President signs Rep. Kelly-introduced Orange Book Transparency Act into Law

The Act will reduce drug prices through increased access to generic drugs

Washington, DC – On January 5, 2021, President Trump signed into law the Orange Book Transparency Act (H.R. 1503), introduced by Congresswoman Robin Kelly, chair of the Congressional Black Caucus Health Braintrust and member of the Health subcommittee on Energy and Commerce.

The new law will increase access to lower-cost generic drugs and bolster competition within the generic drug marketplace to help reduce drug costs. The legislation passed by unanimous consent in both the House and Senate.

"Americans will finally get a break from astronomical drug costs," Congresswoman Kelly said. "The Orange Book Transparency Act will more efficiently achieve lower drug costs and higher quality, lifesaving medicines for Americans while at the same time enhance market competition by getting generic drugs to market more rapidly. We have a moral responsibility to close loopholes that allow drug makers to prevent timely access to information that would lead to new generic drug development. This moves us in the right direction toward transparency and affordable drug costs."

The Orange Book is an important tool for the development and prescribing of generic drugs. Doctors and pharmacists use the Orange Book for information on the approval and availability of generic drugs. Likewise, generic companies use the Orange Book to make critical R&D decisions. Experts, medical professional and advocates have been suggesting Orange Book improvements for many years.

The Orange Book Transparency Act would:

• Clarify the types of patents listed in the Orange Book;
• Require a list of applicable exclusivities for listed drugs;
• Require sponsors to promptly submit a patent withdrawal or removal to the FDA for patents found to be invalid; and
• Empower the FDA to:
  • Add additional patents, if necessary, to the Orange Book,
  • Promptly remove patents from the Orange Book which are found to be invalid, and
  • Reconsider the types of patents listed in the Orange Book within one year of enactment.

The legislation would also clarify that device patents are not to be listed in the Orange Book but should still be shared with the FDA to prevent efforts to delay generic drug competition based on the delivery mechanism.

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