The Senate passed the FDA Safety and Innovation Act (FDASIA) authorizing the collection of some $6.4 billion in user fees to fund FDA. The pay day was enough to halt partisan bickering and bring Senate Democrats and Republicans together quickly. The legislation, approved just before Memorial Day, reauthorizes hefty user fees from drug and medical device companies, along with a host of new requirements that will govern FDA operations over the next five years.
The House is now under pressure to pass their version of the Bill. And, lo and behold, they did so today in overwhelming fashion. The bill includes a section to "fast-track" review of new drugs that potentially treat serious or life-threatening diseases that have no good alternatives. The FDA will also be empowered to pull drugs from the market that have been fast-tracked but don't live up to after market review requirements. See Fierce Biotech.
The House and Senate versions now need to be reconciled, but the biopharma industry should be happy that their lobbying effort has paid off. The reconciled bill should be ready for a vote by October 1st. Then it will be up to the FDA to act.
Posted by Bruce Lehr May 31st 2012.