[Congressional Record Volume 152, Number 106 (Thursday, August 3, 2006)]
[Senate]
[Pages S8818-S8819]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. ENZI (for himself and Mr. Kennedy):
  S. 3807. 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.
  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. The Enhancing 
Drug Safety and Innovation Act is the product of working across party 
lines, and creates a structured framework for resolving safety 
concerns.
  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 3 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 at the FDA 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 a minimum of potential conflicts of interest to 
serve on advisory committees.
  I want to thank the dozens of stakeholders, including the Food and 
Drug

[[Page S8819]]

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.
  I look forward to working with my colleagues to advance this 
important piece of legislation.
  Mr. KENNEDY. Mr. President, Senator Enzi, chairman of the Senate 
Health, Education, Labor, and Pensions Committee, and I are introducing 
the Enhancing Drug Safety and Innovation Act of 2006. The goals of this 
legislation are to enhance the Food and Drug Administration's authority 
over the safety of prescription drugs after they are approved; to 
encourage innovation in medical products; to improve access to clinical 
trials for patients and ensure that the doctors and patients learn 
about 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 nearly 2 years ago 
showed us once again that all prescription drugs have risks, many of 
which we may not know about when a drug is approved or even for years 
after approval. That is why 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 or minimize these risks as soon 
as they are detected.
  Our bill will require every drug to have a risk evaluation and 
mitigation strategy, or REMS, when it is approved. For many drugs, the 
REMS 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 a drug 
that poses serious risks, such as by requiring the drug to be dispensed 
to patients with labeling that patients can understand, that the drug 
company have a plan to inform health care providers about how to use 
the drug safely, or that a drug should not be advertised directly to 
consumers for up to 2 years after approval. If a serious safety signal 
needs to be understood, FDA can require further studies 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 a drug with the most serious side effects, FDA will be able to 
require that its REMS include the restrictions on distribution and 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, and the agency can also modify the labeling or 
otherwise alter a drug's REMS after the approval. The drug's 
manufacturer will propose the REMS, or modifications to it, and the FDA 
and the company will try to work out an adequate REMS. 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 
tools to ensure compliance. Drug user fees will 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 standards for approving drugs 
but to ensure 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 their serious risks for other patients, because FDA 
can better identify the risks and minimize 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, which 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. This database 
would 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 
the Inspector General Office of the Department of Health and Human 
Services would review the content of submissions to the results 
database to ensure they are truthful and nonpromotional. These Federal 
requirements would 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 its 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 Senate colleagues to support it.
                                 ______