NY Times article explains FDA funding mess

Finally a good article on the FDA funding problem, from the New York Times.

The article (which goes into a good deal of detail and has interviews from a variety of sides), follows the path of FDA funding since the 1984 act that effectively created the generic drug market in the US to the revolutionary decision to allow user-fees to fund part of the organization and through to today's problems with Vioxx.

It covers important issues such as the heavy push from the community of AIDS patients to get drugs approved more rapidly that lead to the beginning of the user-fee situation in the first place.

It follows how congress and the administrations effectively cut funding for surveillance research at the FDA by cutting the overall funding in light of the increase in user-fees, despite the fact that the agreement with industry mandated that no cuts be made in the portion of the FDA that approves drugs (in effect causing the cuts to come from other programs).

Also, as more drugs are let onto the market, funding should be increasing, not decreasing for the monitoring of after-release side-effects. Without this, there can be no reasonable expectation that side-effects that can be seen only in large populations will be seen.

Congress and the FDA continue to try and figure out how to reorganize to put the problem straight, but very little of the discussion has focussed on the funding and immediate solution of the problem, instead it has focussed on reorganization of the agency and how it might affect things over the long term.