Lance's Corner

FDA Issues Comprehensive Regulatory Update

Oct 31, 2024

The United States Food and Drug Administration (FDA) has issued its weekly comprehensive regulatory update, which can be read below.

Supply Chain Updates

FDA Efforts to Increase Access and Supply of IV and PD Solutions: Hurricane Helene Recovery in North Carolina

FDA continues ongoing efforts to increase access to and supply of IV and peritoneal dialysis (PD) solutions following Hurricane Helene-related damage to Baxter International Inc.’s North Cove facility in Marion, North Carolina. Specifically, FDA acted quickly to conduct scientific and regulatory assessments, facilitating the temporary importation of 40 different IV and PD fluids from seven Baxter facilities around the world. These supply improvements, combined with increased output from other manufacturers, should help health care providers get more of the product they need over the coming weeks.

On October 28, FDA announced extended use dates for some parenteral drug products, after a review of the stability data submitted by Baxter International. Providers and patients that have the lot numbers in stock will be able to use them through the corresponding new use dates to help with supply. The following extended use dates are supported for specific lot numbers indicated in the linked table.

On October 11, FDA released immediately-in-effect guidance providing new flexibilities related to compounding of IV solutions to help fill the gaps from the impact of Hurricane Helene on Baxter's North Cove facility. This guidance will also make it easier for hospitals and other facilities to make their own IV solutions during the shortage.

HHS Informational Briefing on IV Fluid Conservation Best Practices (October 28, 2024)

Video Frame from HHS Informational Briefing on IV Fluid Conservation Best Practices October 28, 2024
An example of conservation strategies shared by one organization during the briefing. Video length is 36 minutes.

Hear from the Department of Health and Human Services, as well as hospital and group purchasing organization industry leaders, for an informational briefing on strategies to conserve intravenous fluid (IV) products that are in shortage and may be further impacted until Baxter’s North Cove, NC facility is operational.

Statement from Secretary Xavier Becerra on IV Fluid Increase (October 24, 2024)

“I am encouraged by reports that Baxter anticipates restarting the highest throughput manufacturing line at Baxter’s North Cove facility next week – sooner than originally expected. There’s more to do, including meeting regulatory requirements of the product manufactured on the restarted line, but this is good news for partners and patients..." 

Respiratory Illness Updates

Biden-Harris Administration Takes New Action to Halt the Spread of Bird Flu, including in California and Washington (October 24, 2024)

Since the first case of H5N1 was confirmed in cattle, USDA and HHS have led a whole-of-government approach to rapidly respond to the outbreak. In response to the recent spread of H5N1 in lactating dairy cows to California and the resulting human cases and the human cases in Washington resulting from an outbreak among poultry, the United States Department of Agriculture (USDA) and the Department of Health and Human Services (HHS) are working closely with the state and local counterparts to respond to the outbreak and protect public health. While CDC’s assessment of the risk of avian influenza to the general public remains low, USDA and HHS continue to take this outbreak seriously to protect human health, animal health, and food safety. Read more.

FDA Approves RSV Vaccine for Additional Populations (October 22, 2024) FDA approved the vaccine Abrysvo for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Read more.

Emergency Use Authorization (EUA) Updates

Emergency Use Authorization (EUA)

EUA Revisions and Updates

Updated and Revised EUAs - Expiration Dates Extended

Expiration date extension

You can find information about shelf-life extensions of mpox vaccines and therapeutics and other medical countermeasures, on our web page: Expiration Dating Extension. Recent updates:

Quick Links

Events

In Case You Missed It

Many At-Home COVID-19 Tests Have Extended Expiration Dates

Tis the Season to Check, Confirm, and Test

Holiday celebrations are fast approaching. With an increase in social gatherings comes the likelihood of an increase in positive COVID-19 cases. Testing helps prevent and contain the spread of COVID-19 This holiday season, the FDA encourages you to check, confirm, and test.

Check the FDA’s website: Search the current list of authorized at-home COVID-19 tests because many have extended expiration dates.

Video Screenshot: Find Extended Expiration Dates for At Home COVID Tests
Confirm expiration dates: Make sure your at-home tests have not expired. If your at-home tests do not have an extended expiration date and they have expired, do not use them. Check out our video on how to confirm the expiration date.

What does an extended expiration date mean? An extended expiration date means the manufacturer provided data to the FDA showing that the shelf-life is longer than was known when the test was first authorized.

COVID-19 resources 112px
Quick COVID-19 Resources

MCMi FY22 program update report cover illustration
COVID-19, Flu and RSV Information for Consumers (Updated October 24, 2024)

Your guide to FDA-authorized and approved vaccines, tests and treatments for flu, COVID-19, and RSV (respiratory syncytial virus). Talk with a health care professional about what works best for you.

Q and A with FDA podcast
Q&A with FDA Podcast (October 17, 2024)

In our new episode, Understanding Drug Recalls, we answer some of your most commonly asked questions. Previous episodes include conversations about real-world evidence, AI in clinical trial design, drug shortages, and much more.

Thanks for reading. This newsletter is produced by the FDA Office of Public Health Preparedness and Response, in the Office of the Chief Medical Officer (OCMO).

USDOL Issues Comprehensive Employer Guidance on Long COVID

The United States Department of Labor (USDOL) has issued a comprehensive set of resources that can be accessed below for employers on dealing with Long COVID.

Supporting Employees with Long COVID: A Guide for Employers

The “Supporting Employees with Long COVID” guide from the USDOL-funded Employer Assistance and Resource Network on Disability Inclusion (EARN) and Job Accommodation Network (JAN) addresses the basics of Long COVID, including its intersection with mental health, and common workplace supports for different symptoms.  It also explores employers’ responsibilities to provide reasonable accommodations and answers frequently asked questions about Long COVID and employment, including inquiries related to telework and leave.

Download the guide

Accommodation and Compliance: Long COVID

The Long COVID Accommodation and Compliance webpage from the USDOL-funded Job Accommodation Network (JAN) helps employers and employees understand strategies for supporting workers with Long COVID.  Topics include Long COVID in the context of disability under the Americans with Disabilities Act (ADA), specific accommodation ideas based on limitations or work-related functions, common situations and solutions, and questions to consider when identifying effective accommodations for employees with Long COVID.  Find this and other Long COVID resources from JAN, below:

Long COVID, Disability and Underserved Communities: Recommendations for Employers

The research-to-practice brief “Long COVID, Disability and Underserved Communities” synthesizes an extensive review of documents, literature and data sources, conducted by the USDOL-funded Employer Assistance and Resource Network on Disability Inclusion (EARN) on the impact of Long COVID on employment, with a focus on demographic differences.  It also outlines recommended actions organizations can take to create a supportive and inclusive workplace culture for people with Long COVID, especially those with disabilities who belong to other historically underserved groups.

Read the brief

Long COVID and Disability Accommodations in the Workplace

The policy brief “Long COVID and Disability Accommodations in the Workplace” explores Long COVID’s impact on the workforce and provides examples of policy actions different states are taking to help affected people remain at work or return when ready.  It was developed by the National Conference of State Legislatures (NCSL) as part of its involvement in USDOL’s State Exchange on Employment and Disability (SEED) initiative.

Download the policy brief

Understanding and Addressing the Workplace Challenges Related to Long COVID

The report “Understanding and Addressing the Workplace Challenges Related to Long COVID” summarizes key themes and takeaways from an ePolicyWorks national online dialogue through which members of the public were invited to share their experiences and insights regarding workplace challenges posed by Long COVID.  The dialogue took place during summer 2022 and was hosted by USDOL and its agencies in collaboration with the Centers for Disease Control and Prevention and the U.S. Surgeon General.

Download the report

Working with Long COVID

The USDOL-published “Working with Long COVID” fact sheet shares strategies for supporting workers with Long COVID, including accommodations for common symptoms and resources for further guidance and assistance with specific situations.

Download the fact sheet

COVID-19: Long-Term Symptoms

This USDOL motion graphic informs workers with Long COVID that they may be entitled to temporary or long-term supports to help them stay on the job or return to work when ready, and shares where they can find related assistance.

Watch the motion graphic

A Personal Story of Long COVID and Disability Disclosure

In the podcast “A Personal Story of Long COVID and Disability Disclosure,” Pam Bingham, senior program manager for Intuit’s Diversity, Equity and Inclusion in Tech team, shares her personal experience of navigating Long COVID symptoms at work.  The segment was produced by the USDOL-funded Partnership on Employment and Accessible Technology (PEAT) as part of its ongoing “Future of Work” podcast series.

Listen to the podcast

HHS OIG Issues Annual Report on State MFCUs

Per the notice below, the Office of the Inspector General (OIG) of the United States Department of Health and Human Services (HHS) has issued its annual report on the performance of state Medicaid Fraud Control Units (MFCUs).

Medicaid Fraud Control Units Fiscal Year 2023 Annual Report (OEI-09-24-00200) 

Medicaid Fraud Control Units (MFCUs) investigate and prosecute Medicaid provider fraud and patient abuse or neglect. OIG is the Federal agency that oversees and annually approves federal funding for MFCUs through a recertification process. This new report analyzed the statistical data on annual case outcomes—such as convictions, civil settlements and judgments, and recoveries—that the 53 MFCUs submitted for Fiscal Year 2023.  New York data is as follows:

Outcomes

  • Investigations1 - 556
  • Indicted/Charged - 9
  • Convictions - 8
  • Civil Settlements/Judgments - 28
  • Recoveries2 - $73,204,518

Resources

  • MFCU Expenditures3 - $55,964,293
  • Staff on Board4 - 257

1Investigations are defined as the total number of open investigations at the end of the fiscal year.

2Recoveries are defined as the amount of money that defendants are required to pay as a result of a settlement, judgment, or prefiling settlement in criminal and civil cases and may not reflect actual collections.  Recoveries may involve cases that include participation by other Federal and State agencies.

3MFCU and Medicaid Expenditures include both State and Federal expenditures.

4Staff on Board is defined as the total number of staff employed by the Unit at the end of the fiscal year.

Read the Full Report

View the Statistical Chart

Engage with the Interactive Map

GAO Issues Report on Medicaid Managed Care Service Denials and Appeal Outcomes

The United States Government Accountability Office (GAO) has issued a report on federal use of state data on Medicaid managed care service denials and appeal outcomes.  GAO found that federal oversight is limited because it doesn't require states to report on Medicaid managed care service denials or appeal outcomes and there has not been much progress on plans to analyze and make the data publicly available.  To read the GAO report on federal use of state data on Medicaid managed care service denials and appeal outcomes, use the first link below.  To read GAO highlights of the report on federal use of state data on Medicaid managed care service denials and appeal outcomes, use the second link below.
https://www.gao.gov/assets/d24106627.pdf  (GAO report on federal use of state data on Medicaid managed care service denials and appeal outcomes)
https://www.gao.gov/assets/d24106627_high.pdf  (GAO highlights on federal use of state data on Medicaid managed care service denials and appeal outcomes)

CMS Issues Latest Medicare Regulatory Activities Update

The Centers for Medicare and Medicaid Services (CMS) has issued its latest update on its regulatory activities in the Medicare program.  While dentistry is only minimally connected to the Medicare program, Medicare drives the majority of health care policies and insurance reimbursement policies throughout the country.  Therefore, it always pays to keep a close eye on what CMS is doing in Medicare.  To read the latest CMS update on its regulatory activities in Medicare, use the link below.
https://www.cms.gov/training-education/medicare-learning-network/newsletter/2024-03-14-mlnc