The US Drug Enforcement Administration (DEA) is proposing to significantly reduce the amount of opioids produced in 2018.
The proposal to cut opioid production by 20%, published in the Federal Register on August 7, comes on the heels of a 25% or more reduction in opioid production in 2017.
Each year, the DEA proposes and then enforces production quotas as a means of controlling diversion of scheduled substances. It assesses what it thinks is needed in medicine, science, research, and industry. The agency is proposing a reduction in 2018 of more commonly prescribed Schedule II opioid painkillers, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, codeine, meperidine, and fentanyl. Citing sales figures from IMS Health, the DEA says demand for these prescription products has declined.
DEA Acting Administrator Chuck Rosenberg also noted in a statement, “More states are mandating use of prescription drug monitoring programs, which is good, and that has prompted a decrease in opioid prescriptions.”
But John Gilbert, a Washington, DC–based food and drug law attorney, says the agency may also be cutting production in response to the ongoing opioid crisis. The IMS data and data from other prescribing sources “may be justification that quotas should be lowered,” Gilbert told Medscape Medical News.
“The difficulty, in my opinion, about reducing based on the opioid crisis is how do you estimate how much is being abused, and would the reduction then create shortages for legitimate patients,” said Gilbert.
The DEA is proposing to reduce production of hydrocodone for sale from 58.4 million grams to 50.3 million grams in 2018. For oxycodone, the 2018 quota would be 95.6 million grams, down from 108.5 million in 2017. The peak authorized oxycodone production was 153.7 million grams in 2013.
Gilbert said the DEA’s demands for a decline in production in 2017 and 2018 “are significant, because I can’t think of another case where DEA was reducing an entire class of drugs across the board.”
The agency typically has requested and gotten changes in quotas for a given drug from year to year, “but this recent action is different and seems more arbitrary,” said Gilbert.
The 2018 proposal is for aggregate quotas of each substance. Once those quotas are finalized, which will be in October, manufacturers can apply for individual manufacturing and procurement quotas.
Gilbert said he expects manufacturers to object some to the proposed 2018 quotas, especially given the reduction in 2017.
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