What’s In A Name? Hatch And Waxman Stake Claims To Generic Biologics Bill
Executive Summary
Sen. Orrin Hatch, R-Utah, and Rep. Henry Waxman, D-Calif., continue to disagree on how to move toward what could be the next major milestone in the generics industry they essentially created in 1984: generic biologics
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The Senate Health Committee hearing on developing an approval pathway for generic biologics put the brand-name pharmaceutical industry in the unusual position of advocating that Congress adopt a European-style Rx oversight system
HATCH/WAXMAN MAY 3 LETTER TO PMA PRESIDENT ENGMAN ON ANDA LEGISLATION
As the Pharmaceutical Mfrs. Assn. Board of Directors convenes, we would like to share with you our view on a number of issues we believe are of mutual interest. While both of our cmtes. have a large number of health programs that must be reauthorized during this Congress, we also plan to address food safety, drug export reform, and patent term restoration/ANDA this year. As you know, our cmtes. have jurisdiction only over the ANDA portion of the patent term restoration/ANDA bill. We are aware that PMA is currently considering a compromise on the patent term restoration/ANDA issue. A decision on the merits of this package should be made by the pharmaceutical companies themselves. In the absence of such a decision, however, we will seriously consider moving this forward in this Congress to resolve this issue. As you consider these questions, please keep in mind that we are jointly committed to bringing about a final resolution of the patent term restoration/ANDA and drug export reform issues. Sincerely, Orrin G. Hatch, Chairman, U.S. Senate Labor & Human Resources Cmte. Henry A. Waxman, Chairman U.S. House of Representatives Subcmte. on Health & Environment