FDA Commissioner Scott Gottlieb, MD, has announced in a blog post that the agency plans to hold a public meeting on July 18 to identify ways pharmaceutical companies are using FDA rules—including the standards and procedures related to generic drug approvals—to place obstacles in the way of generic competition. Gottlieb revealed that the agency is working on a Drug Competition Action Plan designed to thwart attempts to “game” the system.
One example of such gaming, Gottlieb said, is the increasing unavailability of certain branded products for comparative testing. To perform the studies required to develop a generic alternative to a branded drug, a generics sponsor generally needs 1,500 to 3,000 doses of the originator drug. Generic sponsors are willing to buy these products at fair market value, Gottlieb noted, but in some cases, branded companies may use regulatory strategies or commercial techniques to try to block a generics company from gaining access to testing samples.
Gottlieb also sees problems in accessing testing samples when branded products are subject to limited distribution—whether the company has voluntarily adopted limitations on distribution or the limitations have been imposed as part of a Risk Evaluation and Mitigation Strategy (REMS) program. In some of those cases, he said, branded sponsors may use these limited distribution arrangements as a basis for blocking generics firms from accessing the testing samples they need.
In addition, Gottlieb points out, some branded companies may be using the statutory default requirement to have a single shared REMS across both the branded and generic versions of a drug as a way to block generic entry. “The companies might prolong negotiations with the generic firms over the implementation of these single shared systems, which could delay the entry of safe and effective generic drugs onto the market,” he said.
The FDA is also going to look at how best to coordinate with the Federal Trade Commission (FTC) in identifying and publicizing practices that the FTC finds to be anticompetitive, Gottlieb added.
Source: FDA; June 21, 2017.