US FDA "Doing Better, But Reform Still Needed"

In the federal fiscal year to September 30, the US Food and Drug Administration approved 46 new drugs and 37 new medical devices compared to only 26 drugs and 27 devices in the year earlier, says a Montgomery Securities scorecard.

An FDA spokesman chalked this up to the "culmination of improvements in the review system that date back 10 years or more." Based on a spring 1996 study of comparative review times, he said, "in 1996, the USA is reviewing and approving faster than any country." Credit for the internal FDA improvements goes to the Prescription User Fees Act which made more money available, he said.

Even a spokesman for the Pharmaceutical Research and Manufacturers of America said "improvements have been made in the last couple of years." Drug and device industry analysts say faster FDA approvals are helping firms in both sectors by reducing their R&D risks, and some feel the fact that two bills proposing more flexible and shorter FDA reviews died without action at the end of the House and Senate sessions showed the agency has blunted attacks from outside critics.