FDA Considers Publication of Clinical Trial Data, Complete Response Letters

Mark Mansour, Partner, Bryan Cave, LLP

The medical device industry is pushing back against calls for the FDA to release data from unsuccessful clinical trials, and has stated that, because the agency’s decision not to approve or clear a device often does not constitute final agency action, the FDA lacks the authority to release that data.

In addition, the FDA’s transparency task force is considering publishing the so-called complete response letters sent to drug companies outlining the outstanding issues, in the hope that the publication of the letters will ultimately speed the review process. Some companies, however, have concerns that the agency’s complete response letters contain trade secrets that would compromise their research if shared.

Mark Mansour is a partner in the firm, Bryan Cave, LLP