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Restricted Treatment
Robert Goldberg, Ph.D., Washington Times, 3-29-07

Goldberg takes issue with Senate sponsored FDA legislation that, he believes, would restrict access to many new medicines out of a clumsy attempt to improve drug safety.

The Enhancing Drug Safety and Innovation Act currently under consideration in Congress will ensure that millions of Americans will die waiting for medicines that politicians purport to protect them from.

The act requires that before any drug is approved, a risk-management program (RiskMap) be created. As former FDA Deputy Commissioner Scott Gottlieb points out, this "legislative proposal extends the FDA's ability to restrict which physicians can prescribe a medicine, and which pharmacies can dispense it." Mr. Gottlieb notes that the FDA now limits RiskMaps to about two dozen drugs with very serious or poorly understood side effects. Getting these drugs is burdensome for patients who want them. Severe penalties await doctors and physicians who prescribe and dispense them outside of FDA guidelines. But Congress wants to extend RiskMAPs in order to prevent possible rare side effects by limiting who can prescribe new drugs, for what uses and to whom. Under the current legislation, doctors and pharmacists who violate a RiskMap are subject to civil penalties. No doubt being accused will lead to criminal proceedings and personal injury cases. All of this means that the current legislation takes the off-label prescribing of new drugs—though such prescribing is standard for breast cancer, Alzheimer's and mental illness—and virtually makes it a criminal activity.

I once supported the act, known as Kennedy-Enzi. That was before its authors decided that the best way to protect the public from adverse drug events is to replicate clinical trial conditions in the real world. RiskMap could create the equivalent of a prescription-drug police state, complete with computerized monitoring by the FDA of who gets what. My friend's father was locked out—literally—by a computer from receiving a cancer drug on a clinical trial because his pulse was less than a tenth of second off the interval set by the FDA. No access. No treatment. If the doctor had tried giving him the drug, it would have triggered an investigation and closed down the entire trial.

Project FDA.
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