Groups urge FDA to release info on rejected drugs

By Susan Heavey

WASHINGTON (Reuters) - The U.S. Food and Drug Administration should make more information available to the public, even on drugs and devices that never make it to the U.S. market, consumer advocates told the health agency on Wednesday.

But industry representatives cautioned that findings or data containing confidential company information could harm competition if made widely available.

While the FDA often provides public details on products that win its approval, doctors and consumers could benefit from similar disclosure on those it rejects, several advocates and former FDA staff reviewers said at a public meeting to discuss ways the agency can make its regulatory decisions clearer.

Details on why it declines a new use for a drug already on the market could help protect patients from possible side effects if doctors are already prescribing it for so-called "off-label" use or as rival drugs are developed, said the Pew Prescription Project's Allan Coukell.

"Lives might have been saved," Coukell, director of the nonpartisan consumer safety group, told the panel of eight top FDA officials.

The FDA, which regulates a wide-range of foods, drugs and devices that make up about 25 percent of the U.S. economy, has ultimate say on whether medications can be sold or whether certain foods must be recalled. It also monitors manufacturing sites and monitors drug risks, among other duties.

But it has come under fire amid a number of scandals involving a variety of products including painkillers, contaminated peppers and peanut butter.

Some critics said the agency, which gets much of its funding from company fees, is too cozy with the industries it regulates.