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DRUG DIVERSION: NEW ROUND OF HEARINGS FOCUS ON INTERNATIONAL DIVERSION, FDA

Executive Summary

DRUG DIVERSION: NEW ROUND OF HEARINGS FOCUS ON INTERNATIONAL DIVERSION, FDA efforts in combatting the problem, and state regulatory efforts in Ohio, Florida, and possibly Missouri. The hearings are scheduled while Congress is out of session for the Independence Day recess, on July 10, 15, and 16. Rep. Dingell's (D-Mich.) House Commerce/Oversight Subcmte. is continuing hearings on the issue that began last year and culminated in a committee report and bill. The legislation includes a ban on the reimportation of American pharmaceuticals, greater licensing and recordkeeping requirements for wholesalers, and restrictions on the distribution of drug samples to doctors ("The Pink Sheet" May 26, p. 12). The subcmte. is building its record about the drug distribution system as more information becomes available from FBI and state investigations into criminal diversion activities. Because some of the diversion bill's provisions, such as the sampling restriction, are opposed by the Pharmaceutical Mfrs. Assn. and are certain ot meet congressional resistance, Dingell reportedly hopes to develop an overwhelming case against the current system to build support for legislative changes. Dingell negotiated with Rep. Broyhill (R-N.C.) over the subcommittee bill's sampling provision, reportedly because the chairman felt that quick passage this year required cosponsorship by the ranking minority member of both the subcommittee and full committee. The bill permits drug manufacturers to mail samples to physicians who request them. Reportedly, if the legislation is not enacted this year, Dingell in the next Congress will introduce a version that prohibits delivery of samples to doctors. House Commerce/Health Subcmte. Chairman Waxman (D-Calif.) is expected to be slow to schedule legislative hearings on the diversion issue this year without indications that the Senate will also move quickly. Time for passing new law is dwindling; only about 40 days remain on Congress' legislative calendar this year. A diversion bill would be referred in the Senate to the Labor & Human Resources Cmte., whose chairman, Sen. Hatch (R-Utah), would carefully consider all viewpoints on the proposal.

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