Lance's Corner

FDA Issues Health Care Stakeholders Update

Feb 2, 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.

FDA Stakeholder Update Banner

February 2, 2024

Dear Colleague,

While the FDA continues to focus on protecting the public’s health, using science to guide our decisions, and facilitating access to critical medical products, we also recognize the work of our public health partners. As public health advocates, we know that your work to better our country is invaluable. Your partnership, knowledge and engagement in the public health space are appreciated.

 

Updates

Spotlight!

FDA Celebrates Black History Month!

FDA Celebrates Black History Month February 2024

Alma LeVant Hayden's Contribution to Regulatory Science

A remarkable but unsung leader, Alma LeVant Hayden played a pivotal role in advancing FDA's drug analysis capabilities in the 1950s and 1960s. An expert in spectrophotometry and chromatography, she helped to implement these techniques in FDA's drug review and enforcement work, modernizing the agency's scientific techniques at a critical time in the agency's growth and amidst revolutionary changes in federal drug regulation.

 

Consumer Updates

Don’t Overuse Acetaminophen

Man taking medicine; woman reading drug label

You have flu symptoms, so you’ve been getting some relief by taking a cough and flu medicine every few hours. Late in the day, you have a headache and think about grabbing a couple of acetaminophen tablets (Tylenol, paracetamol and panadol) to treat the pain. Stop right there.

 

Guidance Documents

Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products

The purpose of this guidance is to provide FDA’s expectations for, and recommendations on, use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical studies and clinical trials for FDA-regulated medical products.

Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products

This guidance is intended to assist sponsors, including industry and academic sponsors, developing CAR T cell products. In this guidance, we, FDA, provide CAR T cell specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, and clinical study design.

Human Gene Therapy Products Incorporating Human Genome Editing

In this guidance, we, FDA, are providing recommendations to sponsors developing human gene therapy products incorporating genome editing (GE) of human somatic cells. Specifically, this guidance provides recommendations regarding information that should be provided in an Investigational New Drug (IND) application in order to assess the safety and quality of the investigational GE product, as required in Title 21 of the Code of Federal Regulations 312.23 (21 CFR 312.23).

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!

10 Facts about What FDA Does and Does Not Approve

10 Facts About What FDA Does.jpg

Is It Really "FDA Approved"? Maybe you’ve seen these words on a company’s website or in a commercial promoting a product or treatment. Here are some facts about products that are, and aren’t, FDA approved.

Fact #1: Generic medicines work the same as brand-name medicines.

FDA-approved generic medicines provide the same clinical benefit and risks as their brand-name counterparts. A generic medicine is required to be the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, quality, and administration.

Fact #2: Vitamins, minerals, herbs, and other dietary supplements are NOT FDA-approved to treat or prevent disease.

If a supplement promises a cure or quick fix for a health problem, it may be too good to be true.

 

Webinars and Virtual Workshops

FDA Rare Disease Day 2024

March 1, 2024; 9 a.m. - 4:30 p.m. ET

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This year’s Rare Disease Day is dedicated to patients and health care professionals. Panels will discuss:

  • The legal framework for approving studies and medical products at FDA
  • What FDA does during review processes to approve medical products
  • Decentralized clinical trials and digital health technologies
  • Where to find important information and documents related to clinical trials
  • Information that can be obtained from medical product labels
  • Legal and ethical requirements for consent forms in clinical trials
  • FDA initiatives to advance medical product development for rare diseases
  • Ways for patients to engage with FDA

 

Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice

March 5, 2024; 9 a.m. - 3:30 p.m. ET

This meeting is being conducted to meet the performance goal of convening a public workshop on complex innovative design (CID) included in the seventh authorization of the Prescription Drug User Fee Act (PDUFA VII).

The purpose of this public workshop is to facilitate discussion on the use of external data sources, Bayesian statistical methods, and simulations in complex innovative trial designs as well as trial implementation.

 

Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes

March 7, 2024; 1 - 2:30 p.m. ET

This webinar will discuss how and when to work with FDA to improve your integrated safety analyses and obtain answers to questions you may have about your application. In addition, common mistakes seen in integrated analyses will be discussed to help you avoid making the same mistakes.

 

FDA CBER Webinar: Considerations for the Development of CAR T Cell Products

March 7, 2024; 1 - 2 p.m. ET

The FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual public webinar to discuss a recently finalized guidance document on considerations for the development of Chimeric Antigen Receptor (CAR) T cell products. This guidance is intended to assist industry and academic sponsors that are developing ex vivo-manufactured CAR T cell products.

 

View Upcoming FDA Meetings, Conferences and Workshops
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts

About Us

The Stakeholder 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, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations. For more information, please contact us at: FDAStakeholderEngagement@fda.hhs.gov.

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