Sometimes the best laid plans are upended when you least expect it!
In mid-January, the FDA released draft guidance to facilitate the sharing of information between biopharmaceutical companies and population health decision makers. To say we were pleasantly surprised is an understatement. We had designated this issue as one of our top advocacy priorities for 2017, and were prepared to work hard throughout the year to convince FDA officials and lawmakers of the need to issue guidance.
And now our plans have shifted, but we are not complaining! We have a starting point to make the case that the draft provisions should be finalized to provide the clarity we need.
The draft guidance, issued Jan. 18, largely mirrors consensus recommendations that AMCP developed during two multi-stakeholder meetings last year on the sharing of information on marketed and pipeline products. And we’re proud to note it comes only a few short weeks after we issued our last set of recommendations.
The long-awaited guidance — some components nearly 20 years in the making — clarifies how manufacturers and decision makers can proactively share clinical and economic information on marketed products, as well as on therapies awaiting FDA approval. It specifies clearly what types of information may be shared, with whom and under what conditions. This is crucial because laws and regulations have long placed high barriers on the sharing of any information that is not contained in an FDA-approved label.
But times have changed. Today’s pace of innovation, along with the high costs of many specialty medications, compels decision makers to take an earlier and deeper look at the value of new medicines.
That is why this guidance is so important. It gives decision makers access to information they need to make better coverage decisions for millions of Americans. And it gives manufacturers the confidence they need to initiate the sharing of information.
That was the clarion call that came out of AMCP’s first partnership forum: FDAMA Section 114—Improving the Exchange of Health Care Economic Data. Section 114 of the 1997 Food and Drug Administration Modernization Act (FDAMA) was designed as regulatory safe harbor for dissemination of information, but was little used due ambiguity in its wording and lack of implementing guidance. The guidance adopted many of the forum’s recommendations.
Additionally, the guidance for the first time provides assurances around the proactive exchange of information on products before FDA approval. We’re delighted that this section of the guidance includes many of the recommendations by AMCP’s second stakeholder partnership forum: Enabling the Exchange of Clinical and Economic Information Pre-FDA Approval. The clarification here will help decision makers develop more accurate financial forecasts around the overall benefit, and expedite coverage decisions immediately upon FDA approval, particularly for emerging therapies granted breakthrough designation.
Academy members and other stakeholders have been waiting for this guidance on post-approval communications for a long time. AMCP members raised this issue as a particular concern last year, and asked us to take action. We were happy to do so. And whether the guidance was expedited as part of the Obama Administration’s final flurry of activity, we are glad it has finally arrived. We also firmly believe this guidance is on sound footing, and will be upheld by the Trump Administration.
AMCP is proud to have taken the lead on this issue. In the coming year, we will work to ensure the guidance is understood and adopted by stakeholders throughout managed care pharmacy arena. I’d like to give my staff a well-deserved pat on the back for the hard work in making this happen.
The FDA draft guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers,” is available http://bit.ly/2jnFU1O. AMCP’s consensus recommendations were published in AMCP’s Journal of Managed Care & Specialty Pharmacy. Read recommendations on marketed products at http://bit.ly/2jzMUef, and PIE at http://bit.ly/2jjjkHv.