Slightly More “Granularity”: On The Pending 21st Century Cures Act — Likely To Be Signed By President Obama

life-fda-12-07-16-act My sincere thanks go out to my (long-time) anonymous commenter, over the weekend. I will (in a future, more fulsome reply) offer a little more detail on what the Senate is likely to pass — and the outgoing President is likely to sign into law, before he leaves office. At the moment, I’ll highlight a part of it that addresses long-simmering industry grumblings about FDA hints of enforcement, on additional discussions about any item not already on the approved drug’s labeling. [But in my view, that doesn’t (necessarily) make it all bad — of itself.]

I will — as I indicated in comment replies — withhold my section by section critique and analysis, until we have a better sense of “what else” the incoming Administration might have in mind as to FDA matters, more broadly. [And as if to specifically make my current reticence prescient, Merck and Pfizer are each off over two per cent on the NYSE this morning — due to Trump hawkish tweets, on US drug pricing. So we will hold our fire, until an actual Administration exists, and begins to outline policy priorities.] In the mean-time, this Hogan Lovells explainer provides a nice “middle of the fairway” summary of what the bill is — and isn’t — about:

. . . .The bill does not, however, shed light on the uncertainty that has swirled around the meaning of “competent and reliable scientific evidence”, nor does the bill instruct FDA to issue guidance to clarify this and other aspects of the safe harbor provisions. Other potential areas of ambiguity are the factors for determining whether or not HCEI “relates to” an FDA-approved indication, and whether or not there are any “material differences” between HCEI and a product’s FDA-approved labeling. Determinations of relatedness and materiality can be inherently subjective and without further guidance from FDA, manufacturers may be inclined to over-disclaim or to hold back from utilizing the expanded safe harbor until the Agency’s interpretation of these provisions becomes more clear through enforcement actions or otherwise.

Finally, these provisions do not address certain points that many stakeholders had sought. For example, the exclusion of analyses relating solely to an unapproved indication seems to foreclose the ability to engage in HCEI discussions about pipeline products prior to approval. Also, the proposed audiences for HCEI appear to preclude manufacturers from proactively discussing HCEI with certain entities (such as ACOs, IDNs, or groups developing treatment pathways or guidelines) that often factor economics into their decision-making, but do not make “coverage or reimbursement decisions” per se. . . .

Now you know. We will — as ever — keep a weather-eye, on the horizon here — for additional pings/news.



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