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 …
human and animal medical products, food, dietary supplements, cosmetics, products that …
The statutory case against off-label promotion
N Cortez - U. Chi. L. Rev. Online, 2016 - HeinOnline
One of the most vexing problems in drug and device regulation is" off-label" promotion-when
a company markets uses for a product that have not been approved by the US Food and …
a company markets uses for a product that have not been approved by the US Food and …
Off-Label Promotion: Government Theories of Prosecution and Facts that Drive Them
AD Burroughs, MC Levy, GG Schwab, Y Paik - Food & Drug LJ, 2010 - HeinOnline
The Department of Justice (DOJ) and the US Attorneys' Offices enforce the criminal laws
which, among other things, prohibit pharmaceutical or medical device manufacturers from …
which, among other things, prohibit pharmaceutical or medical device manufacturers from …
Origins of the prohibition against off-label promotion
TS Coleman - Food & Drug LJ, 2014 - HeinOnline
In recent years the federal government has collected billions of dollars from pharmaceutical
and medical device companies in criminal and civil penalties for" offlabel" promotion of their …
and medical device companies in criminal and civil penalties for" offlabel" promotion of their …
Incentivizing pharmaceutical testing in an age of off-label promotion
R Sila - NYUL Rev., 2018 - HeinOnline
Imagine the board rooms of two pharmaceutical companies. Let's call them Company A and
Company B. Company A and Company B are identical in every respect, but they operate …
Company B. Company A and Company B are identical in every respect, but they operate …
When you have a hammer everything looks like a nail: misapplication of the False Claims Act to off-label promotion
RF Hall, RJ Berlin - Food & Drug LJ, 2006 - HeinOnline
The False Claims Act (FCA)'has emerged as a key tool in the government's battle against
healthcare fraud. It has been routinely used against false or fraudulent claims made by …
healthcare fraud. It has been routinely used against false or fraudulent claims made by …
Off-label promotion: is FDA's final guidance on industry-supported scientific and educational programs enforceable?
IS Bass, PE Kalb, BA Berenson - Food and Drug Law Journal, 1998 - JSTOR
For several years, the Food and Drug Administration (FDA) has been evaluating how best to
regulate manufacturer-sponsored efforts to deliver scientific information about new drug and …
regulate manufacturer-sponsored efforts to deliver scientific information about new drug and …
Verify, Then Trust: How to Legalized off-Labeling Drug Marketing
F Khan, J Holloway - Penn St. L. Rev., 2012 - HeinOnline
The Food and Drug Administration (FDA) only allows drugs in the marketplace after
pharmaceutical companies prove that they are both" safe" and" effective." 1 Once the FDA …
pharmaceutical companies prove that they are both" safe" and" effective." 1 Once the FDA …
After Caronia: First Amendment Concerns in Off-Label Promotion
SM Greene - San Diego L. Rev., 2014 - HeinOnline
When a physician prescribes a drug or uses a medical device, most patients would assume
that the drug or device has been approved by the Food and Drug Administration (FDA), the …
that the drug or device has been approved by the Food and Drug Administration (FDA), the …
Off-Label Communications: The Prodigal Returns
J Chasnow, G Levitt - Food & Drug LJ, 2018 - HeinOnline
Recent changes in law and policies relating to" off-label" product communications by
manufacturers (OLPC) bring to mind the biblical parable of the Prodigal Son. 1 In the …
manufacturers (OLPC) bring to mind the biblical parable of the Prodigal Son. 1 In the …