Cancer Cure Coalition Proposes Major Changes at the FDA

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 safety, regulators keep raising
the bar for approval, especially for innovative, high-tech products."
We at the Cancer Cure Coalition agree with Dr. Miller that "What the FDA
needs is competent management, discipline in the ranks, more effective risk-
benefit balancing, a commitment to permitting patients to assume more
responsibility for the risk of medicines, and the banishment of politics from
regulatory decisions and policy."
We think that reform is needed as soon as possible, and we propose the
following steps be taken:
1. Substantial additional funding should be given to the FDA to help it
fulfill the increase in duties placed upon it by the Congress.
2. The "Food" division should be separated from the "Drug" division.
Insuring the safety of food for the United States is an enormous
responsibility and would be best performed by an agency dedicated to that
purpose.
3. A special study should be made by an independent organization to make
sure that the FDA has competent management. Those managers who are incompetent
should be replaced. In the "Drug" division, management is needed that will
recognize the needs of the patients and that will apply effective risk-benefit
balancing.
4. Consideration should be given to using certified non-governmental
agencies to perform the oversight of drug testing and the review of new drug
applications. This would reduce cost while improving the quality of the review
process.
Unless we move for reform now, the FDA will continue to harm the interests
of patients, our health industry and the economy of the United States.
Contact:
Charles A. Reinwald, Chairman
Charles Reinwald, Jr., President
Cancer Cure Coalition
561-747-2174
E-mail: cancercurecoal@aol.com
http://www.cancercurecoalition.org

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SOURCE Cancer Cure Coalition

Charles A. Reinwald, Chairman, Cancer Cure Coalition, or Charles Reinwald,
Jr., President, Cancer Cure Coalition, cancercurecoal@aol.com, or
+1-561-747-2174