FDA unveils efforts to speed complex generic approval

SILVER SPRING, Md. — As it continues to expand on its Drug Competition Action Plan, the Food and Drug Administration has outlined new efforts to make it easier for manufacturers to bring complex generics to market. In a post on the FDA’s blog, commissioner Dr. Scott Gottlieb noted that in many instances complex drugs — which include drugs with complex active ingredients and complex drug-device combination products — do not have generic competitors for various reasons.

“The new policies we’re announcing today are aimed at ensuring that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs,” Gottlieb wrote. “This focus is critical because, first and foremost, these drug products provide important therapies to patients. They are also becoming increasingly significant to the economic health of the generic drug industry. Being able to ‘genericize’ a complex drug can be a high-value opportunity for a generic drug maker that helps underwrite the costs of other generic applications.”

Among the efforts is a draft guidance to assist manufacturers submitting abbreviated new drug applications for complex generics in creating and submitting preliminary requirements. The draft guidance is designed to give the FDA the ability to give better advice to sponsors looking to enter the complex generics space.

“These meetings will allow for enhanced communication between generic drug applicants and FDA early in the generic drug development process, allowing for more efficient generic drug development, review, and approval pathways. We’ve found from analyzing our new drug program, that early and better meetings between FDA and sponsors can improve development timelines. We want to bring these same types of opportunities to developers of complex generics."

The agency also is issuing another draft guidance to help manufacturers determine when submission of an ANDA for peptides — compounds made up of 40 or fewer amino acids, which constitute a number of branded medicines that don’t currently have generic competition despite having lost exclusivity — would be appropriate. Gottlieb said that the draft guidance would help ensure that the risk of an immune responsive from a generic due to impurities will not differ from the reference drug.

“We’re doing all of this without sacrificing the scientific rigor of the process one bit,” Gottlieb wrote. “A central aspect of our approach, and our efforts to spur innovation and generic competition, is focused on adopting more rigorous and sophisticated science, including sophisticated quantitative methods and computational modeling, in drug development, evaluation and review.”

Gottlieb said the agency would be releasing more policies to spur complex drug competition, and that it would be doing more than releasing guidances. In the next year, he said the FDA would be looking to identify gaps in science and develop more tools aimed at better clinical endpoint testing, particularly for complex drugs that can’t be measured through typical bioequivalence methods or that don’t have an efficient or convincing bioequivalence test method. It also will hold scientific workshops around quantitative modeling approaches, among other opportunities for complex drug development, in the hope that they will speed product development and keep development costs down while improving patient access.

“Our announcements today are part of a broader effort by the administration to address the high and rising cost of drugs and in the coming months, we’ll advance other policies aimed at enabling generic competition to complex drugs,” Gottlieb said.