FDA Criticizes Massachusetts Regulations Aimed At Zohydro

Massachusetts Regulations on Zohydro Prescribing

A physician treating an injured worker suffering from severe chronic pain may prescribe one prescription drug after another, including potent opioids, in search of relief for the patient. The use of opioid painkillers can lead to overdose, addiction, accidents, permanent disability, and even death. Governor Deval Patrick, responding to Massachusetts’ heroin and opioid addiction epidemic, which claimed 140 lives in the first months of 2014, banned the opioid ZohydroTM ER. His action was nullified by U.S. District Judge Rya Zobel, who granted manufacturer Zogenix’s request for an injunction halting the ban.

Massachusetts and Vermont in April 2014 both implemented statewide regulations that require health care providers to justify the medical indication before prescribing Zohydro, after screening patients for risk of abuse. These regulations were criticized by Dr. Margaret A. Hamburg, Commissioner of the Food and Drug Administration (FDA), who, although she acknowledged the states’ role in preventing a facilitator of opioid abuse — physicians’ inappropriate prescribing practices — cautioned that legislators and regulators should not focus on one drug, Zohydro, alone. Commissioner Hamburg argued for comprehensive policy solutions. She defended the FDA’s decision in October 2013 to approve Zohydro for doctors to prescribe for their patients who are experiencing severe pain, requiring 24-hour chronic treatment, and for whom Zohydro may be their last resort after trying other treatments that have proved inadequate.

Risks and Benefits of Zohydro in Pain Management

Dr. Hamburg characterizes Zohydro as providing more benefits and fewer risks for people who must cope with severe chronic pain and need relief to have any hope for an acceptable quality of life. For example, acetaminophen, a potent liver toxin, is found in such painkillers as Vicodin, but not in Zohydro. Such long-acting opioids as Oxycontin and extended-release morphine have about the same potency as Zohydro. Zohydro is also subject to stringent Drug Enforcement Administration prescribing restrictions imposed on all Schedule II drugs, such as patients being required to have a written prescription from their doctor, rather than one phoned in to the pharmacy, and not being permitted to refill the prescriptions. Dr. Hamburg contends that the FDA’s approval of Zohydro therefore does not significantly change overall opioid prescribing by physicians and use by patients suffering from severe chronic pain, since the most likely candidates to receive Zohydro will already be receiving opioids, such as potent painkillers like hydrocodone products or other long-acting opioids.

Twenty-Nine State Attorneys General Ask FDA to Withdraw Approval for Zohydro

Prior to the FDA’s October 2013 approval of Zohydro, the FDA’s own advisory committee had voted 11-2 against approval for Zohydro, due to the drug’s potential for misuse. The attorneys general of 29 states have since asked the FDA to reconsider its approval, as reported in an April 23, 2014 New England Journal of Medicine article. The attorneys general believe that the requirements enacted by Massachusetts and Vermont are in line with the pain management guidelines propounded by numerous medical societies. In fact, those practices are what responsible physicians should already be doing. The attorneys general contend that the states, as regulators of medical practice, should have the power to enforce these guidelines.

If you have become ill or been injured at work, for more information about the workers’ compensation process, contact a Boston workers’ compensation attorney from Pulgini & Norton to schedule a free consultation to find out more about what our lawyers can accomplish for you. Contact us with a brief description of your situation or reach us by phone at our Downtown Boston, Hyde Park, or Braintree, Massachusetts office locations.

More Posts:

Pain Management and Workers’ Compensation, Massachusetts Workers’ Compensation Lawyer Blog, April 23, 2014

The Top Five Most Expensive Workers’ Compensation Claims, Massachusetts Workers’ Compensation Lawyer Blog, March 26, 2014

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