Law Commons^™

The Continuing Battle Of Fda Regulation Of Dietary Supplements And Their Adverse Affect On Young Adults And Other Individuals, Andrew Bernard Jaffe

Andrew Bernard Jaffe

THE CONTINUING BATTLE OF FDA REGULATION OF DIETARY SUPPLEMENTS AND THEIR ADVERSE AFFECT ON YOUNG ADULTS AND OTHER INDIVIDUALS

Abstract

Ever since the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA) the Food and Drug Administration (FDA) has struggled to regulate dietary supplements. This is due to the definition of dietary supplements as foods in the act. This gives supplement manufacturers greater loopholes when introducing supplements on the market. The FDA’s inability to regulate dietary supplements efficiently has been present for decades. Multiple battles are still occurring today which is proven to have an adverse effect …

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

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 …

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 …