Financial Disclosure by Clinical Investigators

By Marcus L. Stevenson, J.D., LL.M. candidate

Effective February 2, 1999, clinical investigators will be required by the Food and Drug Administration (FDA) to disclose certain information regarding their compensation and financial interests in clinical trials. On February 2, 1998, FDA promulgated a final rule intended to provide FDA with information regarding clinical investigators' financial interests in the clinical trials they are helping to conduct. 63 F.R. 5233 (1997). The regulation requires a sponsor of any drugs, biologics, or medical devices to disclose:

  1. compensation made to the clinical investigator in which the value of the compensation could be affected by the study outcome;
  2. a proprietary interest by the investigator in the tested product, such as a patent;
  3. a significant equity interest in the sponsor of the covered study; or
  4. significant payments by the sponsor of the covered study of other sorts, such as a grant to fund ongoing research, compensation in the form of equipment, or retainers for ongoing consultation or honoraria.
Opponents of this regulation are concerned that FDA does not have the authority to obtain such financial data and that it should not be allowed to acquire the data by means of a reviewing division within the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, or the Center for Devices and Radiological Health. Opponents also argue that there is no evidence that the public’s health and safety has been jeopardized because FDA has not received financial data regarding interested clinical investigators. Other opponents expressed concern that financial disclosures may negatively affect the acceptance of foreign data used to support various approval applications for drugs, biologics, and medical devices. Despite these concerns, FDA believes that its position is sound and that such disclosures will ferret out biased information that would undermine the integrity of a clinical trial and, ultimately, the strength of the drug, biologic, or medical device.

The regulation amended the various provisions governing the disclosure requirements of drugs, biologics, and medical devices. Importantly, in the event of a failure to include the financial interests of the clinical investigators, FDA may refuse to file the Investigational New Drug and New Drug Application, Product and Establishment License Applications, and PreMarket Approval applications. FDA has expressed its intentions to broaden the scope of these regulations to include submissions for marketing approval of human foods, animal foods, and animal drugs in the future.

03/13/98