"There has certainly been consensus among Democrats and Democratic policy-makers that FDA has failed to live up to expectations and hasn't aggressively addressed laws on the books on the pre-market side and post-market side," said John Manthei, a partner at the law firm Latham & Watkins and former majority counsel to the House Energy and Commerce Committee.
"We should fully expect to see a much more aggressive FDA
as we move into 2009."
The next Congress will likely look to new device and drug industry user fees as a way to increase FDA funding, Manthei
Democratic lawmakers agree that FDA
needs more resources, but given other Obama administration priorities and the huge federal sums already poured into the financial bailout plan, increased FDA appropriations could be hard to come by, he
"There's going to be a lot of competition for those funds, which makes the user fee much more appealing," Manthei
But new user fees would face industry opposition, particularly from smaller device companies, noted Manthei
, who serves as outside counsel for the Medical Device Manufacturers Association
also predicted that the aggressive oversight seen in the recent Congress will shift from FDA
to industry, with a Democratic Congress uninterested in calling Obama appointees to task.
"I think oversight of FDA
is going to come to an immediate halt this January," he
"This time, industry will be in the congressional crosshairs."
In particular, industry will be scrutinized for its performance on product safety issues, and its willingness to be "forthcoming" with FDA
with safety data, Manthei
Device firms should also expect to see more FDA-related legislation, attorney Manthei said.
"Industry kind of fell within a comfort zone that amendments to the FDA authorizing statute would largely occur about once every five years, in conjunction with the reauthorization of the prescription drug user fee act and the medical device user fee act," he
"I would not be surprised for Congressman Waxman to make that a priority, and for that guidance document to potentially be pulled," Manthei
Nevertheless, "it's too important of a position, and I would expect the nomination process to happen shortly after the beginning of 2009," Manthei
"That obviously is going to eliminate a number of potentially very qualified candidates," Manthei