Cancer Cure Coalition Proposes Major Changes At The FDA

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.