FDA Commissioner Scott M. Gottlieb told a congressional panel July 27 the agency could always do more if its budget were bigger but refused to criticize the Food and Drug Administration’s current funding levels.
“We could always do more with more,” Gottlieb told lawmakers at the House Judiciary Committee's Subcommittee on Regulatory Reform, Commercial and Antitrust Law July 27 hearing on “Antitrust Concerns and the FDA Approval Process,” but he said he felt confident the FDA could meet its responsibilities with the resources it currently has.
Gottlieb acknowledged the agency’s Office of Generic Drugs faces a particularly heavy workload with a backlog of applications to get through and a steady stream of new applications coming. Even given those challenges, “we will get there shortly,” he said.
Starting in October, the FDA has promised to review high-quality generic drug applications much more quickly. Currently, the average review time for a generic drug application is 42 months. The new initiative will bring that down to between eight and 10 months.
Gottlieb said he’d report back to Congress on the OGD’s progress on the expedited reviews in fall of 2018.
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