Communicating healthcare economic and preapproval information. Section 114 of the food and drug administration modernization act fdama of 1997 it defines health care economic information as an analysis that identifies, measures or compares the economic consequences of the use of the drug to the use of another drug, another health care intervention, or no intervention. The fdas regulation of health economic information. Manufacturer communications with payors, formulary. The food and drug administration modernization act of 1997 fdama 114 was congress first attempt at creating a safe harbor for promotional claims supported by something less than substantial evidence. Clarity on how pharmaceutical companies can communicate. Other factors, such as growth in communication of health economic information through dossier submissions to formulary committees in response to unsolicited requests, may have also played a. Home health fda official offers interpretation of fdama 114 standard for health care economic information hcei.
Amcp seeks an end to 20 years of confusion over fdama section 114. Meanwhile, section 114 of the fda modernization act fdama 114 sets different parameters for how health economic evidence may presented to payers. The fda was responding in part to a provision in the 21st century cures act that congress passed in december. Section 3037 aimed to clarify several ambiguous statements in an effort to eliminate barriers to the proactive dissemination of healthcare economic information hcei for approved products by manufacturers. This act is related to the regulation of food, drugs, devices, and biological products by the fda. Us fda modernization act, section 114 springerlink. The value of prefda approval healthcare economic information. Under the fda modernization act of 1997 fdama, certain healthcare economic information is permitted to be distributed by pharmaceutical manufacturers to defined categories of managed care decision makers 1. A 20yearold part of legislation, section 114 of the food and drug administration modernization act of 1997 fdama,5 represents the primary regulatory. The communication of health care economic information. The impact of legislative changes and regulatory guidance on. User attitudes towards fdamas section 114 on health care economic information. Fda official offers interpretation of fdama 114 standard for health care economic information hcei dr. The fdas regulation of health economic information health.
The exchange of health care economic information hcei is vital in todays changing health care. This is a limited, but potentially important exception that has some potential relation to cer. Cea registry center for the evaluation of value and risk in. Administration modernization act of 1997 fdama public law 105115 and section 3037 of the 21st century cures act public law 114255, includes the following provision regarding communication. These changes were made in order to recognize the changes in the way the fda would be operating in the 21st century. Posted on june 6th, 2012 by fda official offers interpretation of fdama 114 standard for health care economic information hcei dr.
Section 114 of the food and drug administration modernization act of 1997 fdama was specifically designed to allow companies to more readily disseminate health care economic information hcei to those who need it for formulary decision. Fda official offers interpretation of fdama 114 standard. Did fdama section 114 lead to a decline of economiccontent drug advertising in medical journals. User attitudes towards fdama s section 114 on health care economic information. Proactive communications about medical products between. Greater clarity is important given demands by payers and other stakeholders for evidence of value. Amcp forum issues recommendations for fda guidance on fdama section 114 diverse stakeholders seek broader dissemination of health economic information to. Jul 09, 2015 section 114 of the food and drug administration modernization act fdama of 1997 it defines health care economic information as an analysis that identifies, measures or compares the economic consequences of the use of the drug to the use of another drug, another health care intervention, or no intervention. Health care economic information this draft guidance on communication of hcei, released in january 2017, aimed to clarify fdama section 114, which was passed nearly 20 years earlier to facilitate hcei exchange. Break in the silence around fdama section 114 springerlink. Administration modernization act of 1997 fdama public law 105115 and section 3037 of the 21st century cures act public law 114 255, includes the following provision regarding communication. Drugsguidancecomplianceregulatoryinformationguidancesucm537347.
Preapproval communication of health care economic info to. Definition from fdama 114 real world evidence information derived from real life experience for disease states, drugs, or. Did fdama section 114 lead to a decline of economic content drug advertising in medical journals. Such communication is governed by section 114 of the food and drug modernization act fdama, which stipulates that health economic information provided under these circumstances shall not be considered false or misleading if it directly relates to an indication approved and is based on competent and reliable scientific evidence rather. Us food and drug administration modernization act of 1997, pub l no. This guidance provides answers to common questions regarding firms communication of health care economic information hcei regarding. We conducted a webbased survey of a convenience sample of 35 outcomes directors of major. Fdama 114 finally, fdama 114 allows manufacturers to provide healthcare economic information not in labeling to formulary committees and similar entities. Opportunities following the 21st century cures act and fda guidance. Overview of the key provisions of the 21st century cures act. Jan 23, 2017 industry and related stakeholders have been waiting for this guidance since 1997, when congress first enacted section 114 of the food and drug administration modernization act fdama, which created a safe harbor for proactive manufacturer communication of health care economic information based on competent and reliable evidence, if such. Section 114 of the 1997 us fda modernization act fdama is an important vehicle for pharmaceutical companies to promote the economic value of their drugs to formulary decision makers, but little is known about how the section has been interpreted and used.
Frontiers communicating healthcare economic and pre. Drug and device manufacturer communications with payors. Section 114 of the food and drug administration modernization act of 1997 fdama was specifically designed to allow companies to more readily disseminate health care economic information hcei to those who need it for formulary decision making. Industry and related stakeholders have been waiting for this guidance since 1997, when congress first enacted section 114 of the food and drug administration modernization act fdama, which created a safe harbor for proactive manufacturer communication of health care economic information based on competent and reliable evidence, if such. Fdama section 114 health care economic information health care economic information provided to a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for selection of drugs for managed care or other. Real world evidence panel introductions and implications to.
Fda clarifies that hcei pertains to the economic consequences related to the clinical. Health care economic information and its impact on valuebased. Food and drug administration modernization act of 1997. During president clintons second term, congress passed the food and drug administration modernization act fdama. Definition from fdama 114 real world evidence information derived from real life experience for disease states, drugs, or therapies. Amcp forum issues recommendations for fda guidance on fdama. The impact of legislative changes and regulatory guidance. Fda official offers interpretation of fdama 114 standard for. The fdas regulation of health economic information health affairs. You also will consider whether fdama 114, or other areas of existing laws and regulations, should be expanded to provide pharmacoeconomic information to additional entities, including payers, health care providers, patient advocacy groups and organizations that develop value frameworks. Food and drug administration modernization act of 1997 section 114 fdama 114 provides guidance on proactively communicating health care economic information hcei to payers, formulary committees, and similar entities. The united states food and drug administration modernization act of 1997 fdama amended the federal food, drug, and cosmetic act. Amcp seeks an end to 20 years of confusion over fdama.
The frequency of economiccontent advertising in medical journals has declined somewhat in recent years, possibly spurred by section 114 of fdama. Improving the exchange of pharamcoeconomic information. Fda actions against health economic promotions, 20022011. The frequency of economic content advertising in medical journals has declined somewhat in recent years, possibly spurred by section 114 of fdama. Robert temple, cders deputy director of clinical science, recently presented slides at a meeting of the national pharmaceutical council on potential uses for comparative effectiveness research.
Us fda modernization act, section 114 strategic evidence. Robert temple, cders deputy director of clinical science, recently presented slides at a meeting of the national pharmaceutical council on. Health care economic information includes revisions to fdama sect. Section 114 of the fdama states health care economic information provided to a formulary committee, or other similar entity, in the course of carrying out its responsibilities for the selection of drugs for managed care or other similar organizations, shall not be considered to be false ormisleading y if the healthcare economic. A 20yearold part of legislation, section 114 of the food and drug administration modernization act of 1997 fdama,5 represents the primary regulatory structure for how drug manufacturers can distribute and use pharmacoeconomic information in the promotion of their drugs. Niyazov a and lenci d 2018 communicating healthcare economic and preapproval information with healthcare decisionmakers. Amcp forum issues recommendations for fda guidance on.
Information program on clinical trials for serious or lifethreatening diseases. Preapproval information exchange december152016 final. Section 114 of the food and drug administration modernization act of 1997 fdama was specifically designed to allow companies to more readily disseminate health care economic information hcei. Modifies fdama section 114 fda subsequently issued draft guidance regarding communication with payors. Under the fda modernization act of 1997 fdama, certain health. Communication of health care economic information hcei to payors regarding approved drugs under.
Article information including the type of intervention evaluated, the country of the analysis, the funding source, information regarding methodology including whether the article correctly calculated incremental costutility ratios, the analytic time horizon and analytic perspective and more. The fda regulates the use of information by biopharmaceutical companies in their promotional activities. Amcp forum issues recommendations for fda guidance on fdama section 114 diverse stakeholders seek broader dissemination of health economic information to meet payer, provider, and patient needs. But what will be permitted in the new environment remains unclear. We conducted a webbased survey of a convenience sample of 35 outcomes directors of major pharmaceutical and. Among other things, that law enabled prescription drug manufacturers to provide information about the economic consequences of using their products to certain groups of people while meeting. During this session, health care economic information hcei will be looked at in relation to fdama 114, the 21st century cures act, and the potential changes to the law that may occur under the current administration. Fda releases draft guidance on drug and device manufacturer. The statute provides that certain healthcare economic information hcei shall not be considered false and misleading if. The goal of fdama 114 was to facilitate the exchange of hcei between. Section 114 of the food and drug administration modernization act of 1997 regulates the promotion of health economic information by pharmaceutical companies to us health plans.