Bipartisan bill would reform DEA’s opioid production quota process

Bipartisan legislation introduced in the U.S. Senate on Monday would direct the U.S. Drug Enforcement Administration (DEA) to consider opioid diversion, public health, and overdose deaths when setting opioid production quotas to help address the nationwide opioid epidemic.

The DEA currently sets annual quotas that determine the exact amount of opioid drugs that can be sold in the country in a given year by considering factors like estimated demand and past sales. The DEA approved significant increases in opioid drug production from 1993 to 2015, culminating in more than 14 billion doses of opioid drugs going to market each year today.

In addition to requiring the DEA to consider drug diversion, public health and overdose deaths in setting production quotas, the Opioid Quota Reform Act of 2018 would also require the DEA to publicly explain the public health benefits for approved production increases and disclose manufacturer-level quota increase trends in anonymized data reported to Congress each year.

U.S. Sen. Dick Durbin (D-IL), a sponsor of the bill, said opioid drugs are “being overproduced, over-prescribed and over-dispensed,” and 100 Americans die from overdoses each day as a result.

“DEA plays an important gatekeeper role over the volume of opioids that can be produced each year,” Durbin said. ”And, while DEA has taken recent steps to lower opioid quotas, their ability to do so is limited. Opioid quota reform is needed so DEA can take important factors like diversion and abuse into account when setting quotas, rather than chasing the downstream consequences of this crisis. And this bipartisan legislation will allow DEA to do just that. But our work is not done. These quotas should continue to come down, doctors must be more judicious in their prescribing, drug companies must stop misleading the public about their products and we simply must do more to help those who are currently addicted get treatment.”

U.S. Sen. John Kennedy (R-LA), an additional sponsor of the bill, noted that overdose deaths have tripled since 1999, and the opioid epidemic costs his home state of Louisiana $296 million annually.

“This is unacceptable,” Kennedy said. “If even one of these prescription opioid-related overdoses can be prevented by our bill, we are one step closer towards winning the war on drugs.”

The bill would also strike a provision of current law that prevents the DEA from considering dosage variations when setting quotas to allow for its determinations to be more granular. Additionally, the DEA would be directed to find ways to better incorporate data collection and changing medical practices into its quota-setting process.