Articles Posted in Drugs & Biotech

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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

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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

Posted in: Drugs & Biotech

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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

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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

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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

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Plaintiffs, a group of prisoners, filed suit against the FDA for allowing state correctional departments to import sodium thiopental (thiopental), a misbranded and misapproved new drug used in lethal injection protocols, in violation of the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 381(a), and the Administrative Procedure Act (APA), 5 U.S.C. 706(2)(A). The court concluded that, because there were clear statutory guidelines for the agency to follow in exercising its enforcement powers, the FDA's compliance with section 381(a) was subject to judicial review under the standards of the APA. The court also concluded that the FDA's policy of admitting foreign manufactured thiopental destined for state correctional facilities were not in accordance with law because section 381(a) required the agency to sample and examine for violations of any drug offered for import that had been prepared in an unregistered facility. The court concluded, however, that the district court erred by failing to seek the joinder of the state governments whose possession and use of the thiopental at issue the court declared illegal. Accordingly, the order of the district court pertaining to the thiopental already in the possession of the states was vacated, but the underlying judgment of the district court was affirmed. View "Cook, et al. v. FDA, et al." on Justia Law

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AstraZeneca, a manufacturer of pharmaceutical products, appealed from the district court's grant of summary judgment. AstraZeneca sought declaratory judgment that the FDA could not approve generic versions of its Seroquel product and sought to restrain the FDA from approving abbreviated new drug applications (ANDAs) for such competing products until the expiration of a period of exclusivity. As a preliminary matter, the court determined that its decision would affect AstraZeneca's actual rights and the case was not moot. On the merits, the court concluded that AstraZeneca's claims failed because the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301-99, only provided exclusivity for changes approved as part of a supplement. Because the FDA reasonably considered Table 2, a table summarizing previously submitted glucose data, as separate from the pediatric supplements, Table 2 was not a change approved in the supplement and therefore the statute did not entitle AstraZeneca to exclusivity for Table 2. Accordingly, the court affirmed the judgment. View "AstraZeneca Pharmaceuticals LP v. FDA, et al" on Justia Law

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This case stemmed from Cytori's application to the FDA to market two new medical devices, the Celution 700 and the StemSource 900. Two devices that use adipose tissue as a source of stem cells that could later be used in lab analysis or, potentially, in regenerative medicine. The FDA concluded that the Celution and the StemSource were not substantially similar to devices on the market that extract stem cells from blood or bone marrow. Thus, the FDA ruled that Cytori must go through an extensive premarket approval process for new medical devices, rather than go through the streamlined premarket notification process for new devices that would be substantially equivalent to another device already on the market. Cytori appealed. As a preliminary matter, the court concluded that it was the proper forum for direct review of the FDA's substantial equivalence determination. On the merits, the court concluded that the FDA reasonably concluded and reasonably explained, for purposes of the Administrative Procedures Act, 5 U.S.C. 500 et seq., that the Celution and StemSource did not meet either the "intended use" requirement or the "technological characteristics" requirement for a substantial equivalence determination. View "Cytori Therapeutics, Inc. v. FDA" on Justia Law

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Hill filed a successful drug application with the FDA for a corticosteroid called "Derma-Smoothe." The FDA later approved three abbreviated new drug applications submitted by Identi for generic versions of Hill's products. Hill sued the FDA arguing that the FDA's approval of Identi's products was arbitrary and capricious under the Administrative Procedures Act (APA), 5 U.S.C. 500 et seq. The district court granted summary judgment to the FDA and Hill appealed. The court held that the district court did not abuse its discretion in refusing to consider 21 extra-record declarations; Hill's arguments challenging the FDA's decision to grant bioequivalence waivers to Identi have no merit; and the court rejected Hill's argument that the FDA should not have approved Identi's drugs because Identi did not use the same labeling as Hill. Accordingly, the court held that the FDA's actions were not arbitrary and capricious, and affirmed the district court's grant of summary judgment. View "Hill Dermaceuticals, Inc. v. FDA, et al" on Justia Law