By Lisa Seachrist
WASHINGTON — To address concerns that financial links between clinical investigators and sponsors of drug applications could result in biased reporting of trial data, the FDA has issued its proposed final rules requiring disclosure of such arrangements.
In its proposal, the agency would require sponsors of drug, device and biologics marketing applications to disclose whether clinical investigators held a proprietary interest in the tested product, maintained a significant equity investment in the sponsor of the study or received a significant payment from the sponsor. After the regulations take effect, the FDA may refuse to file marketing applications without the requisite disclosure or a certification that no such financial arrangement exists.
"Although some have argued there is nothing inherently wrong with scientists in the private sector and academia having financial interest in the products that they study, FDA must be aware of these relationships as it evaluates the clinical data from those trials," said Michael Friedman, lead deputy FDA commissioner. "This regulation will help assure that the process is thoroughly open and above board."
Much of the attention the agency is placing on financial arrangements between investigators and sponsors of clinical trials comes from the fact that companies were offering investigators stock and stock options in return for participating in the study. Because the investigator now owns part of the company, there is a theoretical incentive for the investigator to ensure the clinical results prove the product is safe and effective.
The FDA states it does not believe it should ban any types of financial arrangements, but asserts it should be aware of the arrangement when evaluating marketing applications in order to give such studies particularly close scrutiny to be sure everything is above board.
The agency defines a significant equity investment as $50,000 or more in the sponsor of the covered study. The agency also wants to know about payments that sponsors of the covered study make to investigators, such as research grants, honoraria, equipment, and retainers for ongoing consultation that are in excess of $25,000. In addition, sponsors must identify if any of the investigators hold the patent on the product being tested.
"We generally don't believe there is a problem with disclosing this information," said Allan Goldhammer, director of technical affairs for the Biotechnology Industry Organization (BIO). "This simply allows the agency to remove even the perception of bias when considering marketing applications. However, with appropriate study design and blinding, there shouldn't be much opportunity for bias."
BIO Supported Disclosure Rules
Goldhammer said BIO filed comments in support of such regulations in December 1994. In its comments, BIO suggested disclosures submitted should be kept strictly confidential by the FDA, and the agency should use the information only to evaluate the potential for bias.
The Pharmaceutical Research and Manufacturers of America (PhRMA) noted that in the proposed final rules published in the Federal Register Feb. 2, the FDA "declined to state that the information would remain private." In fact, the agency said it would consider patent ownership public information and maintained that other information would be considered private unless circumstances clearly outweighed the privacy interest. However, the agency did not identify what type of circumstance would allow the release of information.
"We are asking our companies whether we should submit comments to the agency about their proposal at this time," said PhRMA media spokesman Jeff Trewhitt. He said PhRMA is concerned there could be inconsistent weighing of privacy issues, and the organization is considering asking the agency to prepare a guidance document addressing this issue.
The FDA will accept comments on its proposed final rule until April 3, 1998. *