The FDA has broad discretion to reject generic drug applications for political reasons.

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The FDA has very limited discretion to reject generic drug applications for political reasons. Federal law requires the agency to approve ANDAs (Abbreviated New Drug Applications) if the applicant proves bioequivalence—chemical identity to the brand-name drug. FDA spokesperson Andrew Nixon stated the agency "has very limited discretion in deciding whether to approve a generic drug" meeting equivalency standards. This legal constraint explains why Makary approved Evita despite political pressure: rejecting a scientifically valid application would trigger litigation the FDA would likely lose.

The FDA has broad discretion to reject generic drug applications for political reasons.

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