Lobbyists Seek To Slow Legislation That Would Allow Generic Biotech Drugs

Pharmaceutical and biotechnology industry lobbyists are seeking to slow the passage of a bill that would permit the marketing of generic biotechnology drugs, which they argue are too complex to approve without first conducting clinical trials, the Boston Globe reports (Henderson, Boston Globe, 4/16). Companion bills (HR 1038 and S 623) introduced earlier this year by Rep. Henry Waxman (D-Calif.) and Sens. Charles Schumer (D-N.Y.) and Hillary Rodham Clinton (D-N.Y.) would allow FDA to approve “comparable” and “interchangeable” generic versions of biotech medications through an “abbreviated” process. Companies that seek to market comparable generic versions of biotech medications would have to prove that their treatments have active ingredients “similar” to those of the brand-name versions. Companies that seek to market interchangeable generic biotech medications would have to prove that their treatments have molecular structures “comparable” to those of the brand-name versions and that their treatments have the same effects as the brand-name versions in all patients. The legislation would not specifically require companies that seek to market comparable or interchangeable generic biotech medications to conduct clinical trials. However, the legislation would allow FDA to require trials on a case-by-case basis (Kaiser Daily Health Policy Report, 4/10). Pharmaceutical and biotechnology industry lobbyists also argue that clinical trials are needed after FDA approval to determine whether a brand-name or generic product is responsible for side effects that might arise. Pharmaceutical, medical device and other health product companies have spent nearly $182 million between January 2005 and June 2006 lobbying Congress on the legislation, the Center for Public Integrity reported this month. PoliticalMoneyLine reports that between July 2006 and December 2006, the Pharmaceutical Research and Manufacturers of America spent $8.8 million for lobbying expenses. Comments
“In congressional hearings, the most vocal opponents have been echoing concerns expressed by the powerful industry lobbies,” according to the Globe. Sen. Orrin Hatch (R-Utah) — who PoliticalMoneyLine says has received $1.4 million in health care political action committee contributions since 1980 — said that the legislation too heavily favors generic manufacturers and could “stultify” innovation. Rep. Tom Davis (R-Va.) — who has received $380,497 from health-related political action committees since 1994, according to PoliticalMoneyLine — said, “If you don’t have legislation that specifically addresses [clinical trials], we’re not going to get the innovation that I think the country needs.” Rep. Darrell Issa (R-Calif.), who has been approached by industry lobbyists and Amgen, said, “To pretend that we don’t need clinical trials … flies in the face of common sense.” William Vaughan, senior policy analyst at Consumers Union, said, “I never saw a more powerful domestic economy lobby than the pharmaceutical lobby. They are pervasive. They’ve got so much money” (Henderson, Boston Globe, 4/16).

“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.

About the Author

srima has written 1902 stories on this site.

Write a Comment

Gravatars are small images that can show your personality. You can get your gravatar for free today!

You must be logged in to post a comment.

Copyright © 2009 Medical News. All rights reserved.
Powered by WordPress.org, Custom Theme and ComFi.com Calling Card Company.
Close