Healthy Skepticism Library item: 10782

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Publication type: news

Goldstein J.
Capitol Recap: Generic Biotech, Industry Payments to Doctors
The Wall Street Journal Health Blog 2007 Jun 28
http://blogs.wsj.com/health/2007/06/28/capitol-recap-generic-biotech-industry-payments-to-doctors/?mod=yahoo_hs

Full text:

Time for a quick double-dose of congressional action on the business of health.

1. Generic versions of biotech drugs could come to market under a bill passed unanimously by a Senate committee. The bill would guarantee branded biotech drugs 12 years of market exclusivity – a provision the Generic Pharmaceutical Association labeled “arbitrary,” “excessive,” “unnecessary” and “unwarranted,” all in a single sentence. The proposed law would give the first maker of a biogeneric a year of generic exclusivity, according to Congressional Quarterly.

The bill would also require at least one clinical study of any proposed generic, but would give the FDA the authority to waive that requirement, Bloomberg reports. Generic versions of traditional drugs can be approved without clinical studies, but traditional drugs are much less chemically complex and much simpler to manufacture than biotech drugs.

Generic biotech drugs would mean increased competition for a number of biotech products, chief among them anemia drugs such as Amgen’s Aranesp and Johnson & Johnson’s Procrit.

2. A national registry of drug industry payments to doctors could be in the offing. Two Senators said they would push for such a registry, following a charged hearing on industry ties with physicians, the New York Times reports.

Senator Claire McCaskill, Democrat of Missouri, mentioned that her brother, a restaurateur, told her “that the most lucrative part of his business was the private room that is used mostly by drug companies” for meetings with doctors. “He said that you wouldn’t believe how much expensive wine these guys buy.”

McCaskill said the Senate was adopting ethics rules that would bar senators from taking meals from lobbyists. And any gifts to senators must be recorded already. “And if it’s good for Congress,” she told the Times, “it’s good for the medical profession in terms of cleaning up all this lobbying – because that’s what it is.”

The drug industry trade group said that registries of gifts to doctors inhibit “access to critical scientific information about the benefits and risks of treatment options that help patients win their battle against disease.”