A Biotech’s Guide to FDA’s 2016 Agenda

February 17, 2016 Peter J. Pitts



It is often said that the FDA loves ambiguity – because it gives the agency unlimited authority.  As a former regulator, I know that’s true. However, what’s more important to the men and women of the FDA is to be an innovation accelerator. And that means the agency has to lead through … clarity.

That wish is apparent when you study the FDA’s recently released 2016 Guidance Agenda, which outlines what the agency views as its top priorities for 2016.

The document is worth perusing in its entirety, but to save you some time, I have assembled what I view as some of the more interesting items for biotechs to watch.

The Debate Over Off-label Communication

Manufacturer Communications Regarding Unapproved, Unlicensed, or Uncleared Uses of Approved, Licensed, or Cleared Human Drugs, Biologics, Animal Drugs and Medical Devices.

Why should this be of interest to the biotech industry? Well, if you have a product on the market or under development that has applications beyond its (current or potential) FDA label – you should be paying very close attention.

The New Gold Standard

Adaptive Design Clinical Trials for Drugs and Biologics; Revised Draft

Meta-Analysis of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biologic Products

Multiple Endpoints in Clinical Trials

Let’s face it. Big, expensive randomized clinical trials may have been the gold standard for 20th-century blockbusters, but in today’s world of precision medicine, genomics presents many opportunities for smaller, more adaptive protocols. And that can potentially mean smaller, subpopulation trials. Sound interesting?

For the Biosimilar Brotherhood, Three Things to Consider

Considerations in Demonstrating Interchangeability With a Reference Product

Labeling for Biosimilar Products

Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

Now that we’re living in a world with US biosimilars for filgrastim and infliximab, how will the agency’s thinking on issues ranging from extrapolation to post-market surveillance evolve?  And what will this mean for both innovators and biosimilar manufacturers? Market-share is waiting.

The Evolution of Discussing Risk Information

Presenting Risk Information in Prescription Drugs and Medical Devices Promotion; Revised Draft

Postmarketing Safety Reporting for Human Drugs and Biological Products Including Vaccines

What you say can and will be held against you – and what you don’t say may cause you even more problems. Since the FDA formed its new Super Office of Pharmaceutical Quality, post-marketing safety and surveillance are taking on a far more robust place in the regulatory spectrum. Are you ready?

What’s on CDER’s list is interesting … as well as what is not.

2016 is going to be an exciting year. Let's talk.

Be sure to check out all of the YourEncore Thought Leadership blog for more stories on the biopharma and biotech industries.

Peter J. Pitts  is an authority on global regulatory policy issues and an Executive Partner at YourEncore. He is a former FDA Associate Commissioner, the Chief Regulatory Officer for Adherent Health Strategies, and the President of the Center for Medicine in the Public Interest, a policy institute he founded in 2004.

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