Congress Eyes Generic Biotech Drugs

Law360, New York (December 22, 2006, 12:00 AM EST) -- When Democrats take over Congress in January, they are likely to push for giving the Food and Drug Administration a process for approving generic biotechnology drugs, or follow-on protein products.

The move, which could have a large impact on the pharmaceutical industry, comes after years of officials and insurers clamoring for change. Currently, there is no statutory pathway for lower price biotech drugs, even after patents expire.

This fall Sen. Hillary Clinton (D-N.Y.) and Sen. Charles Schumer (D-N.Y.) with Rep. Henry Waxman (D-Calif.) proposed the Access...
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