Justia U.S. D.C. Circuit Court of Appeals Opinion Summaries

PMRS petitioned for review of the FDA's denial of PMRS's application to market a prescription opioid drug. The DC Circuit rejected PMRS's challenges under the Administrative Procedure Act (APA), and held that the FDA's decision to deny the application was reasonable and consistent with law. The court held that the FDA examined the material factors, considered the record as a whole, and provided a reasonable explanation for its decision to deny PMRS's application. In this case, the court had no basis to question the agency's conclusion that the operative version of PMRS's proposed label created the false and misleading impression that the drug possessed abuse deterrent physical and chemical properties. The court also held that the FDA's decision to deny PMRS's request for a hearing was not an abuse of discretion. View "Pharmaceutical Manufacturing Research Services, Inc. v. FDA" on Justia Law

The DC Circuit affirmed the district court's grant of summary judgment in favor of Eagle, in an action brought by Eagle, alleging that the Orphan Drug Act's (ODA), 21 U.S.C. 360aa–360ee, plain language required the FDA to automatically grant Eagle marketing exclusivity upon designating its drug as an orphan drug and approving it for marketing. The court held that the district court correctly determined at Chevron step one that the FDA's post-approval clinical superiority requirement was forbidden and that Eagle was automatically entitled to a seven-year period of exclusive approval when it approved Bendeka for marketing. View "Eagle Pharmaceuticals, Inc. v. Azar" on Justia Law

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

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

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

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

Levoleucovorin is better known by the brand-name Fusilev, which Spectrum has sold since 2008 for the purpose of counteracting liver damage during a type of chemotherapy known as methotrexate therapy. Under the Orphan Drug Act amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. 360aa-ee, intended to increase incentives for companies to develop new orphan drugs, Spectrum received exclusive marketing rights to the Methotrexate Indications for seven years. Spectrum then received approval from FDA to market Fusilev for an altogether new use: helping patients with advanced colorectal cancer to manage their pain. Two days after Spectrum’s exclusivity period expired for the Methotrexate Indications, Sandoz received FDA approval to market a generic version of levoleucovorin for the Methotrexate Indications. Spectrum argued that Sandoz’s sole intended use of the generic was to treat patients with colorectal cancer, even though the label provided for use only in patients undergoing methotrexate therapy. The district court granted summary judgment against Spectrum. FDA concluded that it need look no further than the use indicated in Sandoz’s abbreviated new drug application (ANDA) to make certain the generic drug will not trench on the prior grant of exclusivity to Spectrum. The court agreed and found FDA's interpretation of the Orphan Drug Act reasonable. The statute does not unambiguously foreclose FDA's interpretation that “for such disease or condition” refers only to the uses included on a drug’s label. The court noted that, to the extent FDA has discretion in choosing how best to implement the Orphan Drug Act, it is up to the agency to strike the balance between the congressional policy goals of drug affordability and innovation. The court rejected Spectrum's remaining arguments and affirmed the judgment. View "Spectrum Pharm., Inc. v. Burwell" on Justia Law

After Congress directed the FDA to establish a twelve-member Tobacco Products Scientific Advisory Committee to, among other things, report on the safety of menthol cigarettes, plaintiffs filed suit claiming that the FDA appointed to the Committee three members with pecuniary interests hostile to their products, in violation of relevant conflict-of-interests statutes and regulations, and that these appointments injured plaintiffs. Plaintiffs claim that the FDA’s appointments of these Committee members caused them three injuries: (1) an increased risk that the FDA will regulate menthol tobacco products adversely to plaintiffs’ interests; (2) access by the challenged Committee members to plaintiffs’ confidential information, with a probability of their using the information to plaintiffs’ detriment; and (3) the shaping of the menthol report to support the challenged members’ consulting and expert witness businesses, with injuries flowing both from the report itself and from its use as support for their expert testimony and consulting. The court concluded that plaintiffs' alleged injuries are too remote and uncertain. Because the alleged injuries are insufficiently imminent to confer standing, the court vacated the district court's grant of summary judgment for lack of jurisdiction and dissolved the district court's injunction barring the use of the menthol report and ordering the reconstitution of the Committee. View "R.J. Reynolds Tobacco Co. v. FDA" on Justia Law

In 2008, ReGen Biologics, manufacturer of the Collagen Scaffold, obtained FDA approval to market the device. After allegations that improper political pressure tainted the clearance process, the FDA conducted an internal investigation and concluded that some procedural irregularities had occurred during the agency's review of the device. Asserting its inherent reconsideration authority, the agency reevaluated the scaffold and concluded that it had erred in allowing the device to be sold. The FDA issued an order rescinding its clearance decision. ReGen immediately pulled the scaffold from the market and subsequently filed for bankruptcy. ReGen and its successor in interest, Ivy, filed suit challenging the FDA's decision to rescind and the district court granted summary judgment for the agency. The court reversed, concluding that the FDA did not follow the proper statutory procedure for reclassifying a device. Rescinding its determination had the effect of putting the device into Class III, and thus required completion of the extensive pre-market approval process before the scaffold could be marketed again. Accordingly, the court vacated and remanded for further proceedings. View "Ivy Sports Medicine, LLC v. Sebelius, et al." on Justia Law

The government filed suit against appellants, alleging that they violated federal laws regulating the manufacture and labeling of drugs and biological products by producing, as part of their medical practice, a substance consisting of a mixture of a patient's stem cells and the antibiotic doxycycline (the "Mixture"). The Federal Food, Drug & Cosmetic Act (FDCA) 21 U.S.C. 301 et seq., and the Public Health Service Act (PHSA), 42 U.S.C. 201 et seq., are statutes that promote the safety of drugs and biological products, respectively, by setting forth detailed requirements for how such substances are to be manufactured and labeled. The court held that, by virtue of its use of doxycycline, the Mixture was within the scope of drugs - and, by extension, biological products, - regulated by section 331(k) of the FDCA; appellants failed to establish that the Mixture was exempt from the FDCA's manufacturing and labeling requirements; the Mixture was per se adulterated where it was undisputed that appellants' facilities, methods, and controls for processing the Mixture violated federal manufacturing standards in numerous respects; because its label failed to provide the minimum information necessary to qualify for either exemption from section 352(f), the Mixture was misbranded; and the district court properly enjoined appellants from committing future violations of the FDCA's manufacturing and labeling provisions. Accordingly, the court affirmed the judgment of the district court and dismissed appellants' counterclaims. View "United States v. Regenerative Sciences, LLC, et al." on Justia Law