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
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
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.
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,
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.