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The U.S. Drug Enforcement Administration has announced plans to reduce the amount of opioids that can be manufactured by drug makers in a given year to further combat the opioid epidemic.
This is consistent with President Trump’s “Safe Prescribing Plan” that seeks to “cut nationwide opioid prescription fills by one-third within three years.” The new proposal decreases manufacturing quotas for the six most frequently misused opioids during 2019 by an average of 10 percent, compared to 2018.
This would help reduce the amount of drugs potentially diverted for trafficking and used to facilitate addiction. Under the proposed new rule, if the DEA believes a company’s opioids are being diverted for misuse, they will reduce the amount of opioids that company can make.
The new regulatory plan comes after West Virginia sued the DEA over its drug quota rules, arguing the agency’s policy wrongfully sets manufacturing quotas based on the amounts of pills that drug makers expect to sell, not on legitimate medical needs.
The state has argued that this approach has contributed to increasing the addiction problem and the illegal diversion of pain medication, while bowing to the interests of the drug industry.
The new DEA proposal calls for the government to take into account input from important stakeholders, including states and the components of the U.S. Department of Health and Human Services, such as the Food and Drug Administration, the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services, when setting quotas.
The unveiling of the proposal on last Tuesday comes after federal, state and local law enforcement officials in West Virginia announced a crackdown on an opioid trafficking ring in Huntington, an area known as “ground zero” for the epidemic.
West Virginia has been among the hardest-hit states by the country’s opioid crisis.
According to the CDC, 42,000 people died nationwide from opioid overdoses in 2016, the last year with publicly available data.
The DEA has proposed to reduce more commonly prescribed schedule II opioids, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl.
Ultimately, revised limits will encourage vigilance on the part of opioid manufacturers, help DEA respond to the changing drug threat environment, and protect the American people from potential addictive drugs while ensuring that the country has enough opioids for legitimate medical, scientific, research, and industrial needs.
Once the aggregate quota is set, DEA allocates individual manufacturing and procurement quotas to those manufacturers that apply for them. DEA may revise a company’s quota at any time during the year if change is warranted due to increased or decreased sales or exports, new manufacturers entering the market, new product development, or product recalls.
In 2016, the Centers for Disease Control and Prevention issued guidelines to practitioners recommending a reduction in the prescribing of opioid medications for chronic pain. DEA and its federal partners have increased efforts in the last several years to educate practitioners, pharmacists, manufacturers, distributors, and the public about the dangers associated with the misuse of opioid medications and the importance of proper prescribing. Controlling the supply of opioids is a potentially important addition to the government’s ability to help control the opioid epidemic.
If you have questions about how the new regulations could affect your health care plan, your employees, and your organization, contact your Marsh & McLennan representative.