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News & Press: Government Affairs News

Drug Enforcement Agency Proposes Rule to Limit Annual Opioid Production

Tuesday, April 24, 2018   (0 Comments)
Posted by: Bradley Coffey, MA, AAOE Government Affairs
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Washington, DC - The Drug Enforcement Agency (DEA), an agency of the Department of Justice (DOJ), has released a proposed rule (NPRM) that would amend the controlled substance quota requirements currently found in federal law. The NPRM was published in the Federal Register on April 19, 2018 and would limit manufacturers' annual production of opioids in certain circumstances.

The proposed rule, if finalized, would allow the DEA to limit the production of opioids based on the extent to which a drug is diverted for abuse. If the DEA determines that a particular controlled substance is habitually diverted for misuse, the agency would have the authority to reduce the allowable production amount for a given year. The agency believes that this will "encourage extra vigilance on the part of opioid manufacturers" and incentivize them to take responsibility for the use of their products.

The proposed rule also allows states to take a greater role in setting yearly quotas. If finalized, states could object to a "potentially excessive aggregate production quota" and would allow for an administrative hearing with the agency when a state objects to the proposed quota. Additionally, the proposed rule allows the DEA administrator to alter the aggregate production quotas throughout the year. This is an attempt to address concerns that a reduction to manufacturing quotas could lead to a drug shortage for patients that need opioids for acute or long-term pain.

AAOE encourages members to provide comments on this proposed rule at regulations.gov. Comments are due by May 4, 2018. When providing comments, it is helpful to the agency to receive comments that provide insight into how the proposed rule would affect patient care. Some things to consider in your comments:

  • How many patients do your physicians treat with opioids?
    • How many are acute?
    • How many are long-term?
  • How would a shortage of an opioid affect your practice's ability to provide care?
  • Would an opioid shortage result in any delays to care?
  • Are there any legitimate off-label uses for opioids?
  • How many "pill-seekers" does your practice receive on average?
  • What is your practice's policy for dealing with "pill-seekers"?

Comments may be submitted via regulations.gov by May 4, 2018. 


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