Because No One is Immune to the Law
March 03, 2020 - United States, FDA, COVID-19, Healthcare

FDA Working to Address 2019 Novel Coronavirus (COVID-19): Supply Chain (Part II)

Federal Circuit Corrects USPTO on Reasonable Efforts When Calculating Patent Term Adjustment

FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including product safety, monitoring supply chain disruptions, and supporting emergency efforts to diagnose and treat the disease. In addition, FDA is addressing safety concerns with its own workforce. In this three-part series, we explain FDA’s efforts in each of these areas and highlight the impact on different sectors of the healthcare industry impacted by the coronavirus and FDA’s focused efforts. Please read Part I of our series.

FDA is anticipating that supply chain disruptions will occur as a result of the COVID-19 outbreak. In fact, FDA confirmed on February 27, 2020, that a drug manufacturer with a human drug product is now included on the drug shortages list as a result of the impact of the outbreak on a site that is manufacturing the active pharmaceutical ingredient of the drug product. The COVID-19 outbreak follows shortly on the heels of FDA’s focused efforts last fall on drug shortage issues and, in October 2019, FDA issued a report, “Drug Shortages: Root Causes and Potential Solutions,” that attempts to identify root causes and offer recommendations to help prevent and mitigate drug shortages.

FDA has redirected agency resources to proactively communicate with drug and device firms that could be impacted by the outbreak. Since January 24, 2020, FDA has been in touch with more than 180 manufacturers of human drugs, not only to remind them of applicable legal requirements for notifying FDA of any anticipated supply disruptions, but also asking them to evaluate their entire supply chain, including active pharmaceutical ingredients (the main ingredient in the drug and part that produces the intended effects, e.g., acetaminophen) and other components manufactured in China. Also, as part of FDA’s proactive supply chain management efforts, they have identified about 20 other drugs, which solely source their active pharmaceutical ingredients or finished drug products from China and FDA has been in direct contact with those firms to assess whether they face any drug shortage risks due to the outbreak. Drug firms are required by law to proactively communicate drug shortage risks and also respond to FDA inquiries regarding management of drug supply issues.

No law exists requiring medical device manufacturers to notify FDA when they become aware of a circumstance, including discontinuation of a product, that could lead to a potential shortage, and manufacturers are not required to respond when FDA requests information about potential supply chain disruption. FDA has identified 63 manufacturers which represent 72 facilities in China that produce essential medical devices and has proactively contacted these firms. FDA has confirmed that a number of these facilities are impacted by the outbreak, but is not reporting any medical device shortages in the U.S. market as of February 27, 2020. Despite reported challenges in obtaining personal protective equipment, such as respirators, gloves and masks, FDA is not reporting a shortage in the supply chain at this time. FDA has established a unique email box to receive information about device shortages: and is encouraging voluntary cooperation from device firms in assessing supply chain impacts.

FDA also has a number of regulatory tools available, beyond the immediate surveillance and monitoring activities described above, to address the supply chain impact of the coronavirus outbreak. In addition, the President’s budget contains specific proposals that FDA is now emphasizing could help FDA address coronavirus supply chain disruption. First, FDA is strongly advocating that Congress update the legal authority regarding medical device supply chain disruption reporting and cooperation. Second, FDA advocates that it be able to obtain infrastructure information, such as manufacturing quality and capacity, in a proactive process. Third, FDA recommends that it be given the legal authority to require medical product firms (drugs and devices) to prepare and test against risk assessments of supply chain vulnerabilities and be required to maintain emergency contingency plans. Finally, FDA suggested that it should be granted the legal authority to require drug manufacturers to revise and lengthen expiration dates to the maximum date scientifically validated to address supply chain disruptions. We will continue to monitor these proposed changes to FDA’s legal authorities.