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Homan J, Betzel B, Aarts EO, van Laarhoven KJ, Janssen IM, Berends FJ

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We think Eli Lilly is using state law to enforce the terms of the FDCA [Federal Food, Drug, and Cosmetic Act], which is a task generally reserve[d] to the FDA, Altman wrote, adding that the court will not allow Lilly to use state law as a back door to private enforce the FDCA. As the Supreme Court has made clear, the FDCA and its regulations provide the United States with nearly exclusive enforcement authority, the judges ruling states

The direct-pay structure particularly benefits self-employed individuals, gig workers, and those with high-deductible health plans (HDHP)