New Federal Regulation Limits Opioid Production

Under new U.S. Drug Enforcement Administration (DEA) regulations, the volume of opioids that pharmaceutical companies can produce will be cut by 20 percent. Starting in 2018, manufacturers can produce no more than 98,145 kilos of oxycodone, 38,047 kilos of morphine, and 1,342 kilos of fentanyl. DEA regulation of the volume of controlled substances started nearly five decades ago to avoid shortages, but, in the midst of a national opioid epidemic and pressure from the U.S. Congress, the quota system has been used to help stem supply.

“It is clear that we need to reduce the amount of oxycodone and hydrocodone that [the] DEA approves for manufacture each year and hold ‘Big Pharma’ accountable for manufacturing a product that is leading to the deaths of hundreds of people every day,” said Sen. Edward Markey (D-MA), who has introduced several bills addressing the opioid crisis.

To set the quotas, the DEA said it relies on estimates of legitimate medical need from the U.S. Food and Drug Administration, prescription levels from the previous year, manufacturers’ forecasts, and other data. While the DEA is required to publish the aggregate quota amounts each year, it is prohibited from making public the individual quotas it awards to specific manufacturers.

Sen. Markey has sponsored a bill that would require the DEA to release individual quota levels for manufacturers, with the hope that, in the face of greater public awareness, drug makers perceived to be contributing to the addiction crisis will become more responsible actors.

Because of the potential for hospital shortages and access issues for pain patients who have legitimate medical needs, many experts are unsure about using the quota system as a tool to constrain supply. Stakeholders have proposed alternative strategies for stemming the opioid crisis, including more responsible prescribing practices per guidelines issued by the Centers for Disease Control and Prevention and state laws limiting prescription length.

Source: STAT News, December 18, 2017.