Resolution Calling for the Reform of the Food and Drug Administration Exposed

The Resolution Calling for the Reform of the Food and Drug Administration is listed under ALEC's Health and Human Services Task Force and was included in the 1996 Sourcebook of American State Legislation. ALEC has attempted to distance itself from this piece of legislation after the launch of ALECexposed.org in 2011, but it has done nothing to get it repealed in the states where it previously pushed for it to be made into law.

CMD's Bill Summary

This Resolution promotes a potential weakening of FDA review of new drugs and medical therapies. It also prohibits FDA authority over tobacco control and regulation of pharmaceutical advertising.

ALEC Resolution Text

Summary

A Resolution urging Congress to reform the Food and Drug Administration (FDA) to ensure that health care products, therapies, and cures are brought to the American public as quickly as possible. It also suggests that the FDA should significantly cut back on its bureaucratic procedures and policies that tend to delay the time a drug or therapy hits the marketplace.

Model Resolution

WHEREAS, better health care for all Americans is a paramount national goal, and one component to improved health care is the development and approval of safe and effective new medical technology, and

WHEREAS, innovative private sector firms in the medical technology industry have research underway that is making significant advances in the practice of medicine, and

WHEREAS, new therapies derived from medical technology are improving the lives of millions of Americans, and with meaningful Food and Drug Administration (FDA) reform, could significantly reduce health care costs, and

WHEREAS, minimizing delays between the creation and eventual approval of a new product derived from the genius of medical technology is a vital public health goal, and

WHEREAS, the competitiveness of the United States biotechnology, medical devices and pharmaceutical industries is dependent on bringing products to the market quickly, and

WHEREAS, repeatedly the FDA has fallen short of its own guideline for clearing medical devices and new drug applications for sale on the market. This, despite a FDA staff increase of 449% since 1960 and an annual gross budget authority exceeding $935 million, and

WHEREAS, regulatory delays are forcing companies to move their innovation overseas to countries that have regulatory systems consistent with the rapid pace of innovation.

NOW THEREFORE BE IT RESOLVED, that the {insert state legislative body} strongly urges Congress and the Administration to reform the governing statutes and operation of the FDA this calendar year to ensure that health care products can be brought to the market as quickly as possible while preserving the safety of all Americans, and

BE IT FURTHER RESOLVED, that it is imperative that the federal government be responsive to the changing health care market and ensure that the excellence of medical innovation in the United States is maintained, and

BE IT FURTHER RESOLVED, that a reexamination of the policies and procedures of the FDA is necessary to facilitate better and more rapid access to new therapies and cures, and

BE IT FURTHER RESOLVED, that even with the acknowledged regulatory obstacles and bureaucratic foot-dragging by the FDA, its current attempt to enter the tobacco control arena, an area already regulated by 13 federal agencies, departments, commissions and agencies and 138 offices and programs within those federal agencies, would continue to erode vital resources intended for the job FDA was supposed to do, and

BE IT FURTHER RESOLVED, that the FDA should be denied power over any information-disseminating activities of a pharmaceutical manufacturer to the extent they concern cost-effectiveness comparisons between FDA-approved products.

1996 Sourcebook of American State Legislation