New Law to "Shine Light" on FDA Drug Approvals

A bill just approved by Congress will provide the public with better information about drugs approved by the Food and Drug Administration (FDA), according to news from the Union of Concerned Scientists (UCS).

The Food and Drug Administration Revitalization Act, approved by the House of Representatives by a 405 to 7 vote, is actually a combination of six separate bills. Four bills reauthorize existing FDA programs that would have expired Sept. 30, while two new bills expand the FDA's authority to assess and manage drug risks and encourage the development of specialized pediatric medical devices.

In addition, the new legislation requires the FDA to post all clinical drug trials and results on a public online database managed by the National Institutes of Health. It calls for the FDA to gradually reduce, over the next five years, the number of conflict-of-interest waivers it can grant to doctors and scientists appointed to drug review advisory panels. The bill also provides greater protection for FDA scientists to publish their research.

The FDA's use of drug-industry experts on advisory panels has come under frequent fire from watchdog groups. Such groups have also complained about numerous cases of political interference with government scientists' research, publications and speech

"This bill, now approved by both chambers of Congress, will make a difference," said Francesca Grifo, senior scientist and director of the Scientific Integrity Program at UCS. "The bill contains transparency language that will shine a light on the FDA drug approval process, ensuring that the dissenting views of drug reviewers are heard and not suppressed and ignored."

"The FDA reform bill ... represents a step forward in protecting scientific integrity at the Food and Drug Administration," said Merrill Goozner, science director for the Center for Science in the Public Interest. "However, given the magnitude of the problems in drug and food safety that have come to light in recent years, the bill falls far short of spurring the dramatic changes that the public needs and deserves."

A UCS survey last year of nearly 1,000 FDA scientists found that 20 percent said supervisors had asked them to provide "incomplete, inaccurate or misleading information" to the public, media or government officials. Other UCS surveys have found similar complaints of intimidation and political interference at the U.S. Fish and Wildlife Service, NASA, the National Oceanic and Atmospheric Administration and the Environmental Protection Agency.

Grifo said the UCS will continue to watch the FDA to see how it puts the new legislation into action.

"Of course the ultimate test will be how well and comprehensively the FDA creates and implements regulations required by this bill," she said. "We will closely monitor the FDA's performance to ensure that the public gets full access to the information they need."

Union of Concerned Scientists, "Congress Passes Law Improving FDA Drug Approval Process to Better Protect Consumers." URL: (http://www.ucsusa.org/news/press_release/congress-passes-law-improving-0064.html)