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Articles 1 - 10 of 10
Full-Text Articles in Law
"Rfra Exemptions From The Contraception Mandate: An Unconstitutional Accommodation Of Religion", Frederick Mark Gedicks, Rebecca G. Van Tassell
"Rfra Exemptions From The Contraception Mandate: An Unconstitutional Accommodation Of Religion", Frederick Mark Gedicks, Rebecca G. Van Tassell
Frederick Mark Gedicks
Litigation surrounding use of the Religious Freedom Restoration Act to exempt employers from the Affordable Care Act’s “contraception mandate” is moving steadily towards eventual resolution in the U.S. Supreme Court. Both opponents and supporters of the mandate, however, have overlooked Establishment Clause limits on such exemptions. The fiery religious-liberty rhetoric surrounding the mandate has obscured that RFRA is a “permissive” rather than “mandatory” accommodation of religion—that is, a voluntary government concession to religious belief and practice that is not required by the Free Exercise Clause. Permissive accommodations must satisfy Establishment Clause constraints, notably the requirement that the accommodation not impose …
After Caronia: First Amendment Concerns In Off-Label Promotion, Stephanie Greene
After Caronia: First Amendment Concerns In Off-Label Promotion, Stephanie Greene
Stephanie Greene
After Caronia: First Amendment Concerns in Off-Label Promotion by Stephanie M. Greene* Abstract The government has successfully prosecuted pharmaceutical companies for off-label promotion of drugs, maintaining that such promotion impermissibly undermines the FDA’s pre-market approval process and jeopardizes the public health. In several recent cases, however, pharmaceutical companies have alleged that regulations prohibiting such promotion are unconstitutional because off-label promotion is protected under the First Amendment. Two recent Supreme Court cases contain language that gives broad protection to advertising and marketing in the pharmaceutical field. This paper questions the reach of these cases as applied to the practice of off-label …
The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq
The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq
Vincent J Roth Esq
Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …
The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq
The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq
Vincent J Roth Esq
Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …
Visual Gut Punch: Persuasion, Emotion, And The Constitutional Meaning Of Graphic Disclosure, Ellen P. Goodman
Visual Gut Punch: Persuasion, Emotion, And The Constitutional Meaning Of Graphic Disclosure, Ellen P. Goodman
ellen p. goodman
The ability of government to “nudge” with information mandates, or merely to inform consumers of risks, is circumscribed by First Amendment interests that have been poorly articulated in the relevant law and commentary. New graphic cigarette warning labels supplied courts with the first opportunity to assess the informational interests attending novel forms of product disclosures. The D.C. Circuit enjoined them as unconstitutional, compelled by a narrative that the graphic labels converted government from objective informer to ideological persuader, shouting its warning to manipulate consumer decisions. This interpretation will leave little room for graphic disclosure and is already being used to …
Reports Of Its Death Are Greatly Exaggerated: Ebay, Bosch, And The Presumption Of Irreparable Harm In Hatch-Waxman Litgation, Kenneth C. Louis
Reports Of Its Death Are Greatly Exaggerated: Ebay, Bosch, And The Presumption Of Irreparable Harm In Hatch-Waxman Litgation, Kenneth C. Louis
Kenneth C. Louis
No abstract provided.
Waging War On Specialty Pharmaceutical Tiering In Pharmacy Benefit Design, Chad I. Brooker
Waging War On Specialty Pharmaceutical Tiering In Pharmacy Benefit Design, Chad I. Brooker
Chad I Brooker
Specialty drugs represent a growing concern for both health insurance issuers and beneficiaries given their exceedingly high (and growing) costs—representing almost half of all drug spend by 2017. Payers have sought to reduce their specialty drug spend by sharing more of the cost of these drugs with the beneficiaries who depend on them through the creation of specialty drug tiers. This has forced some patients to choose between forgoing other needs to pay for their medications or not take them at all. While several states have sought to outlaw the use of specialty drug tiers or limit pharmaceutical OOP cost-sharing, …
Rescuing Access To Patented Essential Medicines: Pharmaceutical Companies As Tortfeasors Under The Prevented Rescue Tort Theory, Richard Cameron Gower
Rescuing Access To Patented Essential Medicines: Pharmaceutical Companies As Tortfeasors Under The Prevented Rescue Tort Theory, Richard Cameron Gower
Richard Cameron Gower
Despite some difficulties, state tort law can be argued to create a unique exception to patent law. Specifically, the prevented rescue doctrine suggests that charities and others can circumvent patents on certain critical medications when such actions are necessary to save individuals from death or serious harm. Although this Article finds that the prevented rescue tort doctrines is preempted by federal patent law, all hope is not lost. A federal substantive due process claim may be brought that uses the common law to demonstrate a fundamental right that has long been protected by our Nation’s legal traditions. Moreover, this Article …
Conflicting Federal And State Medical Marijuana Policies: A Threat To Cooperative Federalism, Todd Grabarsky
Conflicting Federal And State Medical Marijuana Policies: A Threat To Cooperative Federalism, Todd Grabarsky
Todd Grabarsky
The legal status of medical marijuana in the United States is something of a paradox. On one hand, federal government has placed a ban on the drug with no exceptions. On the other hand, over one-third of the states have that legalizes the cultivation, distribution, and consumption of the drug for medical purposes. As such, the usage of medical marijuana is an activity that is at the same time proscribed (by the federal government) and encouraged (by state governments through their systems of regulation and taxation). This Article seeks to shed light on this unprecedented nebulous zone of legality in …
Federal Prohibition Of Medical Marijuana In Pain Management: Undue, Unimportant, And Irrational, Michael L. Timm Jr.
Federal Prohibition Of Medical Marijuana In Pain Management: Undue, Unimportant, And Irrational, Michael L. Timm Jr.
Michael L. Timm Jr.
This paper provides a review of the historical right of the people of the United States to seek, and use, alternative medicinal treatment options in the realm of managing both the pain and symptoms associated with a variety of illnesses. The focus then turns to the right involved: a patient’s ability to employ medical marijuana instead of a commonly prescribed narcotic or mass-market non-steroidal anti-inflammatory analgesic (NSAIA) drug to manage pain and increase quality of life under the advice and consent of a treating physician. No one article has argued that there is a fundamental, important, or at least recognizable …