HHS NEWS

U.S. Department of Health and Human Services


P98-5                                FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE                Print Media:         301-827-6242
February 2, 1998                     
                                     Consumer Inquiries:  800-532-4440

FDA ANNOUNCES FINANCIAL DISCLOSURE RULES

The Food and Drug Administration today announced requirements that sponsors of drug, device and biologics marketing applications disclose whether clinical investigators have financial interests that could affect the reliability of submissions for approval. The rule addresses concerns that clinical data submitted in support of a medical product application might be influenced by financial considerations not disclosed to FDA.

"Although some have argued that there is nothing inherently wrong with scientists in the private sector and academia having financial interest in the products they study, FDA must be aware of these relationships as it evaluates the clinical data fromthose trials, "said Michael A. Friedman, M.D., FDA's Lead Deputy Commissioner. "This regulation will help assure that the processis thoroughly open and above-board."

The final rule, which goes into effect a year from today, requires firms applying for drug, biological product or medical device marketing approval to either disclose, or certify to the absence of, the following types of financial interests andarrangements:

compensation made to the clinical investigator whose value could be affected by the study outcome;

proprietary interest -- such as a patent -- by the investigator in the tested product;

significant equity interest in the sponsor of the study;or

significant payment by the sponsor of other sorts, such as a grant to fund ongoing research, compensation in the form of equipment, or retainers for ongoing consultation or honoraria.

After these regulations take effect, FDA may refuse to file marketing applications without the requisite disclosure or a certification that no such financial arrangement exists.

The agency intends to propose similar requirements for submissions dealing with foods, animal foods and animal drugs inthe future.

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