>> William B. Schultz, 59, partner at the Washington offices of Zuckerman Spaeder LLP, focuses on laws related to food, drugs, and the public interest. Those interests merged when he opposed a lawsuit filed by a patient advocacy group, the Abigail Alliance, which sought greater access to experimental drugs.
Schultz, working on behalf of a different group of patient advocates [The National Organization for Rare Disorders], endorsed the robust clinical trials that the Food and Drug Administration now requires before allowing patients wider access to promising therapies.
On Aug. 7, the US Court of Appeals for the District of Columbia Circuit ruled against the lawsuit; a US Supreme Court appeal is likely. As deputy assistant attorney general, Schultz also supervised the Department of Justice's lawsuit and appeals against the tobacco industry. Schultz spoke with Globe reporter Diedtra Henderson.
Q: The Abigail Alliance lawsuit, which seeks earlier access to experimental treatments, appears to cut to the core of the FDA's mission. Is that a reasonable take?
A: In Abigail Alliance, some patients were arguing that the terminally ill had a constitutional right to purchase drugs from companies after only the most minimal testing for safety—and before any testing to find out whether they worked. The concern was that if drug companies could market drugs without testing them, they'd have little incentive to do the rigorous and very expensive testing that the FDA requires.
The FDA's major contribution to medical care is its review of drugs for safety and efficacy before they can be marketed. Without that testing system, medical care as we know it would be very, very different.
Q: Better or worse?
A: In my opinion, it would be significantly inferior. <<
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