As the Pharmalot blog reports, another letter has graced the FDA Commissioner's desk from the Senate explaining the intent of the recent biosimilar legislation passed during healthcare reform.
This letter from Senators Tom Harkin, John McCain, Chuck Schummer and Sherrod Brown asserts that the biosimilar legislation is clear that the FDA can "begin reviewing biogeneric applications during the 12-yr exclusivity period". They argue the intent of the law is to speed biosimilars to the market thereby saving patients thousands of dollars. This group of Senators say "we strenuously object to any further efforts that would further block or delay generic competition at the expense of patients in need."
This is in marked contrast to the Senate letter written a couple weeks ago from Orrin Hatch, Kay Hagan, Michael Enzi and John Kerry that suggested there was a 12-year data exclusivity period in the legislation and that brand name manufacturers could earn up to another 12 years if their drugs were changed in a way that enhanced safety or effectiveness.
If I'm sitting in the FDA Commissioner's seat, the situation should be as clear as mud. Now, all the FDA has to do is formulate the policy to make everybody happy. A piece of cake.
Posted by Bruce Lehr Jan 25th 2011.