Judge blocks Massachusetts ban on painkiller

BOSTON (AP) – A federal judge has blocked Massachusetts from banning the powerful new painkiller Zohydro.

U.S. District Court Judge Rya Zobel on Tuesday issued a preliminary injunction after the maker of the drug, Zogenix, argued in a lawsuit that the ban ordered by Gov. Deval Patrick last month is unconstitutional.

Zobel said in issuing the injunction that Massachusetts appears to have overstepped its authority in banning the prescription medication, which had been approved by the federal Food and Drug Administration, and that Zogenix was likely to succeed in its pursuit of a court order to lift the ban permanently.

The San Diego-based drugmaker hailed the ruling, saying that allowing states to essentially overturn decisions of the FDA would “set an alarming precedent.”

The ban is believed to be the first attempt by a state to block a federally approved drug, according to the National Alliance for Model State Drug Laws.

Patrick ordered the ban after declaring a public health emergency in light of a surge of drug overdoses and overdose deaths in the state. The state argued that Zohydro would “exacerbate a severe public health crisis” because the narcotic can be easily crushed, then snorted or injected to create an immediate and potentially lethal high.

Secretary of Health and Human Services John Polanowicz said Tuesday the administration is reviewing the ruling.

In her decision, Zobel noted the FDA’s approval of the drug in October and said federal law pre-empts Patrick’s emergency order.

“When the Commonwealth interposed its own conclusion about Zohydro ER’s safety and effectiveness by virtue of the … emergency order, did it obstruct FDA’s Congressionally-given charge? I conclude that it did,” Zobel wrote.

She said allowing the ban would “undermine the FDA’s ability to make drugs available to promote and protect the public health.” She said Patrick’s suggestion that the ban might be lifted if Zogenix created a non-crushable “abuse-resistant” version of the prescription medication would force Zogenix to return to the FDA to seek approval for a drug different from the one that the FDA has already deemed safe.

Zogenix has also been able to show injury to its reputation by the highly publicized ban, Zobel said.

The judge said the state’s concerns can’t trump the legitimate use of the drug.

“Although the ban may prevent someone from misusing the drug, the ban prevents all in need of its special attributes from receiving the pain relief Zohydro ER offers,” she wrote.

Roger Hawley, chief executive officer of Zogenix, called the decision “a positive step forward for Massachusetts patients.”

“We invite concerned officials to engage with us to discuss fair and appropriate safeguards for pain medications like Zohydro ER rather than seeking to ban or restrict one specific treatment,” Hawley said in a written statement.

Lawyers for the state had argued that the Massachusetts ban wouldn’t affect the federal approval process or the company’s ability to sell the drug elsewhere in the United States, but simply represented “another hurdle” the company must surpass in order to market the drug in Massachusetts.

(Copyright 2014 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.)

WKBN 27 First News provides commenting to allow for constructive discussion on the stories we cover. In order to comment here, you acknowledge you have read and agreed to our Terms of Service. Commenters who violate these terms, including use of vulgar language or racial slurs, will be banned. No links will be permitted. Please be respectful of the opinions of others. If you see an inappropriate comment, please flag it for our moderators to review.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s