US FDA eases throttle on generics with highest-ever approvals in a single month

Published On: 06, Dec 2017 | Source:

Viswanath Pilla @@viswanath_pilla

The US drug regulator said it gave 26 first generic drug approvals in October, setting an all-time record for the most such approvals in a single month.

The 26 first generic approvals represent 29.9 percent of 87 approvals issued in October. In the same month last year, US Food and Drug Administration approved 54 generic drugs. The regulator also gave 325 complete response letters against 151 in October last year.

The record push in terms of approvals is part of US FDA efforts to lower prescription drug costs, an election promise of US President Donald Trump.

US FDA head Scott Gottlieb, who was appointed as commissioner in May this year, has made lowering drug costs a top priority. Since then, US FDA has been scaling up approvals of generic drugs — the low-cost copies of branded drugs — to bring more competition and drive down the prices of medicines.

By the end of the USFDA's 2017 fiscal year, which ends in September, the regulator approved 763 new generic versions of drugs—112 more than it had in 2016, almost twice as many as in 2014.

Before May, the agency approved an average of about 57 generic applications per month. In May through September, the number jumped to almost 73 per month.

Gottlieb announced in October about US FDA plans to make it easier to approve “complex” drugs – a category that include medications that are extremely difficult to replicate.

Subsequently, the agency published guidance material or resources to help companies trying to submit ANDAs for complex drugs that include tips such as what kind of lab evidence needed to demonstrate equivalence.

The guidance also talks about okaying generic copies with some design differences as a substitutable product, provided those differences don't hurt a patient's ability to use the product the way it is intended.

For Indian companies, the pace of US FDA approvals is a mixed bag. In 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.