US FDA DRUG MARKETING PROPOSALS VIEWED

Commenting on the US Food and Drug Administration's notice of proposed rulemaking for a regulatory framework for the Prescription Drug Marketing Act of 1987 and the Prescription Drug Amendments of 1992, the American Society of Hospital Pharmacists repeats its opposition to the manufacture and distribution of drug samples, but offers the following suggestions:

- concerning the definition of "blood components" and "prescription drugs," the ASHP notes that since the PDMA was passed, the use of commercial blood component preparations has expanded as more have become available. "Many practitioners have raised questions about whether the agency considers such 'products' to be blood components or drugs, and especially how such a classification would be related to PDMA's sales restrictions," it says. Further, it asks if the FDA makes a distinction between human and recombinant products in such classifications, noting that many commercially-available products do not necessarily fit the proposed definition of "blood component;"

- the ASHP agrees that "starter packs" should not be considered "drug samples," but adds that they should also be guarded against diversion through the manufacturer and/or distributors' establishment of accounting, audit and security systems;