Industry Analysis: Impact of FDA's Recent Guidance on Payer Communications, New Webinar Hosted by Xtalks

TORONTO, July 17, 2018 (Newswire.com) - 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 In January 2017, the FDA released draft guidance for public comment to explain its thinking around the amended language, which generated significant interest from both the life sciences and managed care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 voiced 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Significant changes from the draft guidance (January 2017) to the final guidance (June 2018) include: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While the guidance provides additional clarity not found in the draft guidance, it lacks clarity and definition in a few key areas including a key contention point on scientific exchange versus promotional activity – what, why, how, when, to/by whom, etc.

Industry experts from ICON Nathan White, CPC, Senior Vice President of Integrated Access and Outcomes Solutions Access, Commercialisation and Communications and Sean P. Wagner, MPH, Senior Vice President of Strategic and Client Services, US Market Access & Reimbursement, will explore how manufacturers can successfully implement this guidance and integrate these new communication channels with payers.

This live webinar upcoming on Monday, July 23, 2018, at 10 a.m. EDT (3 p.m. BST/UK) 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 labeling in medical communications
• Challenges with the promotional versus scientific exchange debate
• Key opportunities and considerations for industry

For more information about this complimentary webinar visit: Industry Analysis: Impact of FDA’s Recent Guidance on Payer Communications.

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Contact:

Nima Rajan

Tel: +1 (416) 977-6555 ext 352

Email: [email protected]

Source: Xtalks