FDA ENFORCEMENT BILL: TIME RUNNING OUT FOR ENACTMENT

Executive Summary

FDA ENFORCEMENT BILL: TIME RUNNING OUT FOR ENACTMENT before Congress adjourns for the year. Congressional staffers continued to meet the week of Oct. 15-19, but had not secured agreement on a compromise bill among health legislators in both House and Senate -- including bill sponsor Rep. Dingell (D-Mich.) and Rep. Waxman (D-Calif.) from the Energy & Commerce Committee, and Sens. Kennedy (D-Mass.) and Hatch (R-Utah) from the Labor & Human Resources Committee. Congress is expected to work at least part of the week of Oct. 22, but not much longer. Because the congressional session is winding down and the bill (HR 4810) has yet to be marked up in committee, Dingell's strategy was to speed passage of the bill by unanimous consent in both chambers. However, under the procedure, one opponent could stop the bill. Sen. Metzenbaum (D-Ohio) has strongly objected that the latest version of the compromise measure would authorize sanctions only for the generic pharmaceutical industry. Metzenbaum maintains that the bill should extend not only to the innovator pharmaceutical firms, but to all FDA-regulated industries. Rep. Waxman advocates including the brandname industry. One approach that had been considered was to include civil monetary penalties for malfeasance by brandname companies, and the Pharmaceutical Manufacturers Association had agreed not to fight such a provision ("The Pink Sheet" Oct. 15, T&G-3). Another sticking point has been the amount of time generic firms that defraud the drug approval process could be debarred from further participation in that process. The latest proposal would establish an 18-month debarment period. As originally introduced, HR 4810 would require a minimum of three years' debarment; generic industry lobbyists had advocated 18 to 12 months of exclusion. Even if he could secure House agreement on the bill, Dingell reportedly plans not to take it to a floor vote unless he believes he can also get the bill through the Senate. Having the House on record as supporting a particular version of the FDA enforcement proposal could reduce Dingell's flexibility if he has to take up the bill again next year. Dingell is expected to keep the spotlight on both the generic industry and his proposal to strengthen FDA's enforcement powers -- and might intensify his focus if fewer issues with the prominence of this year's Clean Air bill are competing for his attention.