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Event: AMPC Partnership Form, FDAMA 114: Improving the Exchange of Pharmacoeconomic Data

Date: March 01, 2016 – March 02, 2016
Location: Marriott Marquis, Washington, D.C.

Precision for Value is excited to be leading a presentation at the upcoming AMCP Partnership Forum, FDAMA 114: Improving the Exchange of Pharmacoeconomic Data, to be held March 1-2, 2016 at the Marriott Marquis in Washington, DC.

A number of efforts have attempted to clarify Section 114 of the Food and Drug Modernization Act of 1997 (FDAMA 114), which regulates promotion of health economic data by pharmaceutical companies to managed care decision makers – such as a claim that a drug reduces healthcare costs in a given population. Most recently, new legislation was drafted – The 21st Century Cures Act – that accelerates the development of new medical treatments. It also features a section that amends FDAMA 114 with the aim of providing clear guidance for industry in their communications with payers.

AMCP is holding a Partnership Forum specifically to discuss FDAMA 114 and the evolving FDA guidance on how health economic information is to be presented to payers. Since many of Precision’s thought leaders are former payers and health economists, we understand the payer landscape. AMCP turned to Precision for Value to help structure the event, set the agenda, and recruit speakers.

The invitation-only event will help obtain consensus on how data should be developed, exchanged, and disseminated among payers and manufacturers. Recommendations will be presented to the FDA to provide guidance on regulations. In addition, recommendations will be made on whether or not FDAMA 114 should be expanded to provide information beyond payers.

On March 1, 2016 from 11:15 am to noon, Christopher Blanchette, PhD, MBA, Vice President, Evidence Strategy, Precision for Value will lead a panel discussion, What is Pharmacoeconomic Information Under FDAMA 114?

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.