FDA Charged With and Observations About Unnecessarily Restricting Drugs From the Public

Food and Drug Administration
Emblem courtesy of Itchmo on Flickr website

The escalation in the cost of clinical trials, which now take an average of one billion dollars and require 10 years for approval according to the Cancer Cure Coalition (CCC), occurred partially because of the FDA‘s flawed policies and bad decisions. The CCC contends that this resulted in an increased amount of deaths and suffering for patients and greatly increased the cost of medical treatment in the United States by delaying and even preventing the availability of many promising treatment options.

Since the FDA is failing in its mission and greatly harming the American population, It’s time to reform the FDA.

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, and

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.

For more information, please visit their website: http://www.cancercurecoalition.org/

(Ed: Here are the first thoughts out of the chute about the above:

With respect to the CCC and its concerns, I offer some additional suggestions:

First a side thought. Concerning that the FDA’s actions “resulted in an increased amount of deaths and suffering for patients and…,” the reason the food was recalled lately was because “adequate” testing for the public’s safety by FDA was Not performed. Would it be better that, in an attempt to save some, our government released something into the public that might result in more deaths than the drug might have saved? Yes, there are those that can say, “Well, some of it was caused by other countries not safely preparing the foods.” To that the Light of Reason (LOR) says, that is no excuse, as once it is known that something is to get into the public, it is the government’s responsibility and FDA’s in this case, to guarantee that it is safe. In addition, the current administration’s closing of FDA testing labs and under-funding of the department has not helped.

To continue…

Even though the CCC has a comprehensive understanding of the problem and the LOR doesn’t, the LOR feels that politics of all parts of our federal government should be prevented from interfering in the objectives of any governmental agency or department. In fact, the LOR would support a Congressional bill that would prevent the politics of any person or governmental body, regardless whether local, state, or federal government, from distorting the duties of any governmental agency, etc. from performing their assigned responsibilities. Since
the LOR feels that most people do the best they can, the administrators and managers could then be rightly accused of not doing what they should have done. As we all have seen, there are too many instances in which a political appointee or elected official has used their office to distort their duties or those of others, based upon a political party’s agenda and, now, with a religion’s agenda. In addition, it would be desirable to prevent not adequately funding a governmental body because of political reasons, as well. With Bush, the son, we know only too well how the head of a government can say one thing and not follow through on what he has said, whether it was a lack of funding or a lack of commitment once he made the statement. Once political influence has been removed, adequate funding has been awarded, and as with any organization, incompetents should be replaced.

Concerning the CCC’s charge that the length of the FDA’s clinical trial requirements are excessive, the LOR fully agrees that “the needs of the patients…risk-benefit balancing” should be a cornerstone of the agency’s mission. At this point, the LOR adds that if in the patient’s doctor’s judgment that all avenues of medical attention have been exhausted, patients should be given the option whether or not they would want to use a medicine that is currently in clinical trials. This would take risk-taking out of the hands of government and place it were it belongs, which is in the hands of those that have the most to lose.

Of course, adequate funding is necessary to permit any governmental body to properly discharge their responsibilities. This includes bringing salaries to the level necessary to attract technically qualified personnel to join the organization. About the FDA’s “information technology (IT) infrastructure (being) inadequate,” not knowing exactly what the CCC is referring, LOR assumes that the level of computer hardware, software systems, and the integration between different systems cannot be justified as being where is should be in the information age.

Adequate funding should be awarded for personnel and for upgrading the “IT infrastructure” AND with applying the adequate ongoing oversight required for the upgrade projects to see that the taxpayer gets the expected amount of value for his investment.

Concerning separating the Food and Drug activities into different agencies, LOR agrees that the concept is a good idea. However, we suggest that the two organizations maintain a close relationship to exchange new methods, ideas, etc. that would improve the capability of each agency to perform its duties and further safeguard the American public, as some governmental agencies seem to inhibit a cross pollination of ideas and methods between them.)

Source for this post: Cancer Cure Coalition

Website: http://www.cancercurecoalition.org/

Scroll to Top