FDA Drops Proposed Rule Requiring Sponsors to Report Falsified Clinical Data

The FDA has scrapped a proposed rule that would have required drug sponsors to report possibly fabricated data in clinical trials.

The now-defunct measure — first introduced in February 2010 — would have amended regulations to require sponsors to report any evidence showing clinical trial data or results may have been doctored.

The FDA determined the proposed rule was no longer needed to protect research subjects or ensure the integrity of clinical trial data used to support marketing applications and requests for product approvals.