Lance's Corner

FDA Issues Health Care Stakeholders Update

Dec 9, 2024

The United States Food and Drug Administration (FDA) has issued its weekly regulatory update for stakeholders.  You can read the FDA regulatory update for stakeholders below.

new weekly update bannerDecember 9, 2024

Dear Colleague, 

The FDA works to safeguard the public against potential health risks, ensures the safety and efficacy of medical products, and the safety of our nation’s food supply and cosmetics. The Public Engagement Staff is responsible for engaging, educating and communicating with external partners including patients, caregivers, health care providers, consumers, academia and trade associations on the agency’s policy priorities. We also recognize the invaluable work of our external partners in achieving these goals. Your partnership, knowledge and engagement in the public health space are appreciated. 

Sincerely,

The Public Engagement Staff
Public Engagement Staff | FDA

Updates

Spotlight!

FDA’s New Chapter | FDA In Your Day Ep. 17
FDAIYD Ep 17

Recently, the FDA completed one of its largest transformations, impacting almost every part of the agency. This installment of FDA In Your Day highlights two of the many examples of the important work the FDA is doing every day to keep us safe!

Consumer Updates

Keep Your Dogs and Cats Safe From Holiday Hazards

Holiday Hazards graphic

Happy holidays? Not if your pet gets sick. The Food and Drug Administration’s Center for Veterinary Medicine discusses some unhealthy holiday temptations and how to keep your pets safe.

FDA Voices

Youth Tobacco Product Use Continues to Decline as FDA Actions Build Momentum

Youth tobacco graphic

By: Dr. Brian King, Director of FDA’s Center for Tobacco Products

Brian KingAs Director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), I often reflect on conversations with the public, including the people behind tobacco product use statistics. This type of reflection started in the early days of my career when I answered calls for a tobacco quit line. On a daily basis, I spoke with people who had a desire to quit smoking. Each had a different reason for wanting to quit: living to meet their grandchildren, walking their child down the wedding aisle, or taking a dream vacation with their spouse. While their reasons varied, they had heartbreaking similarities – a deep desire to be there for their families and to celebrate life’s precious moments with the ones they love.

Guidance Documents

Draft Guidance for Industry: Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions

CVM GFI #49 Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis

Accelerated Approval – Expedited Program for Serious Conditions

Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry

View all Official FDA Guidance Documents and other Regulatory Guidance

You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

ICYMI!

Primary Care Providers Can Prescribe with Confidence

Graphic 2

An estimated 5.7 million people over the age of 12 have an opioid use disorder (OUD) in the United States. Based on that prevalence, if you are a primary care provider it is very likely that you already provide medical care to people who also have OUD.

Webinars and Virtual Workshops

NIH-FDA Nutrition Regulatory Science Workshop

December 17 - 18, 2024; 1 - 2 p.m. ET

The U.S. continues to face high rates of morbidity and mortality from diet-related diseases. The U.S. Food and Drug Administration (FDA) uses evidence-based approaches to help advance nutrition and support healthier dietary patterns in the U.S. However, critical research gaps and limited awareness of research resources related to nutrition regulatory science remain. The National Institutes of Health (NIH) has invested in a wide range of nutrition-related initiatives, research resources, and infrastructure that could be leveraged and augmented to further inform FDA efforts and benefit public health.

Webinar on Allergen Labeling for Retail Food Stores and Food Service Establishments

December 18, 2024; 2:00 - 2:45 p.m. ET

Labeling errors associated with undeclared allergens are one of the leading causes of food recalls in the U.S. Therefore, it is important for industry, including retail food stores and food service establishments, to follow FDA’s food allergen labeling requirements. This webinar is intended to help industry better understand and comply with these requirements.

View Upcoming FDA Meetings, Conferences and Workshops

Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts

About Us

The Public Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, patients and patient advocacy organizations, consumer groups, trade associations, think tanks and academia, and other interested parties, in order to better inform our policy making process, identify policy hurdles or misconceptions, and create strategic collaborations. For more information, please contact us at: PublicEngagement@fda.hhs.gov. For patient specific inquiries, please contact us at: Patients Ask FDA.

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