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Sep 12, 2019 10:40 AM ET

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

iCrowd Newswire - Sep 12, 2019

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 In January 2017, the FDA released draft guidance for public comment to explain its thinking around the amended language, which generated significant interest from both the life sciences and managed care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Significant changes from the draft guidance (January 2017) to the final guidance (June 2018) include:

While the guidance provides additional clarity not found in the draft guidance, it lacks clarity and definition in a few key areas including a key contention point on scientific exchange versus promotional activity – what, why, how, when,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.



Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends, and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit

For information about hosting a webinar visit


Nima Rajan

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

Email: [email protected]

Contact Information:

Nima Rajan

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

[email protected]

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