FDA generics backlog improves, although criticism continues

May 3, 2016

While many groups are criticizing the FDA backlog of generic drug approvals, the agency has released the numbers on approvals and tentative approvals for 2015.

While many groups are criticizing the FDA's backlog of generic drug approvals, the agency said the situation has improved.

See also: Biosimilars' savings may reach $100 billion by 2020

FDA’s Office of Generic Drugs (OGD) awarded 580 generic drug approvals and 146 tentative approvals in 2015. In December 2015 alone, OGD issued 99 approvals and tentative approvals, “the most approvals and tentative approvals granted in a single month since the start of the generic drug program,” FDA said in a statement. 

However, the Campaign for Sustainable Rx Pricing, backed by the National Coalition on Health Care, is pressing legislators to grant FDA more resources, to allow quicker processing of generic drug applications. The group's members include AARP, ASHP, numerous health plans, providers, and Walmart.

”The FDA faces a backlog of nearly 4,000 generic drug applications, yet approval times can be three or more years,” the group said in a policy statement. “The FDA should be provided necessary resources to clear this backlog and prioritize generic drug approval applications.”

The group is also calling for a reduction in the 12-year exclusivity period for biologics and says that regulatory policies should “encourage market entry and uptake of biosimilars, as they have significant potential to expand treatment options and reduce costs of expensive biologics through increased competition.”

Significant 2015 approvals

At the same time, FDA touted its generic drugs approval process in a recent report to Congress, especially for first-time generics.

See also: Legislators call for transparency in generic drug pricing

“FDA considers first generics to be a public health priority and prioritizes review of these submissions,” the agency said.

Among the agency’s significant 2015 approvals of first generics are: estradiol vaginal inserts (Vagifem) for menopause, ariprazole (Abilify) for schizophrenia and bipolar disorder, eptifibatide injection (Integrelin) to prevent blood clots during a heart attack or angioplasty,  levoleucovorin calcium injection (Fusilev) to prevent the adverse effects of methotrexate in patients with bone cancer, and linezolid (Tygicil) to treat pneumonia and severe infections.

In addition, FDA said, after a major restructuring, the law Generic Drug User Fee Amendments (GDUFA) of 2012 is working. The agency has committed to review and act on 90% of all backlogged abbreviated new drug applications (ANDAs), prior approval supplements (PASs), and amendments by the end of fiscal year 2017, the agency said in the report. So far, FDA has taken action on 82% of the backlog.

FDA says its response to generics companies' ANDAs is about 15 months. By October 2016, companies should expect to get an FDA response within 10 months.

 

GDUFA restructuring

The GDUFA restructuring through FY 2015 was a “deep, foundational transformation which has prepared FDA to meet goal dates, starting in FY 2015, agreed upon in the Generic Drug User Fee Act Program Performance Goals and Procedures (GDUFA Commitment Letter),” wrote FDA Commissioner of Food and Drugs Robert M. Califf, MD, in the report.

The restructuring of the GDUFA included the hiring and training of many new employees, reorganization of the Office of Generic Drugs (OGD) into a Center for Drug Evaluation and Research (CDER) “Super Office,” establishment of a new Office of Pharmaceutical Quality, replacement of fragmented information technology systems with a new integrated system (i.e., CDER Informatics Platform), and substantial enhancement of review and business processes, Califf wrote.

“Now that FDA has successfully accomplished this transformation, there are still goals and challenges ahead to continue the modernization of the generic drug program," he wrote.

"For example, GDUFA goal dates for FY 2015 ANDAs went into effect on October 1, 2014. As such, an ANDA received on October 1, 2014, received a 15-month GDUFA goal date of December 31, 2015; therefore, it is too soon to report on FDA’s final performance on its FY 2015 ANDA review goals,” Califf wrote.