An excellent analysis on the PDUFA legislative process by the Politco's Brett Norman:
By BRETT NORMAN | 6/25/12 10:36 PM EDT
The bipartisan treatment the FDA user fee bill has enjoyed did not fall like manna from heaven. It came at the insistence of the pharmaceutical and medical device industries, the FDA and legislators on both sides of the aisle who agreed early on they would get a deal done. And then actually did it.
The Senate is expected to send the Food and Drug Administration Safety and Innovation Act — a major piece of election-year health care legislation — to President Barack Obama late Monday or Tuesday. The bill, which would provide the FDA with more than $6 billion in industry user fees over five years to fund a share of its medical products reviews, passed the full House last week with scarcely a complaint.
Read more: http://www.politico.com/news/stories/0612/77815.html#ixzz1z0fEUZiA
By BRETT NORMAN | 6/25/12 10:36 PM EDT
The bipartisan treatment the FDA user fee bill has enjoyed did not fall like manna from heaven. It came at the insistence of the pharmaceutical and medical device industries, the FDA and legislators on both sides of the aisle who agreed early on they would get a deal done. And then actually did it.
The Senate is expected to send the Food and Drug Administration Safety and Innovation Act — a major piece of election-year health care legislation — to President Barack Obama late Monday or Tuesday. The bill, which would provide the FDA with more than $6 billion in industry user fees over five years to fund a share of its medical products reviews, passed the full House last week with scarcely a complaint.
Read more: http://www.politico.com/news/stories/0612/77815.html#ixzz1z0fEUZiA
