Amarin Corp Plc (AMRN)

[Biobillionair]

Significant comment to FDA free speech policy by Academy of Managed Care Pharmacy:
https://www.regulations.gov/document?D=FDA-2016-D-1307-0017
http://www.amcp.org/

Population health decision makers are organizations and entities that bear financial risk and are responsible for the care of large populations of patients, such as payers, provider sponsored health plans, pharmacy benefit managers, accountable care organizations, and integrated delivery networks. Population health decision makers are extremely sophisticated recipients of health care economic information (HCEI) as they have the education,training, and expertise to critically analyze and evaluate HCEI for credibility and relevance to the patient populations they serve. Enabling communications matters to population health decision makers because they are charged with evaluating the totality of evidence for a particular medication or disease state and then applying
that body of evidence to best care for the patients they serve. In the current legal and regulatory framework,
population health decision makers are significantly restricted to accessing information based on unsolicited requests only, which is a very cumbersome process that hinders access to comprehensive, accurate, and reliable information about treatments before and after FDA approval. Therefore, population health decision makers need access to better and timelier information from biopharmaceutical manufacturers so they can have access to available HCEI to best care for the patients they serve.







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