Investigator Financial Disclosure Revised Rule Limits Retrospective Reports

Retrospective collection of financial information about clinical investigators' equity interests in publicly traded companies has been eliminated from FDA's "Financial Disclosure by Clinical Investigators" final rule.

In the original final rule, published Feb. 2, 1998, the reporting requirements included all financial arrangements from completed studies in any marketing application submitted on or after Feb. 2, 1999 ("The Pink Sheet" Feb. 9, 1998, p. 7).

The revised rule, issued Dec. 31, specifies that "information on the equity interests in a publicly traded corporation, when such interests exceed $50,000," must be collected only for "those covered clinical studies that are ongoing as of Feb. 2, 1999" or begin after the effective date of the rule.

The revision eliminates "the potential administrative burden to sponsors of reconstructing records after the fact, thereby reducing the information collection burden on regulated industry without compromising the integrity of the final rule," FDA explained.

FDA revised the final rule in response to a July 31 petition for reconsideration from the Pharmaceutical Research & Manufacturers of America ("The Pink Sheet" Aug. 10, 1998, p. 13). The petition was supported by the Health Industry Manufacturers Association in Aug. 17 comments.

In addition, manufacturers will now only be required to collect and report those payments of less than $1,000 to physicians or $2,500 to institutions made on or after Feb. 2, 1999.

While PhRMA had argued that the administrative burden of tracking relatively small payments is unjustified and advocated the elimination of the provision, FDA remarked that it is "reluctant to create a mechanism that could be used to circumvent the reporting requirement entirely by making many small payments to an investigator or institution."

The modification of the submission date "reasonably addresses sponsors' concerns about the burdensomeness of the requirement," FDA concluded.

The final rule still requires retrospective collection of information regarding "compensation affected by the outcome of clinical studies," "proprietary interests in the tested product" and "ownership interest whose value cannot be readily determined through reference to public prices," for investigators participating in "ongoing or already completed" studies used to support applications submitted on or after Feb. 2, 1999.

FDA said it is not changing these requirements because "the agency believes that the information required...with regard to any ownership interest" whose value cannot be determined publicly "is the most critical to the agency and therefore, its collection should not be deferred."

The definition of "covered clinical trials" was also amended in the final rule to exclude financial reporting for "Phase I tolerance studies or pharmacokinetic studies, most clinical pharmacology studies (unless they are critical to an efficacy determination), large open safety studies conducted at multiple sites, treatment protocols and parallel track protocols."

With regard to safety studies, "the agency has concluded that only those studies in which a single investigator makes a significant contribution to the demonstration of safety will be included in the definition of covered clinical study."

FDA also amended its original definition of "clinical investigator" to clarify that the definition is intended to include only listed or identified investigators who are directly involved in the treatment or evaluation of research subjects and who had "significant roles" in covered clinical studies. The prior definition included an investigator's spouse and dependent children. FDA upheld its inclusion of "subinvestigators" within the covered definition, despite PhRMA's objections.

FDA estimates that from 1%-10% of applications will need disclosure statements. The cost estimate to industry remains the same in the revised final rule.

The agency "now believes that its original figure of less than $450,000 annually may have understated the reporting costs of the rule as published on Feb. 2, 1998, but reasonably reflects that reporting costs of the final rule as amended."

FDA will consider issuing a guidance clarifying the financial disclosure final rule after the agency and those subject to the rule gain some experience with its implementation, the agency said.