Financial Disclosure Reg Should Exempt Publicly-Sponsored Studies - PhRMA

Publicly-sponsored studies should be considered outside FDA's definition of "covered clinical studies" requiring financial disclosure information, the Pharmaceutical Research & Manufacturers of America told the agency in recent comments.

"Pharmaceutical firms that lend modest support to publicly sponsored studies," generally via donation of study drug or "modest monetary contributions" to support lab work, "do, obviously, have prospective commercial interest," PhRMA admitted.

"But their lack of operation control (in such respects as selecting, monitoring and communicating with investigators), and their lack of visibility to investigators, renders those interests of little or no significance for purposes of financial disclosure," the trade group pointed out.

FDA's final rule on financial disclosure by clinical investigators requires disclosure of investigator compensation and equity interests above $50,000, as well as disclosure of significant payments of other sorts, including consulting fees and honoraria, greater than $25,000. FDA released a draft guidance describing implementation of the rule on Oct. 25, 1999 (¹ (Also see "Investigator/CRO Financial Disclosure Required By FDA; Feb. Rule Expanded" - Pink Sheet, 1 Nov, 1999.)).

PhRMA described "multiple compliance obligations" that could arise if financial disclosure is mandated for publicly-sponsored studies.

"Given uncertainty at the threshold as to whether a publicly-sponsored study may ultimately be submitted in support of a marketing application, there may be no choice but to err on the side of caution and initiate financial disclosure...at the start of each study," PhRMA said. "Often, these efforts will prove to have been unnecessary, if no private firm ultimately makes use of the data for regulatory purposes."

PhRMA is also advocating for exemption of Phase I pharmacokinetic studies in special populations (e.g., elderly, renal-impaired) and drug interaction studies from the financial disclosure rule.

FDA should clarify that "completion of a study" refers to completion of study at an individual site rather than the completion of the overall study, PhRMA said.

PhRMA is asking FDA to define completion of a study as meaning that "all study subjects have been enrolled and follow-up of primary endpoint data has been completed on all subjects enrolled at the investigator's study site in accordance with the study protocol." The disclosure rule requires that investigators report financial arrangements for one year following completion of a study.

Merck similarly suggested that the agency collect financial disclosure information only from study start through the "locking" period of the clinical database. Bristol-Myers Squibb suggested that FDA establish a "period of time prior to submission of a regulatory filing after which financial information received by an application need not be submitted to FDA."

While FDA's guidance indicates that an applicant does not need to submit new financial information to FDA after submission of an application for regulatory approval, FDA did not set a "cut-off date before an application is filed after which such financial information need not be submitted," Bristol noted. "This will make it impossible for an applicant to complete an application for regulatory approval." Bristol suggested 120 days as a sufficient period of time.

PhRMA noted it is industry's understanding that "when the sponsor of a trial is not a publicly traded subsidiary of a publicly-traded parent corporation, the sponsor does not have to collect information about, or certify concerning an investigator's equity holdings in a parent corporation."

The association added that an FDA representative "confirmed that interpretation of the rule" at a November Drug Information Association workshop (² (Also see "Investigator Payments Made Prior To Study Do Not Trigger Disclosure - FDA" - Pink Sheet, 8 Nov, 1999.)).

"Any other interpretation...would impose complex reporting requirements on investigators and sponsors, to track the relationships between companies, that would distract from the investigator's attention to the protocol requirements for the study," PhRMA said.

The association's interpretation provides that, for example, an investigator participating in a Wyeth-Ayerst study would not need to report any equity interest in Wyeth parent American Home Products, while companies without subsidiaries, like Merck, would have to disclose investigator's interests.