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FDA Reform: A Prescription for More and Better Drugs and Medical Devices

June 20, 2016
By Alden Abbott

This paper, written by Heritage Foundation Edwin Meese III Center for Legal and Judicial Studies deputy director Alden Abbott, examines how reforming the Food & Drug Administration (FDA) can increase the quality and reduce the price of medical drugs.

stethoscope and insurance docs

This paper, written by Heritage Foundation Edwin Meese III Center for Legal and Judicial Studies deputy director Alden Abbott, examines how reforming the Food & Drug Administration (FDA) can increase the quality and reduce the price of medical drugs and treatments.

FDA regulations are delaying innovation and increase prices, Abbott writes.

“Current FDA regulation imposes an enormous burden on the American economy in terms of forgone, prohibitively costly, and delayed improvements in medications and an excessive reliance on inflexible and outmoded regulatory approaches that do not reflect modern developments in science,” Abbott wrote.

FDA regulation is overly cautious and should be reevaluated, Abbott writes.

“FDA regulation has been scrutinized intensively in recent years, and a wide variety of reform proposals have been put forth,” Abbott wrote. “Much of the discussion centers around the concern that FDA regulatory processes, based primarily on lengthy clinical trials designed to approve drugs and devices that have broad application, have not kept up with dramatic changes in biogenetics and information processing that allow medications to be targeted more precisely to individual needs. Many valuable medications that benefit relatively small populations are not approved because of these old methodologies. Risks to individuals who may not derive benefit from particular drugs are given precedence over the harm to the unseen millions of people who are denied new treatments—a result that is at odds with maximizing welfare.”