A federal district court, indicating that state lawmakers “may not use vague regulations to sidestep or countermand federal law” for opioid dispensing, has struck down two Massachusetts regulations that would ban or limit sales of Zohydro ER, the only opioid analgesic whose sole active ingredient is hydrocodone. The drug, which was approved last October by the FDA, is unlike other hydrocodone analgesics. It contains no acetaminophen, which may cause liver damage. As an "extended release" medication, Zohydro dispenses pain relief over a twelve-hour period. The drug, however, lacks an "abuse resistant formulation," permitting individuals to crush the pills, inhale or inject them, and immediately experience the full effect. Some officials worried that Zohydro could cause or worsen opioid abuse within the Commonwealth. Governor Patrick declared a public health emergency in March and the state’s Board of Registration in Medicine later issued emergency regulations stating, in part, that prescribers of Zohydro ER, or similar drugs, must provide a “letter of medical necessity” that “verifies that other pain management treatments have failed” for a patient receiving the drug. Zogenix Inc., the maker of Zohydro ER, sought injunctive relief, arguing that the letter requirement and a pharmacist restriction also enacted by the Board were unconstitutional and resulted in a “de facto ban” of the drug in Massachusetts. While the court left in place the “pharmacist-only” regulation, it enjoined the “letter of medical necessity” regulation.
Thomas A. Robinson, J.D., the Feature National Columnist for the LexisNexis Workers’ Compensation eNewsletter, is a leading commentator and expert on the law of workers’ compensation.
LexisNexis Online Subscribers: Citations below link to Lexis Advance. Bracketed citations link to lexis.com.
See Zogenix, Inc. v. Patrick, 2014 U.S. Dist. LEXIS 92382 (D. Mass., July 8, 2014) [2014 U.S. Dist. LEXIS 92382 (D. Mass., July 8, 2014)]
See generally Larson’s Workers’ Compensation Law, § 94.03 [94.03]
Source: Larson’s Workers’ Compensation Law, the nation’s leading authority on workers’ compensation law.
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