In one of the last FDA emails of 2015, I learned that the U.S. Army received approval on December 23 of a oral dosage form of pyridostigmine bromide to protect soldiers against the nerve gas, Soman. The Army had also been the drug’s NDA sponsor when it was last approved in 2003 but the drug was discontinued for unexplained reasons. The drug was approved under the agency’s Animal Efficacy Rule. The rule allows animal experiments to serve as a surrogate for effectiveness in humans since clinical testing would be unethical.

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