Jeffrey Gruenglas, Executive Vice President, Oncology Business Unit

In the wake of the passing of the 21st Century Cures Act last December, Food and Drug Administration (FDA) released several guidance documents aimed at providing manufacturers with expanded regulatory latitude for product-related communications and promotion. With mounting pressure from industry and advocacy to expedite market approval of new therapies, FDA’s efforts signals a leaning to release or minimize regulatory restrictions that in the past have restricted the ability of manufacturers to promote products. New guidances now reveal a willingness of FDA to relax its position on certain statutory provisions, but not without clearly defined parameters.

Market forces and political dynamics have played critical roles in the development and release of the new guidance documents. The two documents (“Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities” and “Medical Product Communications That Are Consistent With the FDA-Required Labeling”) reflect historical and recent legal challenges by manufacturers in drug and product communication to customers such as healthcare providers and payers. They further account for mounting pressure from the public and those challenging commercial free speech based on First Amendment protections.

The Value of Healthcare Economic Information

Communication of healthcare economic information (HCEI) now takes a front row in arming manufacturers with claims-based analyses for investigational (i.e. pre-market approval) products. This is not entirely new terrain for FDA; guidance points to the agency’s perceived value of quantifying clinical outcomes for formulary decision makers prior to availability of drug in the market. This mirrors provisions of the Cures Act, which grants FDA authority to allow HCEI in its review as “any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences…” As a result, development of medical policies can subsequently facilitate access of therapy for their members. HCEI carries import for the non-clinician who plays an instrumental role in the supply chain of healthcare delivery—inclusive of influencers at commercial and government plans, integrated delivery networks, and hospital systems.

As anticipated, with allowance comes restrictions. FDA guidance outlines a panoply of criteria for acceptable usage of HCEI. These include considerations in study design and methodology: type of analysis, modeling technique, patient population, perspective/viewpoint, treatment comparator, time horizon, outcome measures, cost estimates, and assumptions. Additionally, FDA suggests that economic-related analyses highlight limiting factors that may account for generalizability of the data.

Consistent with but Not Included in Product Labelling

Another equally significant shift for FDA stems from manufacturers seeking to communicate product claims not explicitly contained within labeling, but that are still “related” to the label. Historically, FDA has set clear guidance on product claims that fall outside the confines of the approved label, issuing warnings that state misbranding of product through false or misleading information. Under new consideration is the agency’s evaluation of such claims insofar as they are substantiated and supported by required levels and types of evidence of safety and effectiveness. Further, FDA signals its inclination to assess clinical benefit and utility though a risk-benefit evaluation. Sponsors will be expected to include any unfavorable or inconsistent finds related to the product. The agency will continue to engage the public and industry but it ensure that the standard remains rooted in competent and reliable scientific evidence.

This recent guidance signals an inflection point in FDA’s trajectory of shaping regulation for product communications. But all compasses are bound to change direction by competing forces. It remains to be seen whether forthcoming executive policy and legislative actions will have the gravitational pull to alter forward progress.

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