FDA’s recent guidance provides clarity in communicating health care economic information to payers, but questions remain
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Enacted in late 2016, the 21st Century Cures Act significantly amended the Food and Drug Administration Modernization Act of 1997 (FDAMA) position surrounding communication of health care economic information (HCEI) to payers. In January 2017, the FDA released draft guidance for public comment to explain its thinking around the amended language, which generated significant interest from both the life sciences and managed care industries.
During the public comment period, many stakeholders across the pharmaceutical, medical device, managed care, pharmacy benefit management, and health system sectors submitted questions and voice concerns to be addressed in the final guidance. FDA has now released final guidance to industry, which will need to quickly establish new policies and procedures to maintain compliance with the new regulations.
Significant changes from the draft guidance (January 2017) to the final guidance (June 2018) include:
- Expansion of scope to include investigational products and unapproved uses of approved products
- Inclusion of compliance and adherence studies as an example of HCEI analyses
- Bench tests and detailed examples on ways to present these studies
- Other information that should be communicated about unapproved products/uses
- Details of study details (design, methodology, full findings)
- Disclosure of how the product/use is not approved, and/or a copy of most recent FDA-required label
While the guidance provides additional clarity not found in the draft guidance, it lacks clarity and definition in a few key areas including a key contention point scientific exchange versus promotional activity – what, why, how, when, to/by whom, etc. Our experts will explore how manufacturers can successfully implement this guidance and integrate these new communication channels with payers. This webinar will cover:
- The history of FDAMA section 114 and rationale for amendment legislation
- Differences between the draft and final FDA guidance
- Industry and public concerns and questions
- “CFL guidance” related to consistency of labelling in medical communications
- Challenges with the promotional versus scientific exchange debate
- Key opportunities and considerations for industry
Nathan White, CPC
Senior Vice President, Integrated Access and Outcomes Solutions, ICON
Sean P. Wagner, MPH
Senior Vice President, Strategic and Client Services, US Market Access & Reimbursement, ICON
Pharma, biotech and medical device professionals working in the areas of HEOR, RWE, market access, managed markets, field managed care, medical affairs, scientific communications, legal, or regulatory affairs.