Bush Signs Legislation Giving FDA More Oversight

The FDA will have new authority to regulate medications and medical devices that are already on the market under a bill recently signed by President Bush.

The Food and Drug Administration Amendments Act of 2007, H.R. 3580, (at the Library of Congress' THOMAS Web site type "HR 3580" in the search bar after selecting "Bill Number") gives the FDA the authority to take various actions to help determine if approved drugs or medical devices pose health risks, including by providing on-line access to studies on the drugs or medical devices.

"When studies are done, that information will be made available on a Web site so the public and scientists can have access to that information," said Diana Zuckerman, Ph.D., president of the National Research Center for Women and Families, explaining some provisions of the bill.

Under the new law, the FDA has the ability to limit distribution of a product and order label changes on products that pose a risk. In addition, the agency will have more resources and authority to monitor medications and medical devices that already are on the market.

The measure was passed as part of legislation to reauthorize the Prescription Drug User Fee Act, or PDUFA, and the Medical Drug User Fee Modernization Act, or MDUFMA. Companies that make medical products pay the FDA user fees under PDUFA and MDUFMA as part of the approval process for drugs and medical devices respectively. The acts were set to expire on Sept. 30 before Bush signed H.R. 3580 into law on Sept. 27.

In recent years, a few blockbuster drugs and widely used implants have caused life-threatening and life-ending illnesses in some patients, prompting the enhancement of the FDA's regulatory powers under H.R. 3580, which is intended to "close some of these gaps in safety," said Zuckerman.

Some consumer advocates are convinced that the FDA has gotten too close to the pharmaceutical and medical device industries in recent years, weakening the agency's role as a regulator and causing the agency to "disregard patient protections," to approve drugs faster, Zuckerman said in an interview with AAFP News Now. Zuckerman and other consumer advocates are disappointed that the new law does not give the FDA more regulatory authority, such as the power to preview all direct-to-consumer ads to make sure they are not misleading.

Rich Buckley, vice president of federal government affairs for AstraZeneca, a pharmaceutical company, disagrees that the law does not give the FDA enough regulatory authority. The law represents a "bi-partisan compromise" that "will give the (FDA) additional resources and tools to do its job," says Buckley.

"That is a benefit to the pharmaceutical industry, but more importantly it is a benefit to the millions of patients and families who rely on the agency to do its job," he said.

Buckley strongly disagrees with "the notion that the FDA is rubber-stamping drug applications."

"To the contrary, our experience with the agency is they are very diligent with their work, that they take their job very seriously, and when they see a problem, they don't hesitate to act," he said.