STATEMENT BY SENATOR EDWARD M. KENNEDY ON DRUG SAFETY (AS PREPARED FOR DELIVERY)

Millions of Americans rely on the drugs that the FDA reviews to protect them from sickness. But now, the FDA itself urgently needs treatment. For too long, the agency has been without a confirmed leader. Science has too often had to take a back seat at the very agency which should be setting the standard for objectivity and integrity. There is also growing evidence that the dedicated professionals at the FDA have been pressured to trim their scientific views to the prevailing political winds. These are symptoms of a serious illness, and we should act without delay to provide the cure.The Institute of Medicine has done a valuable service for the nation by diagnosing the problem, and providing a prescription for treatment. It’s up to us to see that the patient takes the right medicine, and hopefully has a quick recovery. The stakes are high. The FDA oversees products accounting for a quarter of the US economy. Every day, it makes decisions that mean the difference between life and death for American patients. It is an honor to welcome, Sheila Burke, who served the Senate with such distinction on the staff of our former colleague Bob Dole. Sheila is now Deputy Secretary of the Smithsonian, but she found the time to chair the panel at the IOM that made these important recommendations on drug safety. As the IOM report makes clear, FDA has many needs that Congress must address. Its budget is $1.8 billion a year. That may sound like a lot, but it works out to about $6 a year for every American. In Washington, DC, you can barely buy a sandwich for $6 – yet for that amount, we expect the FDA to assure the safety of the food we eat, the drugs we take, and the medical devices that save so many lives. Clearly, we need to increase FDA’s budget, so that it can do a better job of guaranteeing drug safety. But money alone won’t meet all the challenges. Additional authority is needed as well. The Institute of Medicine’s report recommends that FDA have the power to require post-marketing risk assessment and risk management programs for new drugs, and to require the industry to make the results of drugs safety studies available to the public. The Enhancing Drug Safety and Innovation Act, which Chairman Enzi and I introduced earlier this year, addresses these needs. Like the Institute of Medicine report, our bill emphas the need for a “life-cycle” approach to drug regulation, both before and after approval. The bill would require every drug approved by the FDA to have an enforceable Risk Evaluation and Mitigation Strategy, tailored to fit the risk profile of each new drug. Where appropriate, the strategy could include special requirements for labeling, post-market clinical studies, and limitations on marketing the drug directly to consumers. For drugs with the most dangerous side effects, the strategymight require that only doctors with specialized training be allowed to prescribe the drug. If a manufacturer fails to implement a precaution that it has agreed to, the FDA will have new authority to assess civil monetary penalties to enforce compliance. By providing a legally enforceable yet flexible way for the FDA to oversee safety throughout the life cycle of a drug, the bill gives the agency the authority it now lacks to take effective action to ensure safety. The legislation also creates a public-private partnership to improve the science of drug safety and drug development. It will help patients and physicians make more informed decisions by requiring the results of drug trials to be included in a public database. Our bill also takes stronger steps to avoid financial conflicts of interest by members of FDA advisory committees. Again, Mr. Chairman, I commend you for calling this hearing. I look forward to working with you and our colleagues on both sides of the aisle to give the FDA the authority it needs to restore public trust in the safety of prescription drugs. I welcome our witnesses and look forward to their testimony.