Changing the way the Food & Drug Administration works may be an idea whose time has come, or one that has run out of time this election year.
For opponents of the current legislative proposals to revamp the agency, time is an ally. Congress doesn't have much of it left before quitting to campaign full-time. They are hoping to run out the clock. Time is on the mind of the reform supporters, too. They want to reduce the time it takes to approve new drugs and medical devices. They remain publicly optimistic that the House and Senate can pass their separate reform plans (neither has yet), resolve the differences between them in a conference, and send a compromise acceptable to the President for his signature in October. As a practical matter most observers believe bills must clear both bodies for conference before Congress adjourns for the political party conventions in early August.
For the most part, pharmacy has viewed FDA reform legislation as a means to an end: use it as a vehicle to kill the proposed MedGuide patient information leaflet program and to get the agency to leave pharmacy compounding enforcement solely to the states. National pharmacy associations are united on those points.
But as chances for FDA reform dwindie, alternative vehicles have been sought. An amendment that would kill MedGuide has been added to the FDA's appropriation by the House. Senate appropriators would postpone MedGuide for 120 days to give the private sector time to come up with its own action plan. Aside from that, pharmacy associations have expressed little interest in the legislative details aimed at overhauling the prescription drug approval process and other pieces of FDA's vast regulatory mandate.
On a broad basis, ASHP's board last year approved a policy position supporting management reforms at FDA "that minimize the time and expense associated with approval of drug products, without compromising the agency's vital mandate of ensuring that new drug products are safe and effective and that all drug products and drug manufacturers meet minimum quality standards." The board also expressed support for the overall mission of the agency. The ASHP house of delegates endorsed the board's stand at its annual meeting in June and added support for sufficient federal funds for the FDA to carry out its public health mission.
Making changes in the world's premier consumer protection agency is a monumental task. The FDA's purview ranges over products that account for 25% of U.S. consumer spending. Its regulations cover drugs, blood, medical devices, most foods, bottled water, cosmetics, veterinary medical products, and even pet turtles. One of the most controversial features in the drug and device arena concerns use of strict deadlines and FDA-certified third-party reviewers to speed up the approval process.
To opponents, such as Public Citizen's Health Research Group, use of private reviewers "would sacrifice the objectivity and independence of the FDA. …