FDA Considering Releasing Information on Rejected Devices

No more secrets.

That is the edict U.S. Food and Drug Administration (FDA) officials have set for themselves as they attempt to transform the agency into a more transparent, trustworthy organization. In keeping with this self-imposed decree, FDA executives are considering making a significant change to its product approval process.

An agency task force has recommended that the FDA disclose company inspection reports as well as letters sent to companies about a product’s approval or rejection. Currently, the FDA only releases data about products it approves; agency officials will not discuss pending applications, even if that information already has been released by a company (FDA advisory committees don’t usually abide by this unwritten rule, though).

Similarly, the FDA does not routinely release inspection reports. The agency typically releases such reports only in high-profile cases, such as Johnson & Johnson’s recent recall of Tylenol liquid medicine for children and infants.

The recommendations to release inspection reports and data on rejected devices and drugs are among 21 suggestions included in a 67-page report released last month by the FDA’s Transparency Task Force. The agency formed the task force to help the FDA make its activities and decision-making more readily available to the public in a timely manner and in a user-friendly format. The task force report contains 21 draft proposals for public comment on public disclosure policies aimed at helping consumers, stakeholders and others understand how the FDA operates and makes decisions while maintaining the confidentiality of trade secrets and individual identifiable patient information.

“At the FDA, we recognize that the successful implementation of this principle [promoting openness in government] will enhance our ability to promote and protect public health,” task force chairman and FDA Principle Deputy Commissioner Joshua M. Sharfstein, M.D., said in the report. “The public, Congress, media and industry should all understand how FDA operates and why the agency makes key decisions.”

The Task Force is accepting public comments on the proposals and will decide which of the suggestions to recommend to FDA Commissioner Margaret Hamburg, M.D., for implementation. The FDA is collecting public comment on the draft proposals’ content as well as on those that should be given priority, until July 20.

Providing the public with data about rejected devices and drugs could enhance the credibility of the FDA’s decisions and explain its concerns about failed applications, according to the task force report. Consumer advocates argued last summer that such a disclosure could better protect patients against harmful devices and/or drugs. Industry representatives, however, claimed that releasing data that contained confidential company information could harm competition.

The task force contends that routinely releasing inspection reports would prompt companies to correct violations on their own. “Public disclosure of this information makes firms accountable not only to FDA, but to the public at large,” the task force report stated. “Further, other firms are provided with information that will help them make more informed decisions about companies they choose to do business with. Market pressures may create incentives for firms to correct violations quickly or prevent violations from occurring in the future.”

Those interested in commenting on the task force report should visit www.fda.gov/transparencyreport.