[PDF][PDF] The law and practice of off-label prescribing and physician promotion

SA Syed, BA Dixson, E Constantino… - J Am Acad Psychiatry …, 2021 - academia.edu
Prescription of medications for off-label indications is an increasingly common practice;
recent events highlight such prescribing as one of the cornerstones of evolving clinical …

Dr. Robot

JR Bambauer - UCDL Rev., 2017 - HeinOnline
Predicting the future is a surefire way to embarrass oneself. But it is a relatively safe bet that
Artificial Intelligence (" Al") will transform the practice of healthcare to some appreciable …

Snake oil speech

JR Bambauer - Wash. L. Rev., 2018 - HeinOnline
Snake oil is dangerous only by way of the claims that are made about its healing powers. It
is a speech problem, and its remedy involves speech restrictions. But First Amendment …

Live Free or Die-Liberty and the First Amendment

TA El-Haj - Ohio St. LJ, 2017 - HeinOnline
Recent years have witnessed an extraordinary expansion of the First Amendment. In a
number of critical areas, the Roberts Court has significantly elevated the level of protection …

The Indirect Consequences of Expanded Off-Label Promotion

PJ Zettler - Ohio St. LJ, 2017 - HeinOnline
The US Food and Drug Administration (FDA) plays a vital public health role. It oversees
human and animal medical products, food, dietary supplements, cosmetics, products that …

Off-Label Innovation

DA Simon - Ga. L. Rev., 2021 - HeinOnline
In 1966, the Food and Drug Administration (FDA) approved the drug amantadine
hydrochloride (amantadine) for the prevention of Asian influenza A (H2N2). J Doctors began …

Off-Label Speech

DA Simon - Emory LJ, 2022 - HeinOnline
This Article argues that the Food and Drug Administration (" FDA') should regulate drug
manufacturer speech about off-label uses based on the evidentiary support for the relevant …

The FDA's Power over Non-Therapeutic Uses of Drugs and Devices

PJ Zettler - Wash. & Lee L. Rev., 2021 - HeinOnline
Although we often-and rightly-think of the US Food and Drug Administration (FDA) as
regulating important therapies for patients, the agency also can regulate non-therapeutic …

No Longer Business as Usual: FDA Exceptionalism, Commercial Speech, and the First Amendment

C Wiersum - Food & Drug LJ, 2018 - HeinOnline
ABSTRACT FDA's crucial mission of protecting the safety and integrity of our nation's food
and drug supply has led to several areas of" FDA exceptionalism"-a tendency to apply …

A dangerous concoction: Pharmaceutical marketing, cognitive biases, and First Amendment overprotection

CM Ho - Ind. LJ, 2019 - HeinOnline
Is more information always better? First Amendment commercial speech jurisprudence takes
this as a given. 1 However, when information is only available from a self-interested and …