Cancer Cure Coalition Proposes Major Changes ...( PALMS BEACH GARDENS Fla. Feb. 21 ...),Health

PALMS BEACH GARDENS, Fla., Feb. 21 /PRNewswire/ -- Flawed policies and bad decisions at the FDA have contributed to an escalation of the cost of clinical trials which now take an average of one billion dollars and require 10 years for approval. This has delayed and even prevented the availability of many promising treatment options, resulting in increased death and suffering for patients and greatly increasing the cost of medical treatment in the United States.

It's time to reform the FDA. It is failing in its mission and greatly harming the United States.

The FDA itself has acknowledged that it cannot do the job given to it by Congress and that it is failing in its mission. In a November 2007 report entitled "FDA Science and Mission at Risk," prepared for the FDA by its own subcommittee on Science and Technology, it states:

"The FDA cannot fulfill its mission because:

1.2.1) Its scientific base has eroded and its scientific organizational structure is weak.

1.2.2) Its scientific workforce does not have sufficient capacity and capability.

1.2.3) Its information technology (IT) infrastructure is inadequate."

It further states that "the lack of new science capability/capacity places the FDA mission at risk for those many products at the leading edge of innovation."

Proposals have been made by many that substantial additional funding be given to the FDA. There has even been a foundation, A Coalition for a Stronger FDA, formed to achieve this end. But as Dr. Henry I. Miller of the Hoover Institution pointed out in his book "To America's Health / A Proposal to Reform the Food and Drug Administration," and also in a letter to The New York Times published on February 10, 2008, additional resources alone are not enough. He stated, "the agency's most significant problems are mismanagement and a culture that is excessively risk-averse. Repeatedly accused (unjustly) of not being sufficiently concerned about drug sa
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