FDA Reform Bill Strengthens Drug Review Process and Shines Light on Clinical Trials Using Markey Provisions

By:  Ed Markey
Date: July 11, 2007
Location: Washington, DC


Representative Edward J. Markey (D-MA), a senior member of the House Energy and Commerce Committee, today applauded the expected passage of legislation tonight that will make the most sweeping safety and regulatory changes to the Food and Drug Administration in years. The bill, H.R. 2900, contains critical language to strengthen the FDA's power to monitor drugs after they have been approved and to shine light on the clinical trials process, based on a bill authored by Rep. Markey and Representative Henry Waxman (D-CA) earlier this year, H.R. 1561. In addition, H.R. 2900 incorporates legislative language authored by Rep. Markey and Representative Mike Rogers (R-MI) to encourage development of medical devices for children.

"Families should never have to play "Rx Roulette" when they reach into their medicine cabinets. Recent failures in our drug approval and post-market monitoring system have harmed patients and undermined the confidence of the American public in the safety and effectiveness of prescription drugs. VIOXX, Ketek, Avandia, Paxil - these drugs have harmed families across our country and come to symbolize the urgent need for reform," said Rep. Markey.

"I am proud that, based on legislation Mr. Waxman and I authored earlier this year, today's bill will finally give the FDA authority to conduct reviews of drugs even after they have been approved for the market and will create clinical trials databases that will give the public access to information about all the clinical trials ongoing. Drug companies will no longer be able to pick and choose which clinical trials they are willing to make public, instead all trials and results will be made available so doctors and patients will have complete information about drugs."

The provisions in H.R. 2900 based on H.R. 1561 will give the FDA the authority to require label changes, order post-market studies to follow up on safety concerns and gather information needed to reassess the risks compared to the benefits of a drug already on the market. The establishment of a new "Post-Market Risk Identification and Analysis System" will help identify harmful side effects and uncover signals of unexpected adverse events without compromising patient privacy.

Also based on H.R. 1561, today's bill will establish both an online clinical trials registry and a clinical trials results database. Both will be available to the public online. The registry will contain vital information on which drugs are the subject of clinical trials, where the trials are being conducted and how consumers can learn more details. The results database will allow doctors and their patients to have complete and accurate information about how drugs performed during clinical trials.

"Today's legislation is a major step forward for all health care consumers and should go a long way to reaffirming Americans' faith on our drug approval system," concluded Markey.

The bill will be voted on tonight before going into a conference to settle differences with similar legislation passed by the Senate earlier this year.

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