AMA furthers policy to address nation’s growing drug supply shortages

ORLANDO, Fla. – WEBWIRE – Friday, November 15, 2024

With drug shortages reaching the highest they have been in a decade, the American Medical Association (AMA) today adopted policy during the Interim Meeting of its House of Delegates furthering its work to address this worsening public health issue. The AMAs new policy supports efforts to encourage federal review and oversight of the practice by compounding pharmacies to advertise drugs that are actively in shortage, combat artificial drug shortages, and offer incentives to manufacturers seeking to invest in manufacturing processes.

The advertising practices of on-patent drugs such as semaglutide, and other glucagon-like peptide-1 (GLP-1) agonists, have led to highly-publicized shortages over the last year. Semaglutides increase in popularity can largely be attributed to a massive advertising presence, particularly through social media, despite the drug being in constant shortage. Prolonged shortages combined with ultra-high demand have led to significant concerns over counterfeit products being sold to pharmacies struggling to keep up with new and existing patient needs, and compounding pharmacies finding loopholes to develop compounded versions of semaglutide that contain different active ingredients and have not been evaluated for safety and efficacy by the U.S. Food and Drug Administration (FDA). To help alleviate these shortages and ensure the drugs being sold are safe and effective, the AMAs policy calls on the FDA, Federal Trade Commission, or other relevant oversight entities, to examine the practice by which compounding pharmacies use to advertise drugs that are actively in shortage, particularly when targeted to new patients.

Drug shortages in the U.S. continue to frustrate physicians and are increasinglyjeopardizing patient safety and the quality of health care patients receive. Along with manufacturing issues and supply chain disruptions that have led to drug shortages over the years, now bad actors are using deceptive marketing practices to prioritize profits over patient well-beingleading to prolonged drug shortages that make it challenging for patients with valid prescriptions to obtain the medications and treatments they need, said AMA Board Member Alexander Ding, M.D., M.S., M.B.A. The AMA will continue to adopt policies and support initiatives to help alleviate drug shortages to ensure patients have timely and continuous access to their medications.

According to the American Society of Health-System Pharmacists statistics, drug shortages have worsened over the last year with new drug shortages continuing to rise and existing drug shortages taking longer to resolve. For the first quarter of 2024, there have been 48 new drugs in shortage. So far this year, the five classes of drugs facing the largest number of shortages include, central nervous system therapies, antimicrobials, hormones, chemotherapies, and fluids/electrolytesplacing significant burden on physicians and patients across all health care settings, including urban, rural, outpatient and inpatient.

To help address these drug shortages, the newly adopted policy was informed by a Council on Science and Public Health report that examined three categories of drugs in shortage, including controlled substances, generic drugs, and on-patent drugs, as well as proposed government actions to address them. The report notes that manufacturing quotas from the Drug Enforcement Administration (DEA) have unnecessarily led to drug shortages for some controlled substances, including mixed amphetamine salts used for the treatment of attention-deficit hyperactivity disorders. The new policy opposes laws, regulations, or business practices which create artificial drug shortages that limit patient access to medications, such as limitations on pharmacy procurement or restrictions on the pharmacies a patient can use, which prevent the filling of an otherwise valid prescription from their physician.

The new policy also aims to bolster drug manufacturing through the use of incentives such as prioritized regulatory review, reduction of user fees, and direct grant opportunities for manufacturers seeking to invest in manufacturing processes.To support the development of strategies and technologies to strengthen supply chain networks, the new policy calls for economic incentives for building climate and disaster resiliency and redundancy into new or updated facilities, increasing emergency stockpiles of key products, and incentivizing the innovation and adoption of reusable medical products to resist the impact of supply chain disturbances.

The policy adopted today builds upon AMAs long-standing efforts to address the growing drug shortages and ongoing supply challenges for essential medications. Recognizing that prescription drug shortages have a widespread impact on patient care and treatment, the AMA will continue to work with other interested parties to further evaluate and implement recommendations that contribute to solutions to address this ongoing public health issue.

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AMA Viewpointby AMA President Bruce A. Scott, M.D.: Combating drug shortages requires multifaceted approach.

About the American Medical Association

The American Medical Association is the physicians powerful ally in patient care. As the only medical association that convenes 190+ state and specialty medical societies and other critical stakeholders, the AMA represents physicians with a unified voice to all key players in health care. The AMA leverages its strength by removing the obstacles that interfere with patient care, leading the charge to prevent chronic disease and confront public health crisesand, driving the future of medicine to tackle the biggest challenges in health care.

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