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Brand-Name Companies Could Face Generic Competition On Biotechnology Drugs

18 Jul 2007
http://www.medicalnewstoday.com/articles/77025.php

The San Francisco Chronicle on Sunday examined how biotechnology companies soon could face generic competition under a bipartisan Senate bill (S 1695) proposed by Democrats Edward Kennedy (Mass.) and Hillary Rodham Clinton (N.Y.) and Republicans Orrin Hatch (Utah) and Mike Enzi (Wyo.). Under the legislation, biotech companies would get 12 years of market exclusivity after FDA approval, compared with five years for traditional brand-name medicines.

The Generic Pharmaceutical Association said a 12-year period of market exclusivity is "arbitrary and excessive." Association CEO Kathleen Jaeger said, "It's just going to unjustifiably delay access to consumers."

However, "some advocates of generics acknowledge that biological medicines are harder to develop than traditional drugs," the Chronicle reports. The Senate bill includes a provision that would require generic biologic makers to perform clinical trials to prove drug efficacy, a step not required of traditional generic drug manufacturers. FDA would be allowed to waive that requirement under the legislation.

Members of a congressional conference committee over the next few weeks will "try to cobble together" a bill that "both the Senate and House can accept," the Chronicle reports (Tansey, San Francisco Chronicle, 7/15).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Article URL: http://www.medicalnewstoday.com/articles/77025.php

Main News Category: Pharma Industry / Biotech Industry