US judge blocks Mass. ban on painkiller
The Boston Globe - 04/15/2014
A federal judge struck down the state’s first-of-its-kind emergency ban on Zohydro on Tuesday, saying Massachusetts had no authority to overrule a federal decision to approve the powerful, controversial painkiller.
US District Court Judge Rya W. Zobel said in a five-page ruling that the Food and Drug Administration approved Zohydro after a screening process, in spite of the state’s concerns that it could lead to opiate addictions, and so the state could not enact an outright ban singling out the drug.
“If the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health,” Zobel said in her ruling, saying the Supremacy Clause of the US Constitution gives the federal regulatory agency more weight than the state.
She also said the state could not force Zohydro’s maker, Zogenix, to make a crush-resistant form of the drug that could not be used by addicts, because that formulation has not been approved by the FDA.