Justia Drugs & Biotech Opinion Summaries

Articles Posted in Government & Administrative Law
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Amiodarone was developed in the 1960s for the treatment of angina and was released in other countries. Amiodarone is associated with side effects, including pulmonary fibrosis, blindness, thyroid cancer, and death. In the 1970s, U.S. physicians began obtaining amiodarone from other countries for use in patients with life-threatening ventricular fibrillation or ventricular tachycardia who did not respond to other drugs. In 1985, the FDA approved Wyeth’s formulation of amiodarone, Cordarone, as a drug of last resort for patients suffering from recurring life-threatening ventricular fibrillation and ventricular tachycardia. The FDA’s “special needs” approval issued without randomized clinical trials. In 1989, the FDA described Wyeth’s promotional activities as promoting an unapproved use of the drug. In 1992, the FDA objected to promotional labeling pieces for Cordarone. Other manufacturers developed generic amiodarone, which has been available since 1998.Consolidated lawsuits alleged that plaintiffs suffered unnecessary, serious side effects when they took amiodarone, as prescribed by their doctors, for off-label use to treat atrial fibrillation, a more common, less serious, condition than ventricular fibrillation. The FDA never approved amiodarone for the treatment of atrial fibrillation, even on a special-needs basis. The court of appeal affirmed the dismissal of the lawsuits. The claims are preempted as attempts to privately enforce the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301, regulations governing medication guides and labeling and have no independent basis in state law. The court also rejected fraud claims under California’s unfair competition law and Consumers Legal Remedy Act. View "Amiodarone Cases" on Justia Law

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This appeal arose from an Idaho district court decision affirming a declaratory ruling issued by Respondent Dave Jeppesen (the Director) in his capacity as Director of the Idaho Department of Health and Welfare (the Department). Appellant Grace at Twin Falls, LLC (Grace), a residential assisted living and memory care facility, partnered with a preferred pharmacy to offset costs associated with a software system that coordinated the tracking and delivery of residents’ prescription medications. Because residents who failed to choose the preferred pharmacy did not receive the offset, Grace sought to charge those residents an additional $10.00 each month to cover the difference. Grace brought a petition for declaratory ruling to the Department, asking the Director to declare that Idaho Code section 39-3316(12)(b) and IDAPA 16.03.22.550.12.b did not prohibit Grace from charging the $10.00 fee to those residents who did not choose the preferred pharmacy. The Director denied the petition, declaring that Grace would not “be permitted to assess a non-preferred-pharmacy fee as such fee violates residents’ right to choose their pharmacy or pharmacist . . . .” Grace sought judicial review before the district court, which affirmed the Director’s declaratory ruling. Grace then appealed to the Idaho Supreme Court. Finding no reversible error, the Supreme Court affirmed the district court. View "Grace at Twin Falls, LLC v. Jeppesen" on Justia Law

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Liquid Labs manufactures and sells e-liquids that generally contain nicotine and flavoring for use in e-cigarettes. The e-liquids qualify as “new tobacco product[s]” under the Family Smoking Prevention and Tobacco Control Act, 21 U.S.C. 387-387u, and may not be introduced into interstate commerce without the FDA’s authorization. The FDA must deny a premarket tobacco product application (PMTA) if the applicant fails to “show[] that permitting such tobacco product to be marketed would be appropriate for the protection of public health,” as determined with respect to the risks and benefits to the population as a whole, including users and non-users of the tobacco product.” FDA Guidelines have highlighted that flavored e-liquids’ had a “disproportionate appeal to children.”Liquid Labs submitted PMTAs covering 20 e-liquid products and submitted a marketing plan setting forth plans to discourage youths from using its products. The FDA denied the PMTAs, concluding that Liquid Labs had not shown that the benefits of the products sufficiently outweighed the risks they posed to youths. The documents indicated that evidence could have been provided through “randomized controlled trial[s] and/or longitudinal cohort stud[ies],” or other evidence that reliably and robustly evaluated the impact of the new flavored vs. tobacco-flavored products on adult smokers’ switching or cigarette reduction over time.” The Third Circuit denied a petition for review. The FDA’s order was within its statutory authorities and the Administrative Procedure Act. View "Liquid Labs LLC v. United States Food and Drug Administration" on Justia Law

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Gripum manufactures and distributes flavored liquids for use in e-cigarette devices. Gripum submitted a “premarket tobacco product application” to the federal Food and Drug Administration (FDA) in 2021. The agency denied the application, reasoning that Gripum had failed to demonstrate public-health benefits as required by the Family Smoking Prevention and Tobacco Control Act, 21 U.S.C. 387j. The 2016 “Deeming Rule,” promulgated under the Act requires denial of an application to market a new tobacco product if the manufacturer fails to show that the product would be “appropriate for the protection of public health,” considering the risks and benefits to the population as a whole, including users and non-users, the “increased or decreased likelihood that existing users of tobacco products will stop using such products and those who do not use tobacco products will start using such products.The Seventh Circuit upheld the denial. The FDA required Gripum to show that its flavored e-cigarette products were relatively better at reducing rates of tobacco use than products already on the market. It properly applied the comparative standard mandated by the statute. Gripum failed to provide evidence specific to its products; its studies of other products did not even compare tobacco-flavored e-cigarette products to flavored products resembling Gripum’s products. View "Gripum, LLC v. United States Food and Drug Administration" on Justia Law

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The First Circuit denied Petitioners' petition for review in this action challenging a final rule promulgated by the Drug Enforcement Administration (DEA) that set the framework through which applicants may register to lawfully manufacture and cultivate cannabis for research purposes, holding that Petitioners were not entitled to relief on their claims.Petitioners - Dr. Lyle Craker, a botany professor, and Scottsdale Research Institute (SRI), a clinical research company - brought this action raising two perceived procedural defects with the DEA's notice of proposed rulemaking that would demand that the final rule be set aside. The First Circuit denied relief, holding (1) Petitioners were not entitled to relief on their claim that the APA required the DEA to include more detail about the legal basis of the proposed rule; (2) the proposed rule did not exceed the DEA's rulemaking authority; (3) Petitioners' challenge to the DEA's definition of "medicinal cannabis" was unavailing; and (4) the DEA's new regulatory framework for registrations was not arbitrary, capricious, or otherwise contrary to law. View "Craker v. U.S. Drug Enforcement Administration" on Justia Law

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Petitioners Wages and White Lion Investments, LLC, d/b/a Triton Distribution (“Triton”) and Vapetasia, LLC (“Vapetasia”) sought to market flavored nicotine-containing e-liquids for use in open-system e-cigarette devices. Petitioners needed to submit premarket tobacco product applications as required by 21 U.S.C. Section 387j—which the Food and Drug Administration (“FDA”) deemed applicable to e-cigarette tobacco products. FDA denied the requested marketing authorizations, finding that Petitioners failed to offer reliable and robust evidence (such as randomized controlled trials or longitudinal studies) to overcome the risks of youth addiction and show a benefit to adult smokers. Petitioners sought review of those marketing denial orders (“MDOs”), and prior to the consolidation of the two cases. Petitioners argued that the FDA lacks the authority to impose a comparative efficacy requirement and that FDA acted arbitrarily and capriciously by “requiring” scientific studies.   The Eleventh Circuit denied the petitions for review. The court explained that Congress passed the Family Smoking Prevention and Tobacco Control Act (“TCA”) in an active effort to protect public health. Relevant here, the Deeming Rule subjected e-cigarette manufacturers to the TCA’s prior authorization requirement—manufacturers of “new tobacco product[s]” must submit premarket tobacco product applications (“PMTAs”). The court held that the FDA’s consideration of the lack of cessation as a risk and comparing that risk between new tobacco products and old tobacco products “fall[s] squarely within the ambit of the FDA’s expertise and merit[s] deference.”  As such, the court cannot say that FDA acted arbitrarily and capriciously by disagreeing with Petitioners as to the significance of the evidence they presented. View "Wages and White Lion Investmen v. FDA" on Justia Law

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In this case concerning the medical marijuana licensing and regulatory process the Supreme Court affirmed in part and dismissed in part this interlocutory appeal from the circuit court's denial of Defendants' motion to dismiss this action on the basis of sovereign immunity, holding that the circuit court erred in its ruling.Plaintiff brought this complaint seeking a writ of mandamus and declaratory relief to compel Defendants - the Arkansas Department of Finance and Administration, the Arkansas Alcoholic Beverage Control Division, and the Arkansas Medical Marijuana Commission - to revoke a cultivation facility license granted to another company and instead award it to Plaintiff. The circuit court denied Defendants' motion to dismiss on the doctrine of sovereign immunity. The Supreme Court remanded the action, holding (1) the circuit court did not err in denying the motion to dismiss the writ of mandamus on the basis of sovereign immunity; (2) the circuit court erred in denying gate State's motion to dismiss Plaintiff's claim of declaratory relief; and (3) to the extent that Appellants were seeking relief under the APA the case must be dismissed for lack of subject matter jurisdiction. View "Arkansas Department of Finance & Administration v. 2600 Holdings, LLC" on Justia Law

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The Supreme Court held that the federal Defend Trade Secrets Act (DTSA) prohibits disclosure, under the Nevada Public Records Act (NPRA), of documents from pharmaceutical companies and pharmacy benefit managers collected under S.B. 539.The Nevada Independent (TNI) filed a petition with the district court seeking an order directing the Department of Health and Human Services (DHHS) to release the documents at issue. The district court concluded that the documents were not subject to disclosure under the NPRA because the information contained in them comprised trade secrets protected under the DTSA. The Supreme Court affirmed, holding (1) because the DTSA classifies the requested documents, obtained pursuant to S.B. 539, as confidential trade secrets, the documents were exempt from disclosure under the NPRA; and (2) TNI's remaining allegations of error were without merit. View "Nevada Independent v. Whitley" on Justia Law

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An attorney sought guidance on how a physician could administer psilocybin to a terminally ill patient without incurring liability under the Controlled Substances Act (CSA), specifically asking the Drug Enforcement Administration (DEA) how the CSA would accommodate the Right to Try Act (amending the Food, Drug, and Cosmetic Act) to give patients the possibility of access to new investigational drugs under certain circumstances. The DEA responded by identifying the available exemptions in the CSA and indicating that the Right to Try Act did not create any additional exemptions.The Ninth Circuit dismissed a petition for review for lack of jurisdiction, reasoning that DEA’s response was not a final decision of the Attorney General under 21 U.S.C. 877. To be considered final, the agency action must mark the consummation of the agency’s decision-making process and must be one where rights or obligations have been determined, or from which legal consequences flow. The DEA’s response was the sort of advice letter that agencies prepare multiple times a year. There was no indication that the letter represented the consummation of a decision-making process. The letter did not lead to legal consequences for the prescribing physician but only provided guidance about the interaction of the Right to Try Act and the CSA. View "Advanced Integrative Medical Science Institute v. United States Drug Enforcement Administration" on Justia Law

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The Food and Drug Administration denied Breeze’s Premarket Tobacco Product Applications for its electronic nicotine delivery systems (ENDS). Breeze sought a stay of the FDA’s order. Under the Family Smoking Prevention and Tobacco Control Act “any person adversely affected by” the denial of a Premarket Tobacco Product Application may seek judicial review of the denial, 21 U.S.C. 387l(a)(1)(B). Breeze argued that seeking a stay from the FDA would have been impracticable because the order takes effect immediately and the FDA can take months to consider an agency-level request for a stay.The Sixth Circuit denied the requested stay, finding that Breeze had not made a strong showing that it is likely to succeed on the merits.” Breeze has not made a strong showing that it would likely succeed on its claim that the FDA’s review of its application was arbitrary or capricious nor that the FDA’s denial of its application contradicted the FDA’s nonbinding 2019 guidance. That guidance contemplated more rigorous scientific data than contained in Breeze's application that its ENDS product adequately protected public health. The FDA cited well-developed evidence showing that flavored ENDS products’ special appeal to youths harms public health to a degree not outweighed by the (far-less-supported) effects of adult cigarette smokers switching to e-cigarettes. View "Breeze Smoke, LLC v. United States Food and Drug Administration" on Justia Law