FDA Aims to Make Its Decisions More Visible

The U.S. Food and Drug Administration said on Tuesday it had formed a task force to look for ways to make its decisions regarding medicine and public health matters more transparent.

"While the agency cannot disclose all types of information, I believe the agency can do a better job of providing useful information to the public in a timely manner," FDA Commissioner Margaret Hamburg told reporters.

The FDA has been described as a "black box" because of its lack of transparency.

"The agency can and should communicate with the public in a way that provides more clarity about agency activity and processes - not less," Hamburg said.

She said increasing transparency and helping the public understand the reasoning behind FDA decisions was "very important to our credibility."

The task force will be chaired by FDA Principal Deputy Commissioner Joshua Sharfstein and is scheduled to deliver recommendations to Hamburg within six months.

Physicians and consumer groups have criticized the FDA for withholding data on the grounds that it must protect companies' trade secrets. For example, the FDA typically does not disclose when it rejects a drug or medical device and why.

Critics have said such information is vital to public health.

Investors have complained that the FDA's silence about its progress on drug applications makes it difficult to gauge prospects for approval.

Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America, said, "Any proposal to disclose information about medicines during the FDA review process should be carefully considered to ensure that the competitive development process remains intact to serve patients and the public health." PhRMA is the industry's main lobbying group.

According to an FDA notice in the Federal Register, the task force will look for ways to make information more readily available to the public "in a manner compatible with the agency's goal of protecting confidential information, as appropriate."

Sharfstein said the task force wants public input regarding disclosure of clinical trial data and information related to product recalls and approvals. A public meeting has been scheduled for June 24 and another will be held in the fall, the FDA said.