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Court Cannot Block FDA Enforcement of Regulatory Standards on Selective Basis
Description Appeals court reversed a trial court decision that the FDA could not prevent one drug maker from distributing a particular drug when it did not subject other makers of the same drug to specific standards. FDA enforcement may target drug makers who are found to have particular quality assurance problems without violating equal protection principles.
Topic Consumer Protection
Key Words FDA Approval; Equal Protection
C A S E   S U M M A R Y
Facts The FDA enforces its Current Good Manufacturing Practices (CGMP) for drug makers by inspecting their facilities for quality control. FDA conducted six CGMP inspections of a drug manufacturing facility run by Sage and found numerous violations. FDA sued Sage for its violations. The trial court ordered Sage to stop distributing certain drugs until FDA was satisfied with their quality, but would not prevent Sage from distributing one particular drug because the FDA had not set standards for production of that drug that would also apply to other makers of the drug. The court held that to be selective prosecution in violation of equal protection principles. The FDA appealed.
Decision Reversed. The trial court abused its discretion in preventing the FDA from enforcing its regulations. Equal protection principles are not violated unless a party shows that others similarly situated have not been subject to enforcement proceedings by the government and that there was an impermissible basis for the decision to bring an enforcement action. The fact that the FDA enforced certain regulations against this drug maker, while ignoring other drug makers is not an equal protection violation. The FDA can target particular drug makers when it sees particular problems with violations.
Citation U.S. v. Sage Pharmaceuticals, Inc., 210 F.3d 475 (5th Cir., 2000)

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