Grassley-Dodd Bill Seeks Separation of Powers

PharmaManufacturing.com
05/05/2005

A recently proposed U.S. Senate bill seeks to create an independent FDA branch to monitor and control drugs already on the market. The proposed office, the Center for Postmarket Drug Evaluation and Research (CPDER), would report directly to the FDA commissioner and carry out its business separate from CDER, which evaluates and authorizes new drug approvals (NDAs). It would have the power to take drugs off the market, monitor product labels and advertising, and levy fines for noncompliance with its mandates.

The legislation, the FDA Safety Act of 2005, has been put forth by Iowa Republican Sen. Charles Grassley, an outspoken proponent of FDA and drug policy reform, and Connecticut Democrat Christopher Dodd. FDA “needs to be a more vigilant watchdog,” Grassley said recently. “Some say we need a Rottweiler as opposed to a Chihuahua.”

The two senators aim to “restore confidence in the words ‘FDA Approved,’ and ensure that the FDA has all the tools that it needs to protect patients,” said Dodd in a speech on the Senate floor. The legislation, he said, would “allow the FDA to act quickly to get answers when there are questions about the safety of a drug, and to act decisively to mitigate the risks when the evidence shows that a drug presents a safety issue. With these authorities, we will never again have a situation where a critical labeling change takes two years to complete, as was the case with Vioxx.”

The Bill faces stiff opposition, most notably from influential Republican Sen. Mike Enzi, of Wyoming, and thus an uncertain path. Enzi favors keeping the approval process and post-market oversight in the hands of CDER.