Madam President, I ask unanimous consent that the pending amended be set aside so that I may call up amendment No. 2125. Madam President, I ask unanimous consent that that amendment be set aside so I may call up my amendment No. 2141.…
Madam President, I ask unanimous consent that the pending amended be set aside so that I may call up amendment No. 2125.
Madam President, I ask unanimous consent that that amendment be set aside so I may call up my amendment No. 2141.
Madam President, I rise to discuss the FDA Safety and Innovation Act, the bill now under consideration here in the Senate.
I applaud Chairman Harkin and Ranking Member Enzi for their leadership in moving this critical legislation through the HELP committee, and now to the Senate floor.
As an agency of the Department of Health and Human Services, the FDA has as part of its broad mission to protect Americans' health by assuring the safety of drugs, biologics, medical devices, our Nation's food supply, vaccines, tobacco, cosmetics, and animal food and drugs. Every single day, every single American depends on the vital work of FDA's employees.
There is a second key element to the FDA's work--helping to speed innovations to the marketplace through the drug, biologic, and medical device approval process. It's that component of the FDA's mission that we are addressing this week--reauthorizing the user fees that help fund the approval process.
I'm proud of the FDA's workers--the majority of the agency's more than 11,000 employees are based at its headquarters in Silver Spring, MD. It's
there that the process of medical innovation, which begins at NIH with basic research, is completed as lifesaving drugs and medical devices are approved for use.
A recent report from the IMS Institute for Healthcare Informatics found that in 2011 ``medicines with new mechanisms of action were launched in greater numbers than in prior years, with many representing significant breakthroughs and first-time therapies became available to treat several types of cancer, multiple sclerosis, hepatitis C, and cardiovascular conditions.''
At the same time, we know that greater resources are needed for the agency to be able to fulfill its mission in a timely and effective manner. For all of our Nation's investment in health care research, additional new medicines will not reach patients promptly unless the FDA has the necessary funds to perform its regulatory duties.
That's why the user fee amendments are so important. This 5-year reauthorization bill is Congress' opportunity to improve and update the regulatory process, and augment appropriations so that the agency can achieve its goals.
The purpose of the user fee program is to reduce the time in which FDA can review and make decisions on marketing applications. Lengthy review times affect drug and medical device manufacturers, who face delays in bringing their products to market, and more importantly they affect patients, who face delays in receiving needed treatments and cures.
The bill reported out of committee will move us forward. It will reauthorize the prescription drug user fee program, PDUFA, through October 1, 2017.
This is necessary so that the Federal Goverment can continue to collect application, establishment, and product fees from drug companies to support the review process for the next five years.
It will also reauthorize the medical device user fee program, MDUFA, through 2017 as well, and in an effort to ensure that the FDA's personnel needs are met, it would authorize a streamlined hiring of employees. Additionally, the Critical Path Public-Private partnerships, which are so important in encouraging medical product innovation, are reauthorized through 2017.
Two new user fee programs are established in the bill for generics and one for biosimilars. It's estimated that the monies generated from the generic user fee program will enable the FDA approval time for generics to be shortened from the current time frame of 30 months to 10, speeding savings to patients and to all taxpayers, as Medicare, Medicaid, and CHIP programs will reap considerable cost savings.
The base bill takes key first steps toward resolving the vexing issue of drug shortages. I want to acknowledge Senator Klobuchar's work in this area.
All of us have heard from our community hospitals and physicians about the anguish they feel when they cannot secure medicines necessary to treat the patients in their care. I certainly have, and I have also heard from patients themselves who cannot fathom how such shortages could occur.
Carey Fitzmaurice of Bethesda, who is undergoing treatment for ovarian cancer, wrote to me:
My doctor put me on Doxil and carboplatin to try to get rid
of some tumors. Doxil was chosen because of recent research
showing that it works especially well in those patients with
the BRCA gene, like me.
I had four treatments with both drugs and was responding
very, very well. I have now missed three doses of Doxil due
to the shortage. I am ``treading water'' with the Carbo but
am frustrated that I am no longer making progress towards
remission. Then there is all of the stress involved with the
shortage--not knowing if there is anything I can do, or what
will happen next or how long I will be in treatment.
I am trying to continue to be a wife and mother and to hold
down a job. This shortage is adding insult to injury. I
wonder why we are being asked to raise money to find cures
when we can't even get access to the cures that exist now.
Carey is one reason why I am a cosponsor of Senator Klobuchar's bipartisan bill, the Preserving Access to Life Saving Medications Act, and I am pleased that the bill's early notification requirement provisions are included in the PDUFA bill we are considering today. It also requires the Secretary to establish a task force and create a strategic plan to address shortages.
This is also an urgent matter because shortages affect the ability to conduct clinical trials. Senator Rockefeller and I worked together some years ago to get Medicare beneficiaries coverage for the routine costs associated with clinical trials.
As a result of Senator Brown's work on the Affordable Care Act, insurance companies now must also cover the routine costs of trials. Access to trials often means the difference between life and death for cancer patients, and the availability of trials has enormous implications for the effectiveness of treatments for all patients going forward. There are more than 150 cancer clinical trials being conducted now at the NIH Clinical Center in Bethesda.
But the impact of shortages on clinical trials has not received a great deal of attention outside the research world. It is an extremely important issue for Medicare beneficiaries, who have the highest rates of cancer incidence. Cancer trials do not usually use placebos.
Rather, they compare standard of care drugs, versus, or in combination with, the experimental drug.
Doctors face difficult choices when the standard of care drug is in short supply. They must decide whether to use the limited supply of an existing drug to treat new patients, or use it in clinical trials to help find a cure for those who are seeking new therapies. Cancer trials have been delayed, limited the number of patients enrolled in the trial or stopped the trial entirely because there is simply not enough of the standard of care drug.
So I am pleased that the bill contains language requiring the Secretary's strategic plan to considering the impact of drug shortages on research and clinical trials.
The Finance Committee held hearings on drug shortages earlier this year as well, and we learned that the majority of shortages are found in the generic drug market. Some are due to a lack of raw materials, while others occur because the drugs yield lower profits than newer generics, and the interest in continuing to market those drugs is no longer there.
The notification language in this bill is a good start, but I believe it should be strengthened to better ensure compliance, and so I have cosponsored Senator Blumenthal's amendment establishing civil monetary penalties for manufacturers who knowingly fail to notify the FDA of shortages for essential medicines.
I express my appreciation to Senator Pryor for his leadership on nanotechnology. I am pleased to join him in this effort and am hopeful that the language we have sponsored can be included in this bill.
Nanotechnology has become increasingly indispensible in our daily lives--everything from cellphones and MP3 players, to packaging of our snack foods, to cancer treatments in development employ the use of nanotechnology.
As this burgeoning technology continues to power more of our consumer products and drive job creation in America, it is essential that we fully assess, understand, and address any risks that it may pose to safety, public health and our environment.
By soundly assessing the safety of nanotechnology and developing best practices, the Nanotechnology Regulatory Science Act of 2011 will further job creation, public safety and growth in the industry.
Our bill would establish a program within the FDA to assess the health and safety implications of using nanotechnology in everyday products, and develop best practices for companies using nanotechnology. This new program would bring more highly-skilled research jobs to Maryland.
FDA's laboratories and research facilities at its consolidated headquarters are ideally suited to conduct the scientific studies required under the bill.
The USDA's Beltsville Agricultural Research Center, BARC, is similarly equipped to provide innovative scientific technology, training, methods development, and technical expertise to improve public health.
Lastly, I urge my colleagues to support language addressing the lack of available information on the benefits and adverse effects of drugs and medical devices for minority populations.
Today, warnings and safety precautions are included as part of the initial approval by the FDA. The Agency
may also require them post approval--after the drug has been approved and sold for months or years. We know that additional side effects or risks may become known once a product is in the market and a much larger, diverse patient population is using it.
Ideally, a detailed conversation between physician and patient about the risks versus the potential benefit of taking a drug would always take place in a timely and informed manner. However, this is not always the case and is especially true if the warning is added after drug is initially prescribed and been on the market for an appreciable time period.
The randomized controlled trials used by the FDA when reviewing new drug applications, while the gold standard for examining efficacy, do not necessarily reflect the overall population for a variety of reasons.
For example, members of minority groups are generally underrepresented in clinical drug trials even though they are disproportionately affected by diseases such as diabetes, hypertension, colorectal, prostate and cervical cancer, stroke, congestive heart failure, acute coronary disease, and asthma.
We know that there are racial and ethnic differences in responses to pharmaceuticals, and they may not become known until the drug is in wide use, certainly beyond the constraints of a controlled clinical trial.
In today's world, post-approval surveys and studies are becoming more prevalent, and our ability to discern the effect of a drug over time on a variety of patient types is significantly improving. This information should be made available in a variety of ways to ensure that it reaches physicians, payors and patients, and I have filed an amendment that would greatly improve access to this information.
It would build on the current HHS ``Strategic Action Plan to Reduce Racial and Ethnic Health Disparities'' by directing the Secretary to develop a communications plan to ``address the best strategy for communicating safety alerts, changes to the label or labeling of drugs, including black box warnings, biological products or devices, health advisories, any information identifying particular subpopulations, and any other relevant information as determined appropriate to enhance communication, including varied means of electronic communication.''
This amendment has the support of the chairman and the ranking member, as well as the FDA and BIO, and I urge the Senate to adopt it.
Mr. President, PDUFA reauthorization is essential to furthering the Nation's health, bringing the medical innovations conceived by researchers and entrepreneurs into practice, and creating jobs. I look forward to working through the process to improve this bipartisan legislation.
Again, I thank and congratulate Senator Harkin and Senator Enzi for their incredible work in bringing forward this bill that is so important to the public health of our Nation. We are dealing with the safety of drugs, biologics, medical devices, our Nation's food supply, vaccines, cosmetics, and the list goes on and on. It is critically important that we have the proper authorization so that the FDA has the resources it needs to advance innovation into the marketplace, products that fall within the jurisdiction of the FDA.
We know that the basic research has gone on at NIH. To get products to market, it is important that the FDA have the resources in order to move the process forward. I am proud of the 11,000-member workforce headquartered in Silver Spring, MD, for the FDA. They work very hard. This reauthorization legislation of the user fees will give them the tools in order to get the job done. I am particularly impressed that this is a 5-year reauthorization bill that will give them predictability, which is needed in order to get the job done.
I applaud Senator Harkin and Senator Enzi. We don't see enough of these bills moving forward with the type of process our leaders have brought forward. They have resolved a lot of the issues, and we thank them for that. They have brought us a bill that enjoys broad bipartisan support and is in the best interest of our Nation. I am proud to support this legislation, and I thank them for the manner in which they have proceeded in committee and now on the floor.
Also, I point out that this bill deals with the drug shortage issues. I applaud the occupant of the chair, Senator Klobuchar, and her efforts in dealing with those issues. We need more effective notification of potential shortages so that we can take appropriate action to make sure the people of this Nation have an adequate supply of medicines.
Let me share with my colleagues a letter I received from Carey Fitzmaurice of Bethesda, MD, who is undergoing treatment for ovarian cancer. She wrote:
My doctor put me on Doxil and carboplatin to try to get rid
of some tumors. Doxil was chosen because of recent research
showing that it works especially well in those patients with
the BRCA gene, like me.
I had four treatments with both drugs and was responding
very, very well. I have now missed three doses of Doxil due
to the shortage. I am ``treading water'' with the Carbo but
am frustrated that I am no longer making progress towards
remission. Then there is all of the stress involved with the
shortage--not knowing if there is anything I can do, or what
will happen next, or how long I will be in treatment.
I am trying to continue to be a wife and mother and to hold
down a job. This shortage is adding insult to injury. I
wonder why we are being asked to raise money to find cures
when we can't even get access to the cures that exist now.
That is a frustration that is out there on drug shortages. I am very pleased that this legislation will move us in the right direction in answering that question.
It doesn't only affect those under active treatment, it also affects a number of clinical trials. There are currently about 150 clinical trials at NIH involving cancer and trying to find answers and cures for cancer. The problem is that on these clinical trials they don't use placebos, they use the current drug therapy that is known for the treatment against an experimental process. If there are not enough drugs available to treat people for the current protocols, how can those drugs be used in a clinical trial. As a result, we are finding it very challenging to move forward with the clinical trials that are needed. This legislation recognizes that concern and specifically deals with it. I congratulate the committee leadership for addressing that issue.
I also will mention one other issue: nanotechnology. I congratulate Senator Pryor for his leadership in this area. Programs at FDA to access health safety facts and using nanotechnology in everyday products is something we need to do. This legislation advances that. I point out that I am proud that the lab facilities at the FDA are fully capable of dealing with the challenges presented by nanotechnology. This legislation acknowledges that.
We also, in Maryland, are proud of the Beltsville Agricultural Research Center, which will advance nanotechnology and the impact it has on everyday products and safety. Those issues will be addressed also by the underlying bill. We very much appreciate the leadership of the committee.
Let me talk for a moment about the two amendments I have brought forward. Amendment No. 2125 deals with safety warnings, particularly as they affect the minority community. Clinical trials don't always represent the diversity of our community. We know there is underrepresentation of minorities within clinical trials. Quite frankly, when the FDA gives approval, they give approval to the known risks, as I am sure you are all aware, but it doesn't always represent the impact on all communities. We also know there are racial and ethnic differences in response to pharmaceuticals, and they may not become known until the drug is in wide use, certainly beyond the constraints of a controlled clinical trial. So we do have the initial approval of FDA that includes the known risks, but we also have the capacity under FDA to do postapproval warnings. My amendment deals with that aspect.
Health and Human Services has a strategy to deal with minority health and health disparities. It is called the Strategic Action Plan to Reduce Racial and Ethnic Health Disparities. We also now have an institute at the National Institutes of Health that deals solely with minority health and health disparities. We have a commitment to do a better job as a nation in dealing with minority health disparities. This amendment would help us move forward in that regard.
One particular drug that is used to treat an inflammatory disorder has been determined by several studies to have a mortality risk that is three times higher for African-Americans than the general public. However, it is still widely prescribed, and ads for the product on the Internet and on television prominently feature African-American actors.
This is an area in which the National Medical Association and many other groups concerned about the quality of minority health have focused on for years. Beyond the black box warning, which is the most serious warning that can be issued about the side effects of approved drugs, there are other concerns about products that are marketed for the overall population that may have side effects, but the specific data has not been developed yet to warrant a black box warning.
The amendment I have offered directs the FDA to develop communication plans to address the best strategy for communicating benefits and risks, safety alerts, changes to the label or labeling of drugs, including black box warnings, biological products or devices, health advisories, any information identifying particular subpopulations, and any other relevant information as determined appropriate to enhance communication, including a variety of means of electronic communication.
I might point out this amendment has the support of the FDA and BIO, and it is budget neutral. So I would urge my colleagues to support this amendment to advance the commitment we all have made to deal with reducing and hopefully one day eliminating minority health disparities in our health care system. It is totally consistent with the Strategic Action Plan to Reduce Racial and Ethnic Health Disparities at the Department of Health and Human Services.
The second amendment I have brought forward, amendment No. 2141, deals with small businesses. This is a very appropriate amendment, as it is being considered during Small Business Week. We all acknowledge the importance of small business in the growth of our economy. Two out of every three new jobs are created through small business. We get more innovation through our small businesses on a per-employee basis than we do through larger companies. It is critically important small businesses be energized if our economy is going to rebound, as we know it needs to.
This is particularly true as we deal with innovation in drug development or medical devices. My amendment deals with the issues of coordinating the work between the FDA and small business. It provides a listing of the staffing levels at the small business offices of the FDA so that we know the capacity we have and we can evaluate that. It is our responsibility to do that. It provides an overview of the status of partnership efforts between the FDA and the SBA. We want the two agencies, the Food and Drug Administration and the Small Business Administration, to be working in concert to advance the cause for small businesses as well as the mission of the FDA.
My amendment provides a summary of all outreach efforts to small businesses and small business associations. It details the number of small businesses receiving protocol assistance. It shows the number of unsolicited and solicited grant applications to small businesses, again, so we can evaluate that. Most importantly, it calls for the examination of existing barriers, particularly as it relates to the generic drug shortages.
It is interesting that with regard to the fee schedule, the FDA has the authority to do waivers as it relates to brand names. We know a lot of the generics are where we have our shortages because of the economics of the circumstances. But the SBA has limited ability to waive the fee structure as it relates to the general development of generic drugs. My amendment would ask the SBA to report back to Congress on what impact that has on small businesses being innovative in developing generic drugs to help us generally with less costly drugs that are available for treatment, but also to make sure we deal with the drug shortage issue, which I alluded to earlier.
This amendment is also supported by Senator Landrieu, the chairman of the Small Business Committee, on which I have the pleasure of serving. I urge my colleagues to support both amendments I have brought forward. I believe they only enhance the strength of the bill before us and are totally consistent with the work of the chairman and the ranking member of the committee.
With that, Madam President, I would again urge my colleagues to support both amendments and to support the underlying bill.
I yield the floor, and I suggest the absence of a quorum.