The FDA released its proposed budget and legislative proposals for FY 2024 (summary can be found here). Besides certain requests for additional funding, reauthorization of the user fee programs for new and abbreviated animal drug programs, a host of safety issues, as well as new record retention requirements to fight data integrity problems in applications and clinical testing, the Agency is also seeking legislative relief in the form of a “safe harbor” provision for the so‑called skinny label.
For those new to this blog and/or the concept of a “skinny label,” a few other posts that will outline the issue in greater detail can be found here, here, here, here, here, and here. In brief, the concept is pretty straightforward. The Hatch‑Waxman amendments, as they are written, permit an ANDA‑(505(j)) applicant or a 505(b)(2)‑NDA applicant to exclude a use for a multiple‑use product if the reference listed drug (RLD) has patents or periods of market exclusivity that cover one or more of the uses, if there is at least one use that is not preventing approval because of patent or exclusivity, or the exclusion of the protected information does not make the ANDA or (b)(2) applicant’s product less safe than the RLD.
Well, there have been some recent court challenges to the skinny‑label provisions of the Act and (most notably) a recent court case (see below) that found that an ANDA applicant’s marketing of a product with a skinny label caused an inducement to infringe a patent held by the RLD applicant or patent holder because, among other issues, the applicant advertised that its product was bioequivalent (i.e., AB rated) to the RLD. Due to the fact that an ANDA approval requires a finding of bioequivalence, such a truthful disclosure would seem to be a no brainer, but the court disagreed.
The skinny‑label provision was one element of the Drug Price Competition and Patent Term Restoration Act that, together with other important elements, forged a delicate balance between NDA holders’ rights and generic applicants’ ability to seek approval of their products prior to patent or exclusivity protection of the innovator in certain circumstances. The FDA best understands this balance and how effective it has been in fostering competition ever since the 1984 enactment of the Act. And now, in its FY 2024 legislative proposals, the FDA is calling for further legislative protection for the skinny label.
The FDA says it “is proposing that the provisions the Hatch‑Waxman Amendments and the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) added to section 271 of title 35 of the U.S. Code be amended to create a safe harbor from patent infringement liability for human and animal generic drug applicants and 505(b)(2) applicants who market a drug with ‘skinny labeling,’ by excluding such labeling from the evidence that can be used to support a claim of patent infringement, and by clarifying that statements regarding therapeutic equivalence cannot be used as evidence to support an infringement claim. In GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., No. 18‑1976, the majority Federal Circuit decision held that substantial evidence supported a jury verdict finding that Teva induced infringement of a patent‑protected method of use for its generic version of Coreg (carvedilol) tablets, including during a period when Teva had carved out the corresponding condition of use from its labeling. While the majority decision indicates that the decision is narrow and fact dependent and should not upset the careful balance struck by the Hatch‑Waxman Amendments regarding labeling carve‑outs, FDA is concerned that this decision imperils an important statutory marketing pathway that allows earlier generic drug market entry for conditions of use of a drug not protected by a patent. Without this change, FDA expects that the Federal Circuit’s GSK v. Teva decision could significantly impact the timely availability of generic drugs.”
While those of us who have been involved with generics and 505(b)(2) applications for the some thirty‑nine years since Hatch‑Waxman was passed already believe that the process works well, it is because of the court case cited above that the FDA is proposing a legislative fix that will strengthen the skinny label provisions of the Hatch‑Waxman Act to work as Congress intended.