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Some Thoughts on the FDA

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. This valuable knowledge on off-label use should be available to our dedicated health care 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. They should intervene only when patients are at risk, thereby broadening our health care choices.

Whenever Congress considered giving the FDA more control over nutritional supplements, voters inundate their representatives with protests. The American public clearly wants the freedom to choose what vitamins and minerals to take. We should respect the choices of our fellow Americans.

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.We must alleviate this situation by allowing terminally ill patients to “opt-out” of the approval process. They would 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 has ignored this decision and in has been censured by the court for its failure to comply. As citizens we should make sure that the FDA abides by our Constitution, the law of the land.

Our goal must 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.

We need to move 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. The American people and you yourself must help to achieve the longest, most productive life possible for all of us.

This information is intended for educational and informational purposes only. It should not be used in place of an individual consultation or examination or replace the advice of your health care professional and should not be relied upon to determine diagnosis or course of treatment.