Tell Congress: Fix the FDA Before the System Shatters

What Experts Say About the FDA

A recent report prepared by the FDA Science Board’s Subcommittee on Science and Technology contains numerous critical comments about the Agency’s ability to fulfill its mission. Below are comments directly from the report titled "FDA Science and Mission at Risk."

“The importance of the FDA in the nation’s security is similarly profound. The FDA plays a central role in protecting the nation from the potential effects of terrorist attacks1, such as anthrax, smallpox, attacks on the food supply, nerve agent attacks and radioactive contamination, as well as from naturally occurring threats, such as SARS, West Nile virus and avian influenza. Thus the nation is at risk if FDA science is at risk.” (Pg 1)

“…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.” (Pg 2)

“…the scientific demands on the Agency far exceed its capacity to respond. 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.” (Pg 2)

“The subcommittee found substantial weaknesses across the Agency...” (Pg 3)

“The nation’s food supply is at risk.” (Pg 3)

“FDA’s inability to keep up with scientific advances means that American lives are at risk. While the world of drug discovery and development has undergone revolutionary change — shifting from cellular to molecular and gene-based approaches — FDA’s evaluation methods have remained largely unchanged over the last half century. Likewise, evaluation methods have not kept pace with major advances in medical devices and use of products in combination. (Pg 3)

“The world looks to FDA as a leader — to integrate emerging understandings of biology with medicine, technology and computational mathematics in ways that will lead to successful disease therapies. Today, not only can the Agency not lead, it cannot even keep up with the advances in science.” (Pg. 3)

“Strong scientific leadership is needed at all levels to develop a new vision to build a strong science base within the Agency…” (Pg 4)

“The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.” (Pg 4)

“The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.” (Pg. 5)

Tell Congress not to add tobacco regulation to the FDA's plate. Fix the system before it shatters.

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