Drug Approval Law Will Likely Deter Pharma Delay Tactics

Law360 (February 25, 2020, 3:52 PM EST) -- Pharmaceutical manufacturers have used many strategies to delay competition from lower-cost equivalent products over the years. While so-called pay-for-delay has garnered more media attention, manufacturers have also blocked competition by denying access to product samples needed for development of lower-cost equivalents.

But in late December, Congress enacted a law that seeks to prevent this practice. Tucked away in the 700-plus page omnibus Further Consolidated Appropriations Act is a bipartisan bill known as the Creating and Restoring Equal Access to Equivalent Samples, or CREATES, Act, H.R. 965/S. 340. Both sides of the political aisle will laud their party’s efforts in passing this...

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