FDA AUTHORITY TO INVESTIGATE PAID MEDICAL EXPERTS FOR DRUG COMPANIES

FDA AUTHORITY TO INVESTIGATE PAID MEDICAL EXPERTS FOR DRUG COMPANIES is needed if FDA is "to seriously attempt to enforce the law against promotion of drugs and devices for off-label uses," the House Government Operations/Human Resources Subcommittee asserts in a report released Nov. 23. The report focuses on off-label promotion of drugs and devices -- particularly Ortho's Retin-A promotional efforts for the off-label use of treating photodamaged skin. The report also looks at cosmetic uses of silicone and collagen injections. The subcommittee, chaired by Rep. Payne (D-N.J.) since the death of Rep. Weiss (D-N.Y.) in September, concludes the report with eight recommendations. Heading the list is a recommendation that Congress give FDA "the statutory authority to obtain all information needed to determine whether researchers or physicians are receiving money from manufacturers." The subcommittee report notes that "there is often a fine line between the sharing of research results and the promotion of a drug." The FDA enforcement bill, which died before reaching the House floor, would give the agency the subpoena authority "to obtain information whether individuals are directly or indirectly paid for their 'sharing of scientific information,'" the report states. According to the report, the subcommittee was able to obtain information from J&J that enabled it to "determine which physicians and scientists who were extolling the benefits of Retin-A had received research grants, honoraria, and consulting fees from the company." FDA did not have the same information, the report states, "because they claim to not have the authority to demand that information from a company or a researcher." The report asserts that "university faculty acted essentially as paid spokespersons, promoting a drug for an unapproved use." According to the subcommittee report, J&J did not directly pay the researchers, but instead paid "a third party, such as a university or public relations firm, which then paid the researcher." As an example, the report maintains that J&J "gave grants to Boston University Medical School and to a public relations firm, who then gave money to individual faculty members who praised the drug at professional meetings or in 'educational materials.'" The report further suggests that J&J's use of third parties to distribute funding to researchers allowed those researchers to later deny having received money from the company. "Similarly," the report states, "when the FDA criticized the company for their promotional activities, the company claimed that the researchers were acting independently and that their promotional activities were not under the control of the company." The subcommittee, in a September 1990 report to HHS recommending medical conflict-of-interest regulations, cited Ortho's promotion of the anti-wrinkling indication ("The Pink Sheet" Sept. 10, 1990, p. 2). Ortho's Retin-A promotional efforts were also the subject of a June 1991 subcommittee hearing ("The Pink Sheet" June 17, 1991, p. 7). At that hearing, FDA reported that it had turned its investigation over to the Justice Department. Justice says the investigation is "ongoing." The subcommittee also documents FDA's "unsuccessful" efforts over the past three years to halt the promotion of Retin-A for unapproved uses. A month after Ortho's January 1988 press conference on Retin-A at which researchers described the product's anti-aging benefits, FDA said it was looking into the promotional activities. "However, the FDA did not request documents from Ortho until Aug. 31, 1989," the report says. Weiss requested information about Retin-A from FDA in November 1989, and FDA again contacted the firm. The report also points out that Ortho ran an ad campaign in 1990 that emphasized the product's Delcap dispenser but did not mention that the product was approved only for acne. FDA later met with the firm, at which time the ads were changed to include the words "for acne," the report notes. The report also recommends that FDA use its authority to fine companies that promote unapproved uses of a drug. The report indicates that FDA told the subcommittee that "the usual maximum penalty for the promotion of a drug for an off-label use would be $100,000 for an individual and $200,000 for an organization." However, according to the subcommittee, "it is possible [for FDA to] fine a company up to twice the gross gain that resulted from the infraction." Because FDA has "not used that authority," the report charges, "companies believe that they can continue to promote drugs for off-label uses with little risk of substantial penalty." Other subcommittee recommendations for FDA include: funding research or demonstration projects to increase physician reporting of adverse reactions to drugs and devices for both approved and unapproved uses; taking criminal action against manufacturers that "wilfully" violate the laws regarding adverse reaction reporting; working with medical schools to develop curricula on the importance of establishing the safety and efficacy of a product. In addition, the report recommends that Congress pass legislation to clarify FDA's authority to review protected court documents that concern the safety and effectiveness of products regulated by the agency. Two dissenting opinions were published with the report. Committee members Thomas (R-Wyo.), Kyl (R-Ariz.), Schiff (R-N.M.), McCandless (R-Calif.), Horton (R-N.Y.) and Clinger (R-Penn.) state that they agree with the report that FDA should play a more active role in regulating the promotion of unapproved uses. However, they do not support extending FDA's enforcement authority and argue that the use of unapproved treatments "is something that we will never be able to regulate or legislate out of existence." An NDA for J&J's Renova tretinoin formulation for treatment of photoaging has been at the agency since July 1989. Part of the NDA was withdrawn by the company in March 1991 in response to FDA questions regarding the formulation and was later resubmitted in October 1991. FDA's Dermatologic Drugs Advisory Committee, in April, unanimously recommended that the product be approved for improving the appearance of photodamaged skin ("The Pink Sheet" April 13, p. 3).