FTC to Probe Big Business Supply Chain Issues – Medical Products Supply Chain Week in Review | Alston and bird
Over the past two weeks, the Federal Trade Commission (FTC) has ordered major US companies to provide information on their supply chain issues and solutions. The FDA has issued an Emergency Use Authorization (EUA) for a monoclonal therapy to include all children. An independent survey of pharmacies indicates they are still experiencing supply chain issues. Please see details of these and other supply chain developments below:
- On November 29, the FTC ordered nine major US companies to provide the government with information about their supply chain operations. Specifically, the FTC is investigating to determine the reason for the delays. The FTC has asked the companies to provide information about the main disruptors in their supply chain and what the companies have done to address the issues. Companies have 45 days to respond.
- On November 30, the FDA released a statement that discusses its oversight plan for the omicron variant. The plan includes ongoing reporting by stakeholders on the impact of the variant on tests, vaccines and treatments. At this time, the FDA expects the variant to have a low impact on testing capabilities and infrastructure. Information will be released 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 treatment for all pediatric patients, including neonates, who test positive. to the COVID-19 test and who are at high risk of progression. to severe COVID-19. The drug combination is now also licensed for post-exposure prophylaxis for the prevention of COVID-19 in all pediatric patients, including neonates, at high risk of progression to severe COVID-19. The decision comes after the FDA’s evaluation of clinical trial results that showed the therapy to be safe and effective.
- On Dec. 3, the Federal Reserve released a note based on textual analysis of earnings calls to account for the effects of the supply chain bottleneck on prices. The winning SMS calls from the S&P Global Market Intelligence database were searched for certain terms and were categorized 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 that the automotive sector is suffering the greatest number of negative impacts. In an analysis of companies facing high versus low supply chain disruptions, those that faced high disruptions experienced a statistically significant price increase. Overall, stronger global demand, supply bottlenecks and chip shortages had the biggest effect on prices. Importantly, capacity issues and shipping bottlenecks did not result in price increases due to increased mentions in calls.
- On Dec. 8, the FDA issued an EUA for AstraZeneca’s Evusheld, an injectable drug combined with a monoclonal antibody. The authorization is for use in adults and adolescents 12 years of age and older who also have moderately to severely weakened immune systems or who are not recommended for vaccination due to serious adverse reactions. Data from a clinical trial demonstrated a 77% reduction in the risk of contracting COVID-19 after treatment, with efficacy lasting up to six months.
- On Dec. 8, the FDA released draft guidance, “Considerations for Using Real-World Data and Evidence to Support Regulatory Decision-Making for Drugs and Biologics.” The aim of the guidance, which would satisfy a mandate under the 21st Century Cures Act 2016, is to facilitate increased efficiency in approving 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 comments before finalizing the documents. Additionally, sponsors need to consider and address data privacy issues related to the use of real-world data.
- On December 9, the Treasury Department’s Office of Foreign Assets Control (OFAC) imposed sanctions on foreign government officials and entities in observance of International Anti-Corruption Day. The initiative targets, among others, heads of state and entities that have participated in corruption in the context of “COVID-19 purchases”. Specifically, officials who have engaged in kickback schemes, price inflation of medical devices and PPE, and improper awarding of contracts are subject to sanctions. Government officials and their families have also been subject to US visa penalties.
- On December 9, at the Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference, Elizabeth Miller, FDA Assistant Commissioner for Medical Products and Tobacco Operations in the Office of Regulatory Affairs, revealed that the agency is planning a pilot program to conduct unannounced inspections in India and will expand the program to China.
- On Dec. 10, the Department of Transportation announced that the agency had awarded $12.6 million in America’s Marine Highway Program (AMHP) grants to nine marine highways to help deal with disruptions in the chain. supply and movement of goods. The AMHP, which operates as a public-private partnership, seeks to decongest land, support transport options and improve the performance of the transport system. Some specific projects noted include funding a New York/New Jersey barge project to increase trailer hauling, expansion of operational capacity at the Richmond, Virginia marine terminal, and equipment upgrades. from a shipping terminal in North Carolina.
- On December 10, the Center for Devices and Radiological Health released a working paper titled “3D Printing Medical Devices at the Point of Care.” The paper provides context, insight into how these devices might be approved for point-of-care use, and the challenges of this approach. The authors also pose 16 questions on which they would like to receive feedback. Public comments are due February 8, 2022.
- On December 16, the FDA released draft guidance, “Inspection of Injectable Products for Visible Particulates: Draft Guidance for Industry.” The guidelines aim to provide industry with risk-based procedures to “evaluate, correct and prevent the risk of visible particulate contamination”. Serious adverse events have been observed following injectables contaminated with visible particles. Manufacturers conducting risk assessments and implementing mitigation strategies for injectables containing visible particles should consider the type of particles, components and container closure systems, as well as quality assurance procedures, among other factors. Comments are due by February 14, 2022.
- The International Coalition of Medicines Regulators has published an article from its COVID-19 Task Force, “Remote GCP and GMP Regulatory Oversight Inspections”. The document provides an assessment of how regulators have provided remote monitoring during the pandemic, implementation challenges, and program success. The working group noted that while the opportunities offered by remote monitoring facilitate new methods of monitoring, they should not replace traditional inspections. However, there is room for complementation with these new tools.
- The National Community Pharmacists Association has released survey results showing that supply chain issues continue to plague 60% of independent pharmacies. In addition to these disruptions, independent pharmacies continue to cite staffing, low reimbursement rates and market forces as reasons for concern. Supply chain disruptions have increased consumer wait times for prescriptions. Overall, 41% of respondents believe that the state of the industry can be classified as bad to very bad.
- Amazon has invested in a private supply chain network that has helped the company circumvent supply chain issues. The company uses chartered freighters, its own shipping containers, ships that bypass the busiest ports of Los Angeles and Long Beach, and aircraft that completely bypass the ports. 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. It is estimated that Amazon now ships 72% of its merchandise. Additionally, Amazon increased the number of seasonal hires by 50% and increased the number of new installs.