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Capitol Health Call
March 8, 2016

Senator Criticizes FDA Delays in Approving Generic Drugs

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Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2016;315(10):970. doi:10.1001/jama.2016.1780

Despite receiving an extra $1 billion in fees from the generic drug user fee program, the Food and Drug Administration (FDA) has slowed the pace at which it approves generic drugs, leading to less competition and higher costs for consumers, according to Lamar Alexander (R, Tenn), chair of the Senate health committee, at a recent hearing (

A survey of generic drug makers found that median approval times are now 48 months, Alexander said. He noted that when the generic drug program was established in 1984, its goal was to approve them in 180 days.

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