FDA generics backlog improves


FDA generics backlog improves, although criticism continues

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

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.

“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.

Leave a Reply