HCP Head Barbara J. McNeil, MD, PhD, was one of several experts tapped to advise the FDA’s Science Board on the agency’s science and technology capacity. This review by the Subcommittee on Science and Technology—only the second in FDA history to examine the agency as a whole entity—comes at the 100th anniversary of the FDA.
After an extensive investigation, the subcommittee concluded that the FDA suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities. Unfortunately, the impact of these deficiencies is profound, since science is at the heart of the FDA’s activities. Among the findings in the group’s report are that the agency does not have the capacity to ensure the safety of the nation’s food supply, because basic functions such as inspection, enforcement, and rulemaking are severely eroded; and that the agency cannot adequately monitor development of food and medical products because it is unable to keep up with scientific advances.
The subcommittee’s findings were heavily covered by the media, including the New York Times and USA Today. The group’s report is available on the FDA website.


