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DRUG SAMPLE THEFTS ARE NOT ADEQUATELY REPORTED TO FDA

Executive Summary

DRUG SAMPLE THEFTS ARE NOT ADEQUATELY REPORTED TO FDA by drug manufacturers as required by the Prescription Drug Marketing Act (PDMA), FDA Newark District investigator Kerin Eberle told a June 3 agency-sponsored meeting in New Brunswick, N.J. Discussing results of eight PDMA surveillance inspections conducted by the Newark district office, Eberle said that among the observations one "significant point was failure to report the theft of samples completely and accurately to the agency." Some firms reported "half the drugs that were stolen from an automobile to be stolen and neglect the other half," Eberle said. Other firms "simply failed to [report] thefts in general." Under the PDMA, reporting thefts to the agency is mandatory. The June 3 conference was the first in a series of six regional seminars on the PDMA, also known as the Dingell Drug Diversion Act. FDA is holding the meetings to provide guidance to companies on how they should comply with the law's requirements. Feedback from the industry also will aid the agency in designing an upcoming rule to complement the September 1990 rule on state licensing of wholesalers. FDA regulatory counsel Richard Arkin told the conference that the agency hopes to have the proposed policies and procedures rule "published by the end of the year." Arkin added that in light of the "couple of hundred questions we received today, I would assume we will be receiving a significant number of comments on this proposal." The proposed rule will replace three guidance letters previously issued by FDA to provide information on the requirements of the law. CDER Office of Compliance Division of Drug Quality Evaluation Deputy Director Charma Konner noted that the agency has "conducted a survey of the drug sample accountability, controls, and practices of drug manufacturers under PDMA." The results may be available "within the next four weeks." Eberle told the conference that "for the most part, we found that the industry in general is complying with the act." Companies "seem to understand enough that they were able to set up their own regulations inside and teach it to their own people especially to their detail representatives," she added. While most of the problems found during inspections were not serious enough to warrant mention in FD-483 inspection reports, Eberle noted that a few of the findings were "so significant" that FDA sent a notice of adverse findings to one company. In another case, the district recommended that a notice of adverse findings be sent to a firm, but the recommendation was denied. Other letters "are still under consideration," she added, "so it's not something that the agency is taking lightly." Other problems with PDMA reporting uncovered during agency inspections include "situations where the firm does not maintain its written receipt for the delivery of prescription drugs through the mail," Eberle said. An example, she noted, would be a company using Federal Express to deliver drug samples to a physician "and only getting back the computer printout from [the] shipping firm," and not a receipt with the physician's signature as the law mandates. Inspectors also "found a number of physician receipts for samples to be incomplete," the FDA investigator said. Complete receipts are necessary to detect possible incidences of drug diversion. FDA also discovered that some companies were not auditing transactions between detail reps and physicians. During Q&A, FDA Division of Field Investigations Director Robert Fish noted that the agency has "a little over 1,000 investigators" and last year hired about 300 new investigators. FDA hopes to be able to hire 200 to 300 more investigators next year. Fish added that about 70 investigators have completed a criminal investigator training course at the Federal Law Enforcement Training Center. Another 100 investigators are receiving on-the-job training and taking courses in criminal investigations. FDA hopes to have 50 of the 100 criminal investigators that the agency plans to hire "on board by the end of the year," Fish said.
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