Justia Drugs & Biotech Opinion Summaries

Articles Posted in US Court of Appeals for the District of Columbia Circuit
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The DC Circuit affirmed the district court's judgment sustaining the Tobacco Control Act and its application to e-cigarettes. The court held that e-cigarettes are indisputably highly addictive and pose health risks, especially to youth, that are not well understood. Therefore, the court held that it is entirely rational and nonarbitrary to apply to e-cigarettes the Act's baseline requirement that, before any new tobacco product may be marketed, its manufacturer show the FDA that selling it is consistent with the public health. Furthermore, the First Amendment does not bar the FDA from preventing the sale of e-cigarettes as safer than existing tobacco products until their manufacturers have shown that they actually are safer as claimed. The court explained that this conclusion was amply supported by nicotine's addictiveness, the complex health risks tobacco products pose, and a history of the public being misled by claims that certain tobacco products are safer, despite disclaimers and disclosures. Finally, the court held that nothing about the Act's ban on distributing free e-cigarette samples runs afoul of the First Amendment where free samples are not expressive conduct and, in any event, the government's interest in preventing their distribution is unrelated to the suppression of expression. View "Nicopure Labs, LLC v. FDA" on Justia Law

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The FDA counted both the sale to a minor and the failure to verify age as two separate violations on Orton's second failed inspection and assessed the maximum penalty of $500 for three violations within a 24-month period under the civil money penalty schedule. The DC Circuit denied Orton's petition for review, finding no merit in Orton's contention that the Tobacco Control Act precludes the FDA's methodology of charging multiple violations in a single inspection, and that the FDA violates the law by failing to provide a process for retailers to challenge first violations before the issuance of a warning letter. The court held that the statute was easily understood to permit multiple violations where multiple regulations were breached, and the FDA interpreted the statute consistently. The court also held that the FDA's adjudication of the subsequent violation provided a meaningful opportunity for a retailer to be heard regarding the underlying first violation, at the time that the first violation carried legally significant effects. In this case, due process required nothing more. View "Orton Motor, Inc. v. HHS" on Justia Law

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This appeal involved two antipsychotic drugs primarily used to treat schizophrenia and bipolar disorder: Abilify Maitena, manufactured by Otsuka; and Aristada, manufactured by Alkermes. Otsuka sought judicial review, contending that the FDA's same-moiety limitation on the scope of a drug's marketing exclusivity conflicted with the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355(a). The DC Circuit affirmed the district court's grant of summary judgment for the FDA and Alkermes, holding that the FDA's same-moiety test was a reasonable construction of the statute and was consistent with the agency’s regulations. View "Otsuka Pharmaceutical Co. v. Price" on Justia Law

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Masters filed suit challenging the DEA's 2014 decision to revoke the company's certificate of registration, without which it cannot sell controlled substances. The DC Circuit denied the petition for review, holding that the Administrator's conclusions -- that whenever an order for controlled substances was held by the SOMS Computer Program, that order was presumptively "suspicious" under 21 C.F.R. 1301.74(b), and Masters' employees rarely undertook the investigation required to dispel the suspicion surrounding held orders -- were well founded. The court held that Masters failed to identify any prejudicial errors in the Administrator's decision. View "Masters Pharmaceutical, Inc. v. DEA" on Justia Law