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From Health Law Daily, July 24, 2013

FDA policy allowing importation of lethal injection drug without inspection violates law

By Kathryn S. Beard, JD

The FDA is required to examine samples of any drugs that were created or processed in an unregistered establishment; if the samples appear to violate the Food Drug and Cosmetic Act (FDC Act) (21 U.S.C. sec. 301, et seq), the FDA must refuse to admit the drug (Cook v FDA, July 23, 2013, Ginsburg, D). All future shipments of sodium thiopental, an anesthetic, that appear to be misbranded or unapproved must be refused admission; however, the FDA cannot require return of the drug from the possession of states which were not joined as parties to the litigation.

Drug imports. Under the FDCA, it is unlawful to introduce a misbranded drug (Sec. 331(a)) or an unapproved new drug into interstate commerce (Sec. 355(a)). A drug that is manufactured, prepared, propagated, compounded, or processed in an establishment that is not duly registered with the FDA is considered misbranded (Sec. 352(o)). Unapproved new drugs are those which neither general exports nor the FDA consider safe and effective for its proposed or labeled use (Sec. 321(p)(1)). In regulating the importation of drugs, Section 381(a) of the FDC Act provides that if any drugs imported into the United States made or processed in an unregistered facility, HHS “shall request” delivery of samples of such drugs. If it appears, from the examination of such samples or otherwise, that that the drug is misbranded or is an unapproved new drug, the drug “shall be refused admission.”

Background. A group of death row prisoners sued the FDA and HHS for allowing correctional departments in Arizona, California, and Tennessee to illegally import sodium thiopental for use in legal injections. The drug was prepared and marketed by an unregistered establishment, Archimedes Pharma UK, Ltd. and sold by an unregistered wholesaler, Dream Pharma Ltd. Upon import, the FDA detained the first two shipments of sodium thiopental because it appeared to be a misbranded and unapproved new drug. The FDA released the shipments after state officials explained the purpose of the drug, and then issued a policy statement to not review future shipments of sodium thiopental for compliance with the FDC Act. The district court granted summary judgment and an injunction ordering the FDA to stop permitting imports of sodium thiopental in violation of the FDC Act, as well as to immediately notify state correctional departments to return to the FDA any amount of the drug in their possession.

No sampling discretion. The FDA argued that Section 381(a) provides the FDA unreviewable discretion to determine both whether to make a determination that a law was violated and whether to deny admission. Following a textual analysis, the court held that the directives in Section 381(a) are unambiguously binding. The FDA must request samples of imported drugs made in an unregistered facility, must examine the samples for violations of law, and if any sample appears to violate the FDC Act, the FDA must refuse to admit that drug. The requirements apply only to drugs imported from an unregistered facility, and require examination of a sample, not the entire supply. Lastly, the FDA must only refuse admission if a drug appears to violate the FDC Act following examination of a sample. As applied to sodium thiopental, the FDA may no longer refuse to review samples of the drug. If its review shows that the shipment appears to violate the law, the FDA may not admit it.

Failure to join states. The governments of states that use and possess sodium thiopental were not joined as parties to the case. The district court declared the states’ use and possession of the drug illegal without allowing the states to protect their interest in the shipments they have already received. Therefore, the portion of the district court’s order requiring the FDA to demand return of the sodium thiopental from states in possession of it was vacated by the appeals court. The remainder of the judgment was affirmed.

The case number is 12-5176.

Attorneys: Stuart F. Delery, U.S. Department of Justice, Civil Division, for the Food & Drug Administration, and its Commissioner, Margaret Hamburg and the U.S. Department of Health and Human Services, and its Secretary, Kathleen Sebelius.

Companies: Food & Drug Administration; U.S. Department of Health and Human Services

MainStory: TopStory CaseDecisions FDCActNews DrugBiologicalNews InspectionNews ImportNews MisbrandingNews DistrictofColumbiaNews

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