Today a Massachusetts judge, again, ruled against Governor Deval Patrick’s proposed ban on the powerful and controversial painkiller Zohydro.
When US District Court Judge Rya W. Zobel initially overturned the state’s emergency ban in April, he said the ban would deny the patients suffering from chronic pain the relief the drug would provide. This week, Zobel ruled that the federal approval by the Food and Drug Administration overrules the state’s authority on this issue because the state’s rules on the ban were “too vague.’’
According to The Boston Globe, Zobel will allow the state a chance to redefine Zohydro restrictions so that they do not violate the drug maker’s rights.
Despite the fact that the painkiller was approved by the FDA in Oct. 2013, Zohydro use has been opposed by 29 states, a “fairly unusual’’ occurrence, Jo Ann Shotwell Kaplan, an assistant attorney general, told The Boston Globe in April. Even the Advisory Committee convened by the FDA voted 11 to 2 against Zohydro’s approval in December 2012. But Massachusetts is the first state to ever seek to ban a drug already approved by the FDA. State and health officials worry that the availability of this drug will only worsen the state’s opioid addiction epidemic.
In case you weren’t sure why there’s so much controversy surrounding this powerful painkiller, check out these warnings from the FDA’s Medication Guide on the drug:
“Taking ZOHYDRO ER can cause opioid addiction, abuse, misuse, overdose and death, even if you take your dose correctly as prescribed. Because of this, ZOHYDRO ER is used only to manage pain that is severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.’’
In April, the state Board of Registration in Medicine began requiring physicians to sign an agreement that all treatment options had to fail before they prescribed Zohydro, a move most physicians supported.
“Physicians recognize the severity of the problem of prescription abuse in the Commonwealth and support the Board of Registration in Medicine’s emergency regulation on hydrocodone,’’ said Ronald W. Dunlap, MD, FACC, president of the Massachusetts Medical Society, on the Board of Registration in Medicine’s emergency regulations in April. “Any new form of painkiller should be the subject of legitimate discussion about its use and potential impact in clinical practice and its potential for addiction.’’
Many are turning to the FDA to further regulate powerful drugs like these, in order to remove the burdern from state level regulations.
“Building on its own work to advance the science of abuse-deterrent formulations, the FDA should also require that prescription opioids meet basic deterrent standards and should facilitate the gradual reformulation of existing products to meet such standards,’’ wrote Dr. Yngvild K. Olsen, REACH Health Services Medical Director for the Institutes for Behavior Resources in a New England Journal of Medicine editorial on the issue. “In declining to apply such a standard to Zohydro, the agency noted that existing deterrent mechanisms have had minimal impact by themselves. However, even modest safeguards have been shown to reduce the potential for inappropriate use.’’