FDA chief promises ANDA submission guidance by year’s end

SILVER SPRING, Md. — The Food and Drug Administration’s efforts to improve competition in the generics market — its Drug Competition Action Plan — is officially underway. The regulator held an open meeting on July 18, at which FDA commissioner Scott Gottlieb said would be the beginnings of a new internal strategy for dealing with abbreviated new drug applications, as well as a guidance on the best submission practices.

“Consumers derive greater value when they have access to more choice and competition,” Gotlieb said. “This is especially true when it comes to new drug categories. … The benefits of competition are equally obvious when it comes to generic drugs. But in some cases, we know that branded companies are using our rules that are intended to protect consumers, or meant to make the regulatory process more predictable, and taking advantage of these rules in order to deliberately forestall the entry of expected generic drug competition.”

Besides identifying where companies are gaming the system to reduce competition, Gottlieb said the FDA also is working on the efficiency of the review program, and that before the end of 2017, the FDA would issue a Manual of Policies and Procedures pertaining to internal policies a the FDA that will streamline the review process.

“This efficiency doesn’t mean lowering our standards,” the FDA commissioner said. “In the United States, approximately 90% of drugs that are dispensed are generics. That’s because when consumers go the pharmacy, they can be confident that a generic will work the same as the brand. FDA will continue to be the gold standard for review and approval of all drug applications, and we will make sure that consumers can continue to trust in that gold standard.”

Additionally, he said the agency would issue a “Good ANDA Submission Practices” guidance for manufacturers. Gottlieb said the guidance would outline common, recurring shortcomings of applications and offer suggests on avoiding these pitfalls to ensure the first submission is as complete as possible.

“Neither our internal MAPP nor the guidance alone can ensure that ANDAs will be approved more efficiently,” he said. “But taken together, I believe they will help effectuate real and measurable change.”