DOW JONES NEWSWIRES - US Senate Panel Approves 12-Year Biologic Drug Exclusivity | Friends of Cancer Research

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DOW JONES NEWSWIRES - US Senate Panel Approves 12-Year Biologic Drug Exclusivity

By Patrick Yoest, The Senate Health, Education, Labor and Pensions Committee approved an amendment late Monday that would protect makers of biologic drugs from competition from generic drug manufacturers for 12 years.

The drugs -- which are manufactured by living cells -- represent a growing segment of the pharmaceuticals industry. The committee vote on the amendment, sponsored by Sens. Orrin Hatch, R-Utah, and Mike Enzi, R-Wyo., gives the biotechnology industry a major victory.

The amendment was approved by a 16-7 vote. It is now part of a larger health-care overhaul measure expected to be approved by the committee as soon as Tuesday.

Consumer groups and AARP, the largest lobbying group for older Americans, campaigned hard for a shorter exclusivity period for the drugs. The Biotechnology Industry Organization sought at least 12 years of exclusivity.

Sen. Sherrod Brown, D-Ohio, introduced an amendment that would grant the drugs five years of exclusivity, with the possibility for an extension. Brown pointed to a Federal Trade Commission report that said that a 12- to 14-year period of exclusivity was not necessary.

But Hatch and other supporters of the 12-year amendment said a shorter exclusivity period would stifle innovation and put U.S. companies at a disadvantage to international competitors, especially those in the European Union.

The amendment passed in the committee faces an uncertain future as Congress moves forward on health-care legislation. The White House has stated that it supports seven years of exclusivity for the drugs, while House Energy and Commerce Chairman Henry Waxman, D-Calif., has proposed five years of exclusivity.

Major manufacturers of biologic drugs include Amgen, Inc. (AMGN) and Johnson & Johnson (JNJ).