Final conflict of interest regulations

WASHINGTON - FDA has published a final regulation on financial disclosure that requires any applicant who submits a marketing application for a drug, biological product or device to disclose whether the clinical investigators have financial interests that could affect the reliability of the submissions. The rule, which becomes effective in February 1999, addresses concerns that clinical data submitted in support of a product application might be influenced by financial considerations not disclosed to the agency.

The regulation is the final version of rules that were proposed in September 1994. The final rule requires the applicant either to disclose, or certify to the absence of, financial interests and arrangements affecting the investigators, even if the applicant did not conduct the clinical trials used in the filing. This includes:...