Justia Drugs & Biotech Opinion Summaries

After the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization returned abortion regulation to the states, the Food and Drug Administration (FDA) changed its rules to allow the abortion drug mifepristone to be prescribed online and sent by mail, eliminating the prior requirement for in-person doctor visits. The State of Louisiana, joined by an individual plaintiff, challenged this 2023 regulation (the “2023 REMS”) under the Administrative Procedure Act (APA), arguing that the FDA’s decision was not supported by sufficient data and resulted in illegal abortions and increased Medicaid costs within the state.The United States District Court for the Western District of Louisiana found that Louisiana had standing, was likely to succeed on the merits, and was suffering irreparable harm. However, the district court declined to stay the regulation, reasoning that the balance of equities and public interest favored denying immediate relief. Instead, the district court stayed the litigation to allow the FDA to complete its ongoing review of mifepristone’s safety protocols, which the FDA admitted had previously lacked adequate consideration.On appeal, the United States Court of Appeals for the Fifth Circuit reviewed whether a stay of the 2023 REMS pending appeal was warranted under 5 U.S.C. § 705. The Fifth Circuit concluded that Louisiana was strongly likely to succeed on the merits because the FDA’s removal of the in-person dispensing requirement was arbitrary and capricious, relied on insufficient data, and was inadequately explained. The court further found that Louisiana faced ongoing irreparable harm to its sovereign interests and financial losses. The appellate court determined that neither the FDA’s nor the manufacturers’ interests outweighed Louisiana’s injuries or the public interest, and that a stay of the regulation was appropriate. The court therefore granted Louisiana’s motion for a stay pending appeal. View "Louisiana v. FDA" on Justia Law

Roy Lee Jones, Jr. was involved in a methamphetamine-trafficking organization in North-Central Louisiana. He received large shipments of methamphetamine from his California-based supplier, DeLewis Johnson IV, and redistributed them to Willie Todd Harris, who then sold them to street-level dealers. After a ten-month investigation, federal law enforcement initiated grand jury proceedings, resulting in a five-count indictment. Jones was charged under 21 U.S.C. §§ 841(a)(1) and 846 for conspiracy to distribute and possess with intent to distribute methamphetamine.Jones and Johnson were tried as co-defendants and convicted by a jury. The initial presentence report (PSR) calculated Jones' offense level as 37, recommending a Guidelines range of 210-262 months. The district court sentenced Jones to 210 months' imprisonment. Jones appealed his conviction and sentence, which were affirmed by the United States Court of Appeals for the Fifth Circuit. The Supreme Court denied Jones' petition for a writ of certiorari.Jones filed a motion for a sentence reduction under Amendments 821 and 825 of the United States Sentencing Guidelines. The district court denied the motion, finding that Jones was ineligible for a reduction under USSG § 4C1.1(a)(10) because he had received an aggravating role enhancement under § 3B1.1 and had engaged in a continuing criminal enterprise as defined in 21 U.S.C. § 848.The United States Court of Appeals for the Fifth Circuit reviewed the district court's decision for abuse of discretion, its interpretation of the Guidelines de novo, and its findings of fact for clear error. The court held that either receiving a § 3B1.1 adjustment or engaging in a continuing criminal enterprise is sufficient to disqualify a defendant from a sentence reduction under § 4C1.1(a)(10). Since Jones received an aggravating role enhancement, he was ineligible for a reduction. The court affirmed the district court's decision. View "United States v. Jones" on Justia Law