Criticism persists even as approvals hit all-time high

WASHINGTON — Amid calls for a quicker approval process, the Food and Drug Administration last year cleared for market the most generic drug products in its history.

The FDA said it approved or issued tentative approvals for more than 700 generic drugs in 2015. The announcement may help to blunt criticism from some federal legislators who have lambasted the FDA’s generic drug approval process, asserting that the agency hasn’t approved generics fast enough to foster competition and drive down medication prices.

In 2015, the FDA 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. Last year was also the first time the agency had access to more staffing.

“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 (OGD).

Kathleen Uhl

Still, lawmakers who attended various congressional hearings have questioned why the agency can’t quickly approve generic drugs that can compete and that can reduce prices. Those critics 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.

“Our increased capacity and expansion came at a critical time. With those additional funds came an FDA commitment to reach a variety of goals,” Uhl stated in a recent FDA blog. “We’re on track to meeting all of those goals.”

She pointed out that one major commitment of the Generic Drug User Fee Act was to take a so-called first action (by 2017) on 90% of the Abbreviated New Drug Application backlog prior to GDUFA’s implementation. “We had 2,866 ANDAs and 1,873 prior approval supplements (PASs), but by the end of 2015,we completed first actions on 84% of ANDAs and 88% of PASs — already close to the 90% goals set for 2017,” remarked Uhl.

“Despite our progress, we have a lot more work to do, but we don’t expect to do it entirely on our own. Achieving goals that work for the public requires input from the public, including industry, the research community, lawmakers and other stakeholders.”

Under GDUFA, the industry agreed to pay approximately $300 million in fees each year of the five-year program in exchange for the FDA’s commitment to improved performance goals.

The agency points out it has also achieved significant progress with controlled correspondence, often referred to as controls, which takes the form of product development questions that the FDA answers to help companies develop ANDAs. The agency had a backlog of controlled correspondence submitted before October 2014 when GDUFA goal dates were started. The agency notes that it has essentially eliminated the backlog and that last year OGD closed out a record number of controls (2,065) for the industry.

Similarly, the agency says that the filing backlog for ANDAs has also been substantially reduced. Filing is the process by which the FDA evaluates whether a drug applicant’s submitted application is sufficiently complete to permit the agency’s substantive review.

“In August 2014, there were more than 1,100 applications that had not been reviewed for an initial filing decision; today there is no backlog and filing is performed in real time,” notes the agency.

Improvements in the ANDA approval process continue. For example, in recent weeks Aurobindo Pharma Ltd. received final FDA approval to manufacture and market famotidine tablets USP, 10 mg and 20 mg (OTC). The approved ANDA is bioequivalent and therapeutically equivalent to Pepcid AC tablets (McNeil Consumer Pharmaceuticals Co.) The product is used to relieve heartburn associated with acid indigestion and sour stomach.

Aurobindo also received final approval for rivastigmine tartrate capsules USP, 1.5, 3, 4, 5 and 6 mg, the generic equivalent to Novartis Pharmaceuticals Corp.’s Exelon and for valganciclovir tablets USP, 450 mg, the generic equivalent to Valcyte (Hoffman-LaRoche Inc.)

Meanwhile, Lupin Ltd. has launched its norethindrone acetate and ethinyl tablets USP, 0.5 mg/0.0025 mg and 1 mg/0.005 mg, the generic version of Warner Chilcott’s Fmhrt tablets, used for the prevention of postmenopausal osteoporosis. And Mylan N.V. has brought out what it says is the first and only available intermediate dosage strength (37.5 and 75 mg) of generic Lopressor. Mylan also markets the hypertension treatment in 25, 50 and 100 mg strengths.