Statements on Introduced Bills and Joint Resolutions

STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

BREAK IN TRANSCRIPT

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 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.

http://thomas.loc.gov/