April 27,2005

Senators Grassley and Dodd Expand Effort to Improve Drug Safety System

WASHINGTON - Seeking to enhance the nation's drug safety monitoring system, Sens. Chuck Grassley (R-IA) and Chris Dodd (D-CT) today introduced legislation to set up a new, independent Center inside the Food and Drug Administration (FDA) to review drugs andbiological products once they are on the market.

The bipartisan bill would establish the Center for Post-market Drug Evaluation andResearch (CPDER) by transferring the FDA's existing office of drug safety into the Center andestablishing new authority for post-market review. The director of the CPDER would reportdirectly to the FDA Commissioner.

Grassley and Dodd said the legislation is aimed at the conflicts of interest that todaycloud the ability of the FDA to assess the risks of drugs once they're on the market, and takeaction when a risk is identified.

"The bill addresses the fact that office of new drugs carries too much sway over theFDA's drug-safety apparatus. Today drug makers have the ability to negotiate with the FDAofficials who approved their drugs to begin with when the FDA considers corrective action,"Grassley said. "By creating a Center for post-market review, this legislation puts Americanconsumers where they belong at the FDA, and that's front and center."

"Just as patients have regular check ups with their doctor - and not just one - when itcomes to their health, there needs to be an on-going independent review of previously approveddrugs," said Dodd. "This measure will save patients' lives, help restore consumer confidence inthe safety of prescription drugs, and ensure that the words 'FDA Approved' continue to be thegold standard for safety and quality."

The Food and Drug Administration Safety Act of 2005 (FDASA) would:

Authorize the director to require manufacturers to conduct post-market clinical orobservational studies if there are questions about the safety or efficacy of a drug or biologicalproduct.

Authorize the director to determine whether an approved drug or licensed biologicalproduct may present an unreasonable risk to the health of patients or the general public given theknown benefits.

Authorize the director to take corrective action if a drug or biological product presents anunreasonable risk to patients or the general public, including the authority to make changes to thelabel or approved indication, place restrictions on product distribution, require physician andconsumer education, and require the use of other risk management tools.

Allow the director to withdraw approval of a drug or biological product if necessary toprotect the public health.

Require submission of advertising prior to dissemination and require certain advertisingdisclosures related to risks and benefits to patients if one or more of the three followingconditions is met: the director has determined that the product may present an unreasonable riskto patients, the product is the subject of an outstanding post-market study requirement, or theproduct was approved within the last two years.

Establish strong enforcement mechanisms, including civil monetary penalties, for thosewho fail to comply.

Ensure that the director benefits from all appropriate resources, including consultationwith the Center for Drug Evaluation and Research (CDER) or the Center for BiologicsEvaluation 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 ofmedical devices.

Authorize graduated appropriations totaling $500 million over five years to ensure thatCPDER has the resources to accomplish its goals.

Currently, post-market review of drugs is conducted by the FDA's Office of Drug Safety(ODS) within the Center for Drug Evaluation and Research (CDER). The existing drug safetyoffice does not have the authority, for example, to require post-market studies once a drug is onthe market. In addition, the ODS resides within CDER, which is responsible for approving newdrugs. The role of the drug safety office is primarily consultative to the new drugs office, makingthe office of drug safety effectively subservient to the new drugs office.

"It's very important that the FDA continue to approve new life-saving and life-enhancingdrugs as quickly as possible," Grassley said. "At the same time, the FDA needs to focus onreviewing those products after they're on the market. Valuable new information can be gainedand new risks are sometimes identified once a drug is used by millions of people. Our initiativeto establish this independent drug safety office is part of our effort to restore balance at the Foodand Drug Administration. We need the FDA to be a vigilant watch dog."

"This legislation will allow the FDA to act quickly and decisively to uncover safetyproblems and act to mitigate the risk to patients," said Dodd. "When we are talking about drugsthat are already on the market and in widespread use, any delay can put millions of patients inharm's way."

The legislation introduced today also requires the Secretary of Health and HumanServices to report to Congress on deficiencies in and recommendations for post-marketsurveillance of medical devices.

In February, Dodd and Grassley introduced a separate bill, S.470, the Fair Access toClinical Trials Act, or FACT Act, to make clinical trial results publicly available to researchers,doctors and consumers.

Both pieces of legislation have been endorsed by consumer and health groups includingthe Center for Medical Consumers, the Consumer Federation of America, Consumers Union, theNational Women's Health Network, Public Citizen, and the U.S. Public Interest Research Group.During the last year, Grassley has conducted oversight of the FDA based on concernsabout how the agency resisted making public information about suicide risks associated with thepediatric use of antidepressants and cardiovascular risks associated with the painkiller Vioxx.

Grassley is chairman of the Senate Committee on Finance, which is oversees the Medicare andMedicaid programs. Medicaid spent more than $1 billion on Vioxx before it was pulled from themarket last September. Medicare will offer a new prescription drug benefit beginning in January.Grassley has advocated administrative and legislative reforms to make the FDA's work moretransparent.

Dodd is a senior member of the Senate Committee on Health, Education, Labor andPensions, which is responsible for overseeing the FDA. He has worked throughout his career toensure that drugs are safe and effective for all Americans, including children.