The Battle with the FDA For Patients' Rights:
Will it Ever End?

By Antonio C. Martinez II
October 20, 1998

The Food and Drug Administration (FDA) is one of the most powerful regulatory agencies in this country. It currently regulates 25 cents out of every dollar spent on consumer products, including cosmetics, infant formula, vaccinations, foods, dietary supplements, and pharmaceuticals.

Americans have a love-hate relationship with the FDA. On the one hand, some believe the agency serves an important function, such as making sure infant formula is safe. Patients, however, frequently feel it gets in their way of choosing experimental treatments. The FDA exercises extraordinary power in life-and-death decisions for terminally ill patients, though many believe such decisions belong solely in the hands of individuals-not a federal regulatory agency.

FDA Denies Treatment

I recall the plight of one cancer patient who for over six weeks in 1996 waited for and fought with the FDA to allow him access to an experimental drug that he and his physician had decided was appropriate for his condition. He could no longer endure conventional therapy, and the experimental cancer drug offered him the possibility of keeping a major body organ, not to mention some quality of life in his bout with the disease.

The FDA showed a total disregard for this dying patient's rights and decisions. However, after much public outcry and Congressional intervention, the FDA finally relented and the patient obtained the drug. Unfortunately, this was not an isolated incident. A situation like this can and will happen again despite the FDA's assurances. Until federal law is changed, other Americans will face similar situations.

Supreme Court Upholds FDA's Authority

Nearly 20 years ago, the U.S. Supreme Court upheld the regulatory role of the FDA. In U.S. v. Rutherford (442, U.S. 544, 1979), the Court said that citizens have no right to use new drugs not yet approved by the FDA, even if they face a terminal illness. The justices unanimously ruled that since Congress granted the FDA the power to regulate new drugs, the court could not rewrite the legislation in accord with its own conceptions of prudent public policy. As Justice Thurgood Marshall wrote, "Whether, as a policy matter, an exemption [from FDA regulations] should be created is a question for legislative judgment, not judicial inference." In other words, the Supreme Court interprets the laws; it doesn't write them.

Thus, it is up to Congress to remove FDA's barriers to experimental treatments.

Congress has never thoroughly addressed the public demand for exemptions from FDA regulations. Last year Congress passed the FDA Modernization Act of 1997, which was supposed to increase patients' access to experimental drugs not yet approved by the FDA. While the law may speed up the process a little, it does not guarantee access because the FDA still has veto power over whether a patient may use a given drug.

Thus supporters of alternative medicine and health freedom continue to push for legislation that would allow patients to choose treatments without having to obtain permission from the FDA. Reform proposals would require full disclosure to the government of unapproved treatments and their results. But the final decision would be returned to patients and physicians.

A Solution

Such a proposal is found in the Access to Medical Treatment Act (H.R. 746 and S. 578)-currently being considered in the 105th Congress. It would ensure that terminally ill American may obtain the medical treatments they want, even if not approved by the FDA. Debate and discussion have begun. Until Congress creates an exemption for such patients, the battle with the FDA will go on.

Antonio C. Martinez II is a health care, food, and drug attorney in New Jersey, New York, and Washington, D.C.