The More Things Change: Improvement Patents, Drug Modifications, and the FDA
D Karshtedt - Iowa L. Rev., 2018 - HeinOnline
Pharmaceutical companies often replace prescription drugs that are already on the market
with modified versions that have the same active pharmaceutical ingredient. On the surface …
with modified versions that have the same active pharmaceutical ingredient. On the surface …
Implementing a public health perspective in FDA drug regulation
PJ Zettler, MF Riley, AS Kesselheim - Food & Drug LJ, 2018 - HeinOnline
There is, without question, a public health crisis in the United States arising from both illicit
and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration …
and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration …
Innovating Federalism in the Life Sciences
MS Lewis - Temp. L. Rev., 2019 - HeinOnline
This Article challenges the view that the US Food and Drug Administration (FDA) has
exclusive jurisdiction over life sciences innovations. Many current and forthcoming life …
exclusive jurisdiction over life sciences innovations. Many current and forthcoming life …
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 …
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 …
regulating important therapies for patients, the agency also can regulate non-therapeutic …
Drug Approval in a Learning Health System
W Price, II Nicholson - Minn. L. Rev., 2017 - HeinOnline
This question has been debated vigorously for a long time. Some argue for earlier access
with less information required, claiming that individual clinicians and patients are best suited …
with less information required, claiming that individual clinicians and patients are best suited …
Legitimate Medicine in the Age of Consumerism
M Lamkin - UC Davis L. Rev., 2019 - HeinOnline
The world's most voracious consumer of drugs is awash in controversies over their
legitimate uses.'Amid a devastating opioid epidemic, physicians are targeted for excessively …
legitimate uses.'Amid a devastating opioid epidemic, physicians are targeted for excessively …
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 …
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 …
this as a given. 1 However, when information is only available from a self-interested and …
A farewell to falsity: Shifting standards in Medicare fraud enforcement
ID Buck - Seton Hall L. Rev., 2018 - HeinOnline
Nothing seems certain about the future of American health care administration and delivery
in 2018. With the stunning election of President Donald Trump, and with Republican …
in 2018. With the stunning election of President Donald Trump, and with Republican …