New Clinical Trials Databases, Post-Market Drug Safety Authorities, Incentives for Pediatric Devices Research Are Major Wins for Consumers
WASHINGTON, D.C. – After months of negotiation, the House of Representatives will vote today on legislation, H.R. 3580, to significantly improve the Food and Drug Administration’s oversight of drug safety. Representative Edward J. Markey (D-MA), a senior member of the House Energy and Commerce Committee and co-author of drug safety reform legislation, called the legislation the most significant reform of our country’s drug safety system since Congress first began requiring drug companies to prove the effectiveness of their drugs. 

Rep. Markey said, “Today’s bill is a big victory for consumers. When Americans reach into their medicine cabinet, they should not have to play ‘Rx roulette,’ gambling on the safety of their prescription drugs. Yet the past several years have been marked by a string of drug scandals - Vioxx, Ketek, Paxil, Avandia. These drugs have harmed families across our country and come to symbolize the urgent need for reform at the FDA.

“Now we are giving the FDA critical authority to oversee the safety of drugs even after they have been approved. In addition, we’re breaking down the walls of secrecy around clinical trials and setting up clinical trials registry and results databases, which I have championed since 2004. These registries will be accessible to the public, so that all doctors, scientists and patients have the same information as drug companies about the safety and effectiveness of medicines.”

Rep. Markey negotiated several provisions in the reform bill based on provisions from H.R. 1561, the Waxman-Markey drug safety bill, and H.R.1494, the Markey-Rogers pediatric devices bill. These provisions include:

Creating mandatory clinical trials registry and results databases housed at the National Institutes for Health to be available online. The registry will contain vital information for consumers interested in enrolling in clinical trials. The results database will ensure that the findings produced from clinical trials are made public so that companies can’t game the system and make their drugs appear safer or more effective than they actually are.

Giving the FDA new authority to oversee the safety of drugs even after they have been approved for the public. Today’s bill strengthens the FDA’s ability to monitor drugs after they have been approved, require further studies if necessary, mandate specific warnings, and mitigate potential risks. The bill clarifies that the FDA’s new authorities do not change the responsibility of drug companies to maintain drug labels and warn the public about risks.

Empowering the FDA to impose penalties to failure to complete post-market studies. For the first time ever, the FDA will have the power to impose civil monetary penalties on companies that fail to conduct required post-market studies.

Giving incentives to encourage creation of medical devices for children. While children suffer from many of the same diseases as adults, children are not just small adults, and they require specialized medical devices, from prosthetics to stents. This bill encourages more companies to develop new medical devices for children so doctors are not forced to “jerry-rig” adult devices to accommodate children.

Setting privacy safeguards around new databases. The bill ensures that all data collected by the FDA to evaluate drug risks and side effects will be stripped of individually-identifying information in order to protect consumers.

“Today the Congress is taking much-needed action to respond to the clear failures in our country’s drug safety-net. This bill gives the FDA more muscle to protect American families by arming the FDA with new authority, technology and resources to identify drug safety problems quickly, gather more information if necessary and act decisively to mitigate any risks to the public. This is an historic achievement for all health care consumers,” concluded Rep. Markey.



CONTACT: Jessica Schafer, 202.225.2836