View from the Observation Deck

1. The Prescription Drug User Fee Act (PDUFA) is up for renewal by Congress in 2012. It was last renewed in 2007.
2. PDUFA authorizes the U.S. Food and Drug Administration (FDA) to collect user fees from certain drug manufacturers.
3. Both the House of Representatives and the Senate just passed their respective versions overwhelmingly.
4. The next step is to settle any differences between the bills. A combined PDUFA bill is expected to be passed into law this summer.
5. New language in the revisions includes an accelerated approval process to "fast track" new drugs aimed at rare diseases. (Quest)
6. There were 30 new drug approvals in 2011 – a 7-year high, but the number is right at the average for the past 16 years.
7. While the safety-conscious FDA has made the drug approval process more difficult through the years, drug companies are getting better at choosing which treatments to bring to market. (FierceBiotech)
8. We believe, if passed, that this provision could be a positive development for the drug industry, and one that investors should keep abreast of.