If the FDA cannot do its job, the health and safety of the U.S. are at risk. In recognition of this, in December 2006 FDA Commissioner Andrew von Eschenbach, MD, formed a subcommittee to assess whether the FDA can support current and future regulatory needs.

The subcommittee concluded that the FDA is in a precarious position. It suffers from serious deficiencies, and is not prepared to meet its responsibilities.

The demands on the FDA have soared due to the advance of science and the complexities of new products. At the same time, the resources available to the FDA have not increased to meet this demand.

The FDA will soon flounder and fail unless it improves its scientific research, staff, and information infrastructure. At present, according to the subcommittee:

• The FDA cannot fulfill its own mission because its scientific base has eroded
• The FDA cannot fulfill its own mission because it does not have sufficient capacity and capability
• The FDA cannot fulfill its own mission because its information technology infrastructure is inadequate

That means that the FDA does not have the ability to ensure the safety of food or to adequately regulate medical products.

In Life Extension Magazine, editor William Faloon comments that, “The heartbreaking fact is that tens of millions of Americans have needlessly suffered and died because of FDA incompetence ... and the FDA now admits its own incompetence! These tens of millions of lives lost are not statistics of strangers. Virtually everyone reading this column has family or friends who have been victimized by dangerous drugs or denied access to life-saving ones ...

“If all the FDA did was act so cautiously that it almost never approved a dangerous drug, then at least the agency could point to some consumer value it provides. Instead, we are plagued by an antiquated regulatory agency that stifles the development of novel life-saving medications, while allowing a slew of drugs to be sold that have cumulatively cost millions of lives.”