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Scientific Integrity at the FDA

Recent gains at risk as Congress considers PDUFA and MDUFA renewal

Medical devices and medications have the ability to improve your health if they work—or seriously injure or kill you if they are dangerous. We depend on Food and Drug Administration (FDA) scientists to use their expertise to approve drugs and devices that are safe and effective, and protect us from those that are not.

Unfortunately, the FDA failed to protect us from Vioxx, Avandia, Ketek, and Menaflex. In these situations and many more, political or commercial pressure prevented the FDA from doing its job.

Progress Leads to a Crossroads

But there’s good news. A series of reforms, such as the FDA Amendments Act of 2007 and the agency’s new scientific integrity guidelines, have improved the standards for drug approval and transparency at the agency. And according to a recent UCS survey of FDA scientists, while political and corporate pressure on agency scientists persists, many feel that the agency is heading in the right direction.

Now, the FDA is at a crossroads. Congress will soon vote to renew the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), legislation that tells the FDA how it should do its job. Every five years, Congress by law must approve negotiations between the FDA and the industries it regulates that set the fees these companies pay to the agency. The companies use these negotiations to exact performance goals from the FDA aimed at reducing the time it takes to get a drug or device to market, creating a tension between speed and safety.

Pushing to Loosen the Rules

Drug and device manufacturers are lobbying Congress hard for more influence over the process. One way to increase that influence is by relaxing the stricter conflict-of-interest rules enacted in 2007 that directed the FDA to reduce the number of experts on its advisory panels with financial ties to the industries the agency regulates. 

On this page and on the UCS blog, we are making the case for even stronger scientific integrity standards at the FDA. We will give UCS supporters multiple opportunities to weigh in with the members of Congress whose decisions will determine the FDA’s ability to protect the public.

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