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Full-Text Articles in Health Law and Policy
Does Federal Law Ban Mailing Abortion Drugs? A Textual Analysis Of 18 U.S.C. § 1461, Peter Allevato
Does Federal Law Ban Mailing Abortion Drugs? A Textual Analysis Of 18 U.S.C. § 1461, Peter Allevato
Pepperdine Law Review
As the regulation of abortion availability returned to the States, many have grappled with so-called trigger laws: dormant laws that were set to take effect to restrict or ensure access to abortion should constitutional protection be revoked. While the federal government has no true trigger law, it does have long-unenforced laws prohibiting the mailing of “[e]very article or thing designed, adapted, or intended for producing abortion.” 18 U.S.C. § 1461 is an old law, and it has not been enforced for at least fifty years. But the law’s potential effect on the growing practice of mail-distribution of chemical abortion pills …
The Future Of Healthcare Is Generic: Expanding Hatch-Waxman To Equitably Regulate The Healthcare Products Industry, George Encarnacion Jr.
The Future Of Healthcare Is Generic: Expanding Hatch-Waxman To Equitably Regulate The Healthcare Products Industry, George Encarnacion Jr.
DePaul Journal of Health Care Law
This article serves to address the statutory disconnect in the healthcare industry regarding generic products. There has been marked success in the generics market pertaining to pharmaceutical drugs, but the same cannot be said for medical devices and, in more recent times, biosimilars. The end result for consumers is higher product prices, limited access of care, and a more burdensome healthcare system. This article explores the statutory history of drug and medical device approval and production. It also explores differences between modern regulation of generic drugs and generic medical devices, focusing on key issues of FDA approval, consumer safety and …
Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
Marquette Intellectual Property Law Review
This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …
Billion Dollar Orphans: Tension Between The Legal Intent And Social Purpose Of The Orphan Drug Act, John Sheridan
Billion Dollar Orphans: Tension Between The Legal Intent And Social Purpose Of The Orphan Drug Act, John Sheridan
Texas A&M Law Review
This Comment examines the extent to which Congress empowered the FDA to address the increase in petitions and the general accessibility of orphan drug remedies. Specifically, this Comment seeks to understand why the FDA’s interpretation of the purpose of the ODA seems to conflict with the statutory intent as interpreted by federal courts. This Comment considers a statute’s ultimate goal or social purpose to be the purpose of the statute, whereas the express mechanisms by which Congress seeks to bring about these goals is best understood as the statute’s intent. To understand the FDA and judiciary’s differing interpretations of the …
Prozac: Another Drug Wrongfully Attacked - What Can Be Done To Stop The Legal System From Driving Good Drugs Off The Market, While Protecting State And Federal Interests, Melinda M. Katz
Akron Law Review
This Comment will examine the U.S. Food and Drug Administration (FDA) as a regulatory agency, and the status of pharmaceutical products liability. The Comment will describe Prozac, an antidepressant drug currently caught in the products liability dilemma; its compliance with FDA regulations; and opposition to the drug since FDA approval. The Comment will then review American problems with pharmaceutical products liability, and solutions that other commentators have proposed. Finally, the Comment will propose that Congress erect barriers to filing claims against manufacturers for drugs that meet or exceed a higher level of FDA approval, like Bendectin and Prozac, through a …
The Fda Sends Smoke Signals To Big Tobacco: Will The Fda Suffer Backlash, Will Alcohol Be Regulated Next, And Will The Health Of Americans Prevail?, Angela Turriciano
The Fda Sends Smoke Signals To Big Tobacco: Will The Fda Suffer Backlash, Will Alcohol Be Regulated Next, And Will The Health Of Americans Prevail?, Angela Turriciano
Pepperdine Law Review
No abstract provided.
Direct-To-Consumer Advertising Of Prescription Drugs: After A Decade Of Speculation, Courts Consider Another Exception To The Learned Intermediary Rule, Mae Joanne Rosok
Direct-To-Consumer Advertising Of Prescription Drugs: After A Decade Of Speculation, Courts Consider Another Exception To The Learned Intermediary Rule, Mae Joanne Rosok
Seattle University Law Review
This Comment will explore whether Washington courts should recognize direct-to-consumer advertising as an exception to the learned intermediary rule. With the ultimate goal of advocating the best protection for the consumer, the discussion will suggest that Washington courts should not create an exception. A review of other exceptions to the learned intermediary rule does not support abandoning the doctrine when a drug company advertises its product directly to consumers. Nevertheless, advertising does affect consumer purchases and does influence consumer choices, and drug companies should accept the responsibility to present balanced information. This responsibility should encompass more than meeting the minimum …