H.Res. 787

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, by direction of the Committee on Rules, I call up House Resolution 787 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 have 5 legislative days to revise and extend their remarks.

Mr. Speaker, House Resolution 787 provides for the consideration of two important bills whose focus is to empower the people of this Nation by removing governmental obstacles standing in the way of life and prosperity in this country.

The first bill, H.R. 4566, the Alleviating Stress Test Burdens to Help Investors Act, is a bipartisan effort from the Committee on Financial Services under Chairman Jeb Hensarling, authored by the gentleman from Maine (Mr. Poliquin).

The second piece of legislation in today's rule, H.R. 5247, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, authorizes the use of certain drugs to eligible patients who have been diagnosed with a stage of a disease or a condition for which there is a reasonable likelihood that death will occur in a matter of months.

The rule provides for 1 hour of debate for H.R. 4566, the Alleviating Stress Test Burdens to Help Investors Act, equally divided between the Chair and the ranking members of the Committee on Financial Services.

The rule makes one amendment in order, authored by the gentlewoman from California (Ms. Maxine Waters), the ranking member. Further, the rule provides for the consideration of one motion to recommit with or without instructions.

For H.R. 5247, the Right to Try Act of 2018, the rule provides for 1 hour of debate equally divided between the Chair

and the ranking member of the Committee on Energy and Commerce. Although no amendments to the bill were made in order, the rule does provide for one motion to recommit.

Mr. Speaker, before I speak about the substance of the two bills under consideration in the rule before us today, I do want to take a minute to honor our colleague and the Rules Committee's ranking member, Louise Slaughter, who passed away unexpectedly last week.

I have known Ranking Member Slaughter since I first joined Congress in 2003. We spent countless hours debating every issue one can imagine in the Rules Committee upstairs, often long into the night.

When I joined the Rules Committee in 2013, Ranking Member Slaughter was then the ranking member, but it was under her chairmanship where she ushered through the Affordable Care Act, where my largest memories reside. During the debate for the Affordable Care Act, I went up to H- 313, the Rules Committee hearing room, with 18 amendments under my arm, a small selection of the many ways I felt the law needed to be changed.

Certain that I would only be able to get through a small portion of those amendments before I was cut off, I began my testimony. To the chairwoman's credit, she let me go on and on and on, and despite my being convinced that she was going to gavel me down at any second, she allowed me to finish speaking on all 18 amendments.

Mr. Speaker, it wasn't until I actually became a member of the Rules Committee several years later that I discovered there is, in fact, no time limit for Members and witnesses to speak, much to the chagrin of many Members when we debate the National Defense Authorization Act.

Ranking Member Slaughter was always proud of her background as a microbiologist, and it served her well during her tenure in Congress, because, after all, we deal with, sometimes, almost miniscule, microscopic issues, so time as a microbiologist would be good preparation.

One moment where I was glad to be able to work with Ranking Member Slaughter was in 2007. This was right after the Democrats took control of the House. Ms. Slaughter had been pushing for years for legislation that would prohibit the discrimination of employees based on genetic information.

The legislation was forward leaning, long before companies offered DNA testing kits in every pharmacy of the country. And, in fact, it was former Speaker Newt Gingrich himself who brought this bill to my attention, the Genetic Information Nondiscrimination Act, which I was proud to support as it moved through the Energy and Commerce Committee and was eventually signed into law by President Bush.

I would also like to mention Don Sisson, the staff director for the minority on the Rules Committee. Don has been with the committee for years--even at one point working under Chairman Drier--and has been with the ranking member of the Rules Committee through many events in the past years, including the death of her own husband, who, in fact, often sat in the audience of the Rules Committee and joined Ms. Slaughter during our late-night Rules hearings.

Don is, indeed, a loyal staffer, himself hailing from Rochester, New York, and is a great example of how Ms. Slaughter's life and passing is affecting so many people. I do want to thank Don for his written remarks that were read into the record of the Rules Committee last night from the staff perspective on the passing of Ranking Member Slaughter.

Mr. Speaker, at this point, I would like to hold off making further comments on the legislation before us to allow others to speak.

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

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

Madam Speaker, it was indeed incredibly disappointing last week when our Democratic colleagues did not join us in supporting what was very carefully crafted right-to-try legislation.

The President came and talked to us at the beginning of February, and right to try was one of the issues that he highlighted there from the podium. So it should be to no one's great surprise that this House would indeed take up and work on that issue that the President himself highlighted. Right to try was the one piece of legislation that President Trump specifically promised to the American people in the State of the Union address.

Today, I want it to be known that I stand with the President. I stand with the thousands of Americans with terminal diseases and their families and their friends in getting this important bill passed.

Since 2014, 37 States, including my home State of Texas, have passed a version of a right-to-try law, and through a strong grassroots movement, they have accomplished that.

Today, the House is considering H.R. 5247, the Right to Try Act of 2018, which would improve access to experimental treatments for terminally ill patients and offer them a chance--a second chance, a third chance--at life.

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

Regardless of these achievements, I hear from patients with serious life-threatening conditions, including my constituents from north Texas, who are frustrated with what they see as regulatory barriers from trying and experimenting with new therapies when every other avenue has failed.

It does seem we are at a crossroads when lifesaving treatments, while not yet approved, both exist and remain unavailable to patients.

As a physician, I understand that access to investigational drugs and therapies is a deeply personal priority for those seeking treatment for themselves or loved ones with a serious and life-threatening condition.

It is crucial to mention the multistakeholder efforts that have gone into improving the original right-to-try bill. Chairman Walden of the Energy and Commerce Committee led negotiations with the Commissioner of the United States Food and Drug Administration, Dr. Scott Gottlieb, and with other stakeholders to ensure that this legislation opens the door to innovative experimental drugs for these patients without necessarily compromising the vital work and the mission of the Food and Drug Administration. The product of those negotiations is a bill that strikes the proper balance between ensuring patient safety and granting access to these treatments.

I also want to mention that the Subcommittee on Health did have a hearing in this regard October 3. We heard from the Commissioner of the Food and Drug Administration during that hearing. We heard from a number of patient groups and stakeholders who felt that it was, in fact, in their best interest for us to advance legislation.

Currently, the Food and Drug Administration conducts an expanded access program aimed at helping patients who do not qualify for clinical trials to gain access to therapies that the agency has yet to approve. While this program makes a good faith effort to help those patients, right to try would create an alternative pathway for those individuals, allowing them to access eligible investigational drugs.

The fact is that individuals may not qualify for a clinical trial if they do not meet very specific patient inclusion criteria, which may include factors such as age, gender, type and stage of 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 where those academic clinical trial sites exist.

Most, if not all, of the patients with a terminal medical condition fall into one of these categories. This legislation allows those patients to participate in the alternative pathway 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 worked closely with the Food and Drug Administration to ensure that the new alternative pathway does not hinder or conflict with the critically important oversight that that agency conducts. While some people may have reservations about the safety of a new pathway, 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. This alternative pathway would also be limited to individuals who have exhausted all FDA-approved treatment options.

Additionally, only certain investigational drugs are considered eligible under this legislation. In order to qualify, the drug must have completed a

phase one clinical trial, must have an active application, must be under active development or production by the manufacturer, and must not be the subject of a clinical hold.

Eligible patients include those suffering from a stage of a disease or condition for which there is reasonable likelihood that death will occur in a matter of months or that would result in significant irreversible morbidity that is likely to lead to premature death.

This revised right-to-try bill also provides certainty to manufacturers in the drug approval process. It is essential that we do not create additional hurdles in that process. The legislation 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.''

Since the Health Subcommittee first considered the right-to-try legislation, the bill has passed in the Senate, and we have had many conversations with patients, advocates, the administration, and stakeholders on all sides of this complex topic. That collaborative effort was necessary, and I am certainly grateful to all who participated in those discussions.

Madam Speaker, this represents months of hard work and thoughtful discussions and decisions. I believe this legislation is a positive step forward in our shared goal of improving care for American patients. Again, this was the one aspect of the President's State of the Union Address where he asked us specifically to act on this legislation.

For these reasons, I urge my colleagues to support the rule and the underlying bill.

Madam Speaker, I reserve the balance of my time.

Madam Speaker, I yield 3 minutes to the gentleman from Washington (Mr. Newhouse), who is a fellow member of the Rules Committee.

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

Mr. Speaker, I include in the Record an article from The Dallas Morning News from 2010. The title of the article--and I am not going to read the whole thing--is: ``Pelosi Pulled Strings to Let Dying Dallas Lawyer Try Experimental Cancer Drug.''

[From the Dallas Morning News, 2010]

Pelosi Pulled Strings To Let Dying Dallas Lawyer Baron Try Experimental

Cancer Drug

(By Todd J. Gilman)

Washington.--Dallas' top Democratic donors will cut big

checks to share dinner later this month with House Speaker

Nancy Pelosi. Most will be motivated by a desire to protect

the party's congressional majority.

Lisa Blue will have an extra reason: to say thanks for

Pelosi's efforts when her husband, Fred Baron, was dying of

bone marrow cancer. His only option was an experimental drug

whose manufacturer refused to give permission to use it for

Baron's condition.

``He was a big fan of hers, and now I am as well,'' Blue

said.

Baron, the ``King of Toxic Torts,'' built a fortune suing

on behalf of asbestos victims. He died the week before

Election Day 2008 at age 61.

A prolific Democratic fundraiser, he served as finance

chief that year for his friend John Edwards, who also made

his fortune in court. Baron later acknowledged funneling

large sums to Edwards' mistress--a scandal that gave

ammunition to those who already despised trial lawyers.

But to Blue, first and foremost, Baron was a husband.

The tale she tells of his final weeks is not so different

than any widow might tell, except, of course, that the couple

had friends in especially high places--friends like Pelosi,

who will headline the Aug. 24 dinner to raise cash for the

Democratic Congressional Campaign Committee.

In 2002, Baron was diagnosed with multiple myeloma. By

October 2008, his doctors at the Mayo Clinic were telling him

he had just days to live.

They also offered a glimmer of hope. Over the years, the

couple had donated about $1 million to Mayo. The staff was

especially diligent, Blue said. They tested an arsenal of

drugs and finally discovered that Baron's cancer responded

surprisingly well, in the lab, to a drug called Tysabri.

Mayo had an ample supply, but the drug was--and still is--

approved only for treatment of multiple sclerosis and Crohn's

disease. The manufacturer, Biogen Idec, refused to give

permission, even under special ``compassionate use'' rules

that protect a drug-maker from a black mark in case of an

adverse outcome.

Biogen said it didn't want to jeopardize the drug's

availability to other patients. (The company did not respond

to a request for comment last week.)

``I told Mayo, `I'll sign anything, I'll release anything.

Just give him the drug,' '' Blue said.

Blue, also a top lawyer, began making calls. She started

with Lance Armstrong, the bicyclist and cancer survivor, whom

she had represented.

``I started going through Fred's Rolodex,'' she said. ``I

called every politician, every celebrity that I knew and just

begged them to help. . . . I must have made 200 calls.''

She called clinics in Canada, trying in vain to find

doctors willing to administer the drug without Biogen's OK.

She hired a lawyer and prepared to sue Mayo to force it to

dispense the drug. She even bought some Tysabri online from

Australia, intending to send stepson Andrew Baron to smuggle

it back, she said.

The younger Baron posted an open plea online to Biogen,

noting that Bill Clinton, Sens. John Kerry and Edward Kennedy

of Massachusetts, Sen. Tom Harkin of Iowa and even the head

of the Food and Drug Administration had urged the company to

reconsider.

``You talk about mental anguish,'' Blue recounted. ``Fred,

every day, would wake up and he said, `Am I going to get the

drug?' ''

Others were supportive, she said, but Pelosi ``put her

heart and soul'' into the cause, as did Harkin.

Somehow--Blue still isn't sure how--Pelosi cajoled the FDA

to find a legal justification that let Mayo administer the

drug, even without Biogen's consent.

``Nancy figured out a way,'' she said.

The drug beat back the cancer for a few days, but not

enough.

Blue has no illusion that a typical family could pull such

strings.

``There are so many cases like Fred's,'' she said. ``One

thing he taught me was politics matters. What a personal

experience for me to understand how politics matters.''

And no, she added, ``It's not fair that other people can't

pick up the phone and make the government give them a drug. .

. . It was just such an awakening about how the drug

companies have so much power.''

That's what she'll tell Pelosi over dinner.

Mr. Speaker, this article references events that occurred in 2008.

In 2002, this individual was diagnosed with multiple myeloma. By October of 2008, his doctors were telling him that

he had just days to live. They also offered a glimmer of hope. There was perhaps one chance of therapy. It was an unproven therapy that might, in fact, be helpful to him.

The family made inquiries, made entreaties, but they were not successful until they invoked the then-Speaker of the House, Nancy Pelosi, who actually helped this lawyer get access to this medication. Unfortunately, it was not successful. His disease spread to a point where the therapy was not helpful. But the family observed, ``Nancy figured out a way.''

How about that. The Speaker of the House figured out a way to get this medication to an individual who was dying of a disease, who obviously was very important--a large Democratic donor, and I get that.

But the Speaker of the House intervened because the clinic where he was being treated felt that they did not have the authority to give him the medication. The company that was manufacturing the medication did not feel that it was in anyone's best interest to give him the medication. But Nancy found a way.

Well, Mr. Speaker, today, we are going to find a way. The President asked us, and we are going to find a way for those millions of Americans who are asking for that same chance.

So today's rule provides for consideration of two important consumer- driven pieces of legislation:

H.R. 4566, by Mr. Poliquin, will help alleviate some of the regulations that were put in place under the Dodd-Frank Act.

H.R. 5247, the right-to-try bill which garnered a majority of bipartisan support last week, will give patients who have nowhere else to turn another option to fight the potentially fatal health conditions with which they have been diagnosed.

I do want to thank President Trump and Vice President Pence for their leadership on this issue and helping us understand here in this body how important it is to move forward with this patient-centered legislation.

I urge my colleagues to support today's rule and the two 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 yield myself such time as I may consume.

Mr. Speaker, I thank the gentleman from Texas (Mr. Burgess), my friend, for yielding me the customary 30 minutes for debate.

Mr. Speaker, like my friend from Texas, I was overcome with sadness by the tragic news of Louise's passing, who was not only the ranking member of the Rules Committee, but the first and only woman to have chaired the committee.

For 30 years, Louise poured every ounce of energy she had into serving her constituents in upstate New York. She never hesitated to speak her mind, and she never wavered in espousing her beliefs. I will always be truly grateful for the time that I had to serve alongside her.

Louise was one of my dearest friends in Congress, having not only served with her on the Rules Committee but also on the Commission on Security and Cooperation in Europe, the Helsinki Commission.

Her legacy speaks for itself. She was not just a champion of women's rights. She was a champion of working families everywhere. This Nation has lost one of our fiercest public servants, and her absence will leave an unfillable void.

Mr. Speaker, I offer my deepest condolences to Louise's daughters: Megan Secatore, Amy Slaughter, and Emily Minerva; her seven grandchildren and one great-grandson; as well as to her friends, constituents, and congressional staff during this extremely difficult time. Her spirit and loving memory will forever live in the Halls of Congress. She will be dearly missed.

Mr. Speaker, turning to today's rules, this rule brings the number of closed rules for the 115th Congress to 74. In other words, more than 50 percent of the legislation coming to the Rules Committee has been closed off from an open and honest debate by my Republican friends.

At the beginning of this Congress, we were told by my Republican colleagues that they would run the government in an open manner. They even championed regular order. Well, that spirit has clearly been jettisoned in favor of an overly partisan approach to governing.

By way of example, one of today's bills, H.R. 5247, was introduced last Tuesday, brought to the House floor for a vote on the same day without the committee of jurisdiction holding one single hearing on the bill or Members having the opportunity to offer their amendments.

Not surprisingly, the measure failed to pass under suspension of the rules.

What was the response of my friends on the other side of the aisle when the vote failed? Did my Republican colleagues insist that the Energy and Commerce Committee hold hearings on the measure? Did my Republican colleagues on the committee of jurisdiction invite experts to speak on what the consequences would be if this bill were to become law? Did my Republican colleagues work with Democrats to come up with a bipartisan solution? No.

Madam Speaker, let me tell you what did happen. The Republican leadership ignored the problems with the measure and brought it to the Rules Committee last night for it to be considered on the House floor today.

Now, this flies in the face of regular order, to ask the entire membership of the people's House to vote on something for which no one can honestly say they know what the unintended consequences would be if this bill were to become law.

Bad process makes bad bills, and the process we have witnessed with this bill can't get much worse. Yet it did get worse when the Republican majority blocked the ranking member's, Mr. Pallone's, substitute amendment, an amendment which was both germane and had bipartisan support.

Madam Speaker, the Republican majority took it a step further when they extended the Holman rule for the remainder of the 115th Congress. My friends on the other side of the aisle are yet again seeking to scapegoat Federal employees, make cuts to the Federal workforce, and politicize the civil service system that was established to professionalize agencies and offices, all while ignoring the waste and abuses in the reality show of the Trump administration.

Madam Speaker, challenged by the American people to bring up comprehensive gun reform, House leadership instead brings up one bill that hasn't gone through anything resembling regular order and another bill that weakens and undermines a valuable tool that gives financial companies and regulators an opportunity to identify and correct problems before they could lead to another financial crisis.

Every year, roughly 35,000 people are killed by guns. Moreover, 2,700 children and teens are shot and killed, and over 14,000 more are shot and injured every year. That is an average of 47 American children and teens shot every day.

And the effects of gun violence extend far beyond those struck by a bullet. Gun violence shapes the lives of the millions of children who witness it, know someone who was shot, or live in fear of the next shooting. We have witnessed the effects over the last month with the students from Marjory Stoneman Douglas High School.

This weekend, hundreds of thousands of students and their supporters will descend on Washington, D.C., to demand that the Federal Government take action to stop the epidemic of mass shootings, which have become all too familiar.

No less than this morning when I turned on the television, less than an hour and a half away from here, in yet another school, yet another shooting. Fortunately, it appears that the resource officer there engaged the shooter early on and may have caused there to be less damage, although some people were injured, and one or two critically.

We can no longer ignore what gun violence really is in this country. It is an epidemic.

But do not just take my word for it or the students who witnessed 14 friends' and 3 teachers' lives brutally cut short. The American Medical Association, following the tragedy at the Pulse nightclub in Orlando, declared gun violence in this country ``a very public health crisis,'' a crisis which the Republican majority's only answer is to offer thoughts and prayers and further block any Democratic measures to address this crisis and to continue to block the Centers for Disease Control and Prevention from even researching gun violence.

Instead of finally making permanent the status of Dreamers in this country as full citizens, the Republican majority ignores their calls and the calls of the vast majority of Americans and, instead, brings up one bill that undermines a valuable early warning system of our Nation's economy and another bill that has gone through a completely closed process.

Enough is enough. President Donald John Trump says he wants to fix this problem. The Speaker says he wants to fix this problem. We on this side of the aisle clearly want to fix this problem. So let's do it already.

Madam Speaker, last week, when I was managing yet another useless financial regulation, I commented and I asked the American public to respond:

Would you rather us stop banks from having stress tests or would you prefer that we deal with the deferred action for children in this country, 800,000 of whom are Dreamers, 120 of whom lose their status every day?

Would you prefer that we deal with the measure that is on the floor today or that we deal seriously with a variety of issues having to do with gun violence in our society, which I have described as an epidemic?

Would you prefer as a priority, America, that we deal with these trivial matters that are going nowhere fast or that we center ourselves and focus on those measures that are vital to the survival, security, and safety of all Americans?

Madam Speaker, I reserve the balance of my time.

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

Madam Speaker, last night in the Rules Committee, I had dialogue with the author of this legislation and also the ranking member, Mr. Pallone. I indicated to them that I have very strong sympathies regarding persons who are in the apparent throes of death and seeking some hope, and medication can have its advantages, and experimental medication can have its advantages.

My quarrel with the legislation is that it didn't go through regular order. I don't understand why, with all of the experts. I introduced into the Record in the Rules Committee last night a substantial number of organizations and individuals who have come forward. They all agree that something along the lines of what is being sought ought be undertaken, but it would allow for those persons to have added input into what ultimately may be significant legislation. But my friends on the other side plow right ahead on this matter that I reiterate was brought on suspension last week that failed, and then brought here last night for purposes of a rule along with financial stress legislation.

So it is not that many of us are not sympathetic to the underlying principle that is being offered. It is that it is rank process and that we should not allow legislation to continue to come to the floor of the House of Representatives that blocks out a significant number of persons who may have input that would make the measure be much more salient to a more significant number of people.

It is for that reason that I continue to ask the questions: What are our priorities here? What is the rush with reference to this matter while we are ignoring a significant number of other matters that we could be undertaking?

In addition to that, we were supposed to go to the Rules Committee this afternoon on the omnibus bill; and now, evidently, there is wrangling going on between the parties and bicameral between the Senate and the House, and that measure isn't ready to come to the floor.

Yet we are dealing with something that isn't the highest priority of the moment. I commented last night, anything that will help a person who is facing death is the kind of thing that we would want that person to have that opportunity to deal with. But we have children who have been killed and we have children who are facing the potential for that kind of horror, yet we are doing nothing.

So, Madam Speaker, once again, I rise to appeal to my friends on the other side of the aisle: Please, listen to the American people and do more to help end the epidemic of gun violence that has plagued our Nation and that the American people are demanding Congress to do more.

For example, in a recent Gallup Poll, nearly two-thirds of adults wanted stricter laws on the sale of firearms. According to a recent NPR/Ipsos poll, 75 percent of respondents said they think gun laws should be stricter.

As I indicated earlier, just this morning there were reports of another school shooting just an hour and a half from Washington, D.C., in Great Mills, Maryland. The American people are begging this body to do something to end this epidemic, so I offer the majority this opportunity:

Madam Speaker, if we defeat the previous question, I am going to offer an amendment to the rule to bring up four commonsense gun safety bills: H.R. 4240, the Public Safety and Second Amendment Rights Protection Act; H.R. 3464, the Background Check Completion Act; H.R. 2598, the Gun Violence Restraining Order Act; and H.R. 1478, the Gun Violence Research Act.

These bills would close the dangerous gun show and internet sale background check loopholes, prevent the sale of guns without a completed background check, ensure that people who are a danger to themselves or others can be prevented from possessing a gun, and lift the prohibition on government-sponsored scientific research on the causes of gun violence.

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 urge my colleagues to defeat the previous question so that we can finally do something to address gun violence.

Through you, Madam Speaker, I would advise my friend from Texas that I have no further speakers and I am prepared to close when he is prepared to close.

Madam Speaker, I reserve the balance of my time.

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

I would say to my friend from Washington what I said last night: We would do a great service to Louise's memory if we were to make more open rules here on the House floor; and I will argue for her in that regard.

Madam Speaker, before I close, I want to again reiterate the tremendous loss felt in this Chamber with the passing of our longtime colleague, Congresswoman Louise McIntosh Slaughter. She was a champion of all the issues she cared about and a giant here in the House of Representatives. Her wisdom will be missed every day.

Madam Speaker, the people's House should be approaching our work in a manner that is fair to all Americans, in a manner where the appropriate committee of jurisdiction holds hearings and markups, in a manner where experts in the field are consulted, and in a manner where Members of both parties have the opportunity to offer amendments and debate the contents of the bill.

The process we are witnessing here today is truly a slap in the face to regular order. A bill that has zero input from members on the Energy and Commerce Committee or that has been the subject of any thoughtful discussion is suddenly on the House floor for a vote.

Now, I respect my friend from Texas' view that last year in the Senate, and even perhaps since that time, and throughout the country, right-to-try measures have passed in several States to some degree. But this particular bill that is on the floor that we are making a rule for has not gone through regular order; and that, then, disallows a significant number of persons who would have an opportunity to have input to what could be legislation that all sides could agree upon. Our failure to undertake to do that is a disservice, in my view, to the institution and to the measure that is being sought to be passed here today.

This is not just an affront to normal House procedure; it is downright undemocratic and emblematic of the Republican majority's inability to govern. I think it will redound to their discredit that they are not allowing this House to proceed under regular order.

As I indicated earlier, more than 50 percent of all of the measures that have come to the Rules Committee and have ultimately come to the floor of the House of Representatives have been under closed rules, which means that Members who represent millions of people in America do not have opportunities to offer amendments that might make the measure better or, at the very least, have their views heard with reference to substantive legislation that is moving through this body.

If we continue down this path for the remainder of this session, we will probably break the 100th barrier on closed rules. We have already had more closed rules than in the history of legislating in this country.

That is not fair. That is basically all we are arguing. Open up the process. Let every Member have an opportunity for input on behalf of his or her constituents. It is the right thing to do. What has been happening is the dead wrong thing to do.

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, pursuant to House Resolution 787, I call up the bill (H.R. 4566) to amend the Dodd-Frank Wall Street Reform and Consumer Protection Act to provide relief to nonbanks from certain stress test requirements under such Act, and ask for its immediate consideration in the House.

Mr. Speaker, I ask unanimous consent that all Members have 5 legislative days to revise and extend their remarks and to include extraneous material on the bill under consideration.

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

Mr. Speaker, I rise today in support of H.R. 4566, the Alleviating Stress Test Burdens to Help Investors Act.

Mr. Speaker, I especially want to thank the gentleman from Maine (Mr. Poliquin), one of the most hardworking, enthusiastic, cheerful members of the House Financial Services Committee for all the work that he has done to advance this very strong piece of bipartisan legislation, which, incidentally, passed the Financial Services Committee again with another strong bipartisan vote of 47-8.

Now, the financial crisis led to questions, both domestically and internationally, about how to address financial stability and create a regulatory framework to mitigate systemic risk, all the while ensuring robust economic growth.

At the heart of this bill of the gentleman from Maine is a recognition that our economy can suffer when we get it wrong, when government attempts to dictate the business models and operational objectives of so many of our businesses. It is also a recognition that one-size-fits-all regulations can stifle economic growth and ultimately harm consumers and harm our constituents.

Current bank-centric standards and assessments to nonbank industries, such as the asset management industry, have needlessly saddled Main Street investors with increased costs while they are trying to save for college or retirement or some other important need, and this is perhaps no clearer than in this stress testing regime.

As a former SEC chief economist observed in 2016, who said that, in the current law, ``stress test the big banks; and, oh, you might as well go ahead and do the asset management companies.'' That is his take of what the law says.

In other words, asset management firms that, again, our constituents depend upon for their retirement security or for their financial planning are now subject to bank regulations simply because they operate under the financial services umbrella, even though such firms plainly have legal, structural, and operational characteristics that make them very, very different from banks.

By the way, none of the asset managers had anything to do with the financial crisis that brought about the legislation that we are debating in the first place. For example, unlike banks, asset managers do not have access to the deposit insurance fund or the Fed's discount window.

If that is not enough for you, Mr. Speaker, here is more. Asset managers are legally separated--legally separated from the funds they manage, meaning that the asset and liabilities of the manager are distinct from the assets and liabilities of the funds.

On the other hand, the bank business model directly subjects the bank to the risks and obligations of its assets and liabilities. Again, applying a one-size-fits-all regulatory structure--in this case, a bank-centric model--is not only bad for the asset management industry, but, far more importantly, for our constituents that they serve, who choose to save and invest.

Registered funds are the investment vehicle choices for millions of Americans seeking to buy a home, pay for college, plan for financial security and retirement. Application of unnecessary, ill-suited, bank- centric stress testing requirements to register funds

and advisers will undoubtedly increase cost for these funds and advisers, and, ultimately, this gets passed on to investors without any corresponding benefits that we can discern.

The recent asset management and insurance report issued by the Department of Treasury confirms these concerns. The bill of the gentleman from Maine (Mr. Poliquin) would fix this unequal regulatory structure by exempting certain nonbank financial institutions that have not been designated for supervision by the Federal Reserve Board from the act's stress testing requirement.

Further, in the true spirit of bipartisanship, I want to thank the gentlewoman from New York (Mrs. Carolyn B. Maloney) for recognizing the underlying need for this relief and for working with Mr. Poliquin to offer an amendment during markup that allows the SEC and the CFTC to issue regulations to require certain financial companies they supervise to conduct periodic analysis of the financial condition of such companies under adverse economic conditions.

The approach is common sense. It is not one size fits all. It recognizes that the primary regulator of nonbank financial companies is better suited than a bank regulator to determine whether these stress tests might be useful to address risk. And it recognizes that, as a general matter, stress testing asset managers is difficult and often needless.

Mr. Speaker, I urge all of my colleagues to support this great bipartisan legislation. I believe we have an amendment forthcoming from the ranking member, which I expect our side of the aisle to support. I am led to believe that, with the adoption of her amendment, she would support the underlying bill. I hope that proves to come to fruition, in which case we can have a very strong bipartisan vote on this bill.

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

Mr. Speaker, I yield 6 minutes to the gentleman from Maine (Mr. Poliquin), who is the sponsor of this legislation.

Mr. Speaker, I yield 3 minutes to the gentleman from North Carolina (Mr. McHenry), who is the vice chairman of our Financial Services Committee and the chief deputy majority whip.

Mr. Speaker, I am just amazed that anybody from North Carolina, after being beaten by Texas A&M by 21 points, would make any allusion to basketball whatsoever. I trust our next speaker will not make that mistake.

Mr. Speaker, I yield 3 minutes to the gentleman from Missouri (Mr. Luetkemeyer), who is the chairman of the Financial Services Subcommittee on Financial Institutions and Consumer Credit.

Mr. Speaker, I yield 3 minutes to the gentleman from Illinois (Mr. Hultgren), who is the vice chairman of the Financial Services Subcommittee on Capital Markets, Securities, and Investments.

Mr. Speaker, I yield 3 minutes to the gentleman from Texas (Mr. Williams), who is the vice chairman of the Financial Services Subcommittee on Monetary Policy and Trade.

Mr. Speaker, I yield 3 minutes to the gentleman from Tennessee (Mr. Kustoff), who is a hardworking member of the Financial Services Committee.

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

Mr. Speaker, once again, I want to encourage all of my colleagues to support H.R. 4566, the legislation from the gentleman from Maine. I want to commend him once again. He is one of our most hardworking members on the committee, and he cares passionately about his constituents in Maine.

I also want to commend him for once again working on a very bipartisan basis. He has managed to change his bill from its original concept many times to try to garner more support from the other side of the aisle.

With the acceptance of the ranking member's amendment, again, I am hopeful that we will have a very, very strong vote in the House. Again, this came out of committee with a very strong bipartisan vote of 47-8.

Mr. Speaker, very often we debate regulation. I think that now, fortunately, we have a 3 percent growth Tax Code which has been passed by Congress, but, unfortunately, I do not believe we have a 3 percent growth of finance in the banking system.

That is important. It is important to our constituents who still need credit to buy that first home, a factory worker who needs to get their transmission repaired so that they can go to work, some parent trying to send a kid to college, or people trying to plan for their retirement.

Too often, I think we have a dichotomy between regulation and deregulation, when the real dichotomy is between smart regulation and dumb regulation. It is always incumbent upon us in Congress to look very carefully at these regulations. Sometimes they look very good on the chalkboard, but in reality, they don't quite render the results or benefits that we had hoped for. So we always have to take a look at what this is doing not just to consumer and investor protection, but what it is doing to economic growth as well.

I agree with the ranking member. Stress testing is a good concept. It is one of the reasons why banks and other financial firms typically stress-test themselves daily, weekly, monthly, annually.

What doesn't make sense, though, is that there be no recognition to the cost that it imposes, as the gentleman from Missouri, the chairman of our Financial Institutions and Consumer Credit Subcommittee, was very articulate in reminding us that these submissions can cost us millions and millions of dollars. The reports are not measured in pages; they are measured by the pound. There can be 10- and 20-pound submissions of paper that we wonder if anybody ever reads.

But what especially doesn't make sense is trying to apply a bank stress test to a nonbank financial institution, particularly an asset manager. I know the ranking member was talking a little bit earlier about using an analogy to auto inspections: It makes no sense to have the home inspectors inspect your auto; it makes no sense to have the auto inspectors inspect your home.

The gentleman from Maine is ensuring that whatever stress test is applied, it is applied properly to the business model that needs to be tested for its potential stress of our financial system.

So, again, I just want to commend the gentleman from Maine for his hard work, and I urge all Members to vote in favor of H.R. 4566 because, indeed,

maybe it is not a catchy title, but it is an accurate title. As we alleviate stress test burdens, we do help investors.

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

Mr. Speaker, I ask unanimous consent to claim the time in opposition to the amendment, although I am not opposed.

Mr. Speaker, I am not thrilled with the amendment, but in the spirit of compromise and the spirit of bipartisanship, we have worked with the ranking member and the sponsor of the legislation. It wouldn't be my preferred approach, but that is often what we do around here.

I want to thank the ranking member for working with the majority side in order to advance this, again, as a very strong bipartisan vote in the House, which I hope and anticipate with the inclusion of this amendment.

I would point out, Mr. Speaker, again, I am very happy. On the other side of the Capitol, they have recently advanced a number of kind of smart regulatory measures and capital formation measures. We look forward to negotiating with our friends in the Senate. I am hoping that an overwhelming vote on a bill like H.R. 4566 is one that could be in a final package before it goes to the President's desk.

Again, I still think that, although we have all compromised a little something here, I think we all advance our principles. I think it is something that will help, actually, both financial stability and investor protection, including protecting their opportunities to have a better future.

So again, I want to thank the ranking member for working with us, and I would urge the House to adopt her amendment and adopt H.R. 4566 by Mr. Poliquin of Maine.

Mr. Speaker, I yield to the gentleman from Maine (Mr. Poliquin).

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

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.