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Executive Summary

GENERIC DRUG DEBARMENT BILL CLEARS ENERGY & COMMERCE/HEALTH SUBCOMMITTEE by a unanimous voice vote at a July 29 markup session. The legislation (HR 2454) was reported to the full committee, which will consider the bill at a markup after Congress returns from its August recess. In a group of amendments that were adopted en bloc, the subcommittee deleted one provision of HR 2454 that would have eliminated a current FDA requirement to provide an opportunity for a hearing under section 305 of the FD&C Act before referring a violation to the Justice Department for criminal prosecution. The generic industry, which opposes elimination of the hearing requirement, supported the subcommittee decision. The subcommittee reportedly agreed that a broad enforcement bill, such as the FDA enforcement authorities bill (HR 2597), would be a more appropriate vehicle for deleting the hearing requirement. The remaining amendments were technical in nature and characterized by subcommittee Chairman Waxman (D-Calif.) as "refinements." Waxman also pointed out that HR 2454 has been cosponsored by every member of the full committee and would be moved expeditiously to the full House for consideration. However, the full Energy & Commerce Committee did not get to the generic debarment bill during the week despite holding two markups, one on July 30 and the other on Aug. 1. One reason for the delay in moving the bill into the full committee may be Rep. Hall's (D-Texas) concern with the bill's provision extending the investigative authority of the HHS Inspector General. During the subcommittee markup, Hall asked committee Chairman Dingell (D- Mich.) if he would take time to discuss the matter before the bill is reviewed by the full committee. "I think we need to be very careful about increasing authority for an office that's caused an awful lot of distress in the business community," the Texas Democrat said during the subcommittee markup. Referring to HHS Inspector General Richard Kusserow's "heavy handed" press statements in sanctioning an upstate New York Medicare physician who later committed suicide, Hall contended: "It's bad policy to give additional authority to a person who's been so aggressive and so dictatorial." The Administration has indicated that it feels HHS already has sufficient authority to allow FDA to request help from the Inspector General in criminal investigations, Hall noted. The HR 2454 contains a provision to redelegate the IG with authority for enforcing felony violations of the FD&C Act. In 1989, HHS Secretary Sullivan delegated that authority to the IG and then later rescinded it.

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