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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 …
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 …