Full article view2017-09-21T12:08:00+00:00
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PHE's ESGC Provides Critical Support to New Legislation, FDA Guidelines

 

Congratulations to Precision Health Economics, and in particular the Evidence Strategy, Generation, and Communication (ESGC) practice group, for their outstanding efforts in support of the development of new legislation and FDA guidelines allowing biopharmaceutical manufacturers to more proactively share clinical and economic information with population health decision-makers on emerging therapies.

ESGC scientists, along with Precision Health Economics scientific advisor Peter Neumann, co-authored two proceedings recently published in the Journal of Managed Care Pharmacy that summarized consensus reached from two Academy of Managed Care Pharmacy (AMCP)-sponsored partnership forums. The multistakeholder consensus recommendations developed during this forum led directly to Kentucky Representative Brett Guthrie’s April 6 introduction of the Pharmaceutical Information Exchange (PIE) Act of 2017 (H.R. 2026).

The AMCP forum also facilitated a special sign-on letter initiative, endorsed by numerous population health decision makers, biopharmaceutical and medical device manufacturers, patient advocacy groups, healthcare providers, and health economists, recently submitted to the FDA in support of more proactive sharing of healthcare economic information. In addition, the letter urged the FDA to expeditiously finalize the draft guidance clarifying FDAMA Section 114, providing the means to operationalize proactive communications.

Precision would like to recognize ESGC and Dr. Neumann, as well as executive sponsor Larry Blandford from Precision for Value, for their contributions to the improvement of communication between biopharmaceutical and medical device manufacturers and population health decision makers, moving the US healthcare system closer to a value-based focus and the promotion of better outcomes for patients.

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.

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