On June 21, the Food and Drug Administration announced a Drug Competition Action Plan in order to attempt to address ways that the agency's rules have been, in the agency's view, “gamed” to create obstacles that delay generic drug approvals to reduce generic competition. FDA will be working with the Federal Trade Commission to identify and publicize any such practices that the FTC finds to be anticompetitive.
As part of the process, FDA announced that it is holding a public meeting and opening a public docket (see Federal Register) to solicit input on "how best to preserve the balance Congress intended to strike in the Hatch-Waxman Amendments between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs." The FDA meeting will be held on July 18, 2017, and the deadline for submitting comments is September 18, 2017. The agency hopes to understand better "the interplay between the existing legal and regulatory framework, available incentives and marketplace practices, and consumer access to generic drugs."
FDA is particularly interested in stakeholder input on the following questions:
- How has the balance struck in the Hatch-Waxman Amendments been affected by practices and trends related to the following:
- Exclusivity periods;
- Patents (including patent listing procedures);
- Innovator drug product labeling;
- Post-approval changes to innovator drug products (e.g., reformulations); and
- Other regulatory processes, including the citizen petition process?
- The drugs described in more than half of all FDA-approved ANDAs are never marketed, marketed only after a substantial delay after approval, or marketed only intermittently. Such failures to market contribute to drug shortages, and hinder consumer access to approved products. What marketplace dynamics dis-incentivize the marketing of approved generic products? What should FDA do, within its statutory authority, to help more approved generics reach consumers?
- For approximately 10 percent of all innovator drugs, patent and exclusivity protections have expired, but FDA has not received an ANDA. Are there market niches where the Hatch-Waxman Amendments incentives to develop an ANDA are insufficient? Similarly, are there niches where the incentives are insufficient to seek new drug approval of a marketed unapproved drug product that in turn could serve as a Reference Listed Drug? What should FDA do, consistent with its legal authority, to encourage submission development in any such market niches?
- The statutory requirement that Risk Evaluation and Mitigation Strategies that include elements to assure safe use be implemented through a “single shared system” relies on brand and generic companies agreeing on such a system before generic drugs may come to market. In some cases, challenges in reaching such an agreement between the parties may cause delays to generic competition. How should FDA apply its statutory authority to waive this requirement to implement a “single shared system,” or develop other administrative tools, to avoid these delays?
- Restrictions on distribution, either required by innovators or as part of a REMS ETASU, can prevent generic companies from obtaining drug products for bioequivalence and other testing to support ANDA submissions. FDA published a draft guidance for industry, entitled “How to Obtain a Letter from the Food and Drug Administration Stating That Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable Risk and Evaluation Mitigation Studies for Reference Listed Drugs,” in December 2014. Despite this draft guidance, generic companies have reported continuing difficulties obtaining sufficient samples of drug products for testing. What additional actions should FDA take, within its legal authority, to promote access to these drug products for generic companies seeking to conduct studies required to support ANDA submissions?
- What other elements of drug product development, regulation, and marketing have the potential to disrupt the Hatch-Waxman Amendments' balance between innovation and generic availability, and how should the Agency and other stakeholders address them?
Arent Fox's Food, Drug, Medical Device & Agriculture and Hatch-Waxman Litigation groups plan to attend the public meeting and will continue to monitor key developments in this area. If you have any questions, please contact James Ravitz, Brian Waldman, Brian Malkin, or the Arent Fox professional who usually handles your matters.