Lance's Corner

FDA Issues Health Care Stakeholders Update

Oct 11, 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 bannerOctober 11, 2024

Dear Public Engagement Colleague,

The FDA continues its efforts in safeguarding the public against potential health risks, through utilizing peer reviewed evidence, and ensuring the safety and efficacy of medical products, we also recognize the invaluable work of our public engagement groups. The Public Engagement Staff will continue to work with our external partners so you can engage with the Office of the Commissioner and other FDA centers on priorities. Your partnership, knowledge and engagement in the public health space are appreciated.

Sincerely,

The Public Engagement Staff

Updates

Guidances 

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.

Webinars and Virtual Workshops

Webinar - Draft Guidance: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle

October 15, 2024; 1 - 2 p.m. ET

When finalized, the guidance Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle is intended to provide recommendations on how patient preferences can be collected and shared with the FDA and be considered in decision-making. The guidance will also outline the types of patient preference studies that can provide reliable scientific evidence.

Registration is not necessary.

Benchmarks for Diversity in Oncology Clinical Trials: An FDA - ACS Hybrid Symposium

October 16, 2024; 8:30 a.m. - 2:45 p.m. ET

The Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) and the American Cancer Society (ACS) are co-sponsoring a symposium focusing on setting benchmarks for diversity in oncology clinical trials.

Global IDMP Implementation - Getting Closer to the Goal

October 16, 2024; 1 - 2:30 p.m. ET

This webinar will present an overview of the end-to-end testing results for the Global Pharmaceutical Product Identification (PhPID) Service operating model, which generates global PhPIDs for marketed medicinal products. The session will detail the model's readiness for deployment, including its software functionality, interoperability, processes, and business rules.

Pazur graphic

FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Pazdur + 25—Celebrating a Silver FDA Anniversary”

October 23, 2024; 2 - 3 p.m. ET

Join previous FDA Commissioners and the FDA Oncology Center of Excellence, in recognizing a quarter century of federal government service by OCE Center Director, Dr. Richard Pazdur. The esteemed panel will highlight the many oncology advances and changes at FDA throughout Dr. Pazdur’s tenure.

Live Biotherapeutic Products to Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants

October 25, 2024; 9 a.m. - 4 p.m. ET

The purpose of the public workshop is to exchange information with the medical and scientific community about the regulatory and scientific issues associated with use of live biotherapeutic products to prevent necrotizing enterocolitis (NEC) in very low birth weight (VLBW) infants.

CBER graphic

Finding Your Support Team While Participating in a Clinical Trial

October 30, 2024; Noon - 1:15 p.m. ET

The webinar will feature a panel of patients, care partners, and advocates discussing the following:

  • Experiences with their own support systems as they or a loved one participated in a clinical trial.
  • Tips on how to navigate logistical challenges, such as travel, when participating in a clinical trial.
  • Where and how to find support from friends and family, health care providers, clinical teams, employers, schools, patient advocacy groups, and other communities.

Informed Consent – More than Just Another Document to Sign?

November 8, 2024; 2 - 3 p.m. ET

This webinar will provide patients and researchers with an overview of FDA’s expectations for informed consent.
The webinar will:

  • Give an update on FDA’s efforts to help improve informed consent materials so that they are more understandable for participants;
  • Recommend how informed consent can be presented in a clear, comprehensible way; and
  • Discuss how revised consent can help individuals make an informed decision on whether to join a clinical trial.

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