How Could Opioid Production Restrictions Impact Manufacturers?
The U.S. Drug Enforcement Administration (DEA) is proposing to curb the oversupply of prescription painkillers available on the market. The development comes against the backdrop of an opioid crisis that killed nearly 64,000 people in the U.S. in 2016. The plan, which Attorney General Jeff Sessions announced last month, could reduce the volume of opioids pharmaceutical manufacturers can make per year and would apply to companies whose “drugs are being diverted for misuse.” However, are the suggested production controls good news for drugmakers — and how might they impact the manufacturing industry at large?
Despite past restrictions on opioid production, illegal trafficking networks have continued to divert such drugs for use without required prescriptions. Illicit painkiller distribution channels remain in the U.S., notwithstanding a 25% quota reduction the DEA started enforcing in 2017. Likewise, existing laws have not provided an effective legal framework for the coordination of efforts among various industry stakeholders, including the DEA, federal agencies, states, and drug manufacturers.
Aware of such shortcomings as well as ongoing issues in his home state, West Virginia Attorney General Patrick Morrisey sued the DEA, calling for the federal agency to increase transparency and participation in the development of criteria for dictating how many prescription painkillers a manufacturer may produce annually, according to The Washington Post article. Sessions now seeks to shift the focus of production quotas to proper use, rather than just predetermined sales targets. If implemented, the restrictions Sessions proposes could help seal critical legal gaps that have so far allowed illegal opioid distribution to persist.
While many pharmaceutical manufacturers do well to observe caps already in place, they may contribute to the opioid crisis if unable to keep transparent supply audit trails. The good news is that law-abiding manufacturers need not worry about penalties if the recently proposed production curbs become law. The new rules would encourage clarity and increased supply chain monitoring, which could help even the most reputable manufacturers better track their products and make more informed choices about pharmaceutical distribution. These manufacturers can remain in good books with the DEA by sharing their supply chain and inventory information with the agency.
If such compliance with the proposed rules were to lead to a significant decline in painkiller abuse, many manufacturers would have reason to smile, considering how the crisis has created a shortage of skilled manufacturing labor across the U.S. The more potential manufacturers use prescription pain relievers, even those with valid prescriptions, the more likely they could develop dependencies and the less likely they could be to qualify for the jobs they seek in the industry. Additionally, the proposed opioid production caps match the objectives of various manufacturers who have programs in place to help alleviate the crisis in their respective communities.
Indeed, the yet-to-be-enforced opioid production limits put honest manufacturers in stronger positions to continue making useful drugs that do not end up in the wrong hands or markets. The proposed rules introduce much-needed levels of transparency and engagement among various stakeholders, including drugmakers, law enforcement agencies, federal organizations, and communities grappling with the effects of the deadly opioid crisis.
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