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# Easier Ways of Sharing Pharmacoeconomic Info Urged
- URL: https://www.fdaweb.com/easier-ways-of-sharing-pharmacoeconomic-info-urged/
- Published: 2016-03-08T12:00:00.000Z
- Updated: 2026-09-15T02:41:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135002

> Health care stakeholders participating in an Academy of Managed Care Pharmacy (AMCP) forum reached agreement on recommendations to make it easier for pharmaceutical companies to share pharmacoeconomic information with health care organizations that make coverage decisions. The forum was held 3/1-2 in Washington, DC, and sought to clarify Section 114 of the 1997 FDA Modernization Act (FDAMA). The stakeholders acknowledged that the “nearly 20-year-old law has been underutilized due to uncertainty and lack of guidance from the FDA.”  
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> Forum participants representing drug companies, managed care organizations, academia, health care providers and patient advocates agreed to include the following recommendations to the agency for inclusion in guidance on FDAMA Section 114 that is expected later this year:  
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> Dissemination of information under Section 114 should be expanded to health care decision makers beyond health plan formulary committees, including those making coverage decisions in accountable care organizations and integrated delivery networks, as well as organizations that evaluate pharmacoeconomic information or develop value frameworks and compendia. Such information must be truthful and non-misleading, and be based on the expertise of professionals in the relevant area. It also must be derived and disclosed in a transparent, reproducible and accurate manner. This recommendation stems from a Section 114 requirement that a company support healthcare pharmacoeconomic information with “competent and reliable scientific evidence,” not the stricter “substantial evidence” standard required for drug approval. The lower standard has never been fully defined.  
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> Participants also discussed the types of information, format and processes by which managed care pharmacy and other health care decision-makers seek to receive pharmacoeconomic information from manufacturers. Additionally, they encouraged FDA, Congress and other stakeholders to find ways that will ensure patients have appropriate access to a full range of information about their medications, and that information related to the medication pipeline is communicated to appropriate stakeholders in a timely manner.   
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> The proceedings at the forum are scheduled to be published in the July issue of AMCP's *Journal of Managed Care & Specialty Pharmacy*. AMCP says it will develop a draft guidance document that it will present to the agency.