shkreli could provide that drug to that dying patient.

If S. 204 is signed into law, patients will be taken advantage of and will be harmed. Bad actors exist, and this Republican bill gives them the opportunity to prey on desperate people who are, understandably, looking for any treatment that may help save their lives.

Now, let me also point out that the supporters of this bill claim to be helping desperate patients who are looking for hope. If this is such a patient-centered bill, why does every major patient organization overwhelmingly oppose it? Where is the call from patients for this legislation?

More than 100 patient organizations, including the National Organization for Rare Disorders, Friends of Cancer Research, and American Cancer Society Cancer Action Network, sent a letter to Congress just yesterday opposing this legislation. In the letter, they stated: ``The Senate version of the legislation is less safe than the pathway proposed in the House version and is dangerous compared to the current expanded FDA access process.''

Four former FDA Commissioners from both parties also oppose this Republican legislation, noting: ``There is no evidence that either bill''--that is the House or the Senate--``would meaningfully improve access for patients, but both would remove the FDA from the process and create a dangerous precedent that would erode protections for vulnerable patients.''

Mr. Speaker, S. 204, I know, is a key agenda item for the President and the Vice President; but I think it is dangerous for our patients, and it is an unprecedented attempt to roll back FDA's oversight of investigational treatments.

Mr. Speaker, I urge my colleagues to stand with more than 100 organizations that have come forward to oppose this misguided and, I believe, harmful legislation.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield 3 minutes to the gentlewoman from Florida (Ms. Castor), the vice ranking member of the Energy and Commerce Committee.

Mr. Speaker, I yield 2 minutes to the gentleman from California (Mr. McNerney).

Mr. Speaker, I yield 2 minutes to the gentleman from New York (Mr. Tonko).

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I just want to respond briefly to the previous speaker on the Republican side.

I don't understand how the gentleman can say that the expanded access program will continue even under right to try.

The problem is, sure, on paper it will continue, but there wouldn't be any reason for anyone to go to the FDA. If the FDA is now out of the picture and all you have to do is find somebody who manufactures a drug or treatment and get the doctor to say, ``Okay, I will administer it,'' then you don't need to go to the expanded access program.

You see, the problem is that the gentleman assumes that people will go to the FDA and they will know that the expanded access program exists. I think the very nature of this legislation, which basically says that you don't have to go to the FDA, is going to mean that people won't even know that that is an option. And if they can get somebody to give them the drug without going to the FDA, they will just do it.

Let me just say this. I know the gentleman referred to the FDA's bureaucrats. I guess you could say that the people at the FDA are bureaucrats, but the FDA existed because, for many years before then, in the 19th century and early 20th century, all kinds of snake oil and things were advertised and promoted in the papers and in magazines, saying that this is going to cure that, this is going to cure that, and people demanded that there be some kind of Federal oversight as to whether drugs or treatments actually are effective, whether they have harm, whether they are toxic. That is why the FDA was started.

So I guess I just don't understand, because the bottom line is there is very little evidence that there is any significant number of people who are denied treatment or drugs because of the expanded access program. At least then they know that some agency has looked at this to see whether it is harmful, whether it has some negative impact.

The great concern that those of us on the other side of this issue have is that without the FDA, there is no guarantee that what somebody gets as a form of treatment is actually going to be meaningful, not be harmful.

So I don't want to prolong my response to the gentleman, but I do think that you have to understand that those of us on this side of the aisle actually think that the FDA has a purpose and actually performs an important function, and I don't think we should deny that. I think it is unfortunate that there are those who think that somehow the FDA is not doing its job.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, again, I would like to respond to the previous Republican speaker. He made three comments that disturb me.

One, he said that people should be able to try things, try the drugs or the treatment, when the benefits outweigh the risks. But how are they going to know that when the FDA isn't involved?

When the FDA goes through various phases of clinical trial, not only phase

one, which determines whether something is toxic, but beyond, to determine whether it is effective or whether it has harmful effects, then you do know. The FDA basically will tell you: Yes, the benefits outweigh the risk, and that is why we have an approval process in general for drugs, and that is why we have the expanded access, so that the FDA can look at it and say: Okay. Maybe you are going to risk this, but we want to make sure that you have some protection.

The gentleman said that the FDA process is complicated or time consuming. First of all, there is an emergency process where you can simply get on the phone or the doctor gets on the phone, and within 24 hours you can be approved.

But on the other hand, if it is not an emergency, the average approval time is 4 days. So I don't know how he can say that this is time consuming.

And then the last thing he said is that there is consent, that the doctors and the manufacturers have to agree. But who is going to enforce this?

Right now, because the FDA has to go through the expanded access process, the FDA has the enforcement. They can say: We are going to grant this; we are not; we are going to provide some safety or other protections.

But if the doctor and some fly-by-night manufacturer decide that they want to give you this drug or treatment, who is going to enforce that? How do we know that the doctor is legitimate? How do we know that the manufacturer is not selling snake oil?

Once the FDA is out of the picture, there is no way for the patient to know whether the doctor is unscrupulous, whether the manufacturer is unscrupulous. There is no review. There is no enforcement whatsoever.

So, again, this is the problem once you take the FDA out. I understand there are some that don't like the FDA, don't think maybe they should be involved. But in the absence of the FDA, I don't know how you possibly could know whether this thing is going to help you, whether the benefits outweigh the risk, whether there is a bad actor involved, either with the doctor or the manufacturer.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I want my colleagues on the other side to understand why so many of us over here have been so upset by this proposal today.

As I think I said before, the House bill was bad enough. The Senate bill is worse for at least two reasons.

One is our concern, on the one hand, that rather than these drugs or treatments without FDA approval would be handed to just terminally ill patients, that the Senate bill says that it would apply to people who have life-threatening situations.

And the FDA and the commissioner of the FDA have stated quite clearly that they are concerned about the expansion from terminal to life- threatening, because it could be that people who have diseases like diabetes, severe diabetes, or chronic heart disease, for example, could make the argument that their situation is life-threatening, and, therefore, they can go and get these experimental drugs without FDA approval.

So that is a huge loophole that is very disconcerting.

The second thing is that the prohibition, if you will, on promotional activity with these investigational drugs is taken out by the Senate bill.

So the worst thing of all, we talk about snake oil and advertising, is now is some unscrupulous doctor or manufacturer now going to promote this and say: Well, if you take this, this may save your life?

So that is why the Senate bill is worse.

But I want to go back to the whole idea. The problem that I have with all this is that once you take out the FDA, and the FDA is not involved anymore, the way this bill is set up, how do I know, if I am the patient and I hear from some doctor or through some promotion or whatever, that there is something that might help me, and I am desperate, how do I know that the doctor that I go to or the manufacturer who is promoting this drug, that this is actually not a bad actor, not somebody who is taking advantage of the situation because there is no FDA approval?

In other words, who is going to determine whether this person's life is threatened or whether they are terminally ill? There is no FDA. Who determines that?

Who is going to determine whether this drug has any effectiveness at all?

Well, some of my Republican colleagues say: Well, it has to go through phase one, but phase one clinical trials could have 20 or 30 people. They are sometimes very small.

The FDA doesn't really have any ability to control those clinical trials. Sure, they have some oversight over clinical trials, but there are clinical trials that take place all over the country with very few people, and sometimes the drug manufacturers who are experimenting with these trials, with these small groups, are not necessarily known manufacturers or large ones that we know will be safeguarding these drugs or treatments.

So I just think the problem is, when we talk about snake oil and bad actors, it is almost as if the Republicans assume there are no bad actors.

Because if you assume that there are, which I do, and there are bad actors who are going to promote something that is not going to be effective or is going to harm somebody, and that there is a manufacturer who is not someone we know, who is going to determine whether or not they are a bad actor or what they are doing?

You need to have some kind of enforcement. You need to have somebody who is supervising this. Otherwise, it is any man for himself decides: I will try this drug. It went through phase one. Maybe it is not toxic.

So I really worry that this debate on the other side of the aisle is not taking into consideration that there always are going to be people who want to take advantage of the situation and sell something that they are going to make a buck on that is not necessarily going to have any real oversight in this situation.

So that is my fear. That is my fundamental fear about this bill, that these situations are going to arise, nobody is going to be in charge, nobody is going to know what is going on, and then the person is going to either die earlier or have some awful impact, and then they are going to say: Oh, how come the FDA didn't approve it? Or maybe they are going to assume the FDA approved it, and there is no FDA. They are gone.

Mr. Speaker, in any case, I would urge my colleagues to oppose what I consider very harmful legislation, and I yield back the balance of my time.

Mr. Speaker, I demand a recorded vote.

Mr. Speaker, by direction of the Committee on Rules, I call up House Resolution 905 and ask for its immediate consideration.

Mr. Speaker, for the purpose of debate only, I yield the customary 30 minutes to the gentleman from Florida (Mr. Hastings), pending which I yield myself such time as I may consume. During consideration of this resolution, all time yielded is for the purpose of debate only.

General Leave

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days to revise and extend their remarks.

Mr. Speaker, House Resolution 905 provides for the consideration of three important bills aimed at protecting our country, reducing regulatory burdens in the financial sector, and allowing patients who have nowhere else to turn with another option to potentially save their lives.

These three bills, taken together, show House Republicans' commitment to putting Americans' interests first.

Today's rule provides for a structured rule to begin consideration of H.R. 5515, the National Defense Authorization Act for Fiscal Year 2019. The resolution grants 1 hour of debate equally divided between the chair and ranking member of the House Committee on Armed Services.

In addition, as the first of two likely rules on the fiscal year 2019 NDAA, the rule provides for the consideration of 103 amendments to the defense bill.

Along with the Defense Authorization Act, the resolution today provides for a rule for House consideration of S. 2155, the Economic Growth, Regulatory Relief, and Consumer Protection Act, the Senate- passed bipartisan bill to reduce the regulatory burdens imposed on community and local banks by the Dodd-Frank financial regulatory legislation.

The legislation went through rigorous debate in the House and the Senate, and it mirrors in many ways the House-passed CHOICE Act, passed by the House in the summer of 2017 under the stewardship of Financial Services Chair Jeb Hensarling.

Moreover, the resolution before us provides for a rule to allow the House to consider the unanimously passed Senate bill, S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017.

This legislation, highlighted by the President during his last State of the Union address, has been a top priority of the President for the Congress, allowing terminally ill patients a last chance at survival using a carefully crafted FDA process.

H.R. 5515, the National Defense Authorization Act for Fiscal Year 2019, would authorize appropriations for military activities of the Department of Defense and for military construction, as well as prescribe military personnel strengths for the next fiscal year.

This critical piece of legislation, one of the most important bills that any Congress will consider in any year, provides the resources and the direction necessary for our men and women in uniform to do what they do best: protect and serve our country throughout the world.

As will be discussed by many Members of this body over this week, this bill touches on all aspects of military policy, from the Middle East to the Korean Peninsula to the Arctic waters.

Among the hundreds of amendments the Rules Committee is likely to make in order on this legislation, I am pleased that, once again, my amendment, offered with Ms. Lee, Mr. Lance, Mr. DeFazio, Mr. Jones, Mr. Welch, Mr. Lewis, and Ms. Schakowsky, will again be made in order. This continues to push the Department of Defense to finally complete a full audit of its finances, as required by law.

S. 2155, the Economic Growth, Regulatory Relief, and Consumer Protection Act, corrects some of the more egregious provisions in the Dodd-Frank financial regulatory legislation.

The bill focuses on regulatory relief on smaller financial institutions--namely, community banks and credit unions--so they can more readily meet the needs of their local communities without burdensome Federal regulations stifling their economic growth. This places the focus of the financial institutions back on their customers instead of completing paperwork and answering to agencies in Washington, D.C.

Finally, Mr. Speaker, our final bill in today's rule, S. 204, will look familiar to many people here today, as we are again considering legislation that would bring hope to terminally ill patients across our country.

A similar bill, H.R. 5247, passed this House in March. Minority Leader Chuck Schumer and Senate Democrats have refused to act on H.R. 5247, the revised version of the Right to Try legislation, which passed the House 2 months ago on a strong bipartisan vote.

As this body had heard earlier this year, Right to Try was the one piece of legislation that President Trump came and stood in the well of this House and specifically promised to the American people in his State of the Union address.

Today, I will say again what I said in March when we first took up Right to Try: I stand with the President and I stand with the thousands of Americans with terminal diseases and their families and their friends in getting this important policy to the President's desk.

Mr. Speaker, when we pass this bill today, it doesn't go back to the Senate. It has already been passed by the Senate. It goes immediately down to the White House for a signature and becomes law.

Here is an interesting fact. In the last couple of months since the House passed its Right to Try bill, even more States have joined this strong grassroots movement. Now, 40 States, including my home State of Texas, have passed and signed a version of Right to Try into law.

In nine other States, a version of Right to Try has already been introduced, including the State of New York, which is the home State of the minority leader of the United States Senate.

Last year, the Energy and Commerce Health Subcommittee held a hearing on access to investigational drugs where S. 204 was discussed. At that time, the Commissioner of the Food and Drug Administration, Dr. Scott Gottlieb, and other advocacy groups expressed concerns on the various Right to Try bills introduced in the Senate and the House.

So, when the President asked the Congress to act, the House responded by holding multistakeholder discussions with patient groups, medical research advocates, and the administration in order to improve the original Right to Try bill. I want to commend Chairman Walden for leading these negotiations.

I am also proud of the revised Right to Try legislation that the Energy and Commerce Committee produced because the policies were sound, and I believe it was a positive step forward in granting access to new treatments while allowing additional input from the Food and Drug Administration.

Unfortunately, the minority party on the other side of the Capitol, Senate Democrats, said ``no, thank you'' to the revised House bill. While I am not surprised by their decision, I think the American people, particularly patients

with terminal diseases and their loved ones, would not be satisfied with a ``no, thank you'' nonaction by Congress on such an important issue.

Today, the House is ready to act for the American people and will be considering S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017.

This passed the Senate unanimously last August. This bill will offer terminally ill patients a chance at life. After it passes this House, it will be signed into law.

Our Nation has achieved unprecedented innovation and scientific breakthroughs recently and over the course of the last decade. American patients have widespread access to innovative treatments, thanks to researchers and our academic institutions and those working in the pharmaceutical and medical device industries.

Despite these achievements, we continue to hear from patients with serious, life-threatening conditions, including my constituents from north Texas, who remain frustrated with what they see as regulatory barriers from trying new therapies when everything else has failed them.

As a physician, I understand that access to investigational drugs and therapies is a deeply personal priority for those seeking treatment for loved ones diagnosed with very difficult diseases.

This crossroads where our Nation seems to be--when a potentially lifesaving treatment, while not approved, both exists but remains unavailable--is an important debate that we are having for these Americans. To them, it is not only a matter of life or death but another chance to spend more time with their children, grandchildren, parents, and other family members.

Some of the opponents of Right to Try point to the Food and Drug Administration's current expanded access program, which is aimed at helping patients who do not qualify for clinical trials gain access to therapies that the agency has yet to approve.

While this program makes a good faith effort to help patients, we can do more by passing Right to Try and creating an alternative pathway for these patients to access eligible investigational drugs.

Additionally, we know that many individuals may not qualify for a clinical trial if they do not meet strict patient inclusion criteria, which may include factors such as age, gender, type and stage of their disease, previous treatment history, and other medical conditions.

There are also many patients for whom participation in a clinical trial is not feasible, especially those who live in rural areas far from the clinical trial sites.

Most, if not all, of the patients with a terminal medical condition fall into one of these categories. This legislation that we are doing today allows these patients to participate in an alternative pathway, opening another door to investigational drugs that does not exist today.

While there are a few differences between S. 204 and the House-passed Right to Try legislation, the underlying policies between the two bills are very similar.

For example, only certain investigational drugs are considered eligible under both bills. In order to qualify, the drug must have completed a phase one clinical trial; have an active application at the Food and Drug Administration; be under active development or production by a manufacturer; and not have been approved, licensed, or cleared for sale under current law.

Also, both bills require reporting of serious adverse events, having written informed consent to the treating physician, and notifying the agency when a sponsor provides an investigational drug.

Lastly, Commissioner Gottlieb at the Food and Drug Administration recently expressed support for the Senate-passed Right to Try bill being considered today and said that his agency could ensure an appropriate level of patient safety through guidance and rulemaking.

In other words, while the Food and Drug Administration may have some additional work, the key point is the agency can achieve the proper balance of ensuring patient safety and granting access to new investigational drugs.

I think the Commissioner would agree that we would have preferred the revised House Right to Try legislation, but doing nothing is currently not an option. Hundreds of thousands of Americans with terminal illnesses and their families are looking for us to act. I support restoring hope for these patients and giving them a fighting chance at life.

Mr. Speaker, I urge Members of this esteemed body to support today's rule and all three underlying bills, and I reserve the balance of my time.

Madam Speaker, I yield 2 minutes to the gentleman from Michigan (Mr. Bergman), a member of the Financial Services Committee.

Madam Speaker, I yield 1 minute to the gentleman from Indiana (Mr. Messer).

Madam Speaker, I yield myself 30 seconds for purposes of rebuttal before I yield to the gentleman from North Carolina (Mr. Budd).

As a point of situational awareness, as of last week, in this Congress, over 1,000 amendments have been heard on the House floor: 47 percent Democratic, 41 percent Republican, 15 percent bipartisan.

For a point of reference, the last term that Nancy Pelosi was Speaker of the House, the 111th Congress, less than 1,000 amendments for the entire Congress. We passed that milestone prior to last week. We will continue to hear amendments on the floor.

Madam Speaker, I yield 1 minute to the gentleman from North Carolina (Mr. Budd).

Madam Speaker, I yield 1 minute to the gentleman from Georgia (Mr. Loudermilk).

Madam Speaker, I yield 1 minute to the gentleman from Ohio (Mr. Davidson).

Madam Speaker, I yield 1 minute to the gentleman from Tennessee (Mr. Kustoff).

Mr. Speaker, I yield an additional 30 seconds to the gentleman.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I continue to reserve the balance of my time.

Mr. Speaker, I yield myself 1\1/2\ minutes for the purposes of a response.

I would, of course, lead with the observation that those who do not remember their history are doomed to repeat it. I don't remember precisely who said it, but I think it bears repeating today.

In the 111th Congress, Speaker Pelosi and the Democrats allowed less than a thousand amendments to be considered on the floor.

Of the bills that were considered at that time, the Dodd-Frank bill was one of those bills. The amendments that were blocked by the Democrats in the 111th Congress were precisely the type of amendments that we are now considering today in the bill to alleviate some of the obstructions, some of the gridlock that has occurred with our credit unions and smaller banks--things that people have been asking us for repeatedly for the last 5 to 7 years.

Mr. Speaker, the number of amendments that were blocked in the 111th Congress was significant. We have a chance today to undo some of that process, and I believe we ought to take that opportunity. As of 1\1/2\ weeks ago, over a thousand amendments had been made in order in this Congress.

The Committee on Rules is run differently today than it was in the 111th Congress. It used to be that you had to submit 45 copies of an amendment and you had a time limit by which you had to submit those amendments. You can submit amendments late now.

Mr. Speaker, I yield an additional 30 seconds to myself.

Chairman Sessions has been very accommodating in allowing us to bring amendments to the Committee on Rules late.

There is no clock in the Committee on Rules, as the gentleman well knows. You can talk as long as you want in the Committee on Rules about your amendments, and you can offer whatever amendments you prefer.

The process is not ideal, but it is important that we move forward with these important reforms that people have been asking us for years. And, today, that day is at hand, and those reforms will be delivered.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, seeing no more speakers on my side, I am prepared to close.

Mr. Speaker, I yield myself the balance of my time.

Mr. Speaker, I again want to reiterate, the Rules Committee has spent hours listening and considering Member testimony. We have welcomed over 225 Members to testify during this Congress, and roughly 493 times have made over 1,000 amendments in order, including 474 from Democrats, 383 from Republicans, and over 150 which were bipartisan amendments.

The rule today is important, three important pieces of legislation.

The National Defense Authorization Act. Our number one priority when we are elected to this body is the defense

of our Nation, and we are authorizing that expenditure today.

The bill to reform the financial services institutions is one that has been requested by small banks and credit unions for years, and this body is today prepared to deliver.

Then finally, the Right to Try Act. The President stood in the State of the Union message and said that it was not correct that people had to go to other countries in order to get the medicines that they needed to prolong their lives. He wanted that to end, and today we are taking the step to end that.

Mr. Speaker, I urge my colleagues to support today's rule and the three underlying pieces of legislation

Mr. Speaker, I yield back the balance of my time, and I move the previous question on the resolution.

Mr. Speaker, I was unavoidably detained. Had I been present, I would have voted ``yea'' on rollcall No. 210.

Mr. Speaker, I yield myself such time as I may consume, and I thank the gentleman from Texas for yielding me the customary 30 minutes for debate.

Mr. Speaker, the underlying measures that are in this combined rule are matters of substance that do need to be addressed, and I will get back to it in a moment.

Several of my colleagues will join me today in recognizing a historic moment in this particular body in this great country of ours.

Madam Speaker, let me recognize that tucked inside this rule is the majority's 83rd and 84th closed rules of this Congress--and we are just in May--with more to go.

That is a historic number because it makes the 115th Congress the most closed Congress ever. My Republican friends have made history for all the wrong reasons.

But we should not let this milestone go unrecognized right from the very beginning, because it is a sad point in this Chamber's history. It is why we have ignored virtually every major issue the public cares about. It is why this Congress can't get anything done. It is why we are so dysfunctional.

It is clear to me that the majority has turned a deaf ear, which is absolutely shameful. Please know this: 1,793 amendments offered by Members of this body have been denied.

When I came to Congress in 1992, there was an echo chamber from the right talking about the Democrats' closed rules. Quite frankly, at that time, I did not understand that dynamic. I arrived here, and during that particular session of Congress, we did have open rules, but there were closed rules as well.

When Nancy Pelosi was last Speaker, we had 12 open rules. This Speaker, our now lame-duck Speaker, up to this point, has been and is the only Speaker of the House of Representatives never to have an open rule. What that means is not just Democrats have been shut out but Republicans have been shut out.

Day in and day out, night in and night out, in the Rules Committee, Members offer up meaningful suggestions to this Congress, and they are denied. That is not denying the Member of Congress; it is denying the people those persons are here to represent and who expect them to advance measures that are pertinent to their respective communities.

There will be Members who will talk about the shamefulness of the kinds of amendments that have been denied.

This particular measure authorizes $647 billion in base budget authority for defense programs in the coming fiscal year, as well as an additional $69 billion in overseas contingency operations.

The legislation comes on the heels of the bipartisan budget agreement signed into law in February, which increased the budget caps for defense and nondefense spending for 2 years.

The legislation provides, rightly, a 2.6 percent pay raise for Active-Duty troops, the highest such raise in 9 years. It strengthens the Military Health System, provides assistance to local educational agencies servicing military dependent students, and improves the Transition Assistance Program to provide servicemembers better tailored resources and information as they prepare to enter civilian life.

I was glad to see that this NDAA establishes a prescription drug monitoring program in order to prevent opioid abuse within the military, a proactive step that will help our country combat drug addiction.

What is important about this particular measure is the chairman, Chairman Thornberry, and the ranking member, Adam Smith, have worked together, along with the members of the Committee on Armed Services, to

produce a bipartisan product. It proves it can be done.

This is a bipartisan measure, and most Members in this body will have amendments that will be made in order and will have an opportunity to present their ideas how to better sustain military readiness. That is as it should be.

But there are members of the Committee on Armed Services who belong to other committees of jurisdiction. In those committees of jurisdiction where few hearings are held, no bipartisan effort is undertaken, they are shut out just as well as the rest of the members of the other jurisdictions.

Every jurisdiction in this Congress should be bipartisan and should have input from both parties.

And I find it passing strange that I hear voices saying that Democrats are obstructionists. Obstructionists of what? We can't even get amendments made in order.

The only thing we have left that we can do is voice our objection to the kind of closed process that we have witnessed during this particular session of Congress. I hope the American public understands how much their Members are being denied an opportunity to represent them.

In terms of military readiness, the fiscal year 2019 NDAA dedicates substantial funding toward cutting-edge military capabilities and countering emerging threats through investments in cyber and space. The bill includes funding for thousands of additional Active-Duty troops and authorizes important funding for military construction and infrastructure.

You know what it doesn't include and what it won't? There will be Members who will offer that we have an Authorization for Use of Military Force. Seventeen years have passed since we have had a new Authorization for Use of Military Force. Congress should be declaring war, not Presidents.

And it doesn't mean this President. The three or four before him operating in this Congress were allowed to go forward under the aegis of a 17-years-ago Authorization for Use of Military Force.

I was also pleased to see an improved commitment to Historically Black Colleges and Universities in this year's package--schools that are critical to ensuring a pipeline of highly skilled, diverse college graduates into the United States Armed Forces.

This bill also takes significant steps to support our allies. It provides $6.3 billion for the European Deterrence Initiative and declares that it is the policy of the United States to counter Russian influence campaigns.

The bill also imposes additional sanctions on Russia for violating the Intermediate-Range Nuclear Forces Treaty, and it renews authority in the war against the Islamic State of Iraq and Syria and fully funds Israeli missile defense partnerships.

Madam Speaker, there is a lot that we can be proud of in this NDAA. Unfortunately, despite all of these important investments, there are a few provisions in this bill that raise serious concerns.

I have already spoken to the failure to pass a new military-use-of- force measure. The one that we have is overly broad, and Members have never had an opportunity to vote on a new one, even as we commit to military engagements overseas.

Members on both sides of the aisle agree that an up-or-down vote on a new AUMF is long overdue. So this is the time and the place to do it. My colleague Barbara Lee, I am sure, and my colleague on the Rules Committee Jim McGovern, I am sure, are going to offer measures that will accomplish that.

I am also particularly alarmed that this legislation repeals the Federal ban on military production of low-yield nuclear weapons. Repealing this 15-year ban and pursuing low-yield nuclear warheads for submarine-launched ballistic missiles will have significant ramifications for global security.

Additionally, the NDAA includes a number of provisions targeting DOD's fourth estate, which refers to nonmilitary portions of the Department of Defense. These provisions affect human resources, information systems, and other important services that affect the day- to-day lives of our servicemen and -women as well as national readiness.

Under this bill, these offices are targeted with an unrealistic and unnecessary spending cut, setting up a sequester-like automatic 25 percent reduction to critical support functions.

Madam Speaker, this brings me to the second measure, the Economic Growth, Regulatory Relief, and Consumer Protection Act.

Under the pretext of providing relief to community banks, this bill rolls back important financial and consumer protections and provides a giveaway to large Wall Street banks, allowing them to skirt enhanced regulations aimed at protecting our economy from another financial crisis.

The third measure, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, exposes more patients to harm and further sidelines the Federal Drug Administration's ability to oversee investigational treatments than the bill passed by the House in March.

In fact, during the Rules Committee hearing in March, Energy and Commerce Committee Chair Walden and Health Subcommittee Chair and fellow Rules Committee member Burgess had reservations about this measure, which is why the House took up the more narrowly focused bill in the first place.

Madam Speaker, last Friday, there was another school shooting. Again, America watched in horror as students and teachers fled their classrooms from a murderous gun rampage. Again, community leaders and government officials offered thoughts and prayers. Yesterday, we offered a moment of silence. Again, calls for stricter gun control laws and heightened school security returned.

We all know that this will happen again to our young people. And for that reason, I can state emphatically and without fear of having to correct the Record that the Republican leadership of this House has not only abdicated their responsibility to the American people and our children but their common sense as well.

No other country in the world has as many guns, as many homicides, or as many mass shootings as we do. There is simply no more time to waste. We need to be considering a ban on bump stocks. We need to be considering a ban on assault weapons.

And don't anybody tell me we can't ban assault weapons. We did that when I first came to Congress. We banned assault weapons, and the kind of mass killings we have seen went down after we did that.

We need to be considering protective orders allowing people to petition the court to temporarily remove firearms from an individual in crisis. We have seen evidence of that working when Florida passed its law. One week after that law went into effect, a person had his guns removed who would have been a harm to himself and to others.

We need to be considering comprehensive background checks, and we can't stop there. We need to increase access to mental health services. We need to eliminate the feeling in this country that seeking help carries with it some sort of stigma.

We need to learn to recognize the danger signs and offer a clear course of action. We need to teach students about conflict resolution.

And we need to do more about civility in this Nation, in this House. And we should be its leaders, not standing and offering a moment of silence and returning to do nothing, as we have done, shooting after shooting, mass shooting after mass shooting, in this country.

Madam Speaker, I reserve the balance of my time.

Madam Speaker, I yield 1\1/2\ minutes to the gentleman from California (Mr. Ted Lieu), a member of the Foreign Affairs and Judiciary Committees, to discuss the commonsense issues that we all care about but have been blocked during this closed Congress.

Madam Speaker, I yield 1\1/2\ minutes to the gentleman from Rhode Island (Mr. Cicilline), a member of the Foreign Affairs and Judiciary Committees, to discuss the commonsense issues that we all care about but that have been blocked during this closed Congress.

Madam Speaker, just to respond briefly to Mr. Burgess, it is a good thing that they made a handful of amendments in order that added up to 1,000. If we went through it, they would look like studies and things that were not significant; but when it came to the healthcare measures or when it came to tax reform, not one amendment by a Democrat was made in order.

Madam Speaker, I yield 1\1/2\ minutes to the gentlewoman from Connecticut

(Ms. DeLauro), who is a member of the Appropriations Committee, to discuss the significance of this record-breaking closed Congress and real people affected by these closed rules.

Madam Speaker, may I ask how much time both parties have remaining.

Madam Speaker, I yield 1\1/2\ minutes to the gentleman from Michigan (Mr. Kildee), a member of the Financial Services Committee, to discuss the significance of this record-breaking closed rule and the real people affected by the GOP shutting down our democratic process.

Madam Speaker, if we defeat the previous question, I am going to offer an amendment to the rule to bring up Representative Sarbanes' bill, H.R. 20, the Government by the People Act.

This legislation would overhaul our broken campaign finance system and return to a government of, by, and for the American people.

Madam Speaker, I ask unanimous consent to insert the text of my amendment in the Record, along with extraneous material, immediately prior to the vote on the previous question.

Madam Speaker, I yield 3 minutes to the gentleman from Maryland (Mr. Sarbanes), who is a member of the Committee on Energy and Commerce and the Committee on Oversight and Government Reform, to discuss our proposal.

Mr. Speaker, I yield 1 minute to the distinguished gentleman from Texas (Mr. Gonzalez), a member of the Financial Services Committee, to continue the discussion of commonsense issues that we all care about but have been blocked during this closed Congress.

Mr. Speaker, I yield 1 minute to the distinguished gentleman from Vermont (Mr. Welch), my good friend, a former member of the Committee on Rules who is now a member of the Committee on Energy and Commerce, to discuss the commonsense issues that we all care about that have been blocked during this closed Congress.

Mr. Speaker, I am pleased to yield 2 minutes to the gentleman from Massachusetts (Mr. McGovern), the ranking member of the Committee on Rules, my good friend, who also serves on the Committee on Agriculture, to discuss the significance of this record-breaking closed Congress and real people affected by these closed rules.

Mr. Speaker, I yield an additional 30 seconds to the gentleman.

Mr. Speaker, I yield an additional 15 seconds to the gentleman.

Mr. Speaker, I yield 15 seconds to the gentleman from Massachusetts (Mr. McGovern).

Mr. Speaker, I ask how much time I have remaining.

Mr. Speaker, I would advise the gentleman from Texas that I am prepared to close if he is.

Mr. Speaker, I yield myself the balance of my time.

Mr. Speaker, I ask the American people to look at this chart. Rules under Speaker Ryan: structured rules, 44 percent; closed rules, 56 percent; open rules, zero. That is what we are talking about.

As with all bipartisan measures, this NDAA has many things to like and some provisions that are causes for concern, but it did demonstrate that there can be bipartisan cooperation in order to safeguard our national security, and that should be the case in every one of the jurisdictional undertakings here in Congress.

I commend the committee for once again tackling such a major legislative package, but sadly, this approach is far and away the exception to the rule around here.

Finally, Mr. Speaker, we have a moral responsibility to address gun violence in this country. Gun violence has overtaken our country. We have a moral responsibility to every child who now attends school thinking about, not if a school shooting will happen, but when it will happen to them. This responsibility is not owed to them at our leisure, it is not owed to them next month or next week or tomorrow, but today.

Mr. Speaker, I urge a ``no'' vote on the rule, and I yield back the balance of my time.

Mr. Speaker, on that I demand the yeas and nays.

Mr. Speaker, I demand a recorded vote.

Mr. Speaker, pursuant to House Resolution 787, I call up the bill (H.R. 5247) to authorize the use of eligible investigational drugs by eligible patients who have been diagnosed with a stage of a disease or condition in which there is reasonable likelihood that death will occur within a matter of months, or with another eligible illness, and for other purposes, and ask for its immediate consideration in the House.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and to insert extraneous material on H.R. 5247.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, earlier this year, Members of Congress heard the President during his State of the Union Address make a specific promise to the American people that the passage of right-to-try legislation would occur. This afternoon, I am proud to stand with the President and the thousands of Americans with terminal illnesses, their families, and their friends, in passing this important bill in the House.

Since 2014, nearly three out of four States, including my home State of Texas, have passed a version of right-to-try laws. I am pleased that the House is again considering H.R. 5247, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, so that terminally ill patients have a chance, or maybe a second chance, at life. These patients are our constituents. They could be someone we know. Let us take this opportunity to improve access to experimental treatments for them.

Over the course of the past decade, our Nation has achieved an unprecedented number of innovations and scientific breakthroughs. Through the contributions of researchers in academia and the private sector, Americans have more innovative treatments at their fingertips.

Despite these achievements, I still hear from patients with serious, life-threatening conditions, including my own constituents in north Texas, who are frustrated with what they see as regulatory barriers from trying new therapies when everything else has failed.

Mr. Speaker, as a physician, I understand that access to investigational drugs and therapies is a deeply personal priority for those seeking treatment for their loved ones with serious, life- threatening conditions.

To my friends on the other side of the aisle, I have a simple question: Why do you not want to allow these patients to exercise their right to fight for their future?

It is worth mentioning that the bill before us today is a revised, more narrowly crafted version of the one that passed the Senate last August. Since that time, the Energy and Commerce Subcommittee on Health held a hearing in early October to consider the Senate bill, where Members heard from

the Commissioner of the Food and Drug Administration, Dr. Scott Gottlieb, about the agency's concerns. We also heard testimony from patients and groups that support and oppose right to try.

From then to just recently, our committee engaged in multistakeholder efforts to improve the original right-to-try bill, as passed by the Senate. It entailed numerous conversations with patients, advocates, the Administration, authors of the bill, and stakeholders on all sides of this complex topic.

The Food and Drug Administration was never left out of the discussion. In fact, the agency provided valuable input throughout the process and up until the introduction of H.R. 5247. The aim was to open the door to innovative, experimental drugs for terminally ill patients without necessarily compromising the vital work and the mission of the Food and Drug Administration.

The current compassionate use program at the Food and Drug Administration does make a good faith effort to help patients who do not qualify for clinical trials. But right to try would actually offer patients an alternative pathway to access eligible investigational drugs, so long as they are certified by a physician who is in good standing and abides by the rules laid out in the bill.

Again, we have worked closely with the Food and Drug Administration to ensure that this new, alternative pathway does not hinder or conflict with the critically important oversight that the agency conducts.

Additionally, this bill protects patients from manufacturers mislabeling or misbranding drugs, requires sponsors and manufacturers to report adverse events to the Food and Drug Administration, and provides certain liability protections for parties participating in the new pathway.

Mr. Speaker, this alternative pathway would also be limited to individuals who are suffering from a disease or a condition where there is a reasonable likelihood of death within a matter of months or significant, reversible morbidity, and who have exhausted all FDA- approved treatment options.

Lastly, it is essential that we do not create additional hurdles in this process so that manufacturers in the drug approval process have the certainty that they need.

The revised right-to-try bill clearly states that the Secretary of the Department of Health and Human Services ``may not use a clinical outcome associated with the use of an eligible investigational drug . . . to delay or adversely affect the review or approval of such drug. . . . `'

After months of work and thoughtful discussions, this legislation is a positive step forward in our shared goal of improving care for America's patients. It strikes the proper balance between ensuring patient safety and granting access to new treatments.

The President outlined in his State of the Union Address that this was an important priority for the administration. In the words of our Vice President and former colleague, Mike Pence: ``It's about restoring hope and giving patients with life-threatening diseases a fighting chance.''

Mr. Speaker, for these reasons, I urge my colleagues in the House to vote in support of H.R. 5247, and I reserve the balance of my time.

Mr. Speaker, I yield 3 minutes to the gentleman from Pennsylvania (Mr. Fitzpatrick), one of the authors of the bill.

Mr. Speaker, at this time, I am pleased to yield such time as he may consume to the gentleman from Oregon (Mr. Walden), the chairman of the full committee.

Mr. Speaker, I am pleased to yield 3 minutes to the gentleman from Virginia (Mr. Griffith), a valuable member of the Energy and Commerce Committee, the vice chairman of the Oversight and Investigations Subcommittee.

Mr. Speaker, I yield 4 minutes to the gentlewoman from Indiana (Mrs. Brooks), another valuable member of the Committee On Energy and Commerce and the Subcommittee on Health.

Mr. Speaker, I yield 3 minutes to the gentleman from Arizona (Mr. Biggs), one of the primary drivers on this legislation.

Mr. Speaker, I yield 3 minutes to the gentleman from Georgia (Mr. Allen).

Mr. Speaker, I yield 3 minutes to the gentleman from Tennessee (Mr. Roe), the chairman of the Committee on Veterans' Affairs.

Mr. Speaker, I will be closing.

Mr. Speaker, I yield myself the balance of my time.

Mr. Speaker, yesterday, during the rule debate on this bill, I outlined a case where the previous Speaker, Nancy Pelosi, provided the right to try for a patient, a Democratic donor, back in my home State of Texas. So, really, all we are asking today is that we give regular Americans, the forgotten men and women of this country, the same rights that the Speaker of the House provided to a Democratic donor back in October of 2008.

Yesterday I quoted from an article from the Dallas Morning News. I have a different but similar article today talking about the same case, talking about the individual who had a diagnosis of multiple myeloma.

There was a drug that perhaps would provide some hope. The individual was clearly terminal. This monoclonal antibody that was primarily used to treat multiple sclerosis might show some efficacy in treating the advanced form of multiple myeloma that this patient had. The drug had been through phase 1 clinical trials. The patient did not have time for the drug to go through phase 2 and phase 3 clinical trials.

The article says:

Enter Nancy Pelosi. Through means to which we have never

been privy, Ms. Pelosi got the FDA to give the manufacturer

the all-clear to give the drug to the patient. The patient

got the drug, the patient took the drug, but, unfortunately,

the patient died anyway, but his family remains grateful to

the Speaker for interceding on his behalf.

I don't doubt that they are.

Yesterday, I quoted the Dallas Morning News article where the patient's spouse said, somehow, Nancy Pelosi got it done.

Well, do you know what, Mr. Speaker? You shouldn't have to depend on the Speaker of the House to intercede on your behalf to get the FDA to get the manufacturer to make a drug available. If you are really up against a bad situation, wouldn't it be better if we provided everyone that same pathway?

That is what this bill does today. That is why the right-to-try legislation was advocated by the President of the United States. In fact, I think it was the only legislative priority that the President laid out during his State of the Union Address where he wanted to see Congress act.

So today, we are going to do that. Today, we are going to act. It is an important bill. I encourage my colleagues to vote in favor of it.

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, I claim the time in opposition to the motion to recommit.

Mr. Speaker, while well-intentioned, this motion to recommit falls short of providing vulnerable patients full access to experimental treatments.

Providing clarity on how negative side effects will be accounted for during drug approvals is helpful. Giving manufacturers, sponsors, physicians, hospitals, and clinical investigators certainty on liability protections is meaningful. Taken together, these improvements to the existing expanded access program could lead to enhanced manufacturer and sponsor participation and increased patient access.

But this would not provide an alternative pathway for patients who cannot get into a clinical trial and have been rejected from participation in the existing compassionate use program.

This bill before us today does provide an alternative pathway, one that strengthens patient protections with clearer informed consent and real-time adverse event reporting. This bill--the underlying bill--also makes certain that the FDA is notified when a patient receives an unapproved drug through the new alternative pathway to ensure proper oversight. These are significant patient protections.

With this motion to recommit, we have a choice. The underlying bill is the only choice that gives those patients in the greatest need of help access to investigational drugs, with their consent, even after they were rejected from participating in a clinical trial or expanded access.

Mr. Speaker, the choice is clear. We need to vote to expand patient access. We need to vote down the motion to recommit. We need to vote for the underlying bill.

Mr. Speaker, I yield back the balance of my time.