Criteria For Revision Of 1984 Waxman-Hatch Act

Any revision of the 1984 Waxman-Hatch legislation must meet the sametests as were satisfied by the original statute, in order that the changes constitute a fair balance of the commercial interests at stake for both generic drug manufacturers and innovator companies, according to Congressman Henry Waxman.

Any such revision must clearly improve on the current law, he told those attending the mid-year meeting of the National Association of Pharmaceutical Manufacturers. Anything less than the fair treatment of all interested parties could jeopardize the tremendous benefits which have resulted from the legislation, said Mr Waxman, adding that any revisions which do not meet these criteria would earn his unequivocal opposition.

As for linking the re-authorization of the Prescription Drug User Fee Act to Food and Drug Administration reform, Mr Waxman said his preference would have been that it be re-authorized free of any extraneous proposals. Because that view has not prevailed, he said, many people have forgotten that PDUFA itself is one of the most effective, proven pieces of FDA reform legislation ever enacted.