In the past two weeks, the Federal Trade Commission (FTC) has ordered major U.S. companies to provide information on their supply chain issues and solutions. The FDA issued an emergency use authorization (EUA) for a monoclonal therapy to include all children. An independent pharmacies survey indicates that they are still experiencing supply chain issues. Please see details for these and other supply chain developments below:
- On November 29, the FTC ordered nine major U.S. companies to provide the government with information about their supply chain operations. Specifically, the FTC is conducting the inquiry to determine the reason behind the delays. The FTC requested that the companies provide information on the primary factors for their supply chain disruptions and what the companies have done to remedy the concerns. The companies have 45 days to respond.
- On November 30, the FDA issued a statement that addresses its plan to monitor the omicron variant. The plan includes continued reporting by stakeholders of the impact of the variant on tests, vaccines, and treatments. At this time, the FDA expects that the variant will have a low impact on testing capabilities and infrastructure. Information will be disseminated to the public as it becomes available.
- On December 3, the FDA expanded the EUA for two monoclonal antibodies—bamlanivimab and etesevimab (used in combination)—to include the treatment of all pediatric patients, including newborns, who have positive COVID-19 test results and are at high risk for progression to severe COVID-19. The drug combination is now also authorized for post-exposure prophylaxis for prevention of COVID-19 in all pediatric patients, including newborns, at high risk of progression to severe COVID-19. The decision comes after the FDA’s evaluation of clinical trial results that demonstrated the therapy was safe and effective.
- On December 3, the Federal Reserve published a note based on a textual analysis of earning calls to report on the effects of the supply chain bottleneck on prices. Earning call texts from the S&P Global Market Intelligence database were searched for certain terms and were classified as positive impact or negative impact. Additionally, the authors used a regression model to analyze the impact of supply bottlenecks on concerns. The authors’ findings suggest that the global container shortage is the top concern for most industries and the automobile sector is suffering from the greatest number of negative impacts. In an analysis of firms that faced high supply chain disruptions vs. low disruptions, those that faced high disruptions had a statistically significant increase in prices. Overall, a stronger global demand, supply bottlenecks, and chip shortages had the greatest effect on prices. It is important to note that issues with capacity and shipping bottlenecks did not cause an increase in prices due to increased mentions in calls.
- On December 8, the FDA issued an EUA for AstraZeneca’s Evusheld, a monoclonal antibody combination injection drug. The authorization is for use in adults and adolescents 12 years of age and older who also have moderately to severely compromised immune systems or are not recommended for vaccination due to severe adverse reactions. Data from a clinical trial demonstrated a 77% risk reduction in contracting COVID-19 after treatment, with efficacy lasting up to six months.
- On December 8, the FDA released draft guidance, “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.” The goal of the guidance, which would satisfy a mandate under the 21st Century Cures Act of 2016, is to facilitate an increased efficiency in approving new indications for legally marketed drugs. Sponsors are encouraged to reach out to the FDA to discuss their draft study protocol and statistical analysis plan for review and comments before finalizing the documents. Additionally, sponsors should consider and address data privacy concerns with the use of real-world data.
- On December 9, the Department of Treasury’s Office of Foreign Assets Control (OFAC) issued sanctions to foreign government officials and entities on International Anti-Corruption Day. The initiative targets, among other things, heads of state and entities that participated in corruption in “COVID-19 procurement.” Specifically, officials who engaged in kickback schemes, medical device and PPE price inflation, and improper awarding of contracts are the subjects of the sanctions. The government officials and their families were also the subjects of U.S. visa penalties.
- On December 9, during the Food and Drug Law Institute Enforcement, Litigation, and Compliance Conference, the FDA’s Elizabeth Miller, assistant commissioner for medical products and tobacco operations at the Office of Regulatory Affairs, revealed that the agency is planning on a pilot program to perform unannounced inspections in India and will expand the program to China.
- On December 10, the Department of Transportation announced that the agency has awarded $12.6 million in grants under the America’s Marine Highway Program (AMHP) to nine marine highways to help address supply chain disruptions and movement of goods. The AMHP, which functions as a public-private partnership, seeks to relieve land congestion, support transportation options, and improve the performance of the transportation system. Some specific projects noted include funding for a New York/New Jersey barge project to increase trailer transportation, expanding operational capacity at the marine terminal in Richmond, VA, and equipment upgrades at a shipping terminal in North Carolina.
- On December 10, the Center for Devices and Radiological Health released a discussion paper, “3D Printing Medical Devices at the Point of Care.” The paper provides a background, an overview of how these devices could be approved for use at the point of care, and challenges to this approach. The authors also pose 16 questions they would like to receive feedback on. Public comments are due February 8, 2022.
- On December 16, the FDA posted draft guidance, “Inspection of Injectable Products for Visible Particulates: Draft Guidance for Industry.” The guidance is meant to provide industry with risk-based procedures to “assess, correct, and prevent the risk of visible particulate contamination.” Serious adverse events have been observed as a result of injectables contaminated with visible particulates. Manufacturers conducting risk assessments and implementing mitigation strategies of injectables with visible particulates should consider the type of particulates, components and container closure systems, and QA procedures, among other factors. Comments are due by February 14, 2022.
- The International Coalition of Medicines Regulatory Authorities published a paper by its COVID-19 Working Group, “Remote GCP and GMP Regulatory Oversight Inspections.” The paper provides an assessment of how regulatory agencies provided remote monitoring during the pandemic, the challenges in implementation, and the success of the programs. The working group noted that while the opportunities available with remote monitoring facilitate new ways for oversight, it should not replace traditional inspections. However, there is room for supplementation with these new tools.
- The National Community Pharmacists Association released the results of a survey demonstrating that supply chain issues continue to plague 60% of independent pharmacies. In addition to these disruptions, independent pharmacies continue to report staffing, low reimbursement rates, and market forces as reasons for their concern. The supply chain disruptions have increased consumer wait times for prescriptions. Overall, 41% of respondents felt the state of the industry can be classified as poor to very poor.
- Amazon invested in a private supply chain network that has helped the company to bypass supply chain woes. The company uses chartered cargo ships, its own shipping containers, ships that bypass the most-utilized ports in Los Angeles and Long Beach, and planes that bypass ports completely. By serving as its own ocean vendor, Amazon can use less-frequented ports for deliveries and does not depend on the availability of containers and access by third-party shipping companies. It is estimated that Amazon is now shipping 72% of its merchandise. In addition, Amazon has increased the amount of seasonal hires by 50% and increased the number of new facilities.