Justia Drugs & Biotech Opinion Summaries

The Butter! Spray is a butter-flavored vegetable oil dispensed in pump-action squirt bottles with a spray mechanism. The front label on the product states that the Butter! Spray has 0 calories and 0 grams of fat per serving. Plaintiffs are a class of consumers who brought their lawsuit against the then-manufacturer, Unilever United States, Inc., contending that the product’s label makes misrepresentations about fat and calorie content based on artificially low serving sizes. The district court found that Plaintiffs failed to plausibly allege that Butter! Spray was not a “spray type” fat or oil under Food and Drug Administration (FDA) regulations. The district court further held that the FDCA preempted plaintiffs’ serving size claims.   The Ninth Circuit affirmed the district court’s Fed. R. Civ. P. 12(b)(6) dismissal. The panel held that, as a matter of legal classification, Butter! Spray was a “spray.” In common parlance, a “spray” refers to liquid dispensed in the form of droplets, emitted from a mechanism that allows the product to be applied in that manner. In addition, the notion that Butter! Spray could be housed under the FDA’s legal classification for “butter” is implausible. The panel also rejected Plaintiffs’ argument that Butter! Spray is a “butter substitute” based on how it is marketed so it should be treated as “butter” for serving size purposes, too. The court explained that because Plaintiffs’ challenge to the Butter! Spray serving sizes would “directly or indirectly establish” a requirement for food labeling that is “not identical” to federal requirements, the FDCA preempts their serving size claims. View "KYM PARDINI, ET AL V. UNILEVER UNITED STATES, INC." on Justia Law

The Food and Drug Administration (“FDA”) approved mifepristone to be marketed with the brand name Mifeprex under Subpart H (the “2000 Approval”). In January 2023, FDA approved a modified REMS for mifepristone, lifting the in-person dispensing requirement.  Plaintiffs (physicians and physician organizations) filed a suit against FDA, HHS, and a several agency heads in the official capacities. Plaintiffs challenged FDA’s 2000 Approval of the drug and also requested multiple grounds of alternative relief for FDA’s subsequent actions. Plaintiffs moved for a preliminary injunction ordering FDA to withdraw or suspend (1) FDA’s 2000 Approval and 2019 Generic Approval, (2) FDA’s 2016 Major REMS Changes, and (3) FDA’s 2021 Mail-Order Decision and its 2021 Petition Denial of the 2019 Citizen Petition. The district court entered an order staying the effective date of the 2000 Approval and each of the subsequent challenged actions.   The Fifth Circuit granted Defendants’ motions for a stay pending appeal. The court wrote that at this preliminary stage, and based on the court’s necessarily abbreviated review, it appears that the statute of limitations bars Plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000. However, Plaintiffs brought a series of alternative arguments regarding FDA’s actions in 2016 and subsequent years. And the district court emphasized that its order separately applied to prohibit FDA’s actions in and after 2016 in accordance with Plaintiffs’ alternative arguments. As to those alternative arguments, Plaintiffs’ claims are timely. Defendants have not shown that Plaintiffs are unlikely to succeed on the merits of their timely challenges. For that reason, Defendants’ motions for a stay pending appeal are denied in part. View "Alliance Hippocratic Medicine v. FDA" on Justia Law

The Supreme Court affirmed the order of the circuit court dismissing Appellants' complaint alleging that the Arkansas Medical Marijuana Commission had granted a marijuana cultivation license to a corporate entity that had been dissolved, holding that the circuit court correctly dismissed this appeal on the merits.Appellants, existing cultivation license holders, challenged the Commission's decision to allegedly grant a license to a dissolved corporate entity, arguing that the circuit court erred by holding that it lacked subject-matter jurisdiction and wrongly held that Appellants lacked standing. The Supreme Court reversed, holding that the circuit court (1) erred by not finding that it lacked subject-matter jurisdiction and that Appellants lacked standing; but (2) properly dismissed the complaint because it failed to allege facts sufficient to mount the State's sovereign immunity defense. View "Osage Creek Cultivation, LLC v. Ark. Dep't of Finance & Administration" on Justia Law

Generic versions of ranitidine-containing antacids are sold under the brand name Zantac. In 2019, after an independent laboratory found “significant quantities of NDMA,” a known carcinogen in ranitidine-containing antacids, the FDA issued a public alert. Some manufacturers voluntarily recalled their products. In 2020, the FDA “request[ed that] manufacturers withdraw all prescription and [OTC] ranitidine drugs from the market immediately.”CEH, a nonprofit corporation, sued under Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, Health and Safety Code 25249.5, alleging that the generic-drug defendants continued to expose individuals to NDMA without clear and reasonable warnings regarding the carcinogenic hazards. The trial court dismissed the generic defendants without leave to amend, citing preemption by the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301. The court determined that the generic-drug defendants cannot give a Proposition 65 warning without violating the federal requirement that the generic version of a drug have the same “labeling” as the brand-name version. The court of appeal affirmed that dismissal. Although not all methods of publicly communicating a warning about a drug necessarily qualify as “labeling,” CEH fails to identify any method by which the generic-drug defendants could provide a warning that would satisfy both Proposition 65 and the federal duty of sameness. View "Center for Environmental Health v. Perrigo Co." on Justia Law

Drug makers participating in Medicare or Medicaid must offer their drugs at a discount to certain “covered entities,” which typically provide healthcare to low-income and rural individuals, 42 U.S.C. 256b, 1396r-8(a)(1), (5) (Section 340B). Initially, few covered entities had in-house pharmacies. A 1996 HHS guidance stated that covered entities could use one outside contract pharmacy each; a 2010 HHS guidance stated that covered entities could use an unlimited number of contract pharmacies. Drug makers thought that contract pharmacies were driving up duplicate discounting and diversion and adopted policies to limit any covered entity’s use of multiple contract pharmacies. A 2020 HHS Advisory Opinion declared that Section 340B required drug makers to deliver discounted drugs to an unlimited number of contract pharmacies.In 2010, Congress told HHS to establish a process for drug makers and covered entities to resolve Section 340B–related disputes. In 2016, HHS issued a notice of proposed rulemaking and accepted comments on the proposed ADR Rule. HHS subsequently listed the proposed rule as withdrawn. In 2020, HHS stated that it had just “paus[ed] action on the proposed rule,” responded to the four-year-old comments. and issued a final ADR Rule.Drug companies sued. The Third Circuit held that Section 340B does not require drug makers to deliver discounted drugs to an unlimited number of contract pharmacies. HHS did not violate the APA by purporting to withdraw the proposed ADR Rule before later finalizing it. View "Sanofi Aventis US LLC v. United States Department of Health and Human Services" on Justia Law

Under the Hatch-Waxman Act, a drug may receive “new chemical entity exclusivity” if no active ingredient in the drug was previously “approved.” The drug Aubagio was awarded this exclusivity because the Food & Drug Administration (“FDA”) determined that Aubagio’s only active ingredient, teriflunomide, had never previously been approved. This case concerns a challenge to Aubagio’s exclusivity period, which Sandoz Inc. raises to secure a solo period of marketing exclusivity for its generic equivalent. Sandoz maintains that teriflunomide was previously “approved” as an impurity in the drug Arava. In the alternative, Sandoz argued that teriflunomide was in fact approved as an active ingredient in Arava. The district court granted summary judgment for the FDA, agreeing with the agency that Aubagio was entitled to exclusivity because teriflunomide had never previously been approved.   The DC Circuit affirmed the district court’s judgment. The court held that while Sandoz did not exhaust its statutory argument before the FDA, in the absence of a statutory or regulatory exhaustion requirement, the court found it appropriate to decide Sandoz’s challenge. When the FDA approves a new drug, it does not also “approve” known impurities in that drug for the purpose of new chemical entity exclusivity. And the record is clear the FDA did not approve teriflunomide as an active ingredient when it approved Arava. Aubagio was therefore entitled to new chemical entity exclusivity, and Sandoz cannot benefit from a solo exclusivity period for its generic equivalent. View "Sandoz Inc. v. Xavier Becerra" on Justia Law

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

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

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

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