REMS Abuses: Congressional Panel’s Focus Turns To Federal Trade Commission

During bipartisan, but one-sided, hearing about US FDA’s limited authority to ensure generic drug makers can access restricted distribution reference products for bioequivalence testing, one lawmaker wants to know what FTC is doing about the issue.

Capitol House

A US congressional hearing highlighting FDA’s limited authority to ensure generic drug makers can access brand drugs sold under restricted distribution programs may shift the spotlight to the Federal Trade Commission’s (FTC) enforcement activities.

Lawmakers may want to consider whether more aggressive action by the FTC could dissuade reference product sponsors from using restricted...

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