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A federal appeals court in New York overturned the conviction of a man accused of selling drugs for off-label purposes. In a 2-1 ruling on Monday, the judges ruled that a law banning the sale of drugs for purposes not approved by the FDA violates free speech.
Doctors frequently and legally prescribe drugs for off-label effects. Drug companies, however, are bound by the Food, Drug, and Cosmetic Act, which gives the FDA power of regulation – the sale of a drug for off-label uses is prohibited. Misbranding regulations have long plagued pharmaceutical companies, many of which pay millions, or even billions of dollars in fines for marketing their product for unapproved purposes.
Is pharmaceutical marketing a free speech issue? Who benefits most from this ruling, drug companies, or consumers? How much power should the FDA have over pharmaceutical marketing? Who should decide what a drug is for: the manufacturer, or the government? Have you ever taken a prescription drug for an off-label purpose?
Scott Gottlieb, practicing physician and resident fellow at the American Enterprise Institute; He was deputy commissioner of the FDA and a senior adviser at the Centers for Medicare and Medicaid Services
Allison Zieve, Director, Public Citizen Litigation Group where she focuses on public health litigation, regulatory law, open government, the First Amendment and more; Public Citizen is a nonprofit advocacy group that focuses on citizen rights and consumer safety