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FDA struggles to track shortages caused by a rise in demand.
Soaring rates of respiratory disease, particularly in children, has ignited demand. This demand has sent consumers searching for a range of usually common prescription and over-the-counter cold remedies and, therefore, angering parents, doctors, and health policy makers. While drug companies are required to inform FDA about manufacturing and supply issues likely to lead to product shortages, industry is not required to communicate changes in demand, leaving the regulators often feeling blind-sided by market changes that affect supply chains before any response can be mounted.
Valerie Jensen, associate director of FDA’s Drug Shortage Staff in the Center for Drug Evaluation and Research (CDER), acknowledged FDA’s limited authority for tracking drug demand spikes during a Dec. 1, 2022 webinar sponsored by The Alliance for a Stronger FDA. Jensen urged manufacturers to report such demand fluctuations, while acknowledging that the agency lacks authority to require such information.
Analysts blame the current scarcity of cold and fever therapies able to provide symptomatic relief on a “triple whammy” of high respiratory virus levels from influenza and respiratory syncytial virus (RSV), as well as ongoing COVID-19 infections. This surge in illness also has boosted demand for amoxicillin and other antibiotics, low-cost generic drugs that usually are widely available. Even though these drugs are not effective against viruses, they can treat the bacterial respiratory infections that often result.
Jensen explained that FDA has had authority since 2012 to require manufacturers to report manufacturing and supply situations likely to limit product supplies. Such information can prompt an agency investigation to determine where there is a supply gap or available substitute products. If the drug is needed to address a critical medical situation, FDA may take steps to facilitate access to alternative ingredients or treatments. Additional options are for FDA to qualify a new raw material supplier, authorize a temporary import, extend expiration dates, or approve stop-gap methods to remove particles from a liquid formulation. Jensen noted that FDA also consults regularly with international regulatory authorities to keep informed on what products may be available for import in an emergency. FDA regularly posts information on drug shortages and recently added specifics on the supply situation for antiviral disease treatments.
The current weaknesses in the drug supply chain have prompted leading Senators to call for FDA to more forcefully address shortages in amoxicillin and other disease treatments. The situation also continues to drive interest in “buy American” proposals to boost drug production in the United States and reduce dependence on imports to maintain strong supplies. Legislative “onshoring” policies offer tax incentives for manufacturers to produce antibiotics and other needed drugs for government stockpiles and to have the capacity to meet unexpected demand.
Overall, though, frequent and ongoing supply chain issues for drugs are not unusual, as FDA regularly reports about 100 short supply situations for medicines; FDA’s current list of 123 drug shortages is just above usual levels, Jensen reported in the December 2022 webinar. What concerns her more, though, are “ongoing shortages” that continue from year to year.
Jensen said that alerts from companies of spikes in demand for a product can help address shortages as quickly as possible with fast review and approval of an alternative treatment or permitting continued use of a product while a quality problem is being fixed. For the long run, FDA continues to encourage companies to adopt quality production systems that are more reliable and predictable. And all parties recognize the need for better analytics to identify suppliers with resilient, modern manufacturing systems able to address shortage situations quickly and efficiently.
Jill Wechsler is Washington Report for BioPharm International.