DAK, You are correct about the FDA. The move is to speed up approval times. The article in the NY Times was a story that was carried fairly widely, and was based on the response to a survey to current or former FDA officials. It was extremely unscientific in its methodology and its relevance is certainly debatable (I suspect that some officials disagreed with FDA decisions before the reform was implemented also, including those who thought that an unapproved drug should have received approval).
There is an ongoing molecular medicine revolution which will change medical practice. Physicians will have an ever increasing number of drugs and combinations of drugs available for treatment. There is no effective mechanism for testing such combinations, and short of some extremely complex in vitro screening, there will not be.
Pharmas and Biotechs will continue discovering new drugs and public pressure will increase for faster, not slower approvals.
Panretin and ONTAK were both granted priority review, which means that the FDA must send out a reply with 6 months instead of 12 months. If there are concerns, they can send out a "completed review" letter, like they did with ONTAK, and wait until such concerns are eliminated or reduced, even when the approval vote was 14-0 by the advisory board.
Alternatively, they can send out an "approvable" letter as they did with Panretin, which means that the drug can receive final approval within days (LGND has projected final approval for this month). Such a quick approvable letter can go out, even when the vote to approve is not unanimous (it was 8-1 for Panretin approval).
Of course the advisory board can vote against approval, resulting in a non-approval letter from the FDA (which has not happened with LGND's compounds). |
