HSCA to FDA: Address backlog of generic drug applications

The Healthcare Supply Chain Association (HSCA) recently sent a letter to FDA urging timely implementation of the remaining provisions of the Generic Drug User Fee Amendment (GDUFA).

HSCA notes in the letter that GDUFA is vital to the safety, efficacy and affordability of the generic drug market, the healthcare supply chain and patients, and calls on the agency to improve the approval process for the growing backlog of Abbreviated New Drug Applications (ANDAs) to increase competition in the marketplace.

The GDUFA is now halfway through its 5-year implementation period.

“While FDA has done tremendous work thus far in building the necessary frameworks that will allow this law to get up and running, there is a growing backlog of ANDAs,” said Curtis Rooney, president of the HSCA, told FormularyWatch.

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Before GDUFA, review time was 30 months. By FY2012 it was 31 months; FY2013 it was 36 months; and FY2014 projections estimate a median time of 42 months, according to Rooney. “Additionally, the sum of both tentative and final approvals has fallen. In 2012 there were 612 overall approvals, 2013 had 535 approvals, and 2014 had only 500,” he said.

“These delays affect the ability of formulary managers at hospitals and managed care companies to precisely account for overall manufacturer scheduling, which could result in drug shortages, a decreased availability of generic drug supplies and potential price spikes,” Rooney continued. “Fewer generic drugs in the market affect planning, costs and safety across the entire healthcare supply chain.”

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In its letter, HSCA stated that FDA should speed up its ANDA approval process to remove barriers to market entry in order to increase competition.

“We made two suggestions: First, FDA should publicly post the number of all ANDAs submitted and the backlog on its website,” Rooney said. “Second, FDA’s Office of Generic Drugs [OGD] should fast-track potential generic drugs into markets where high drug prices result from manufacturers taking advantage of shortages and dominate market positions. FDA could focus on generic drugs in shortage or that have a price increase that exceeds the Producer Price Index or Consumer Price Index.”

The reasons for the backlog are not entirely clear, according to Rooney, “but this is a very complex marketplace and FDA certainly has a lot on its plate. Our focus has been on generic drugs where the ANDA process has been too slow.”

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