Advocates of FDA reform said a chance still exists for the House andSenate to pass bills before the 104th Congress adjourns this fall.
Carl Feldbaum, president of the Washington-based BiotechnologyIndustry Organization (BIO), said Monday, "The odds are long, butwe still have a shot at it."
Before leaving for the August recess the House put its bill, which hasyet to make it out of the Commerce Committee, on the "suspensioncalendar." That means the legislation could progress quickly to afloor vote when Congress reconvenes in September. The Senate'sversion was nearing floor action in July, but was postponed.
To get an FDA reform bill Congress can pass and President Clintonwill sign, Feldbaum noted representatives from the House, Senateand White House will have to work out differences this month beforethe legislators return to work after the Labor Day holiday. The 104thCongress adjourns Oct. 4, 1996.
"There's still a lot of work to do," Feldbaum said.
Major points of contention focus on privatization of drug and devicereviews and dissemination of scientific information about potentialoff-label uses of FDA approved therapies.
BIO supports the Senate and House FDA reform bills, which containprovisions for speeding drug approvals and for reducing the cost ofproduct development. In particular the legislation would modernizelaws for regulating biologics.
Key provisions for the biotechnology industry include codification ofadministrative changes made last year by the FDA. Among thosereforms were elimination of establishment licensing applications andlot lease approvals. The former required companies to get anapproval of manufacturing facilities separate from the drug itself andthe latter involved a continuous review of each production lot of anapproved biologic.
The Senate version of FDA reform was offered by Sen. NancyKassebaum (R-Kan.) and is called the FDA Performance andAccountability Act. The most recent House version, called the Drugsand Biologics Reform Act of 1996, was sponsored by Richard Burr(R-N.C.) and is similar to Kassebaum's proposed legislation.
A "hammers" provision in the Kassebaum bill is a controversialelement not included in the House legislation. It would authorizethird-party product reviews if the FDA failed to meet deadlines foracting on marketing applications.
Another difference between the House and Senate bills isdissemination by drug companies of scientific data related toexperimental applications of FDA approved products. The Houselegislation includes that provision, but it was removed from theSenate version.
Both bills call for privatization of some FDA review responsibilities.However, the House legislation would establish a system of third-party review immediately while the Senate plan would implement apilot program.
FDA Commissioner David Kessler, who has argued againstRepublican-led legislative changes for his agency, has been mostvocal in criticizing proposals for third-party reviews of products.
The Clinton administration has tried to head-off rewriting lawsgoverning FDA by implementing changes in various regulatorypractices to mollify concerns of the biotechnology andpharmaceutical industries. n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.