Obama wants 10 years or less of biologicals data exclusivity

Home/Policies & Legislation | Posted 10/02/2010 post-comment0 Post your comment

According to The Associated Press (AP), US President Obama and US House Democrat Henry Waxman have teamed up to make a last-minute push to significantly pare back the 12-year period of data exclusivity lawmakers provided biologicals in the healthcare reform bill. With White House and congressional bargainers moving toward a final health bill, President Obama and Representative Henry Waxman, Chairman of the House Energy and Commerce Committee, are trying to reduce the curbs against competition to 10 years or less.

If they are successful, it would be a major blow to the industry's leading lobbyists at the Biotechnology Industry Organization (BIO) as well as the Pharmaceutical Research and Manufacturers of America (PhRMA), who have managed to hold together a large coalition of US Democrats and Republicans in favour of the long stretch of protection from generic competition.


Mr Waxman has been waging a lengthy fight to keep the protection period relatively short, but fellow House Democrats were not the least bit reluctant to kick back in support of the 12-year provision offered by Representative Anna Eshoo. The 11th-hour twist, though, came in a private meeting on 14 January 2010 between President Obama and US House Democrats when President Obama said he was opposed to the initiative, according to the AP report. The AP speculates that the President could be using the tactic to gain more concessions from Big Pharma or to herald a more consumer-friendly approach to therapeutics in the bill.

Outside lobbying on the issue has intensified on both sides. That battle has been waged for months, with brand-name companies widely outspending their generic rivals.

The drive to shrink the protection period has prompted opposition from the pharmaceutical industry, which argues the longer period is needed to encourage the massive investments required to produce biotech products.

"Fair data protection of at least 12 years is critically important to the future of medical progress in America", said Ken Johnson, a Senior Vice President of the PhRMA.

According to FierceBiotech, it is hard to see, though, how President Obama and Mr Waxman could cobble together enough support from members of their own party to make a switch at this point. Mr Waxman was handed what amounted to a public rebuke by US Democrats on his own committee when they voiced their support of 12 years of data protection. “With all the other compromises built into the reform bill to garner a solid majority of lawmakers, where are the votes in US Congress to buck the outspoken backers of a bill cherished by biotech?” FierceBiotech asks.


John Carroll. Obama mounts fight against 12 years of data exclusivity. FierceBiotech. 2010 January 15.

Alan Fram. Last-ditch lobbying battle over biotech drugs. The Associated Press. 2010 January 14.

Source: FierceBiotech; The Associated Press

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