Saturday, January 16, 2010

President Obama Reportedly Seeks to Shorten the Data Exclusivity Period for Biologic Innovators Previously Agreed to by House and Senate

In recent posts, I have discussed the data exclusivity provision included in pending follow-on biologic legislation, and explained my position that an extended 12 year data exclusivity period for innovators is justified and desirable to promote robust biologic innovation. Others argue in favor of a much shorter period, e.g. five years, including Senator Waxman, the FTC and apparently the Obama administration. Although the healthcare reform bills passed by both the House and Senate include 12 year data exclusivity periods, and one might have thought that this consensus position would have settled the issue for the time being, particularly in view of the numerous and much more pressing issues of controversy currently holding up passage of the bill, today the New York Times reported that Presdent Obama reopened the issue last week in meetings with congressional leaders in which he reportedly pushed for a shorter data exclusivity period.

A link to the New York Times article is provided here. The relevant paragraph reads:
“And even as they tried to resolve their disagreements, Congressional negotiators and the president stirred up a tempest on Friday by reopening an issue on which the House and Senate agreed — establishing procedures for federal approval of generic versions of expensive biotechnology drugs. The House and Senate bills give brand-name companies 12 years to market drugs without fear of generic competition; Mr. Obama wants generics to get to market sooner.”

Jim Greenwood, president and CEO of the Biotechnology Industry Organization (BIO) wasted no time in voicing the chagrin of biotechnology innovators - his blog post is available here.


Anonymous said...

Interesting commentary. I was wondering whether or not you have ties to the pharmaceutical or biotechnology industries? BIO is showcasing your articles and commentary to support the 12 year data exclusivity period. Recently, there has been a fire storm in the medical writing community about authors not fully disclosing their financial relationships after publishing their work.

Just wanted to let you know.

David said...

Holman used to work in the industry before moving to academia, but this is an interesting question I didn't ask when I queried about stock holdings (and took so much heat for asking).

Chris, do you maintain more than casual ties now? Do you write your amici out of sheer good will? Do you still work as a freelancer, or to support their lobbying efforts? What exactly is your interest, beyond intellectual? If it's purely belief, and intellectual support, then that's great. But if there is still some continuing financial involvement, we should know.

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