REP. DINGELL’s FDA BILL "PRESENTS SERIOUS" THREAT

Executive Summary

REP. DINGELL's FDA BILL "PRESENTS SERIOUS" THREAT to the generic drug industry in that its focus is restricted to generic manufacturers, the National Association of Pharmaceutical Manufacturers maintains. In a May 30 memorandum to the association's membership, Chairman Edward Plymack and Legislative Committee Cochairman Michael Reicher asserted that the legislation introduced by Dingell (D-Mich.) "presents serious threats to the very existence of the entire generic drug industry." Introduced May 15, the Dingell legislation (HR 4810) causes NAPM consternation by "singling out generics as the only wrongdoers." In a May 22 position statement, the association contended that "irregularities are not limited to any specific segment of the pharmaceutical industry." The statement adds that "congressional strategy limiting legislation to the generic industry for fear of otherwise incurring innovator companies' opposition is contrary to the American concept of fair play." NAPM said it will oppose HR 4810 "unless and until inequities in the legislation are corrected." During the week of June 4, Rep. Waxman (D-Calif.), who opposes HR 4810, is expected to decide on a date to hold a hearing on the legislation before his Health Subcommittee. NAPM's memo notes that it also considers the HHS legislative proposal a threat to the industry. The department's version of the legislation would give "political appointees authority to essentially put companies out of business, even if they have not been convicted of a crime," the association said. The position statement acknowledges that HR 4810 "contains major improvements over previous drafts" and over the HHS proposal "in that it provides significant due process rights." The statement adds that "NAPM recognizes the need for legislation addressing irregularities in the drug approval process" and would support legislation "consistent with" the association's May 1 position paper. The May 1 document recommended legislation requiring manufacturers to remit to the government all profits from sales of drug products with "tainted" ANDAs or NDAs ("The Pink Sheet" May 7, T&G-15).