DRUG SAMPLES DO NOT INCLUDE STARTER PACKS TO PHARMACIES

DRUG SAMPLES DO NOT INCLUDE STARTER PACKS TO PHARMACIES under the Prescription Drug Marketing Act, FDA Division of Regulatory Affairs Director Albert Rothschild told the Ohio State Board of Pharmacy in a Sept. 21 letter. "'Drug sample' as defined by the PDMA should not be interpreted to include starter stocks," Rothschild said. Explaining the policy, the FDAer noted: "While it is clear that Congress intended to place strict controls on prescription drugs that are distributed to physicians and dispensed to patients without charge, neither the language of the statute nor its legislative history reveals a congressional intent that these controls apply to prescription drugs that are distributed to the pharmacist, without charge, for sale to the consumer." The regulatory affairs director outlined factors to be considered in determining whether a prescription drug is a starter pack or a sample, including "information (such as promotional literature or labeling) demonstrating that the prescription drug products are intended to be provided without charge to a pharmacist for ultimate sale at retail." A second factor to look for in distinguishing a starter pack from a sample is "information demonstrating that the products are distributed in stock containers or in specially-labeled starter pack containers and are not distributed in packages marked 'sample,' 'not for retail sale,' or similar language." Rothschild defined starter packs as "prescription drug products distributed without charge by manufacturers or distributors to pharmacists with the intent that the pharmacists place the prescription drugs in stock and sell them at retail." Starter packs are also known as stock samples, trade packages or starter stocks, he pointed out. In an April 14 letter to FDA, Rep. Dingell (D-Mich.), the primary sponsor of the drug diversion act, urged the agency to require that manufacturers and distributors providing drugs to retail pharmacies free of charge deliver the supplies "only by mail or common carrier and invoiced in a manner sufficient to clearly distinguish them from any similarly packaged products provided to licensed practitioners as samples." Such regulations, the congressman suggested, would help enforcement agents to distinguish promotional deals for pharmacies from sample distributions ("The Pink Sheet" May 22, p. 6). Commenting on the function of starter packs, Rothschild said they are intended to "prime the pump." Pharmacists receiving the drug at no cost will, in turn, fill prescriptions with the new product while becoming "familiar with the manufacturer's product." He added: "Starter packs are a widely used selling tool, and representatives often will make a sales presentation before delivering the starter packs or at the same time they are delivered."