[Congressional Record Volume 153, Number 20 (Thursday, February 1, 2007)]
[Senate]
[Pages S1530-S1532]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. ENZI (for himself and Mr. Kennedy):
  S. 484. A bill to amend the Public Health Service Act and the Federal 
Food, Drug, and Cosmetic Act to improve drug safety and oversight, and 
for other purposes; to the Committee on Health, Education, Labor, and 
Pensions.
  Mr. ENZI. Mr. President, I rise today to introduce a very important 
bill, one that my colleague Senator Kennedy and I have been working on 
for some time.
  For decades, the United States has been the standard bearer in 
bringing new drugs and medications to the world market. Like it or not, 
the FDA

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has a very important role in all of our daily lives. The FDA is 
involved in ensuring the safety of the meals we are eating today, the 
pills we are taking, and even the cell phones in our pockets and 
briefcases. The FDA's role in our health and in our economy is broad.
  Nearly half of all Americans take a prescription drug daily. Anyone 
who prescribes, provides or takes a prescription drug could benefit 
from enhanced safety and risk communication about these life-saving 
products. Over the last few years, a spate of safety issues, such as 
the withdrawal of the arthritis drug Vioxx and the labeling of 
antidepressants for suicidality in adolescents, has caused a crisis of 
public confidence in the FDA. I believe the American people are losing 
confidence in the FDA and its ability to evaluate and weigh the 
benefits and risks of prescription drugs. In addition, staff at the 
agency feel like they are under heavy fire, with little or no 
protection from the prevailing political winds, due to the lack of a 
confirmed Commissioner of Food and Drugs for most of the last six 
years. I believe that only Congress can restore the public's confidence 
in FDA and morale at the agency.
  In 2005, the HELP Committee held two hearings on the issue of drug 
safety. We received over 50 recommendations from witnesses at those 
hearings. At that time, Senator Kennedy and I pledged to develop a 
comprehensive response to the drug safety issues raised. Last August, 
we introduced the Enhancing Drug Safety and Innovation Act. That bill, 
S. 3807, was the product of working across party lines, and created a 
structured framework for resolving safety concerns. Careful and 
comprehensive pre-approval planning of how drugmakers and FDA will 
identify, assess and manage serious risks post-approval is a better way 
to obtain safety information without compromising patient access.
  In September 2006, the Institute of Medicine released its report 
titled ``The Future of Drug Safety: Promoting and Protecting the Health 
of the Public.'' The recommendations in this report had much in common 
with S. 3807. The Senate HELP Committee held a hearing in November 2006 
at which representatives of the IOM, a physician and drug safety 
expert, patient groups, a consumer group, and a pharmaceutical company 
testified about the IOM report, the bill, and the relationship between 
them. In addition, other stakeholder groups made additional comments on 
the bill. Yesterday, FDA released their response to the IOM report. 
Newly confirmed Commissioner Dr. Andrew von Eschenbach has put forward 
a number of promising ideas to improve the internal processes and 
culture at FDA. His leadership is outstanding and his ideas are 
helpful, but internal change is not enough to alter public perception. 
FDA needs new drug safety authorities, and this bill provides those 
authorities.
  While the bill we are introducing today reflects numerous refinements 
to clarify ambiguities or to address issues that S. 3807 had not 
addressed, we realize that there are thoughtful differences of opinion 
and ideas on how best to move forward with drug safety. I welcome any 
and all suggestions on improving this bill, and I look forward to 
working with my colleagues and other stakeholders to understand those 
concerns more fully and incorporate any necessary changes in the bill 
which will be considered in front of the HELP Committee in the next few 
weeks. I hope that all of my colleagues will take another look at this 
legislation and its goals and work with me to change the status quo. 
Everyone agrees: We must do more for drug safety.
  Under the Enhancing Drug Safety and Innovation Act, FDA would begin 
to approve drugs and biologics, and new indications for these products, 
with risk evaluation and mitigation strategies (REMS). The REMS is 
designed to be an integrated, flexible mechanism to acquire and adapt 
to new safety information about a drug. The sponsor and FDA will assess 
and review an approved REMS at least annually for the first three 
years, as well as in applications for a new indication, when the 
sponsor suggests changes, or when FDA requests a review based on new 
safety information.
  The development of tools to evaluate medical products has not kept 
pace with discoveries in basic science. New tools are needed to better 
predict safety and efficacy, which in turn would increase the speed and 
efficiency of applied biomedical research. The Enhancing Drug Safety 
and Innovation Act would spur innovation by establishing a new public-
private partnership between the FDA, industry and academia to advance 
the Critical Path Initiative and improve the sciences of developing, 
manufacturing, and evaluating the safety and effectiveness of drugs, 
devices, biologics and diagnostics.
  The Enhancing Drug Safety and Innovation Act also establishes a 
central clearinghouse for information about clinical trials and their 
results to help patients, providers and researchers learn new 
information and make more informed health care decisions.
  Finally, the Enhancing Drug Safety and Innovation Act would make 
improvements to FDA's process for screening advisory committee members 
for financial conflicts of interest. FDA relies on its 30 advisory 
committees to provide independent expert advice, lend credibility to 
the product review process, and inform consumers of trends in product 
development. The bill would clarify and streamline FDA's processes for 
evaluating candidates for service on an advisory committee, and address 
the key challenge of identifying a sufficient number of people with the 
necessary expertise and the fewest potential conflicts of interest to 
serve on advisory committees.
  I want to thank the dozens of stakeholders, including the Food and 
Drug Administration, patient and consumer groups, industry 
associations, individual companies, and scientific experts who have 
taken the time and effort to give us their comments and input on the 
bill. Their assistance has been invaluable, and I look forward to 
continuing to work with them as we go through this legislative process.
  Senator Kennedy and I believe that this bipartisan effort will bring 
more consistency, transparency, and accountability to the process of 
assuring a drug's safety after it is approved. The 110th Congress will 
hold an exceptionally full agenda with respect to the FDA. In addition 
to updating the FDA's authorities as we are proposing today, Congress 
must renew the drug and device user fee programs, as well as the Best 
Pharmaceuticals for Children and Pediatric Research Equity Acts. The 
introduction of this bill today is the beginning, not the end, of the 
process, and I look forward to working with my colleagues to advance 
these important pieces of legislation.
  Mr. KENNEDY. Mr. President, it is a privilege to join Senator Enzi in 
introducing the Enhancing Drug Safety and Innovation Act of 2007. The 
goals of the legislation are to strengthen the Food and Drug 
Administration's authority over the safety of prescription drugs after 
they are approved; to encourage innovation in medical products; to 
increase access to clinical trials for patients and ensure that doctors 
and patients are aware of the results of clinical trials involving the 
drugs they prescribe and use; and to improve the screening of members 
of FDA's scientific advisory committees to avoid conflicts of interest.
  The withdrawal of the drug Vioxx from the market 2 years ago 
demonstrated again that all prescription drugs have risks, many of 
which are unknown when a drug is approved, or even for years after 
approval. We need a more effective system to identify and assess the 
serious risks of drugs, inform health care providers and patients about 
such risks, and manage and mitigate these risks as soon as they are 
detected.
  Our bill will require drugs to have a risk evaluation and mitigation 
strategy when it is approved. For many drugs, the strategy will include 
only the drug labeling, reports of adverse events, a justification for 
why only such reporting is needed, and a timetable for assessing how 
the REMS is working.
  The FDA will be able to include additional requirements for drugs 
that pose serious risks, such as by requiring that the drug be 
dispensed with labels that patients can understand, that the drug 
company have a plan to inform health care providers about how to use 
the drug safely, and that a drug should not be advertised directly to 
consumers for up to 2 years after approval. If a serious safety concern 
needs to be understood, FDA can require further studies

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or even clinical trials after the drug is approved. Enhanced data 
collection and data mining techniques will help identify risk signals 
earlier and more thoroughly.
  For drugs with the most serious side effects, FDA will be able to 
require that its risk evaluation and mitigation strategy include the 
restrictions on distribution or use needed to assure its safe use.
  The FDA will be able to impose any of these requirements at the time 
a drug is approved. The agency can also modify the labeling or 
otherwise alter a drug's availability after the approval. The drug's 
manufacturer will propose the overall strategy, or modifications to it, 
and the FDA and the company will try to work out an adequate 
compromise. If the agency and the company cannot agree, the agency's 
Drug Safety Oversight Board can review the dispute and recommend a 
resolution to senior FDA officials, who will make the final decision.
  Civil monetary penalties are added to FDA's traditional enforcement 
authority to ensure compliance. Drug user fees will also be used to 
review and implement the program.
  The bill formalizes and makes mandatory what is now only informal and 
voluntary. Our intent is not to change the standards for approving 
drugs, but to see that the FDA has the ability to identify, assess, and 
manage risks as they become known. Better risk management will mean 
that drugs with special benefits for some patients will remain 
available, despite serious risks for other patients, because FDA can 
better identify the risks and manage them.
  The bill helps to improve drug safety in other ways as well. The 
Reagan-Udall Institute for Applied Biomedical Research will be a new 
public-private partnership at the FDA to advance the agency's critical 
path initiative. The initiative is intended to improve the science of 
developing, manufacturing, and evaluating the safety and effectiveness 
of drugs, biologics, medical devices, and diagnostics.
  The Institute will be supported by Federal funds and by contributions 
from the pharmaceutical and device industries. Philanthropic 
organizations will be able to supplement Federal support. The institute 
will have a board of directors and an executive director, and will 
report to Congress annually on its operations.
  The bill will also expand the public database at NIH to encourage 
more patients to enroll in clinical trials of drugs. The database will 
build on the current systems and would include late phase II, phase 
III, and all phase IV clinical trials for all drugs.
  A second, publicly available database would include the results of 
phase III and phase IV clinical trials of drugs, with the possibility 
that late phase II trials would be added later. Posting of results 
could be delayed for up to 2 years, pending the approval of the drug or 
the publication of trial results in a peer- reviewed journal.
  The public needs to know about the results of clinical trials on 
drugs. Tragically, such information was not adequately available for 
the clinical studies of antidepressants in children.
  Posting information in the clinical trials registry and the clinical 
trials results database will be requirements for federal research 
funding and for drug review and approval by the FDA. Both the FDA and 
other appropriate offices in the Department of Health and Human 
Services will review the content of submissions to the results database 
to ensure they are truthful and nonpromotional. These Federal 
requirements will preempt State requirements for clinical trial 
databases.
  Finally, the bill will improve FDA's process for screening advisory 
committee members for financial conflicts of interest. The agency 
relies on advisory committees to provide independent, expert, 
nonbinding recommendations on significant issues. Ideally, committee 
members should be free of any financial ties to the companies affected 
by an issue before a committee. But at times, there may be no 
individual without financial ties to such companies--for example, when 
the issue involves a rare disease or a cutting edge medical technology. 
In these cases, the FDA must be able to grant a waiver to allow an 
individual with essential expertise to serve on the committee. The bill 
will require the agency to seek qualified experts with minimal 
conflicts, clarify how it makes waiver decisions, and disclose those 
decisions at least 15 days before a committee meeting.
  Our bill is a comprehensive response to drug safety and other 
important issues involving prescription drugs and other medical 
technologies. I commend Chairman Enzi and his dedicated staff--
especially Amy Muhlberg--for working closely with us on this proposal, 
and I urge our colleagues to support it.
                                 ______