In March of 2018, President Trump announced an initiative to reduce opioid abuse, focusing on things like insufficient access to evidence-based treatment, primary prevention, and recovery support services. He proposed reducing the demand for drugs through education, awareness, and ending over-prescription, cutting off the flow of illegal drugs across the border, and expanding opportunities for treatment. Last month, consistent with Trump’s plan, the U.S. Department of Justice and the Drug Enforcement Administration proposed aggregate production quotas for certain controlled substances in 2019.

The proposal seeks to decrease manufacturing quotas for the six most frequently misused opioids – oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl – by an average of ten percent as compared to the numbers for 2018. There are many things the DEA needs to take into account when setting these quotas, including estimates of the legitimate medical need for the opioids from the Food and Drug Administration, estimates of retail consumption based on the number of prescriptions dispensed, manufacturers’ history of dispensing and their forecasts, data from their own system for tracking controlled substance transactions, and past quota histories.

According to the DEA, the goal is that new quota limits will help encourage vigilance on the part of opioid manufacturers, help the DEA respond to the changing drug threats, and protect the American people from potentially addictive substances while ensuring that we have enough opioids for legitimate medical, scientific, research, and industrial needs. More generally, President Trump’s goal is reducing opioid prescription rates by one-third in three years.

The proposal is still within the window where public comment is allowed, which also means that experts can submit research and data. The American Hospital Association, for example, urged the DEA to take drug shortages into account.  Although most experts agree that opioids are overprescribed, a shortage in manufacturing could lead to people who legitimately need them not having enough access. Some of these medications are also used for sedation before surgery. The AHA was joined by the American Society of Health-System Pharmacists, America’s Health Insurance Plans, American Society of Clinical Oncology, American Society of Anesthesiologists, and Institute for Safe Medication Practices in writing a letter to the DEA about their concerns. The letter stated in part that “hospitals and other providers are currently facing critical shortages of a number of injectable opioid medications, including morphine, hydromorphone, and fentanyl.”

OPIOID QUOTAS

Once the aggregate quota is set, the DEA will allocate manufacturing and procurement quotas to those manufacturers that apply for them. These can be revised at any time during the year if needed, whether due to increased or decreased sales or exports, new manufacturers entering the market, new product development, or product recalls.

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