Bills
| 3.23.22

Should the FDA’s ‘Orange Book’ of Approved Drug Patents Be Improved to Promote Competition? (H.R. 1503)

Do you support or oppose this bill?

What is H.R. 1503?

(Updated December 25, 2020)

This bill — the Orange Book Transparency Act of 2019 —  would increase access to lower-cost generic drugs and bolster competition within the generic drug marketplace to help reduce drug costs by ensuring that patents listed in the Approved Drug Products with Therapeutic Equivalence Evaluations Publication (aka the Orange Book) are valid and relevant to the approved product. It’d also strengthen requirements surrounding the removal of invalidated patents from the Orange Book.

Specifically, this bill would:

  • Clarify the types of patents listed in the Orange Book (and require the removal of invalidated patents);
  • Require a list of applicable exclusivities for listed drugs;
  • Create a private-sector mandate requiring drug manufacturers to promptly submit a patent withdrawal or removal to the FDA for patents found invalid by the Patent Trial and Appeals Board or another court; and
  • Empower the FDA to: 1) add additional patents to the Orange Book if necessary, 2) promptly remove patents from the Orange Book which are found to be invalid, and 3) reconsider the types of patents listed in the Orange Book within one year of enactment.

This bill would also clarify that device patents aren’t required 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.

This bill would also require the FDA to solicit public comments regarding the types of patient information to be listed in the Orange Book. Within a year of this bill’s enactment, the FDA would then give Congress an evaluation of such comments, including any recommendations about the types of patent information that should be included in or removed from the Orange Book.

This bill would also direct the Government Accountability Office (GAO) to conduct a study that analyzes certain patents with claims relating to devices listed in the Orange Book, and evaluates the extent to which listing such patents have affected the timing for the entry of generic drugs into the market. A report of the GAO’s findings would be due to Congress within a year of this bill’s enactment.

The Orange Book is a list of drug products approved by the FDA under the Federal Food, Drug, and Cosmetic Act that includes patent and exclusivity information and identifies whether a drug is currently being marketed or has been discontinued.

Argument in favor

The Orange Book is an important resource for generic drug development. Generic drugs offer lower prices to consumers, and should be supported by the federal government through initiatives such as the Orange Book.

Argument opposed

The patent invalidation process can be lengthy if the patent holder appeals, so keeping the Orange Book current may prove difficult. This bill could harm innovation in the pharmaceutical and medical device industries by empowering generic manufacturers.

Impact

Pharmaceutical companies; pharmaceutical drug development; generic drug development; the FDA; GAO; and the Approved Drug Products with Therapeutic Equivalence Evaluations Publication (Orange Book).

Cost of H.R. 1503

The CBO estimates that implementing this bill would cost $1 million, primarily for the FDA’s personnel-related expenses to comply with this bill’s reporting requirements.

Additional Info

In-Depth: Rep. Robin Kelly (D-IL) introduced this bill to increase access to lower cost generic drugs and bolster competition in the marketplace to drive down prescription drug costs for American families:

“No one should be forced to choose between lifesaving medicine and putting food on the table. Sadly, this is the everyday reality of too many people. There is more that we can and should do to lower drug costs for American families. This bill will increase access to and competition from generic drugs. The result will be lower out-of-pocket costs for families – a major promise of Democrats’ For the People agenda.”

In a January 2019 press release, the FDA expressed support for making the generics industry “as competitive as possible” to ensure consumers have access to affordable medicines. In the service of this goal, FDA Commissioner Scott Gottlieb acknowledged the importance of an updated Orange Book:

“Maintaining an up-to-date Orange Book also serves many important public health roles. Among its many benefits, the Orange Book helps keep health care providers informed on what drugs are approved and available.”

In testimony to the House Energy and Commerce Health Subcommittee, Association for Accessible Medicines (AAM) president and CEO Chester “Chip” Davis, Jr. expressed his organization’s support for this bill:

"AAM supports the Orange Book Transparency Act and the Purple Book Continuity Act, and recommends additional transparency and disclosure requirements consistent with our comment letter to HHS be included… Efforts to ensure patients are able to fully realize the savings available from generic and biosimilar medicines on the market today combined with Congressional action to advance policies that increase competition is the ultimate equation to achieving the shared goal of enhancing patient access to more affordable generic and biosimilar medicines."

In a House Energy and Commerce hearing on this and other bills, including the Purple Book Continuity Act of 2019, Republican leadership raised the concern that lowering drug costs had become a one-sided issue, as Democrats kept them in the dark on bill language and witness attendance. Republicans contended that many of the bills before the subcommittee lacked bipartisan support due to short notice, and that some of the proposed legislation even made complex changes to the FDA without the agency’s input or attendance at the hearing. Republicans and several witnesses expressed concern that legislation discussed would stifle innovation. Witnesses testified that settlements between branded and generic manufacturers get generic products to market more quickly than requiring parties to pursue the full litigation process. In response, Democrats continuously stressed than more generic competition was needed to immediately lower prices, and many encouraged greater biosimilar market entry and uptake.

In the House Energy and Commerce Committee hearing, Jeff Kushan, Sidley Austin LLP partner, also warned that it would be tedious to update the Orange Book constantly when many of the patents found to be invalid go through several appeals before a final decision.

This bill passed the House Energy and Commerce Committee by a voice vote with the support of 13 bipartisan cosponsors, including 12 Democrats and one Republican.


Of Note: 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 generic drug approvals and availability. 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.

In January 2019, the FDA announced a number of initiatives to improve the Orange Book. These include: new draft guidance for approved drug application holders clarifying the specific categories and descriptions of the information they’re required to give the FDA on the marketing status for their brand and generic drugs and how to provide it in a timely and consistent manner; new draft guidance describing how the FDA evaluates therapeutic equivalence (TE) and assigns therapeutic equivalence codes; and new draft guidance to help drug product applicants and approved application holders in using the Orange Book.


Media:

Summary by Lorelei Yang

(Photo Credit: iStockphoto.com / Anawat_s)