Preapproval Information Exchange (“PIE”) provides an opportunity for manufacturers to engage with representatives of payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis (“Health Care Decision-Makers”) regarding health care economic information (“HCEI”) related to their investigational (i.e., unapproved) products.
Food and Drug Administration (FDA) regulations generally prohibit preapproval promotion of investigational products. However, FDA’s laws and regulations do permit manufacturer communications with Health Care Decision-Makers regarding HCEI prior to FDA approval of investigational products, so long as manufacturers comply with statutory provisions concerning such discussions. FDA released a Draft Guidance to aid manufacturers with legal and regulatory compliance when delivering HCEI communications in the preapproval context. That Draft Guidance states that manufacturers may communicate truthful and non-misleading information about the product, the indication sought, the patient population included in clinical studies, results of clinical or preclinical studies, the anticipated timeline for FDA approval, product pricing information, certain aspects of marketing strategies, and planned product support programs or services to be offered by the manufacturer. FDA recommends that manufacturers include with HCEI communications a clear statement that the product is investigational and that the safety or effectiveness has not been established. In addition, manufacturers should provide information related to the stage of product development (e.g., clinical trial phase and how the clinical trial phase relates to the overall development plan for the product). FDA stated that communications by manufacturers to Health Care Decision Makers should not represent that an investigational product is FDA-approved or otherwise safe or effective for any use for which the product is under investigation.
AMCP has been working to improve the communication of HCEI related to investigational products to improve planning, budgeting, and decision-making relating to future patient access. AMCP offers manufacturers the opportunity to sponsor PIE programs during AMCP Nexus.
Engagement in PIE interactions at AMCP meetings is subject to the following restrictions:
• It is solely the manufacturer’s responsibility to ensure that all invited attendees meet the statutory requirements for Health Care Decision-Makers and that all PIE comply with FDA law, regulations, and Guidance concerning communication of HCEI related to investigational (i.e., unapproved) products.
• Individuals must comply with applicable federal, state, and local laws, regulations, rules, and ordinances, including but not limited to, the Federal Food, Drug & Cosmetic Act section 502(a) [21 U.S.C. 352(a)], FDA regulations and Guidance, the Health Insurance Portability and Accountability Act of 1996 as amended, including its implementing regulations (collectively, “HIPAA”), and the federal healthcare program anti-kickback statute, 42 U.S.C. § 1320a-7b(b).
• AMCP does not endorse any manufacturer or product, is not involved in the authorization of any PIE participant, and assumes no responsibility for or liability associated with any PIE.