FDA Publishes Conflict of Interest Rules for Clinical Trials
On February 2 the FDA published rules which, when they become effective in February 1999, will require disclosure of certain financial arrangements between pharmaceutical companies and certain clinical investigators, when a drug is submitted for marketing approval. Most of this information will come from the companies, since they already know what their financial arrangements with their investigators are; it appears that individual researchers will only need to disclose stock ownership in the sponsoring company. The FDA estimates that only one to ten percent of companies submitting applications for approval of drugs or devices will need to submit disclosures for one or more of their investigators. The FDA will decide case by case whether the information will be made public. The disclosure requirement applies to "any listed or identified investigator or subinvestigator who is directly involved in the evaluation of research subjects," and to immediate family members.The purpose of the new rule is to prevent bias in safety and efficacy studies of drugs and medical devices. We note it here for three reasons:
Clinical researchers may want to avoid the kinds of financial relationships which are likely to raise a red flag at the FDA--particularly "compensation made to the clinical investigator in which the value of the compensation could be affected by the study outcome; a proprietary interest by the investigator in the tested product, such as a patent; a significant equity interest in the sponsor of the covered study; or 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." Disclosure will be required for stock ownership over $50,000 in the sponsoring company, or other payments over $25,000. The new rule does not prohibit any form of compensation; but companies and researchers may want to avoid those which will require disclosure, because they will subject the company's new drug application to extra scrutiny.
Persons investigating conflict of interest in medical research can find detailed background in the 19,000-word FDA publication, which includes in-depth discussion of why certain provisions were and were not included in the new rule, answers objections from industry, and comparison of this rule with other government disclosure requirements.
Even though the February 2 publication is a "final rule," certain parts are still open for public comment until April 3. After that, the FDA will submit the rule to the OMB (Office of Management and the Budget) for final approval, and there will be an additional period for public comment to OMB.
The published regulation appears in the Federal Register, February 2, 1998, volume 63 number 021, 63 FR 5233. If you are doing a computer search of the Federal Register, we found that the phrase "disclosable financial" was a useful search term for finding this publications. You can search the Federal Register without charge through the Web site of the National Archives and Records Administration, http://www.access.gpo.gov/nara/.
