At the end of 2022, the Federal Trade Commission (FTC) released its Health Products Compliance Guidance—a blanket overhaul of the 1998 Guidance, Dietary Supplements: An Advertising Guide for Industry. The 2022 Guidance expands its scope to guide advertising practices for “any health-related product,” including dietary supplements, foods, over-the-counter (OTC) drugs, homeopathic products, devices, health equipment, diagnostic tests, and health-related apps” attempts to “correct misunderstandings” and “urban myths” that have circulated about past FTC substantiation standards. Separately, the Federal Drug Administration (FDA) finalized its Drug Products Labeled as Homeopathic guidance document, which explains FDA’s risk-based approach to prioritizing enforcement action for homeopathic drugs that FDA considers to be illegally marketed.  Join the 4A’s and the Coalition for Healthcare Communication (CHC) for insights from Claudia Lewis, Partner at Venable LLP and co-chair of the firm’s FDA Group, on the federal government’s march toward more stringent substantiation and disclosure standards for marketing healthcare products. She’ll provide her expertise to tease out the gaps between the 1998 FTC Guidance and the updated Guidance and explain how the 2022 guidance memorializes decades of case law and FTC enforcement actions. What likely pitfalls might bring an FTC enforcement action alleging an unfair or deceptive practice for healthcare companies in light of this new guidance? How should stakeholders reevaluate their advertising and marketing materials for health-related products to ensure compliance with FTC standards in light of the 2022 guidance?

• Webinar: Thursday,  March 2, 2023 at 11:00 am ET
• Faculty: Claudia Lewis, Partner at Venable LLP and Co-chair of the firm’s FDA Group
• Zoom link to be provided to registrants
• Tuition: FREE for 4A’s and CHC Members

 

REGISTER HERE

  This is a members only, must-attend event for any 4A’s or CHC member operating in the food, supplement, personal care, health equipment or app, or related industries.  ***CHC members should create a 4A's account through the event registration process to access to the event.*** For further information, please contact apepper@4as.org.

Nearly a year into the Biden administration, Dr. Robert Califf has been nominated to return as FDA Commissioner – amidst a continuing pandemic and criticism of recent FDA decisions and messaging. What’s next for the FDA under Dr. Califf’s leadership? Join us for the insights of Nancy Bradish Myers, president of Catalyst Healthcare Consulting and former Senior Strategic Advisor in the FDA Commissioner’s office. Why did President Biden choose Dr. Califf over other candidates? What does his experience in the Obama administration tell us about what he will do in 2022? What is his vision for the FDA, and what will be his key priorities—internally, on COVID-19 reviews, on drug approvals, on regulating promotional messages? Will there be changes in other senior positions? What are White House and Congressional expectations for the FDA?

• Webinar: Friday, Jan 21, 2022, 12-1 p.m. ET 
• Faculty: Nancy Bradish Myers, president, Catalyst Healthcare Consulting
• Zoom link to be provided to registrants
• Tuition: Only $65 (from member companies) or $80 (from non-member companies)
• If uncertain on membership, please see our list of member companies.
• Online registration open now—see below.

Don’t miss this inside look at an agency with profound impact on our industry! For further information, contact jbigelow@cohealthcom.org.  

Tuesday, Feb. 15, 2022, 12 p.m.-1 p.m. ET What were the most surprising aspects of health policy and regulation during the first year of the Biden administration? And what lies ahead for the second year, given the key players, the continuing pandemic, a tightly-divided Congress, and midterm elections that may flip control in one or both houses? Kate Rawson, senior editor of Prevision Policy and one of the most insightful and practical observers of the health policy scene in Washington, will offer the Coalition her well-informed analysis.

• What has – and hasn’t – happened in the congressional effort to limit prescription drug prices
• Strengths and weaknesses in the response to COVID-19
• How the Affordable Care Act expanded – and will it be an election issue?
• Which of Biden’s health officials seem to have real clout?
• Who are today’s key players in Congress on health issues?
• What are Biden’s health priorities this year, for legislation and regulation?
• Will CMS fully allow reimbursement of Aduhelm?
• What preparation has been done for the next pandemic?
• An early look at the midterms—the key healthcare issues

Join us for a practical and informative look at the year ahead!

• Zoom link to be provided to registrants
• Tuition: Only $65 (from member companies) or $80 (from non-member companies)
• If uncertain on membership, please see our list of member companies.
• Online registration open now—see below.

For additional information, please contact Jon Bigelow at jbigelow@cohealthcom.org  

May 12, 2021, 12-1 pm ET Concern is building in Washington over misuse of personal data and risks to privacy. Meanwhile, Virginia just followed California in enacting comprehensive data privacy regulation, and other states are considering their own laws, forcing businesses to deal with different rules in different states.

• What do we need to know about regulations at the state level?
• Is the effort in Congress to craft bipartisan federal regulation still alive? Who are the key players?
• What would such a bill look like – and can it pass in a tightly-divided House and Senate?
• What is the position of President Biden, Vice President (and former California AG) Harris, and their administration?
• What are the implications of federal action – or inaction – for healthcare marketing, advertising, and communications?

Alison Pepper has been following the data privacy issue for years – as executive vice president for Government Relations for the 4As and previously as assistant general counsel for the Interactive Advertising Bureau. Join us for her informed assessment of what’s possible, what’s likely, and what to watch for.

• Zoom link to be provided to registrants
• Tuition: Only $75 (from member companies) or $90 (from non-member companies)
• If uncertain on membership, please see our list of member companies.
• Online registration open now—see below.

Don’t miss this inside look at an issue affecting all healthcare communications! For further information, contact jbigelow@cohealthcom.org.

Friday, June 4, 2021, 12-1 pm ET What happens at the FDA is central to all health marketing and communications, controlling the flow of new drug approvals and regulating what manufacturers may say about their products. The agency has been through unprecedented challenges over the past two years. Now, with a new president and new FDA Commissioner, what’s ahead?

• Why so long a delay in choosing a new Commissioner, especially during a pandemic?
• What are the priorities for the new Commissioner?
• How will CDER change under its new Director?
• After the political battles over COVID-19 approvals, what does Congress expect from the FDA?
• What to look for in the next PDUFA legislation—funding and strategic direction?
• How will lessons of the COVID experience modify FDA operations?

Kate Rawson, senior editor of Prevision Policy, is one of the most insightful and practical observers of the health policy scene in Washington and an expert on the people and policy at the FDA.

• Zoom link to be provided to registrants
• Tuition: Only $75 (from member companies) or $90 (from non-member companies)
• If uncertain on membership, please see our list of member companies.
• Online registration open now—see below.

Join us for this informed assessment of what’s ahead for the FDA in the Biden administration!

Dec. 16, 2020, 12-1 pm ET

The FDA entered 2020 with a new Commissioner, then soon faced unusual scientific challenges—and unprecedented political attacks—as it worked to cope with the COVID-19 pandemic. Yet, even as its credibility took some hits, the FDA has moved forward aggressively to establish a streamlined process for evaluating COVID-19 vaccines and drugs, and is on track to approve a high number of new molecular entities for other indications. What’s next for the FDA under a Biden administration? Join us for the insights of Nancy Bradish Myers, president of Catalyst Healthcare Consulting and former Senior Strategic Advisor in the FDA Commissioner’s office. Who will be the next Commissioner, and what will his or her priorities be? Where will the agency fit in the Biden’s plans to combat COVID-19? What can the FDA do to rebuild its credibility? What lessons does the pandemic hold for the drug approval process? What will be in the next PDUFA legislation?

• Webinar: Wednesday, Dec. 16, 12-1 pm Eastern time
• Faculty: Nancy Bradish Myers, president, Catalyst Healthcare Consulting
• Zoom link to be provided to registrants
• Tuition: Only $75 (from member companies) or $90 (from non-member companies)
• If uncertain on membership, please see our list of member companies.
• Online registration open now—see below.

Don’t miss this inside look at an agency with profound impact on our industry! For further information, contact jbigelow@cohealthcom.org.

Nov. 19, 2020, 12-1 pm ET It has been a bitterly contested 2020 election season, headlined by the COVID-19 pandemic, a steep recession, and a dizzying array of surprises. When the votes are in, what will it all mean? Join us for an expert assessment by Kate Rawson, senior editor of Prevision Policy. She’ll give us an early look at who the key players are likely to be—in a second Trump administration or a first Biden administration and in Congress—and at their likely priorities for legislation and regulation affecting health marketing and communications. Will there be new approaches to controlling the pandemic? What ideas for limiting drug prices are most likely to be implemented? Will a pharma marketing tax be part of the answer to soaring budget deficits? How will the FDA and CDC regain the public’s confidence?

• Webinar: Thursday, Nov. 19, 12-1 pm Eastern time
• Faculty: Kate Rawson, senior editor, Prevision Policy
• Virtual meeting information to be provided to registrants
• Tuition: Only $75 (from member companies) or $90 (from non-member companies)
• If uncertain on membership, please see our list of member companies.
• Online registration open now—see below.

Participants in the Coalition’s Rising Leaders Conferences consistently praise Kate Rawson’s insightful and practical looks at the Washington scene. Don’t miss this post-election update focused on our industry. For further information, contact jbigelow@cohealthcom.org.

The fourth annual Rising Leaders Conference in Washington offered insights on new thinking about how data privacy will be regulated, a report card on the Scott Gottlieb era and the issues facing a new FDA commissioner, an inside look at how social science research affects FDA regulation of prescription drug promotion, the First Amendment issues involved in prescription drug promotion and taxation policy, an early look at the 2020 campaign, key policy priorities for health communications professionals, and a panel of agency CEOs discussing how the policy issues relate to building careers in health communications. The faculty included Kate Rawson (Prevision Policy), Alison Pepper (the 4As), Dr. Kathryn Aikin (FDA), Nancy Bradish Myers (Catalyst Healthcare Consulting), Jim Davidson (the Advertising Coalition), Dan Jaffe (Association of National Advertisers), Kay Holcombe (former FDA and Hill staffer), Sharon Callahan (Omnicom), Wendy Blackburn (Intouch Group), Dr. Karsten Risch (Havas), and Jon Bigelow (Coalition for Healthcare Communication). Slides and videotape from several speakers can be found on our Resources page, and articles on several speakers at our News page.