Drug Agency May Reveal More Data on Actions

WASHINGTON — For years, the Food and Drug Administration has withheld information about drugs and medical devices from the public when their makers cite trade secrecy — even in cases where the agency suspects that the products are causing serious illness or death.

Now the new leadership at the F.D.A. may change that. The Obama administration plans to announce on Tuesday that it is setting up a task force within the agency to recommend ways to reveal more information about F.D.A. decisions, possibly including the disclosure of now secret data about drugs and devices under study.

The task will be complicated. Agency confidentiality decisions are governed by several interconnected laws, including the Federal Trade Secrets Act. Changing them would “involve more than one Congressional committee and impact thousands and thousands of companies, and thus would be an extremely difficult legislative path,” said Peter Barton Hutt, a former general counsel to the agency.

Still, the goal is to open up a system in which the agency failed to inform the public that a widely prescribed heartburn drug was especially toxic to babies; that a diabetes medicine and a painkiller increased heart attack risks; and that antidepressants increased suicidal thoughts and behavior in children and teenagers.

“Many people have been harmed over the last decade because the F.D.A. has treated clinical trial results of drugs and devices as trade secrets,” said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who has campaigned for the release of such information.

In 2007, Dr. Nissen published a study showing that Avandia, a popular diabetes medicine made by GlaxoSmithKline, increased the risk of heart attack by 42 percent. The data Dr. Nissen used was made public because of a lawsuit, but the agency had known of the possible risk for nearly two years.

Dr. Catherine DeAngelis, editor of The Journal of the American Medical Association, said greater disclosure would allow researchers and publications like hers to help the F.D.A. fulfill its mission.

The agency “can’t possibly know of everything going on,” Dr. DeAngelis said. “If they could be more transparent, we could really help them.”

Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America, said any agency plan to “disclose information about medicines during the F.D.A. review process should be carefully considered to ensure that the competitive development process remains intact to serve patients and the public health.”

The task force will be led by Joshua Sharfstein, the agency’s principal deputy commissioner, and will include other top officials. It will seek outside comment, including the views of supporters of strong protection for trade secrets. It is to submit a written report to the agency’s commissioner, Margaret A. Hamburg, in six months.

Repeated scandals led the Bush administration in 2005 to promise to make public its product safety investigations more quickly, but it did not recommend changing the laws and regulations that govern the release of trade secrets and agency records.

Trade secrets can include company plans to test experimental medicines, the complete results of most clinical trials, and even the F.D.A.’s reasons for rejecting a company’s application to market a product.

Researchers have long complained that keeping such information secret can harm the public. A 2008 study published in The Journal of the American Medical Association found that in the 1990s, five different companies tested similar blood substitute products that were each found to increase the risk of death. Had the findings been made public, the authors argued, some of the companies might have known sooner that their products were dangerous, sparing the lives of some patients in the studies.

A 2007 law requires companies to publish brief summaries of clinical trials, but such summaries rarely provide enough information for an independent study of the product’s safety.

Without such information, doctors say, they may view some medicines as more effective than they really are. In September 2000, for example, The Journal of the American Medical Association published a study of Celebrex, a painkiller made by Pfizer, suggesting that it helped guard against ulcers.

The journal published an authors’ clarification after learning that Pfizer had given the F.D.A. a more complete set of data suggesting that the drug did not protect against ulcers. Even so, Pfizer sales representatives continued to give the original study to doctors’ offices.

The agency’s secrecy provisions have also had financial repercussions. In a case that snared Martha Stewart, ImClone Systems of New York assured investors that its cancer drug, Erbitux, was on a path for approval until the F.D.A. rejected it in 2001. The company then said the agency’s concerns were minor, until a cancer newsletter leaked a secret F.D.A. letter showing profound reservations. (The drug was later approved.)

Like ImClone, other biotechnology companies have come under investigation by the Securities and Exchange Commission for claiming that the F.D.A. viewed their applications more positively than was secretly the case.

Secrecy rules have also prevented the F.D.A. from responding to critics of its decisions to reject some applications. Dr. Hamburg and Dr. Sharfstein wrote an opinion article in The New England Journal of Medicine last week signaling the new effort.

“Whenever possible,” they wrote, “the F.D.A. should provide data on which it bases its regulatory decisions.”