U.S. Rep. Robin Kelly (D-Matteson), 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 (House Resolution 1503) aimed at increasing access to lower-cost generic drugs and bolstering competition within the generic drug marketplace to help reduce drug costs.
The Orange Book is a 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 drug companies use the Orange Book to make research and development decisions. Kelly noted that experts, medical professionals and advocates have been suggesting Orange Book improvements for years.
Kelly’s 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 Food and Drug Administration for patents found to be invalid.
- Empower the FDA to add additional patents, if necessary, to the Orange Book; promptly remove patents from the Orange Book that 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 be shared with the FDA to prevent efforts to delay generic drug competition based on the delivery mechanism.
At a recent Health subcommittee hearing on reducing barriers to competition in the pharmaceutical marketplace, Kelly questioned witnesses on lowering drug prices and the importance of increasing Orange Book transparency.