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MD DRUG SAMPLES ARE TRADED BY BUSINESSES UNRELATED TO DRUG INDUSTRY, OHIO STATE PHARMACY BOARD DIRECTOR WICKHAM TESTIFIES AT HEARING FOCUSING ON SAMPLES

Executive Summary

Businesses unrelated to the pharmaceutical industry trade in diverted physician drug samples, Ohio's State Pharmacy Board Executive Director Franklin Wickham testified at a July 16 hearing before Rep. Dingell's (D-Mich.) House Commerce/Oversight Subcmte. "We had one example that came up during our [state] board hearings of a pharmacist who bought birth control drug products samples from a toy salesman," Wickham said. In another instance, "one of our inspectors and an Akron police officer bought from a TV repairman and a pharmaceutical detailman drugs that they obtained from a freight salvage company." Wickham explained that "it's not uncommon" for wholesalers or retail pharmacies "to buy drugs from freight salvage companies," which retain shipments that the damaged or unclaimed. Wickham maintained, that diversion is easy for sales reps because they are charged with record-keeping of samples. "Some companies keep reasonably good records, depending upon the detailman to provide the accurate records of the disposal" of the samples, Wickham said. However, "common practices" include diversion of samples to a location where a "cooperating physician signs as if he received them, or just flat out forge a physician signature," he said. Although prepared testimony covered institutional diversion and questionable wholesaler practices, most of the Q&A at the hearing focused on physician samples. Dingell's legislation would restrict distribution of samples to doctors who request them and would prohibit distribution by manufacturer representatives, requiring mail or direct-carrier delivery. The provision represents a compromise fashioned by Rep. Broyhill (R-N.C.) and Dingell, who would favor an outright ban on physician samples. Rep. Oxley (R-Ohio) declared that "after today's hearing, our record will be overwhelming in the necessity for absolute prohibition of drug reimportation, hospital and nursing home resales, and for new procedures for licensing drug wholesalers and distributing doctor samples." Oxley added that he anticipates "a rather quick markup on HR 4820." Dingell (D-Mich.) declared that "HR 4820 is picking up cosponsors from members of both parties and most areas of the country." Ohio's Wickham testified that federal legislation "would help us if the violations [of state law] were actually violations of the federal FD&C Act because our laws specifically provide us with the authority to act against licensees who violate the federal" law. Until FDA's testimony at the July 15 hearing, PMA was alone in its opposition to the bill's sampling provisions. FDA Com. Young, however, supported the system as it currently exists. He maintained that the use of samples can be humanitarian. "Under appropriate conditions samples can be used to treat individuals on a trial basis and particularly to help individuals who may not have the resourceds to purchase these drugs," Young said. "I know physicians in large measure to use these samples for these two humanitarian goals, and I think they're laudatory." Not all PMA member companies oppose the Dingell bill in its current form. Marion Labs publicly announced that it supports the legislation, including the sampling provision ("The Pink Sheet" July 14, p. 11). Merck is also reportedly ready to support the measure as introduced.
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