Author:

Jason Velligan

Peculiar Alliances Responding to the FDA v. Alliance for Hippocratic Medicine

The Supreme Court is currently reviewing a 5th Circuit decision to roll back 2016 and 2021 expanded indications of mifepristone, a drug originally approved by the Food and Drug Administration (FDA) in 2000. Given the Supreme Court’s hostility toward administrative agencies in the current term, a judge from a United States District Court may substitute their knowledge for that of agency scientific experts in United States FDA v. Alliance for Hippocratic Medicine.

No Post Hoc Justification for Submitting False Claims

On June 1, 2023, in a unanimous opinion, the United States Supreme Court ruled in United States et al. ex rel. Schutte et al. v. Supervalu Inc. et al. and United States et al. ex rel. Proctor v. Safe-way, Inc. that the scienter element of the False Claims Act (FCA) refers to a defendant’s knowledge and subjective beliefs. Supervalu and Safeway knew they were charging government health insurance programs more for prescription drugs than what they usually and customarily charging regular customers, in violation of the FCA.

Chevron Showdown: Is it the End of a Judicial Doctrine’s Era?

Jason Velligan Associate Editor Loyola University School of Law, JD 2024 Regulatory and legal professionals who understand and work to influence government agency rulemaking are most likely familiar with  the Chevron deference. The statute gives an agency the authority or power to engage in rulemaking by issuing regulations. Rule and regulation are often used interchangeably …
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FDA Oops: Two Orphan Drugs Approved for Same Disease or Condition

An orphan drug treats a rare disease or condition that occurs so infrequently in the United States that there is no reasonable expectation that the cost of making the drug will ever be recovered by the manufacturer. The Orphan Drug Act of 1983 incentivizes pharmaceutical manufacturers to investigate and develop drugs for rare diseases with a low probability of profitability. Orphan drugs have been approved and used to treat various cancers, Huntington’s disease, Fragile X syndrome, pulmonary fibrosis, myelomas, carcinomas, and other rare and unfortunate ailments that impact people’s lives. According to the National Organization for Rare Disorders, the number of approved drugs for treating rare diseases soared from 38 drugs before the act to 6,583 orphan-drug designations by the Food & Drug Administration (FDA) today. Undoubtedly, the Orphan Drug Act has had a positive impact on both patients suffering from rare conditions and the manufacturers that utilized the law.