The Food and Drug Administration is so underfunded that it does not have the science foundation, staff or information technology to meet mounting demands to oversee the country’s drugs, medical devices and food safety, FDA’s Science Board said in a report released Nov. 29.
The Science Board, an advisory group of academics, industry and government experts to FDA Commissioner Andrew von Eschenbach, painted a picture of an agency that lacks resources.
The country’s food supply and the regulatory systems that oversee the drug and device supplies are at risk, a board subcommittee said in a report it expected to present today to FDA. The situation is the result of soaring demands on FDA and resources that have not increased proportionately, the panel said.
“This imbalance is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public,” the report states. The report is the product of a yearlong review by the board’s Science and Technology Subcommittee. FDA, an agency of the Health and Human Services Department, also plays a central role in protecting the country from the potential effects of terrorist attacks.
The subcommittee urged funding to support the agency's scientific base, hiring a broadly capable scientific workforce and building a sophisticated, modern information technology infrastructure.
Past reviews also pointed to FDA’s underfunding. The subcommittee found substantial weaknesses across the agency.
“In contrast to previous reviews that warned crises would arise if funding issues were not addressed, recent events and our findings indicate that some of those crises are now realities and American lives are at risk,” the panel stated in the report.
The deficiencies’ effect is profound because science is at the heart of what FDA does, the subcommittee stated, adding that the agency will fail without a strong scientific foundation.
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