Mixed reaction to new legislation from Waxman et al for follow-on biologics

US Representative Henry Waxman (Democrat, California), together with Representatives Nathan Deal (Republican, Georgia), Frank Pallone  (Democrat, New Jersey), and Jo Ann Emerson (Republican, Missouri), has  introduced HR 1427, the Promoting Innovation and Access to Life-Saving  Medicine Act, a bipartisan bill to allow the Food and Drug  Administration to approve affordable copies of biotechnology drugs.  These medicines, said Rep Waxman, "while often life-saving, are the  fastest growing and most expensive components of the nation's  prescription drug bill. Many of them cost tens of thousands of dollars  a year - prices that put them out of reach of patients and impose an  unsustainable burden on employers, insurers and the federal  government."

Unlike its European counterpart (Marketletters passim), the FDA  currently lacks clear authority to approve generic versions of these  products, allowing companies to charge monopoly prices even after all  patents have expired. "Today's bill gives [the] FDA authority to ensure  that any approved copy of a biotech drug is just as safe and effective  as the original product, and provides the makers of new biotech drugs  ample incentives for continued innovation. The Promoting Innovation and  Access to Life-Saving Medicine Act is consistent with the legislation  described in the President's proposed budget," the Representative noted.  Rep Waxman's bill is the first on follow-on biologics introduced in the  111th Congress, but it is expected that others will follow, including a  new one from Reps Anna Eshoo (Democrat, California) and Joe Barton  (Republican, Texas), who introduced the Pathway for Biosimilars Act  last year (Marketletter March 24, 2008). That bill provided for a  substantially longer period of innovator market exclusivity, ie, 12  years.

Five-year market exclusivity offered