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Executive Summary

GPIA SUPPORTS FDA "ENFORCEMENT" LEGISLATION, whatever the "decision on scope" of the bill, although the association will continue to push for a measure that is not limited to the generic industry. In a May 30 letter to Reps. Dingell (D-Mich.) and Waxman (D-Calif.) congratulating the legislators on producing a jointly sponsored generic debarment bill ("The Pink Sheet" May 24, p. 3), Generic Pharmaceutical Industry Association President Dee Fensterer reiterated the association's position that any bill to strengthen FDA's powers should encompass all regulated industries, not just the generic industry. "Nevertheless," the letter continues, "we understand that the decision on whether to broaden the scope of this bill will be a product of the political process in the House, the Senate, and the executive branch." Whatever the ultimate decision on scope, GPIA said, "we will support prompt passage of enforcement legislation because the public needs to know that the misdeeds of the past involving our industry have been dealt with effectively and that there are adequate sanctions to deter and remedy future offenses." "In addition," the letter continues, "FDA urgently needs to have statutory standards and procedures to govern what are now ad hoc attempts to improvise remedies in this field." The letter says GPIA is ready to be "helpful in accomplishing passage of this legislation." A House Energy & Commerce/Health Subcommittee hearing on the bill is tentatively scheduled for June 24. Both GPIA and the National Association of Pharmaceutical Manufacturers are taking the approach of signaling positive reaction to modifications made to the bill thus far and trying to help shape the bill as it goes through the legislative process, rather than taking a stance of opposition upon the bill's introduction based on remaining areas of concern. NAPM's formal position will be considered by its board of directors at the association's June 5-6 conference in Washington, D.C. In the interim, NAPM has relayed to Capitol Hill that the association finds the bill "supportable" based on a review by its legislative committee. Dingell has pushed for a generic-specific bill even as a broader FDA enforcement proposals are being drafted in the House and Senate, and the bill gained a boost once a compromise version was worked out with Waxman. Introduced May 24 as HR 2454 by Reps. Dingell, Bliley (R-Va.), Waxman, Lent (R-N.Y.) and House Energy & Commerce Committee colleagues, and as S 1164 by Republican Sens. Hatch (Utah), Durenberger (Minn.), McCain (Ariz.) and Kassebaum (Kan.), the bill would require a mandatory minimum debarment of one year and a possible maximum of 10 years for generic firms convicted of felony wrongdoing in connection with the drug approval process. The debarment could be shortened below one year if the offenses were neither authorized nor tolerated by top management. FDA could debar a firm for one to five years for felony misdemeanors or other wrongdoing. NAPM also will continue to advocate broadening the legislation beyond its generic-only focus, but indicated that it has a more favorable view of the debarment bill based on modifications addressing concerns, including industry opportunities for notice and appeal of sanctions. For example, while the bill now institutes a one-year mandatory debarment for felonies with FDA permitted to shorten the debarment period in some cases, earlier drafts called for a three- year minimum with no flexibility. The bill also directs that FDA may withhold ANDA approvals for firms under investigation; NAPM objected that previous versions would have authorized stopping the review process as well. GPIA's letter notes it also has made recommendations to "better implement" the purposes of the early termination of debarment, although the association continues to believe that a mandatory minimum debarment period is "counterproductive."

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