A Meeting to Discuss FDA’s Continuing Conundrum: Innovation vs. Access

On June 21st, FDA announced an all-day public meeting dedicated to the Hatch-Waxman Amendments that will take place on July 18, 2017. The meeting, titled “The Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access,” is part of Commissioner Gottlieb’s Drug Competition Action Plan, which he indicated was forthcoming during a May 2017 House Appropriations Committee hearing.  The meeting is intended to further explore the juxtaposition of innovation in drug development and access to lower cost alternatives to innovator drugs. In an FDA Voice blog post, Commissioner Gottlieb explains that FDA is looking at how regulatory rules might be “gamed” or misused to reduce competition, keeping prices high for consumers. FDA is also bringing in the anticompetitive experts at the FTC to help out.

FDA posed several questions for stakeholder input:

• How have exclusivity periods, patents and patent listing procedures, innovator drug product labeling, post-approval changes to innovator products, and other regulatory processes (such as the citizen petition process) impacted the balance of innovation and access set forth in the Hatch Waxman Amendments?

• Given that many ANDAs are never marketed or subject to substantial delays after approval, what marketplace dynamics dis-incentivize the marketing of approved generics? What can FDA do to help approved generics come to market?

• Why are there so many drugs that have lost patent and exclusivity protection but have no generic competition? Are there areas where Hatch-Waxman Amendment incentives are insufficient to develop a generic?

• How should FDA use its authority to waive shared REMS systems to avoid delay or should it develop other administrative tools to do so?

• What should FDA do to promote access to testing samples?

• 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 address them?

Written comments are due by September 18, 2017. Registration for the public meeting, as well as requests to make oral presentations, is due to FDA by July 3, 2017. We’re sure we’ll see you all at what promises to be an exciting meeting!