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Full-Text Articles in Law
A Dangerous Concoction: Pharmaceutical Marketing, Cognitive Biases, And First Amendment Overprotection, Cynthia M. Ho
A Dangerous Concoction: Pharmaceutical Marketing, Cognitive Biases, And First Amendment Overprotection, Cynthia M. Ho
Indiana Law Journal
Is more information always better? First Amendment commercial speech jurisprudence takes this as a given. However, when information is only available from a self-interested and marketing-savvy pharmaceutical company, more information may simply lead to more misinformation. Notably, doctors are also misled. This can result in public health harms when companies are promoting unapproved uses of prescription drugs that the Food and Drug Administration (FDA) has approved for other purposes—commonly referred to as “off-label” uses. Contrary to judicial presumptions, as well as the presumptions of some doctors and scholars, doctors are not sophisticated enough to always discern what is true versus …
Christopher V. Smithkline Beecham Corporation: An Unsurprising Loss For Pharmaceutical Sales Representatives And An Erosion Of Power For Administrative Agencies, Anna Johnston
Proxy
No abstract provided.
Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang
Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang
University of Michigan Journal of Law Reform
Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …
Provigil: A Commentary, Daniel A. Crane
Provigil: A Commentary, Daniel A. Crane
Articles
Michael Carrier's case study on Provigil' offers new support for the view that Big Pharma is to blame for stymieing competition, retarding innovation, and inflating prices in the drug industry. Carrier argues that Cephalon was able to thwart generic entry by a combination of anticompetitive strategies. It entered into a reverse payment settlement agreement with generics seeking to enter the market. These settlements purported to allow generic entry before the expiration of the patent period, but, according to Carrier, the promise of early entry was negated by the second prong of Cephalon's anticompetitive strategy. During the time that it had …
A Tough Pill To Swallow: Does The First Amendment Prohibit Wv From Regulating Pharmaceutical Companies' Advertising Expenses To Lower The Cost Of Prescription Drugs?, Brienne Taylor Greiner
A Tough Pill To Swallow: Does The First Amendment Prohibit Wv From Regulating Pharmaceutical Companies' Advertising Expenses To Lower The Cost Of Prescription Drugs?, Brienne Taylor Greiner
West Virginia Law Review
No abstract provided.
The Ftc's Injunctive Authority Against False Advertising Of Food And Drugs, Michigan Law Review
The Ftc's Injunctive Authority Against False Advertising Of Food And Drugs, Michigan Law Review
Michigan Law Review
Two judicial decisions in the early 1950s construing the FTC's section 13 (a) power produced a conflict that has not been resolved either by later courts or by the amendments to section 13 enacted in 1973. The dispute basically concerns the depth of the courts' inquiry into whether an advertisement violates- section 12 and the applicability of traditional equitable concepts in the context of the statutory injunction procedure. This Note contends that the legislative history of pertinent provisions of the Act suggests an appropriate resolution of the conflict through a two-step approach that would relax the scrutiny ordinarily accorded petitions …