The US Department of Justice released a statement on August 16th detailing the Drug Enforcement Association (DEA)’s proposal which is aimed to decrease the manufacturing quotas for controlled substances.
An aggregate quota will be set for the manufacturing of necessary controlled substances, once that aggregate quota is in place the DEA will allocate manufacturing and procurement quotas to the manufacturers that apply for them.
The production quota will take into account the legitimate medical need data held by the US Food and Drug Administration (FDA), which includes estimates of prescriptions dispensed, manufacturer’s disposition history and forecasts, and the DEA’s own data system for tracking controlled substances.
The proposal aims to reduce the manufacturing of commonly prescribed Schedule II opioids, including: oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine and fentanyl.
Barbara Carreno, press officer for the DEA told us that “Schedule II is the most restrictive category of legal medication because it has the greatest potential for harm, such as addiction or overdose.”
President Trump’s ‘Safe Prescribing Plan’ details a plan to cut nationwide opioid fills (prescriptions) by a third within three years. With that, the DEA has reduced aggregate manufacturing quotas by 10% to reach this prescription cut within three years.
Quotas & Buffers
Production quotas are based upon data gathered on legitimate need, “The point is [of the proposed plan] to make sure that we meet the legitimate need. It is a mandate in the Controlled Substances Act as well as Attorney General’s sessions new directions,” Carreno explained.
The Attorney General’s final rule on July 11, 2018 amended regulations of the data that needed to be sought in creating quotas. Carreno said that the DEA did take into account the new data they were directed to look at based upon the ruling, and it has since been taken into account when creating the quotas.
The DEA receives data from IQVIA, a company that collects data on prescriptions written for the insurance industry – this data can be purchased by other industries.
“In the Controlled Substances Act it lays out specific criteria for us to take into account in setting the quota and one of those is the amount of prescriptions written – in that sense our quota setting is reactive, in that we look at scripts written last year. That’s one of half a dozen or more things that we look at, but it’s a prominent one,” said Carreno.
She also told us that what was not included in the press release from the Department of Justice is that the DEA created a buffer quota from 2013-2017. In those four years, the DEA added 25% more to quotas based upon allegations that there wasn’t enough for the legitimate need. However, the 25% was not used and proved to be not needed. Thus, some controlled substance quotas have been cut by even more because the buffer has been taken away.
Carreno further explained, “[The prescription fills] of many common opioids have gone down, and that is in relation to prescribing is going down.”
We previously reported that GAO blamed the DEA for drug shortages following a drug ingredient quota that limited manufacturing of the API.
The FDA made a statement on August 22 that steps are being taken to create indication-specific guidelines for appropriate prescribing of opioid analgesics. The FDA awarded a contract to the National Academies of Sciences, Engineering, and Medicine (NASEM) to advance these guidelines.