Over the past two weeks, the Federal Trade Commission (FTC) has ordered major U.S. companies to provide information on problems and solutions in their supply chain. The FDA has issued an Emergency Use Clearance (EUA) for monoclonal therapy to include all children. An independent survey of pharmacies indicates that they still face supply chain issues. Please see details of 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 an investigation to determine the reason for the delays. The FTC has asked companies to provide information on the main drivers of disruption in their supply chain and what they have done to address the issues. Companies have 45 days to respond.
- On November 30, the FDA released a statement that discusses its omicron variant surveillance plan. The plan includes ongoing reporting by stakeholders of the impact of the variant on testing, vaccines and treatments. Currently, the FDA expects the variant to have a low impact on testing capabilities and infrastructure. The information will be released to the public as soon as it becomes available.
- On December 3, the FDA expanded the EUA for two monoclonal antibodies – bamlanivimab and etesevimab (used in combination) – to include treatment of all pediatric patients, including newborns, who test positive for the COVID test -19 and are at high risk of progression to severe COVID-19. The combination drug is now also authorized for post-exposure prophylaxis for the prevention of COVID-19 in all pediatric patients, including newborns, at high risk of progression to severe COVID-19. The move comes after the FDA evaluated the results of clinical trials that showed the therapy to be safe and effective.
- On December 3, the Federal Reserve released a note based on a textual analysis of earnings calls to account for the effects of the supply chain bottleneck on prices. Call SMS messages won 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 primary concern of most industries, and that the automotive sector suffers the most negative impacts. In an analysis of companies facing large supply chain disruptions versus low disruptions, those that experienced large disruption experienced statistically significant price increases. Overall, stronger global demand, supply bottlenecks and chip shortages had the biggest effect on prices. It is important to note that capacity issues and shipping bottlenecks have not resulted in price increases due to the increase in mentions in calls.
- On December 8, the FDA issued an EUA for AstraZeneca’s Evusheld, an injectable drug combined with monoclonal antibodies. 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 whose vaccination is not recommended due to serious side effects. Data from a clinical trial have shown a 77% reduction in the risk of contracting COVID-19 after treatment, with efficacy lasting up to six months.
- On December 8, the FDA released a draft guideline titled “Considerations for Using Real Data and Evidence to Support Regulatory Decision Making for Drugs and Biologics”. The goal of the guidance, which would meet a mandate under the 21st Century Cures Act of 2016, is to facilitate increased efficiency in the approval of new indications for legally marketed drugs. Sponsors are encouraged to contact the FDA to discuss their draft study protocol and statistical analysis plan for review and comment before finalizing the documents. Additionally, sponsors need to consider and address data privacy concerns using real world data.
- On December 9, the Treasury Department’s Office of Foreign Assets Control (OFAC) imposed sanctions on foreign government officials and entities on the International Anti-Corruption Day. The initiative targets, among others, heads of state and entities that have participated in acts of corruption in the context of “COVID-19 purchases”. Specifically, officials who have engaged in bribery programs, inflation in the prices of medical devices and PPE, and improper awarding of contracts are subject to sanctions. Government officials and their families have also faced sanctions for US visas.
- On December 9, at the Food and Drug Law Institute’s Enforcement, Litigation and Compliance conference, Elizabeth Miller of the FDA, deputy commissioner for medical products and tobacco operations in the Office of Regulatory Affairs, spoke revealed that the agency is planning a pilot program to conduct unannounced inspections in India and expand the program to China.
- On December 10, the Department of Transportation announced that the agency had awarded $ 12.6 million in America’s Marine Highway (AMHP) grants to nine maritime highways to help deal with disruption in the water supply chain. supply and movement of goods. AMHP, which operates as a public-private partnership, seeks to reduce land congestion, support transport options and improve the performance of the transport system. Some specific projects mentioned include funding for a New York / New Jersey barge project to increase trailer transportation, increasing the operational capacity of the Richmond, Virginia marine terminal, and upgrading ship equipment. a marine terminal in North Carolina.
- On December 10, the Center for Devices and Radiological Health released a discussion paper titled “Point-of-Care 3D Printing of Medical Devices.” The paper provides background, an overview of how these devices might be approved for point-of-care use, and the challenges of this approach. The authors also ask 16 questions on which they would like to receive comments. Public comments are expected on February 8, 2022.
- On December 16, the FDA released a draft guideline, “Inspection of Injectables for Visible Particles: Draft Guidance for Industry.” The guidelines aim to provide industry with risk-based procedures to “assess, correct and prevent the risk of visible particulate contamination”. Serious adverse events have been observed following injectables contaminated with visible particles. Manufacturers performing risk assessments and implementing mitigation strategies for injectables containing visible particles should consider the type of particles, container components and closure systems, and quality assurance procedures, among other factors. Comments are due by February 14, 2022.
- The International Coalition of Drug Regulators has published an article from its COVID-19 Working Group, “Remote PCB and GMP Regulatory Oversight Inspections”. The document provides an assessment of how regulators provided remote monitoring during the pandemic, the challenges of implementation, and the success of the programs. The Working Group noted that while the possibilities offered by remote monitoring facilitate new monitoring methods, they should not replace traditional inspections. However, there is room for supplementation with these new tools.
- The National Community Pharmacists Association has released the results of a survey showing that supply chain issues continue to plague 60% of independent pharmacies. In addition to these disruptions, independent pharmacies continue to flag staff, low reimbursement rates and market forces as reasons for their concern. Supply chain disruptions have increased consumer wait times for prescriptions. Overall, 41% of respondents felt that the state of the industry can be classified from bad to very bad.
- Amazon has invested in a private supply chain network that has helped the company bypass supply chain issues. The company uses charter freighters, its own shipping containers, ships that bypass the busiest ports of Los Angeles and Long Beach, and planes that bypass ports completely. By serving as its own shipping provider, Amazon can use less busy ports for deliveries and is not dependent on container availability and access by third-party shipping companies. Amazon is now estimated to ship 72% of its merchandise. In addition, Amazon has increased the number of vacation rentals by 50% and increased the number of new installations.