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Opioid drug makers may have to slash production under new DEA proposal

August 9, 2017
  • The Drug Enforcement Agency is mulling a 20% reduction in opioid painkiller manufacturing next year, citing a decline in prescriptions of the drugs in the U.S.
  • In a proposal released on Friday, the agency noted a main target for the reductions are oft-prescribed painkillers such as oxycodone, hydrocodone and fentanyl — the active ingredients in Purdue Pharma L.P.’s OxyContin, Janssen’s Duragesic and the extended release version of Pernix Therapeutics’ Zohydro, respectively, as well as a variety of other branded products.
  • “Physicians, pharmacists, and patients must recognize the inherent risks of these powerful medications, especially for long-term use,” Chuck Rosenberg, acting head of the DEA, said in an Aug. 4 statement. “More states are mandating use of prescription drug monitoring programs, which is good, and that has prompted a decrease in opioid prescriptions.”

Each year, the DEA sets what’s called Aggregate Production Quotas (APQ) for drugs classified as Schedule I or Schedule II controlled substances. The former class includes heroin, LSD and marijuana, while the later includes amphetamine (found in Shire plc’s Adderall) and many opioid-based painkillers.

APQs tell U.S. drugmakers exactly how much of a controlled substance they’re allowed to make. In essence, they’re tools that help the DEA maintain an adequate supply of these drugs for ” legitimate” reasons — medical and scientific research, export requirements, etc. — but also safeguard against excessive production that could lead to improper prescribing or general drug abuse.

When crafting its proposal to lower the APQ for opioid painkillers 20% in 2018, the DEA said it assessed several factors. Chief among them was demand for the drugs, which the agency concluded has recently fallen based on IMS Health data showing lower sales.

The agency then assessed how long the lower demand may last and whether current inventories would be enough for the Food and Drug Administration, retailers and other healthcare stakeholders should demand quickly uptick.

Surely weighing on the minds of DEA higher ups is an opioid epidemic that continues to increase in scope and severity. About 15,000 people died from overdoses related to prescription opioids in 2015 alone, according to the Centers for Disease Control. More recently, the CDC found 142 Americans die each day from opioid overdose.

Amid that backdrop, federal regulators are working to eliminate what appears to be an overabundance of the highly addictive drugs. In June, for instance, the Food and Drug Administration made a rare move in asking a drugmaker to take its product off the market. The company, Endo Pharmaceuticals Inc., later complied with the request and yanked Opana ER (oxymorphone).

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