FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

House Passes CREATES, Patent Reform, ‘Pay-for-Delay’ Bills

May 24, 2019
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The House passed a seven-bill package by 234-183 votes, including three bills proponents say will reform the drug patent system, speed cheaper generics to market and ultimately lower drug prices.

The CREATES Act—officially called the “Creating and Restoring Equal Access to Equivalent Samples”—has failed in previous Congresses but backers believe this time will be different. Introduced to the House by Rep. David Cicilline (D-R.I.), it already has bipartisan support in the Senate, including the endorsement of Finance Committee Sen. Charles Grassley (R-Iowa).

The Protecting Consumer Access to Generic Drugs Act, originally introduced by Rep. Bobby Rush (D-Ill.), would make “pay-for-delay” schemes to keep generics or biosimilars off the market illegal.

The so-called BLOCKING Act would overhaul the 180-day exclusivity granted to the first generic on the market. It was introduced by Rep. Kurt Schrader (D-Ore.).

The three bills head over to the Senate for consideration.

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