DEA Wants To Cut Down On Prescription Opioids

By Paul Gaita 08/08/17

The federal agency issued a proposal to significantly reduce the manufacturing of several "commonly prescribed" opioid medications.

the process of pill production

In a move to bolster the national fight against the opioid dependency epidemic, the U.S. Drug Enforcement Agency (DEA) called for a reduction in the amount of certain prescription opioid painkillers and other controlled substances.

The proposal, published in the Federal Register on August 7, seeks a 20% cut in the manufacture of several "commonly prescribed" Schedule II drugs, including oxycodone, morphine, codeine and fentanyl, by 2018.

The move, which the agency said reflects data that suggested a decline in the demand for such painkillers, will set the national quota, or Proposed Aggregate Production Quota (APQ) for the yearly manufacture of controlled substances, and in turn, hopefully reduce the number of overdose deaths in the country.

The APQ for Schedule I and II controlled substances represent the total amount of 250 such drugs needed to meet the needs of the country's "medical, scientific, research, industrial and export [industries], and for the maintenance of reserve stocks," according to the DEA's press release. In doing so, it also reduces the ability for the black market trade to traffic in opioids and their ingredients by providing a controlled supply.

Before setting the APQ for the year, the DEA reviews data on such drugs from a variety of sources, including estimates from the Food and Drug Administration (FDA), retail and manufacturing statistics and sales information from IMS Health, a company that gives information to insurance companies on prescriptions written and sold in the United States. Guidelines released by the Centers for Diseases Control and Prevention in 2016 on reducing the number of prescriptions for opioid was also a factor in the DEA's proposal.

In establishing the annual APQ, the DEA must "balance the production of what is needed for legitimate use against a production of an excessive amount of potentially harmful substances," as it notes in the press release. The agency statement also stated that once established, the DEA will then set quotas for manufacturers that apply for them; the agency can also change an individual company's quota during the calendar year if sales of a particular product increase, or if a new product or manager joins the market. 

In addition to the aforementioned painkillers, the DEA has also proposed to cut back on the manufacture of the synthetic opioid meperidene, which is also sold under the brand name Demerol; hydromorphone, which is sold as Dilaudid; and oxymorphone, which is marketed under a variety of brand names, including Numorphan and Opana ER.

In June, the DEA took the unusual step of requesting the manufacturer of the latter brand, Endo Pharmaceuticals, to remove Opana ER from the market due to high instances of abuse. Purdue Pharma, which manufacturers Oxycontin, did not respond to a request for comment on the proposal from Reuters.

Please read our comment policy. - The Fix

Paul Gaita lives in Los Angeles. He has contributed to the Los Angeles Times, Variety, LA Weekly, and The Los Angeles Beat, among many other publications and websites.