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Regulating Off-Label Promotion — A Critical Test, Christopher Robertson, Aaron S. Kesselheim
Regulating Off-Label Promotion — A Critical Test, Christopher Robertson, Aaron S. Kesselheim
Faculty Scholarship
In 2012, the U.S. Court of Appeals for the Second Circuit handed down a landmark decision in the case of pharmaceutical sales representative Alfred Caronia. The Food and Drug Administration (FDA) had approved sodium oxybate (Xyrem) for treating narcolepsy, but Caronia promoted it for a wide range of nonapproved (off-label) indications, including insomnia, Parkinson’s disease, and fibromyalgia. Off-label use is common, especially in specialties such as oncology, in which it may even be considered the standard of care. However, surveys have revealed that supporting evidence is lacking for a majority of off-label uses of medical products.1 The uses Caronia …
Deductions For Drug Ads? The Constitution Does Not Require Congress To Subsidize Direct-To-Consumer Prescription Drug Advertisements, Kevin Outterson, Shoshana Speiser
Deductions For Drug Ads? The Constitution Does Not Require Congress To Subsidize Direct-To-Consumer Prescription Drug Advertisements, Kevin Outterson, Shoshana Speiser
Faculty Scholarship
The First Amendment protects lawful, non-misleading advertising as commercial speech, which constrains Congressional attempts to regulate direct-to-consumer advertising (DTCA) of prescription drugs. But the Constitution does not require the federal government to subsidize advertising through the Tax Code. Congress could revoke the legislative gift of tax deductions for DTCA without running afoul of regulating speech. While DTCA proponents maintain that DTCA increases disease awareness and leads to more doctor-patient conversations, Congress could find that these purported benefits are outweighed by other negative consequences, including excessive prescribing.
The New Censorship: Institutional Review Boards, Philip A. Hamburger
The New Censorship: Institutional Review Boards, Philip A. Hamburger
Faculty Scholarship
Do federal regulations on Institutional Review Boards violate the First Amendment? Do these regulations establish a new sort of censorship? And what does this reveal about the role of the Supreme Court?