FDA’s Hatch-Waxman Public Meeting and Progression of the Agency’s Drug Competition Action Plan

On July 18, 2017, FDA held a highly anticipated public meeting discussing the balance between pharmaceutical competition and innovation. Titled “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access,” the meeting drew a tremendous response from industry with dozens of non-FDA or FTC speakers, and scores of other attendees who packed into the “Great Room” in Building 1 on FDA’s White Oak Campus. Academics, payors and providers, pharmaceutical developers and associated representatives, and representatives of the consumer and patient perspective all provided input to a panel of FDA and Hatch-Waxman all-stars (picture below).

FDA Commissioner Scott Gottlieb opened the meeting with a discussion of the Agency’s position and the announcement of the intended 2017 release of two new documents to improve the generic approval process as part of his Drug Competition Action Plan announced earlier this year. The first document, a Good ANDA Assessment Manual of Policy and Procedures (MaPP), will be an internal CDER policy to streamline the ANDA review process inside FDA without lowering approval standards. As part of this MaPP, Complete Response Letters will make clear what aspect of the application needs improvement to obtain approval. The second document is a Good ANDA Submission Practices Guidance, which will point out common recurring deficiencies in ANDA and provide advice on avoiding them in an effort to ensure better higher quality submissions.

Dr. Gottlieb explained that his goal for the Drug Competition Action Plan is to ensure that the competition Congress intended when it passed the Hatch-Waxman Amendments actually occurs. While FDA doesn’t have a direct role in drug pricing, Dr. Gottlieb explained that the acceleration of drug development should lead to a reduction in drug prices. To that end, Dr. Gottlieb said that FDA needs to address “gaming” the system to keep generics off the market, which undermines the balance between affordability and innovation. FDA is therefore looking to identify rule changes that will help ensure competition, alleviate scientific or regulatory obstacles to generic entry, and improve efficiency of generic drug evaluation.

CDER Director Janet Woodcock also discussed FDA’s role in preserving the balance set forth by Congress in the Hatch-Waxman Amendments. Dr. Woodcock highlighted the progress CDER has made in the last five years in addition to new challenges that have arisen: establishing “sameness” of non-traditional complex drugs, drug-device combinations, and setting up a biosimilar pathway. While FDA is addressing these issues, Dr. Woodcock emphasized the importance of establishing the “root cause” of the lack of competition to avoid shortages or price spikes. Markus Meier, of the Bureau of Competition at the FTC also spoke, highlighting the intersection between FDA and FTC.

Most of the presentations addressed the questions posed by FDA in the Agency’s Federal Register notice announcing the meeting and as discussed in our previous blog post. Patient advocates and generic drug industry representatives who spoke focused on:

• the potential use of REMS to block generic competition through protracted shared REMS negotiations;
• innovators’ refusal to provide samples to generic manufacturers;
• the practice of introducing new patented products with minor improvements and subsequent withdrawal of the original (called “product hopping,” incremental innovation, or the seemingly repurposed term “evergreening”);
• the potential to misuse the citizen petition process to delay generic drug approval; and
• pay-for-delay arrangements.

Conversely, innovators maintained that “incremental innovation” is the heart of further development and cited the fear of liability for refusal to provide samples. Meanwhile, they lamented the deterioration of patent and market exclusivity and cited articles (e.g., “Do Fixed Patent Terms Distort Innovation?: Evidence from Cancer Clinical Trials”) indicating a need for revised incentives. (As we previously reported, Professor Erika Lietzan of the University of Missouri School of Law has been looking into this issue, dubbed the “Drug Innovation Paradox.”)

In addition to comments from meeting participants, several written comments have already been submitted to the docket (Docket No. FDA-2017-N-3615).  In fact, former Representative Henry Waxman, of Hatch-Waxman notoriety, even submitted comments! His comments provided FDA with a copy of a recent Commonwealth Fund Report, titled “Getting to the Root of High Prescription Drug Prices.” In addition to the areas highlighted in the Federal Register notice, Rep. Waxman suggested that FDA permit the reimportation of single-source drugs, monitor the drug market to identify conditions that could lead to shortages or other reasons for significant increases in price, expedite review, and allow for early disclosure of patents to generic and biosimilar manufacturers. Consumer groups that spoke at the meeting also submitted comments in advance, as did some individuals. FDA will be accepting comments until September 18, 2017.

Unsurprisingly, quite a few presentations left the Hatch-Waxman track to discuss biosimilars. And others talked more about competition in the market generally and focused on areas in which FDA really can’t do anything, such as the consolidation of purchasers. But FDA panelists tried hard to redirect the conversation back to the issues under consideration and that FDA could actually address.

In fact, FDA panelists actively participated in the discussion with questions for many of the meeting speakers. FDA seems focused on tangible answers to the questions the Agency posed rather than theoretical competition policy or a list of problems in the industry. It seemed clear from the questions raised that FDA is looking for specific tools to address these competition issues while not sacrificing incentives for innovation. None of the speakers offered the magic bullet, but FDA seems to hope that reviewing all of the comments will at least set it on the right track.

FDA panelist questions, combined with Commissioner Gottlieb’s opening remarks, indicates just how serious FDA sees this issue. FDA panelists pushed some of the presenters on their suggestions to determine whether they were actually practical, such as requiring a preliminary finding that Citizen Petitions are likely to be granted or a finding that a reformulated product should prove a benefit in a Prior Approval Supplement.

FDA appears very open to concrete, well-thought out suggestions. Make sure you get yours in by September 18th!