FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

House Passes Orange, Purple Book Bills

May 16, 2019
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The U.S. House unanimously passed a pair of bills backers say will help cut down on drug patent arbitrage by requiring rigorous updates to the government’s logs for exclusivities on drugs and biosimilars.

The Purple Book Continuity Act (H.R. 1520), introduced by Rep. Anna Eshoo (D-Calif.), would create a log for biosimilar patents similar to the Orange Book’s format and would require the FDA to publish an electronic version on its website and update it regularly.

The Orange Book Transparency Act (H.R. 1503),  introduced by Rep. Robin Kelly (D-Ill.), would move up deadlines for updating the drug databases.

Both bills were referred to the Senate Committee on Health, Education, Labor and Pensions on May 9.

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