US drug regulator issues guidance to tackle delays & speed-up generic approvals

Viswanath Pilla
Moneycontrol News

The US Food and Drug Administration (USFDA) announced new steps aimed at speeding up the process for reviewing generic drug marketing applications and boosting competition.

In the latest draft guidance, USFDA tried to tackle a major loophole called 'citizen petitions' used by branded drug makers or innovators to delay the entry of generic drugs.

Citizen petitions are originally intended to serve public interest by allowing patients to raise concerns related to the safety of the generic drug. But nearly all citizen petitions filed with USFDA are at the behest of branded drug makers. USFDA will have to act on these petition within 150 days.

Though USFDA rejects nine out of 10 petitions, these petitions increase the burden on the agency, taking away resources from the daily work of application review and causing delays in approvals.

The USFDA said it will now determine if a particular petition was filed to delay a generic approval and, if so, refer the matter to the competition watchdog: US Federal Trade Commission.

While it didn't specify any solution, USFDA highlighted another widely used tactic of preventing generic drug makers from accessing samples of branded drugs to establish equivalence.

Generic manufacturers need anywhere from 2,000 to 5,000 doses of the branded drug to run studies to prove their generic is equivalent to the branded drug.

"One of the most common tactics we’ve taken aim at are instances when branded firms make it hard for generic manufacturers to get access to physical doses of a branded drug," said USFDA Commissioner Scott Gottlieb.

"Such practices upset the careful balance that Congress sought between product innovation and access. They can make the development and approval process unpredictable, and potentially more costly, for generic manufacturers," he said.

Gottlieb, who was appointed as Commissioner in May last year, has made lowering drug costs a top priority. Since then, the USFDA has been scaling approvals of generic drugs or low-cost copies of branded drugs to usher competition and drive down the price of medicines.

In 2017, USFDA approved/tentatively approved more than 1,000 generic drug applications, setting a record.

Gottlieb said the agency is on track for similar success in 2018.  The agency also brought down the approval timeline from 3-5 years to 10 months.

"We have completely eliminated our pre-user fee backlog of generic applications. We have also published guidance to help developers of complex generic drug products and have prioritised the review of generic applications for products with little competition," Gottlieb said.

For Indian companies, the pace of USFDA approvals is a mixed bag. In the near to mid-term, Indian drug makers will see their pending approvals getting cleared faster, but in the long term more competition will lead to sharper price erosion at a time when the distribution channels are also consolidating.