Capstones

Author

Ross Keith

Graduation Date

12-31-2014

Subject Concentration

Health & Science

Degree Name

Master of Arts (MA)

Abstract

Speedy drug approvals have become increasingly the norm at the FDA, a trend that began in 1992 with the passage of the Prescription Drug User Fee Act. Over the past 20 years, the approval process has shrunk, on average, from three years to ten months. As speed has risen, the number of safety issues has as well. Some notoriously harmful drugs, such as Vioxx and Avandia, that were pulled from the market because of dangerous side effects, were fast-tracked. Some doctors and industry analysts question whether the agency’s laissez faire approach is essentially moving the testing phase of drugs from the laboratory to the medicine cabinet.

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