FDA Promises Easier Generic Drug Applications

The FDA’s new draft guidance to assist generic drug manufacturers on applying for drug approvals - along with other efforts from the agency - are designed to improve overall drug pricing and ease regulatory burdens on generic drug makers, according to FDA Commissioner Scott Gottlieb, MD.

“The creation of a more efficient path for the development and approval of generic drugs is a critical component of our efforts to promote competition and increase access to affordable medications,” Gottlieb wrote in a FDA Voiceblog post. "By providing greater clarity and direction to prospective drug applicants, we hope to help reduce the cost and barriers to bringing new generic medicines to patients.”

 Generic drug manufacturers have long complained about FDA’s delayed approval process and loopholes that allow brand drug manufacturers to stifle generic competition.

Nearly all (98%) of life sciences companies are concerned with FDA regulatory approvals and limitations on approved products, according to the 2017 BDO Life Sciences Risk Factor Report.” In 2013, 94% of the drug makers said they were concerned about the same issues.

In addition, CVS Health, Express Scripts, and several other health-care groups and PBMs are supporting a bill that targets anticompetitive behavior by brand drug manufacturers--behavior intended to stifle generic and biosimilar competition.

The Fair Access for Safe and Timely Generics Act of 2017, also known as the “FAST Generics Act of 2017, was introduced by Reps. Peter Welch (D-VT), and David McKinley (R-WV) in early April.

FDA is developing a group of policies “aimed at closing loopholes that allow branded drug companies to game our rules in ways that forestall the generic competition that Congress intended,” Gottlieb wrote.

In addition, the agency released several policies in early October “aimed at making it easier to bring generic competition to a category of branded drugs known as complex drugs,” Gottlieb wrote.

Complex drugs include metered-dose inhalers for asthma, drug-device combinations, and certain high-priced injectable drugs. “These medicines generally have at least one feature that makes them harder to ‘genericize’ under our traditional approaches. As a consequence, these drugs can face less competition,” Gottlieb wrote. Pricy branded complex drugs may have lost their exclusivity, but still have no generic competition.”

”[A]ny steps we can take to encourage the development of generic competitors to complex drugs will have an outsized impact on access, and prices,” Gottlieb said.

Up next: More FDA guidance news.

ANDAs for complex drugs may undergo more review cycles than other generic drugs, according to Gottlieb, who detailed other challenges for generic drugmakers. "These hurdles, in turn, may result in limited competition and higher prices,” he wrote. “We recognize these problems and are taking a number of new steps to support the development of high quality ANDAs for complex generic drugs.”

FDA’s new draft guidance is meant to assist ANDA applicants in creating and submitting pre-ANDA meeting requests, including meeting package materials, so FDA can give better advice to sponsors looking to develop complex generic drugs.

However, when the agency determines an application doesn’t meet approval standards, companies can learn a lot by discussing with the FDA ways in which they can come back with the information needed for the application, Gottlieb added.

FDA also issued a draft guidance  to help applicants determine when submission of ANDAs for certain complex products that are peptides would be appropriate, Gottlieb wrote.

The new guidance applies to ANDAs for certain specific synthetic peptides, namely, glucagon, liraglutide, nesiritide, teriparatide, and teduglutide, that reference brand-name versions manufactured using recombinant DNA technology.