Doctor concerned with health care law

Breaking news and expert analysis on legal and compliance issues

[Back To Home][Back To Archives]

From Health Law Daily, May 6, 2014

Zohydro™ ER could be classified as schedule I controlled substance in Pennsylvania

By Greg Hammond, JD

In response to the FDA’s approval of the prescription drug Zohydro™ ER, despite an advisory committee’s overwhelming vote recommending that the drug be rejected; Pennsylvania State Representative Gene DiGirolamo (R-18th Legislative District) introduced House Bill 2203 into the General Assembly of Pennsylvania. The bill, if passed, would effectively classify Zohydro as a schedule I controlled substance within the state, thereby placing a number of rules and regulations in place with regard to the handling, sale, and use of the product.

“I am appalled and outraged at the recent decision of the Food and Drug Administration (FDA) to approve the drug Zohydro over the 11-2 vote of its own Anesthetic and Analgesic Drug Advisory Committee,” DiGirolamo wrote to U.S. senators Bob Casey (D-Pa.) and Pat Toomey (R-Pa.). “Our country is in the midst of a public health crisis driven by the prescription drug problem and the availability of this dangerous drug will only make things worse. Zohydro is a more powerful opiate than anything else currently available and is not formulated to be tamper resistant.”

State bans on Zohydro. As previously reported, the U.S. District Court for the District of Massachusetts enjoined a state ban on Zohydro, ruling that the ban was preempted by the FDA’s approval of the drug. However, DiGirolamo has been inconsistent in his comments on whether he intends to ban the use of Zohydro in Pennsylvania. He stated, “[My bill will] not absolutely ban it, but put a lot of different rules and regulations in place here in Pennsylvania before a doctor can prescribe it,” reported NPR. In addition, the bill will “make it much harder for them to prescribe, until we can really look at what this FDA did.” Conversely, DiGirolamo previously stated in a memorandum to Pennsylvania House members that, “In the near future, I intend to introduce legislation to ban the use of Zohydro in Pennsylvania.”

Risk of abuse. In support of his bill, DiGirolamo noted that Zohydro “is a pure formulation of hydrocodone that is not diluted, is not tamper resistant and contains five to ten times more of the heroin-like opioid than any drug produced.” He continued, “Fatal drug overdoses have risen dramatically in the recent past and without action to protect the public, Zohydro will surely contribute to more deadly overdoses.”

DiGirolamo’s concerns echo the consensus among 29 state Attorney Generals who sent a letter to FDA Commissioner Margaret Hamburg, M.D. last December, requesting that the agency reconsider its approval of Zohydro. They wrote, “We believe your approval of Zohydro ER has the potential to exacerbate our nation’s prescription drug abuse epidemic because this drug will be the first hydrocodone-only opioid narcotic that is reportedly five to ten times more potent than traditional hydrocodone products, and it has no abuse-deterrent properties.”

Federal action. In addition to introducing the bill to classify Zohydro as a schedule I controlled substance, DiGirolamo is calling on federal officials to: (1) immediately overturn the approval of the sale of Zohydro in the U.S.; (2) request that FDA Commissioner Hamburg resign; and (3) create a ban that prevents FDA employees from working for a pharmaceutical company, in any capacity, for a period of 10 years after leaving employment with the FDA.

MainStory: TopStory DrugNews StateLegislationNews ControlledNews DrugBiologicalNews PrescriptionDrugNews SafetyNews

Health Law Daily

Introducing Wolters Kluwer Health Law Daily — a daily reporting service created by attorneys, for attorneys — providing same-day coverage of breaking news, court decisions, legislation, and regulatory activity.

A complete daily report of the news that affects your world

  • View full summaries of federal and state court decisions.
  • Access full text of legislative and regulatory developments.
  • Customize your daily email by topic and/or jurisdiction.
  • Search archives for stories of interest.

Not just news — the right news

  • Get expert analysis written by subject matter specialists—created by attorneys for attorneys.
  • Track law firms and organizations in the headlines with our new “Who’s in the News” feature.
  • Promote your firm with our new reprint policy.

24/7 access for a 24/7 world

  • Forward information with special copyright permissions, encouraging collaboration between counsel and colleagues.
  • Save time with mobile apps for your BlackBerry, iPhone, iPad, Android, or Kindle.
  • Access all links from any mobile device without being prompted for user name and password.