Backlog of generic drug applications at FDA

Despite creating a detailed plan to speed up the rate at which generic drug applications are reviewed, experts say a backlog has developed at the Food and Drug Administration’s Office of Generic Drugs.

(For the full chain pharmacy section of DSN's Aug. 25 issue, click here.)



“They are buried,” Robert Pollock, a former acting deputy director of the OGD, told the Wall Street Journal earlier this month.



“They are on track to receive more than 1,500 [applications] this fiscal year,” he said. “The estimates were for between 800 and 850 applications, and the funding was based on assumptions of a workload that were far below what they are seeing. I believe that OGD needs to change the way it reviews applications.”



Pollock, who is now with Lachman Consultants, where he advises generic drug makers on regulatory issues, said the FDA needs to find ways to boost staffing even as it faces budgetary constraints.



Two years ago, the agency was authorized to start collecting fees from generic drug makers in order to increase the number of facility inspections — especially those overseas — and speed up application reviews in order to ensure safety and bring new generics to market faster.



This summer, however, the FDA has seen an unexpected number of applications that have not been processed. Regulators say the situation was created partly by a deadline for submitting applications that reflected required changes in testing medicines.



However, some in the industry contend that the backlog is due to a more fundamental problem, as the FDA struggles to deal with a growing amount of paperwork.



Pollack said he feels OGD’s problems could worsen if the number of applications from companies based in China starts to accelerate. Any further slowdown in approvals, he said, could result in generic drug makers and the FDA sparring over the next round of fees that are used to fund the program.



The number of generic drugs approved by the FDA has been relatively stable over the past few years. In fiscal 2010, the agency approved 426 medicines. A year later, the total hit 458, and the number of approval topped out at 517 in fiscal 2012. Last year, the FDA approved 330 generics.



The number of applications received, however, has not kept pace with the approval rate. The FDA said that in the current fiscal year, it already has received 1,440 approval requests, including 600 in July alone.



While not causing any disruptions in the market so far, some have suggested that further approval delays could adversely impact efforts to control healthcare spending.

According to the IMS Institute for Healthcare Informatics, 86% of all prescriptions in the United States last year were for generics.