4 recommendations for addressing our nation's drug supply chain challenges
A group of health industry associations is asking policymakers to implement a range of legislative and regulatory actions.
The ongoing pandemic is exacerbating problems with the nation’s drug supply chain and affecting patient treatment.
A group comprising the American Medical Association, American Society of Anesthesiologists, American Society of Health-System Pharmacists, Association for Clinical Oncology and the United States Pharmacopeia has released a series of policy and marketplace recommendations to address significant challenges.
“COVID-19 has magnified the dangers inherent in failing to address gaps and deficiencies in the pharmaceutical and medical supply chains,” it said. “Supply chain disruptions can adversely impact patient care by delaying treatment or requiring patients to switch to less-effective treatment regimens. Policymakers must do more to ensure a consistently safe, effective and uninterrupted supply of quality medicines for patients in this country.”
The organizations have long collaborated on recommendations for critical steps to improve the nation’s supply chain and mitigate drug shortages, including a summit in July 2020 that examined the resilience of the U.S. pharmaceutical supply chain in light of the current state of global pharmaceutical manufacturing. The group is asking policymakers to implement a range of legislative and regulatory actions, including:
Incentivize advanced manufacturing technology and develop new continuous manufacturing technology for critical drugs and active pharmaceutical ingredients. The group recommends legislative and regulatory solutions that strengthen the nation’s supply chain by incentivizing the development and use of advanced and continuous manufacturing technology for critical drugs and active pharmaceutical ingredients, including support for advanced manufacturing grant appropriations. Further, it recommends that these technologies be adopted and implemented in both domestic and foreign manufacturing facilities.
Improve the function and composition of the Strategic National Stockpile. The pandemic highlighted weaknesses in the supply chain, including difficulty accessing the Strategic National Stockpile, as well as deficiencies in the medications and devices included in the stockpile. The group recommends regulatory and legislative actions that improve the function, composition and accessibility of the stockpile during public health emergencies.
Improve multinational cooperation on supply chain resilience. It recommends regulatory and legislative actions that increase the overall resilience of the United States supply chain by enhancing international cooperation and collaboration with foreign supply chain partners, including but not limited to foreign governments and manufacturers.
Incentivize quality and resilience. The group recommends regulatory and legislative action that creates incentives for manufacturers to improve drug and device manufacturing quality. It also recommends that policy solutions focus on outcomes that improve the overall resilience of the nation’s medication and device supply chains.
Replicate asks for critical drug manufacturing transparency and oversight for medical devices and ancillary supplies. The CARES Act of 2020 included drug manufacturing provisions designed to mitigate and reduce drug shortages. The group recommends legislative and regulatory action to extend similar provisions to the manufacturing of medical devices and enhance reporting requirements for device manufacturers.