The Food and Drug Administration, beset by congressional criticism that it has contributed to big price spikes for generic drugs, announced Tuesday that it approved the most generic products in its history last year.
The FDA said it approved or issued a tentative approval for more than 700 drugs in 2015. GOP lawmakers have criticized the FDA’s generic drug approval process, saying that the agency hasn’t approved generics fast enough to foster competition and drive down prices.
The agency approved 580 generic products and gave tentative approval to 146 products. Tentative approval refers to generic applications that are submitted for approval before the patent or market exclusivity on a brand-name product expires.
That is more than fiscal 2013, when 440 drugs were approved and 95 received tentative approval.
Last year was also the first time the agency had access to more staffing, the agency added.
“With our ongoing efforts — and strong public input — we are confident that 2016 and beyond will be as successful as 2015,” said Kathleen Uhl, director of FDA’s Office of Generic Drugs.
The approvals come as Americans are increasingly concerned about high drug prices. Notorious cases of a generic drug maker buying up an older drug and jacking up the price have gotten significant publicity.
Most notable was Turing Pharmaceuticals, which raised the price of an anti-malarial drug called Daraprim from $13.50 a pill to $750 overnight.
The actions drew a spotlight on the FDA, specifically its approval process for generic drugs. Republican lawmakers in several hearings have questioned why the agency can’t quickly approve generic drugs that can compete and drive down the price.
Lawmakers have pointed to the FDA’s backlog of generic drug applications, which numbered more than 3,000 applications in 2012.
The agency has issued numerous reforms to address the approval process that a few years ago took more than a year to get through.
A 2012 law allowed the FDA to receive user fees from the generic drug industry in return for using that money for more staff and resources to approve drugs faster.
The agency now has a goal of acting on a generic drug application within 10 months.
