FDA: PhRMA Says Approval Process Is Doing Just Fine
Answering critics who allege that the Food and Drug Administration is approving too many drugs too quickly, the Pharmaceutical Research and Manufacturers of America (PhRMA) asserts that the FDA is in fact working better than ever thanks to recent reforms aimed at speeding the approval process. Alan Holmer, PhRMA's president, told reporters yesterday that FDA standards remain the world's "'gold standard' ... in terms of a rigorous approval process." He said "overheated rhetoric" from consumer groups "might frighten some patients so that they stop taking necessary medications." And Holmer said the rhetoric might prompt lawmakers to pass reforms that would slow the FDA approval process. Decrying "superficial coverage" in the media, Holmer wrote in a recent letter to a newspaper that ran a "critical" story about the FDA: "If your local motor vehicle bureau hired more people and was therefore able to process driver's license applications faster, would you assume the system was letting more unsafe drivers on the road?" (Larson, Washington Times, 7/24).
"FDA Caution Can Be Deadly"
In a Wall Street Journal op-ed, Manhattan Institute's Peter Huber writes that FDA foot-dragging can be as harmful as approving dangerous drugs, and that the agency's role should not be to "superimpos[e] a political layer of review on scientific research." He writes: "It is said that the FDA cannot -- and should not -- move any faster than the progress of verified medical science. But in fact it moves a lot slower. Placing a layer of bureaucratic review on top of all the normal processes of medical science can have no other effect ... The FDA can indulge the presumption that everything it doesn't know should be shunned. AIDS patients cannot. The FDA can set its own, leisurely timetable. Cancer patients cannot" (7/24).