Is FDAMA Section 114 Finally Ready for Prime Time?

Information is the life blood of managed care pharmacy. Of the “competent and reliable scientific” variety, that is.

Our profession operates best when we have broad access to the latest evidence-based data on the multitude of products coming to market today. We can plan, we can assess. With this information, managed care pharmacy professionals can help health care providers and patients select the right drug for the right patient at the right time, while making appropriate use of our scarce health care dollars.

In fact, this is what we mean by providing “value” in health care: with many new therapeutic innovations coming to market―some very complex and some very expensive―managed care pharmacy identifies and encourages the use of the most effective therapies available and at the best price possible. 

And to drive this value, as I mentioned, we need solid information obtained from a variety of credible sources. This need extends well beyond what is provided on the product label.

That’s why we are encouraging the Food and Drug Administration (FDA) and Congress to take a fresh look at a nearly 20-year-old statute, nicknamed FDAMA 114. Originally aimed at allowing biopharmaceutical companies to more easily share “health care economic information,” or HCEI, about products with entities that make formulary coverage decisions, the law has never lived up to its promise.

Specifically, Section 114 of the 1997 Food and Drug Administration Modernization Act (FDAMA) created a regulatory safe harbor for the dissemination of HCEI to formulary decision makers. Why a safe harbor? Because HCEI typically is not included within the FDA-approved labeling, and the agency prohibits manufacturers from distributing such information (unless specifically requested). 

Section 114, however, has been little used because of ambiguity in its wording and lack of implementing guidance from the FDA. 

Good news! The FDA announced that it plans to release guidance this year. To help inform the FDA’s current thinking on the issue, AMCP held a diverse stakeholder forum this spring that produced a series of consensus suggestions. Among them:

●  HCEI includes much more than costs, and should encompass such things as health care utilization (e.g., hospitalizations, emergency department visits), patient benefits, adherence, endpoint extrapolations, quality of life, and adverse events. 

●  “Competent and reliable scientific evidence”—which will form the basis of HCEI—should be defined as “truthful and non-misleading tests, analyses, research, studies, models, or other evidence.”

●  HCEI related to a drug in the pipeline should be communicated to appropriate stakeholders 12 to 18 months prior to approval.  

We will share these and other recommendations with Congress and the FDA.

With the U.S. health care system increasingly focused on the concept of providing value, it is essential that pharmaceutical product value is accurately measured and disseminated. These recommendations are a major step forward in removing a barrier that has prevented health care decision makers from obtaining such information.

[Note: The forum proceedings may be found in the July 2016 issue of AMCP’s Journal of Managed Care & Specialty Pharmacy (JMCP). They can be accessed at www.jmcp.org.]