News that Diabetes Drug May Increase Risk of Heart Attack Underlines Need for FDA Reform

Press Release

By:  Ed Markey
Date: May 21, 2007
Location: Washington, DC


NEWS THAT DIABETES DRUG MAY INCREASE RISK OF HEART ATTACK UNDERLINES NEED FOR FDA REFORM

Rep. Edward J. Markey (D-MA), a senior Member of the Energy and Commerce Committee and the co-author of H.R. 1561, the Enhancing Drug Safety and Innovation Act, released the following statement regarding the study in the New England Journal of Medicine showing that Avandia, the number one oral diabetes drug, may increase the risk of heart attack:

"The news that the world's number one oral diabetes drug may actually increase the risk of heart attack, is one more example of the FDA dropping the ball when it comes to catching serious risks posed by drugs on the market. Now that they are aware of this potential problem, FDA regulators need to quickly reassess the risks and benefits of Avandia and the related class of diabetes drugs, and make clear recommendations to doctors and patients about the use of these drugs. Patients who have diabetes cannot be left in limbo wondering whether the drug their doctors have prescribed will help them or put them at greater risk for a heart attack.

"This case is yet another troubling example of why the Congress needs to pass strong FDA reform legislation now. The FDA cannot cross its fingers and hope nothing bad happens once a drug is approved. Instead, it should implement a life-cycle approach to drug safety and proactively monitor drugs after they are approved and taken by millions of Americans.

"The FDA must regularly review drugs after they are on the market to determine if there are any risks that were not identified pre-approval. If the FDA has a concern, it needs to have the authority to require post-market studies and ensure that they are completed. The bill that I have introduced with Rep. Henry Waxman, H.R. 1561, will give the FDA these important tools so it can do a better job of protecting the public health. As the House considers the reauthorization of the Prescription Drug User Fee Act, I will be working to include provisions to reform the FDA's post-market safety system."