Lance's Corner

FDA Issues Comprehensive Regulatory Update

Jun 6, 2024

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

The latest from FDA

UpdatesPublic health emergency response and other updates from FDA since our last MCMi email include:
More FDA press announcements

HPAI response updates 

Highly pathogenic avian influenza (H5N1) in dairy cows  

Updates on Highly Pathogenic Avian Influenza (HPAI) in dairy cows
In response to requests from the public, on May 21, 2024, FDA published a list of in vitro diagnostic tests (IVDs) that have FDA 510(k) clearance, or granted de novo request, or are authorized for emergency use (EUA), for the detection of influenza in certain specimens from humans. Most tests listed for the detection of seasonal influenza may be capable of detecting influenza A/H5N1, which is a subtype of influenza A. However, only tests specifically designed for subtyping will be able to determine if the person has seasonal flu, or influenza A/H5. Learn more and view the list: Influenza Diagnostic Tests

Recent updates from FDA and our federal partners:

Additional information from FDA and our federal partners:

Consumer information on milk safety from FDA:

 

FDA reorganization update

FDA's reorganization approved for establishing Human Foods Program, new model for field operations and other modernization efforts

FDA reached a significant milestone with approval of its reorganization involving the creation of a unified Human Foods Program (HFP), adoption of a new model for its field operations and other significant modernization efforts. The reorganization implementation is currently targeted for October 1, 2024, notably enhancing the agency’s ability to oversee and protect the human food supply and other products the FDA regulates. 

As noted in a previous announcement, the reorganization will establish an Office of the Chief Medical Officer (OCMO) in the Office of the Commissioner to strengthen central coordination of cross-agency medical issues, including special populations such as people with rare diseases and children. This includes a new Office of Public Health Preparedness and Response to support medical countermeasure policy, emergency preparedness work and medical product shortage coordination across the agency.

The Office of Counterterrorism and Emerging Threats (OCET) and the Office of Regulatory Science and Innovation (ORSI) will merge to form a new office; both offices are currently housed within FDA’s Office of the Chief Scientist (OCS). This new merged office in OCS, proposed as the Office of Regulatory and Emerging Science, will strengthen support of regulatory science and preparedness research efforts.

A full list of the changes can be found in the Federal Register notice. (May 30, 2024)

Emergency Use Authorization (EUA) updates

Emergency Use Authorization (EUA)

Recent new EUAs

Additional information about these EUAs can be found at: In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2 
  • 5/8/2024: Speedy Swab Rapid COVID-19 + Flu A&B Antigen Test (Watmind USA)

EUA revocations

FDA revoked the following EUA for the reasons noted in the revocation letter (PDF): 

EUA quick links

Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens - July 30 - August 1, 2024

 

Events

More events: FDA Meetings, Conferences and Workshops

Information for industry and health care providers

Guidance and updates for industry

FDA issues platform technology guidance to increase drug development efficiency
On May 28, 2024, FDA issued the Platform Technology Designation Program for Drug Development draft guidance.

The platform technology designation program was added to the Federal Food, Drug, and Cosmetic Act by the PREVENT Pandemics Act. This program is intended to result in efficiencies in drug or biological product development, manufacturing, and review processes for drugs and biological products incorporating designated platform technologies. Submit comments by July 29, 2024

Compass representing FDA guidance

Updated FDA safety communication: Evaluating plastic syringes made in China for device failures

On May 23, 2024, FDA announced that Medline Industries, LP, a firm marketing and distributing plastic syringes made in China within the U.S., initiated a recall to stop using affected products which includes unauthorized plastic syringes made in China. Additionally, FDA announced that Jiangsu Shenli Medical Production Co. Ltd, a China-based manufacturer of plastic syringes, initiated a recall to stop using its unauthorized plastic syringes. On June 3, 2024, FDA announced additional recalls. The FDA recommendations have not changed. FDA will continue efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available.

Reminder: Seeking input on clinical research terminology glossary

On May 6, 2024, FDA and NIH published a request for information (RFI) seeking public comments on a proposed glossary of clinical research terminology. This glossary is intended to facilitate communication within the clinical research community by helping establish a common vocabulary to more uniformly characterize clinical research. FDA and NIH identified and developed definitions for 37 terms related to innovative clinical study designs. The public comment period will be open through June 24, 2024

Expiration Date Extension

Expiration date extension

You can find information about shelf-life extensions of COVID-19 vaccines, therapeutics, and in vitro diagnostic (IVD) tests, and other medical countermeasures, on our web page: Expiration Dating Extension, under MCM Expiration Dating Extensions. Recent extension:
  • On May 28, 2024, FDA granted an extension (PDF) of the shelf-life of lot #96867 of the FDA-approved Jynneos vaccine. FDA is extending the expiration date of a single lot of Jynneos (lot #96867), from 4 weeks to 8 weeks when kept +2°C to +8°C after thawing. This expiration is consistent with the expiration of lots of Jynneos used under EUA and distributed by the Strategic National Stockpile (SNS). The lots of authorized Jynneos that have been distributed by SNS and have an 8-week expiry after thawing can be found at: SNS Products: Vaccines and Treatment Available for Use in the Mpox Response (HHS).
Visit At-Home OTC COVID-19 Diagnostic Tests and At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions for more information about expiration date extensions of at-home COVID-19 tests.

In case you missed it

MCMi program update FY 2021
Researching FDA
Join FDA on a journey into the heart of regulatory science, where innovation meets safety, and research drives policy decisions. At FDA, we're committed to advancing science for the benefit of society. This video series showcases our groundbreaking regulatory science work.

Q&A with FDA podcast (CE available)
Q&A with FDA podcast
In this podcast series, FDA’s Division of Drug Information answers some of the most commonly asked questions received by FDA. Previous episodes include conversations about drug shortages, expanded access, avoiding medication scams, and much more.

COVID-19 resources 112px
Quick COVID-19 resources

Frequently Asked Questions
What happens to EUAs when a public health emergency ends? There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ.

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