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The federal Food & Drug Administration is in crisis. Its own scientific advisers say that the Agency can’t fulfill its mission to protect our nation’s health, food supply, medicines and medical devices.
In November, 2007 the FDA’s Science Board Subcommittee on Science and Technology issued a comprehensive report titled, “FDA Science and Mission at Risk.” The report detailed numerous disturbing concerns about the FDA’s ability to fulfill its responsibilities to consumers.
Below are facts taken directly from the Science Board’s recent report. (Review the report yourself.)
Fact: 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.
Fact: The impact of the scientific deficiency at the FDA is profound precisely because science is at the heart of everything the FDA does. The Agency will flounder and ultimately fail without a strong scientific foundation.
Fact: The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
Fact: The nation’s food supply is at risk.
Fact: FDA’s inability to keep up with scientific advances means that American lives are at risk.
Fact: FDA plays a central role in protecting the nation from the potential effects of terrorist attacks, such as anthrax, smallpox, attacks on the food supply, nerve agent attacks and radioactive contamination, as well as naturally occurring threats such as SARS, West Nile virus and avian influenza. Thus, the nation is at risk when FDA science is at risk.
Fact: 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 in the last half century.
Fact: The world looks to the FDA as a leader. Today, not only can the Agency not lead, it cannot even keep up with the advances in science.
Fact: The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
Fact: FDA’s failure to retain and motivate its workforce puts FDA’s mission at risk. Inadequately trained scientists are generally risk-adverse, and tend to give no decision, a slow decision or, even worse, the wrong decision on regulatory approval or disapproval.
Fact: The FDA lacks the IT infrastructure necessary to meet its mandate. Additionally, the FDA has insufficient access to data and cannot effectively regulate products based on new science due to lack of a supportive IT infrastructure.
Despite these, and numerous other problems detailed by the FDA’s own scientific advisers, some in Congress want to add more to the FDA’s plate – requiring them to spend billions of dollars on new tobacco regulations even though numerous federal and state agencies are already working to reduce tobacco use.
Fact: The head of the FDA has expressed concerns about asking the FDA to regulate tobacco. His concerns are detailed in testimony submitted to the US House of Representatives Committee on Energy and Commerce, Subcommittee on Health. Read the testimony of Commissioner Andrew C. von Eschenbach, M.D. here.
Paid for by Reynolds American Inc.
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