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FDA Assessing Opioid Regulatory Reviews, Labeling

Pills in blister packs

(PublicDomainPictures, Pixabay)

4 February 2016. U.S. Food and Drug Administration is evaluating its practices on reviewing applications for new opioid pain drugs and their labeling requirements, in light of the expanding epidemic of abuse and overdose.  An action plan with these steps was released today, although funding for new initiatives was not discussed.

Opioids work by reducing the intensity of pain signals to the brain, particularly regions of the brain controlling emotion, which reduces effects of the pain stimulus. Examples of leading opioid prescription pain medications are hydrocodone, oxycodon, morphine, fentanyl, and codeine. The illegal drug heroin is also an opioid derivative.

Abuse of opioid pain killers is described by Centers for Disease Control and Prevention as a growing epidemic, fueled in part by growing numbers of prescriptions written for pain killing drugs. CDC reports that in 2012, physicians in the U.S. wrote 259 million prescriptions for pain killers, enough for one bottle of pills for every adult in the country. As of July 2014, according to the CDC, 46 people die each day in the U.S. from an overdose of prescription pain killers. The agency says more Americans now die every year from drug overdoses than they do in motor vehicle crashes.

FDA’s plan for revising its opioid regulations calls for reassessing its framework for evaluating risks and benefits of opioids, particularly when considering wider public health needs. FDA’s Science Board meets in March 2016, and is expected to take up this issue, and National Academy of Medicine is being consulted. The agency is also convening an expert committee to advise on new opioid drug applications that do not have properties or mechanisms to deter abuse.

In addition, the plan calls for new labeling requirements for opioids that act immediately, adding in more safety information and warnings. FDA already requires special warnings and safety labeling for extended-release and long-acting opioid formulations. Requirements for immediate-acting opioid drugs would resemble labels for the extended-release drugs. The agency will also convene its advisory committee on pediatric drugs to advise on a new framework for labeling opioids for children.

FDA notes it lacks evidence for evaluating long-term impacts of long-acting opioid formulations and will ask drug companies to provide that evidence in studies conducted after the agency approves marketing of new drugs in the U.S. The agency will also ask drug companies to increase their continuing education for health care providers on appropriate use of these products.

Another part of the plan calls for expanding access to formulations that discourage abuse and treatments for addiction and overdoses. In April 2015, FDA issued guidelines for conducting studies to evaluate opioid pain killers in abuse-deterrent formulations, but the agency now says it will move ahead with approval standards for generic forms of these formulations, which will have a high priority.

Likewise, FDA says it is reviewing options for making naloxone, a drug to treat opioid overdose, more accessible. In November, as reported in Science & Enterprise, the agency approved a nasal spray formulation of naloxone that can be administered by family members or home health caregivers, as well as medical professionals.

FDA’s plan does not give any new funding requirements, but it comes two days after the White House announced it is requesting an additional $1.1 billion in the fiscal year 2017 budget to expand access to treatment for prescription drug abuse and heroin use.

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