Tuesday, April 15, 2014
In a very brief order in Zogenix v. Patrick, federal district judge Rya Zobel enjoined the Massachusetts Emergency Order prohibiting prescriptions of "hydrocodone bitartrate product in hydrocodone only extended release formulation," i.e., the controversial opiate Zohydro ER.
Judge Zobel wrote:
The FDA endorsed Zohydro ER’s safety and effectiveness when it approved the drug. When the Commonwealth interposed its own conclusion about Zohydro ER’s safety and effectiveness by virtue of DPH’s emergency order, did it obstruct the FDA’s Congressionally-given charge?
I conclude that it did. The FDA has the authority to approve for sale to the public a range of safe and effective prescription drugs—here, opioid analgesics. 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.
Thus, the judge found that it was preempted. Judge Zobel issued a preliminary injunction prohibiting the state from enforcing its emergency order, although it stayed its injunction until April 22, 2014.
Does this mean that no state can further regulate any FDA approved drug? Even in the contraception area?