[Congressional Record Volume 151, Number 53 (Wednesday, April 27, 2005)]
[Senate]
[Pages S4426-S4427]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. GRASSLEY (for himself and Mr. Dodd):
  S. 930. A bill to amend the Federal Food, Drug, and Cosmetic Act with 
respect to drug safety, and for other purposes; to the Committee on 
Health, Education, Labor, and Pensions.
  Mr. GRASSLEY. Mr. President, today I introduce Senate Bill 930, the 
Food and Drug Administration Safety Act of 2005. I am pleased that 
Senator Dodd is co-sponsoring another piece of drug safety legislation 
with me. This legislation is part of a sustained effort to restore 
public confidence in the Federal Government's food and drug safety 
agency. Enactment of this bill will be another meaningful step toward 
greater accountability and transparency at the FDA. Importantly, this 
legislation provides the FDA with some much needed authorities to 
ensure the safety and efficacy of drugs for the long haul.
  The Food and Drug Administration cannot always serve the American 
people and the interests of the drug industry at the same time. These 
two interests are often at odds with each other. When there is a 
conflict the American people should win out each and every time. The 
Vioxx situation is a classic example of this inherent conflict. 
American consumers demand and deserve assurances that the medicines in 
their cabinets are safe. The risks associated with a drug should be 
outweighed by its benefits, and this risk-benefit analysis should not 
be negotiated by the industry behind closed doors. Unfortunately, 
reforms at the FDA are necessary to place drug safety front and center 
once and for all.
  When drugs go on the market, they are used by exponentially larger 
numbers of people than were involved in the pre-approval trials. What 
John Q. Public deserves and demands is for the FDA to embrace a renewed 
mission to pursue aggressively key safety questions that the industry 
would sometimes prefer to ignore. The FDA must protect the health of 
the public by considering not only the benefits but also the risks of 
drugs for the tens of millions of Americans who actually use new drugs 
already available in the marketplace. The FDA's post-market evaluation 
and research needs to be a separate but equal partner with pre-approval 
evaluation. Indeed FDA's post marketing surveillance function can no 
longer take a back seat within the agency.
  I have been pressing for necessary reforms at the FDA--both 
administrative and legislative--and the focus of these reforms center 
on a reorganization of the FDA. The Food and Drug Administration Safety 
Act of 2005 will establish an independent Center within the FDA--the 
Center for Post-market Drug Evaluation and Research (CPDER). The new 
Center's primary mission, vision and values will focus on conducting 
risk assessment for approved drugs and biological products once they 
are on the market. The Director of the Center will report directly to 
the FDA Commissioner and will be responsible for monitoring and 
assessing the safety and efficacy of drugs and biological products.
  Today's legislation is focused on the equal importance of pre-
marketing evaluations by the Center for Drug Evaluation and Research 
(CDER)--the pre-market Center--and post-marketing evaluations by the 
newly established post-market Center. Consultation and coordination 
between pre-market and post-market Centers will be essential, but their 
relationship will place them on equal footing with the other. The 
present Office of Drug Safety will no longer be effectively under the 
thumb of the Office of New Drugs. We are hopeful that this 
reorganization of the FDA will go a long way toward eliminating the 
conflict of interest that shadows the FDA's post-market risk assessment 
presently.
  Today's legislation will also: authorize the Director to require 
manufacturers to conduct post-market clinical or observational studies 
if there are questions about the safety or efficacy of a drug or 
biological product.
  Authorize the Director to determine whether an approved drug or 
licensed biological product may present an unreasonable risk to the 
health of patients or the general public, given the known benefits.
  Authorize the Director to take corrective action if a drug or 
biological product presents an unreasonable risk to patients or the 
general public--including the authority to make changes to the label or 
approved indication, place restrictions on product distribution, 
require physician and consumer education, and require the use of other 
risk management tools.
  Allow the Director to withdraw approval of a drug or biological 
product if necessary to protect the public health.
  Require submission of advertising prior to dissemination, and certain 
advertising disclosures related to risks and benefits to patients, if 
one or more

[[Page S4427]]

of the three following conditions is met: the Director has determined 
that the product may present an unreasonable risk to patients, the 
product is the subject of an outstanding post-market study requirement, 
or the product was approved within the last two years.
  Establish strong enforcement mechanisms, including civil monetary 
penalties, for those who fail to comply.
  Ensure that the Director benefits from all appropriate resources, 
including but not limited to consultation with the Center for Drug 
Evaluation and Research (CDER) or the Center for Biologics Evaluation 
and Research (CBER), and makes all decisions based on a risk-benefit 
analysis.
  Ensure that all findings and decisions made by CPDER are transparent.
  Require a report and recommendations to Congress on post-market 
surveillance of medical devices.
  Authorize graduated appropriations totaling $500 million over five 
years to ensure that CPDER has the resources to accomplish its goals.
  Today's legislation is another important step toward reforming the 
FDA. I urge my colleagues to join me in this effort by cosponsoring 
this important legislation.
  Mr. DODD. Mr. President, I rise today to join Senator Grassley in 
announcing the introduction of the Food and Drug Administration Safety 
Act of 2005 (FDASA). I would like to thank Senator Grassley for his 
commitment to this issue and his willingness to work on this important 
legislation in a bipartisan manner. Senator Grassley and I have spent 
the past several months crafting this legislation, which will create a 
new center within the FDA that will be responsible for ensuring that 
prescription drugs are safe once they are on the market.
  Our hope is that the creation of this new center will restore 
confidence in the medicines that so many Americans rely on to safeguard 
their health and well-being. Patients should be able to rest-assured 
that the drugs they take to help them will not hurt them instead.
  The American pharmaceutical industry is a true success story. Their 
incredible innovations over the last few decades have saved and 
improved millions of lives, and made prescription drugs an integral 
part of quality health care. I am proud to say that Connecticut is home 
to a number of leading pharmaceutical companies. There is very little 
question that the American drug industry is the world leader. This is 
due, in no small part, to the FDA. Throughout the world, the FDA seal 
of approval--the words ``FDA Approved''--has stood as the gold standard 
for safety and quality.
  Unfortunately, events of the past year have put patients at risk and 
have seriously tarnished the FDA's image. Recent developments have cast 
into doubt the FDA's ability to ensure that the drugs that it approves 
are safe--especially once they are on the market. These concerns are 
bad for patients, bad for physicians, and bad for the drug industry.
  Like many Americans, I have been deeply disturbed by the revelations 
of significant risk associated with widely used medications to treat 
pain and depression. These revelations raise real and legitimate 
questions about the safety of drugs that have already been approved. It 
would be one thing if these drugs were in a trial phase, but safety 
issues are being identified in drugs that are already on the market and 
widely used. Health risks significant enough to remove drugs from the 
market or significantly restrict their use are becoming clear only 
after millions of Americans have been exposed to real or potential 
harm.
  It has been estimated that more than 100,000 Americans might have 
been seriously injured or killed by a popular pain medication, while 
millions of children have been prescribed antidepressants that could 
put them at risk. This recent spate of popular medicines being 
identified as unsafe underscores the need to take additional steps to 
monitor and protect safety after a drug has been approved.
  The legislation that Senator Grassley and I are introducing today 
will do three things to restore confidence in the words ``FDA 
Approved,'' and ensure that the FDA has all the tools that it needs to 
protect patients. First and foremost, it will establish within the FDA 
a new center--the Center for Postmarket Drug Evaluation and Research 
(CPDER)--which will report directly to the FDA Commissioner and be 
responsible for ensuring the safety and effectiveness of drugs and 
biological products once they are on the market.
  I strongly believe that the creation of such a new, independent 
center is necessary. There have been disturbing reports that suggest 
that the FDA does not place enough emphasis on drug safety, and that 
concerns raised by those in the Office of Drug Safety (ODS) are 
sometimes ignored and even suppressed. An internal study conducted by 
the HHS Office of the Inspector General in 2002 revealed that 
approximately one-fifth of drug reviewers had been pressured to approve 
a drug despite concerns about safety, efficacy, or quality. In 
addition, more than one-third said they were ``not at all'' or only 
``somewhat'' confident that final decisions of the Center for Drug 
Evaluation and Research (CDER) adequately assessed safety. The creation 
of a new center will raise the profile of drug safety within the 
agency.
  Second, our bill will provide the Director of CPDER with significant 
new authorities, including: the authority to require drug companies to 
conduct postmarket studies of their products if there are questions 
about safety or effectiveness; the authority to take corrective 
actions, such as labeling changes, restricted distribution, and other 
risk management tools, if an unreasonable risk exists; the authority to 
review drug advertisements before they are disseminated, and to require 
certain disclosures about increased risk; and in extreme cases, the 
authority to pull the product off the market.
  These new authorities will allow the FDA to act quickly to get 
answers when there are questions about the safety of a drug, and to act 
decisively to mitigate the risks when the evidence shows that a drug 
presents a safety issue. With these authorities, we will never again 
have a situation where a critical labeling change takes two years to 
complete, as was the case with Vioxx. When we are talking about drugs 
that are already on the market and in widespread use, any delay can put 
millions of patients in harm's way.
  Third and lastly, this legislation will authorize the appropriation 
of $500 million over the next 5 years to provide the new center with 
the resources to carry out the provisions of this legislation.
  I would like to thank several groups that have endorsed this bill, 
and that were instrumental in its drafting, including Consumer's Union, 
the Elizabeth Glaser Pediatric AIDS Foundation, the National 
Organization for Rare Disorders (NORD), the National Women's Health 
Network (NWHN), the U.S. Public Interest Research Group (PIRG), the 
Consumer Federation of America, and the Center for Medical Consumers.
  I look forward to working with all of my colleagues, including 
Senator Enzi and Senator Kennedy on the HELP Committee, to see this 
legislation enacted as soon as possible. By strengthening the ability 
of the FDA to ensure the safety of prescription drugs once they are on 
the market, this legislation will allow physicians to prescribe, and 
patients to use, prescription drugs without wondering if the medicines 
intended to help them will hurt them instead. It will help ensure that 
the term ``FDA-Approved'' will remain the gold standard for safety and 
quality.
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