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Full-Text Articles in Law
Catalyst Pharms., Inc. V. Becerra: When The Food And Drug Administration Repeatedly Ignores The Plain Language Of The Orphan Drug Act (Oda), Yifan Wang
Journal of Law and Health
In Catalyst Pharms., Inc. v. Becerra, the court held that the scope of orphan drug exclusivity applies to the disease or conditions for which the drug is designated because the plain language of the 21 U.S.C. § 360cc(a) is clear. The decision is in contrast to the practice of the FDA to narrowly construe the exclusivity to apply only to the uses or indications for which the drug is approved. The court correctly reached its holding using a plain language approach and rejected the FDA’s argument based on legislative history and purpose. The FDA has repeatedly ignored courts interpretations …
A New Age Of Evolution: Protecting The Consumer’S Moral And Legal Right To Know Through The Clear And Transparent Labeling Of All Genetically Modified Foods, Halie M. Evans
Journal of Law and Health
The United States government, until recently, did not require the labeling of genetically modified organisms (GMOs). On July 29, 2016, President Barack Obama signed into law the National Bioengineered Food Disclosure Standard (NBFDS). This law directs the United States Department of Agriculture (USDA) to create regulations that require manufacturers to disclose certain bioengineered products on food labels. On December 20, 2018, the USDA released the final regulations for the NBFDS, which requires food manufactures, importers, and certain retailers to ensure bioengineered foods are appropriately disclosed. The final regulations include provisions that will leave the majority of GMO derived foods unlabeled. …
Time For Change: Stepping Up The Fda's Regulation Of Dietary Supplements To Promote Consumer Safety And Awareness, George Kennett
Time For Change: Stepping Up The Fda's Regulation Of Dietary Supplements To Promote Consumer Safety And Awareness, George Kennett
Journal of Law and Health
People are often looking for that quick fix when it comes to their health. With dietary supplements so readily available on the market, the public assume that they have been through rigorous testing. Dietary supplements are not tested as much as consumers believe. The Food and Drug Administration (FDA) does not initiate the same type of testing and analysis for supplements as it does for food, drink and medication. Given that people are now choosing supplemental meal replacements and the like, as opposed to whole foods, regulations drastically need to be stepped up in an effort to emphasise public safety. …
Solving The Opioid Epidemic In Ohio, Lacy Leduc
Solving The Opioid Epidemic In Ohio, Lacy Leduc
Journal of Law and Health
On May 31, 2017, Ohio Attorney General Mike DeWine took a step in fighting Ohio's opioid epidemic, bringing the first of many lawsuits against five top pharmaceutical companies. However, under Federal and State law, there is an exception called the Learned Intermediary Doctrine, which can absolve drug manufacturers of liability from any misconduct that might be found and transfer that liability to a treating physician. This exception is the way many drug manufacturers were able to avoid being held responsible in the past. This Note proposes that with the current pending lawsuit in the State of Ohio, an exception to …