Cancer Cure Coalition Proposes Major Changes at the FDA

Friday, February 22, 2008 General News
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PALMS BEACH GARDENS, Fla., Feb. 21 Flawed policies and baddecisions at the FDA have contributed to an escalation of the cost of clinicaltrials which now take an average of one billion dollars and require 10 yearsfor approval. This has delayed and even prevented the availability of manypromising treatment options, resulting in increased death and suffering forpatients and greatly increasing the cost of medical treatment in the UnitedStates.

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

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

"The FDA cannot fulfill its mission because:

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

1.2.2) Its scientific workforce does not have sufficient capacity andcapability.

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

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

Proposals have been made by many that substantial additional funding begiven to the FDA. There has even been a foundation, A Coalition for a StrongerFDA, formed to achieve this end. But as Dr. Henry I. Miller of the HooverInstitution pointed out in his book "To America's Health / A Proposal toReform the Food and Drug Administration," and also in a letter to The New YorkTimes published on February 10, 2008, additional resources alone are notenough. He stated, "the agency's most significant problems are mismanagementand a culture that is excessively risk-averse. Repeatedly accused (unjustly)of not being sufficiently concerned about drug safety, regulators keep raisingthe bar for approval, especially for innovative, high-tech products."

We at the Cancer Cure Coalition agree with Dr. Miller that "What the FDAneeds is competent management, discipline in the ranks, more effective risk-benefit balancing, a commitment to permitting patients to assume moreresponsibility for the risk of medicines, and the banishment of politics fromregulatory decisions and policy."

We think that reform is needed as soon as possible, and we propose thefollowing steps be taken:

1. Substantial additional funding should be given to the FDA to help itfulfill 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 enormousresponsibility and would be best performed by an agency dedicated to thatpurpose.

3. A special study should be made by an independent organization to makesure that the FDA has competent management. Those managers who are incompetentshould be replaced. In the "Drug" division, management is needed that willrecognize the needs of the patients and that will apply effective risk-benefitbalancing.

4. Consideration should be given to using certified non-governmentalagencies to perform the oversight of drug testing and the review of new drugapplications. This would reduce cost while improving the quality of the reviewprocess.

Unless we move for reform now, the FDA will continue to harm the interestsof patients, our health industry and the economy of the United States.

This release was issued through eReleases(TM). For more information,visit Charles A. Reinwald, Chairman Charles Reinwald, Jr., President Cancer Cure Coalition 561-747-2174 E-mail:

SOURCE Cancer Cure Coalition

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