FDA Opens Critical Committee Report to Public Comment

January 10, 2008
Angie Drakulich

Angie Drakulich was editorial director of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration?s Subcommittee on Science and Technology released a report in November 2007 announcing that the agency is underfunded and cannot fulfill its mission. The FDA Science Board Advisory Committee has now discussed the report and decided to open a public comment period based on the subcommitee?s findings.

The US Food and Drug Administration’s Subcommittee on Science and Technology released a report in November 2007 announcing that the agency is underfunded and cannot fulfill its mission. The FDA Science Board Advisory Committee has now discussed the report and decided to open a public comment period based on the subcommitee’s findings.

FDA charged the Science Board in March 2006 to review the agency’s “scientific capacities, processes, and infrastructure,” including premarket review and consultation, oversight of product quality, and postmarket product surveillance. FDA also asked the board to provide insight into any agency gaps and to highlight missed opportunities in meeting agency responsibilities. The board created the Subcommittee on Science and Technology, supported by 30 outside experts drawn from industry, academia, and government, to carry out the review.

“The Subcommittee concluded that science at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities,” says the report. In its recommendations, the subcommittee emphasized the need for more FDA funding to address these deficiencies and offered specific suggestions for improvement.

Public comments on the report are due Feb. 3.

For more on this topic:

Read Pharmaceutical Technology’s article on the subcommittee’s report here.

Read the full subcommittee report here.

Read the FDA notice here.