Congresswoman Robin Kelly, chair of the Congressional Black Caucus Health Braintrust and member of the Health subcommittee on Energy and Commerce, has introduced the Orange Book Transparency Act (H.R. 1503) to increase access to lower cost generic drugs and bolster competition within the generic drug marketplace to help reduce 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.
At today’s health subcommittee hearing on reducing barriers to competition in the pharmaceutical marketplace, Congresswoman Kelly questioned witnesses on lowering drug prices and the importance of increasing Orange Book transparency.
The text of the bill can be found here.
