PMA AND APhA EXPLORING STATE APPROACH TO SAMPLING CONTROLS

Executive Summary

PMA AND APhA EXPLORING STATE APPROACH TO SAMPLING CONTROLS following an interassociation study group review of the issue. At a June 9 meeting, the "Study Group on Sampling," under the direction of the American Pharmaceutical Association (APhA), suggested developing "model, uniform state legislation or regulations" to address recordkeeping, labeling, and storage requirements for sample distribution by the pharmaceutical industry and prescribers. The state approach to sampling controls represents an alternative to April recommendations by Chairman Dingell's (D-Mich.) Oversight & Investigations Subcommittee. In a memo in the June 9 study group meeting, no reference was made to two Dingell proposals: (1) that physicians be required to make written requests for samples, and (2) that detail persons be prohibited from delivering samples. The study group apparently is trying to unite the efforts of pharmacy associations and fashion a middle ground position on sampling. A memo on the June meeting requests that organizations contact APhA "as soon as possible regarding whether or not [the] organization is prepared to actively support" the state approach. Participating organizations include the Pharmaceutical Manufacturers Association (PMA), the National Association of Chain Drug Stores, the National Association of Retail Druggists, the American Society of Hospital Pharmacists, and the National Wholesale Druggists Association. The study group suggested developing a state model for sampling control "in concert with the National Association of Boards of Pharmacy [NABP]." NABP reportedly has told APhA that it is willing to work with others on a solution, but not at the expense of discarding its pursuit of federal sampling regulation. PMA has the sampling issue on the agenda for its July 10 board meeting. The association will review recommendations for a sampling position formed by PMA marketing and legal sections. PMA is apparently preparing to seek modifications to Dingell's ban on detailed samples during the next Congress. The interassociation study group is an adjunct to an APhA/PMA joint task force on Rx drug sampling which met last February. That task force was charged with guiding "[APhA and PMA] in their joint efforts to resolve various issues surrounding the practice of sampling of prescription drug products." The task force proposed changes in the present sampling system, such as establishing procedures for manufacturer and prescriber accountability, uniform recordkeeping methods, identification of patient use, limits on amounts of samples dispensed; instituting regulations to prohibit sample resale or bartering; and maintaining a "dialogue with the pharmaceutical industry, the pharmacy profession, and the prescriber professions . . . to assure . . . an environment which minimizes the potential for misuse of samples."