President G.W. Bush
Presidential Personnel Office
The White House
Washington, DC 20500

Dear President Bush,

I am enclosing my Presidential Personnel Application Form and resume in order that you might consider my appointment as FDA Commissioner. Because you have already invited a number of market-minded individuals to your team, I hope that you will look favorably on my pro-market orientation.

My nomination for FDA Commissioner is likely to enjoy widespread support, especially from the groups listed below.

1. Pharmaceutical industry. For almost twenty years, I was a research scientist at a major pharmaceutical company and understand the impact of regulatory delays. Former FDA Commissioner, Alexander Schmidt, once remarked that "The failure to approve an important new drug can be as detrimental to the public health as the approval of a potentially bad drug." As your appointee, I would pursue a more cooperative approach with pharmaceutical firms in order to speed the delivery of new, life-saving medications to the American public.

2. Physicians. Doctors often prescribe approved medications for off-label uses in order to give their patients the best health care options. However, the FDA discourages drug companies from sharing information that would educate physicians about these choices for their patients. As your appointee, I would make this valuable knowledge on off-label use available to our dedicated health care practitioners.

3. Alternative practitioners. Health care professionals who utilize non-traditional methods of treatment are often subjected to prejudicial treatment by the FDA, even in the absence of patient complaints. As your appointee, I would intervene only when patients were at risk, thereby broadening our health care choices.

4. American public. Whenever Congress considered giving the FDA more control over nutritional supplements, voters inundated their representatives with protests. The American public clearly wants the freedom to choose what vitamins and minerals to take. As your appointee, I would honor the choice of my fellow Americans.

5. Dedicated FDA employees. FDA examiners are in a no-win situation. If they delay approving a drug with life-saving potential, many Americans, especially those with terminal diseases, die needlessly. If the FDA approves a drug and unpredictable side effects occur, the FDA is blamed. As your appointee, I will alleviate this situation, by allowing terminally ill patients to "opt-out" of the approval process. They will then have access to potentially life-saving medications which are not yet through FDA review.

In 1999, a Federal Appellate Court ruled 11-0 that the FDA must abide by the First Amendment of the U.S. Constitution and permit truthful health claims for antioxidants, fiber, folic acid, and omega-3 fatty acids (Pearson vs. Shalala). The FDA ignored this decision and in February of this year was censured by the court for its failure to comply. As your appointee, I would make sure that the FDA abides by our Constitution, the law of the land.

As your appointee, my goal will be to facilitate the conversion of the FDA from a bureaucratic regulatory regime into a market-oriented support system that maximizes our access to life-savings medications. Of course, only a team effort will achieve this dramatic shift. Win-win strategies, such as the ones described above, can help create alignment among groups who may sometimes be at odds with each other. I believe that I have the experience and the skills to create such an environment.

I hope that you will seriously consider moving the FDA in a direction that will stimulate innovative drug development. After all, before we are politicians or special interest groups, we are human beings. Whether we enjoy a long life or a short one will largely depend on the availability of life-saving medications. I would be honored, as your appointee, to help the American people–and yourself–achieve the longest, most productive life possible.

Sincerely,

Mary J. Ruwart, Ph.D.

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