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CREATES Act Has a Penalty Problem

 
• By Derrick Gingery

Republican House Energy and Commerce Committee members say potentially taking a company's revenue for blocking a generic company from obtaining samples, rather than profit, is excessive.

Washington DC Capitol dome detail with waving american flag

US legislation intended to prevent the use of FDA safety measures to prevent generic entry may hinge on the penalty that would be imposed for a violation.

As currently drafted, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act would allow a court to impose damages equivalent to the revenue the company collected during a...

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