All I want for Christmas is ...

Dear Santa:

I’ve been a good policy wonk this year, so here’s my FDA wish list for 2016 …

·      Thoughtful guidance on differential nomenclature for biosimilars that recognizes that “similar” doesn’t mean “identical” and prioritizes the need for savvy pharmacovigilance

·      Further agency thinking on biosimilar label extrapolation

·      Physician notification x 50 states, Puerto Rico, and the District of Columbia (not under FDA authority -- but since we're on the subject)

·      21^st century bioequivalence written guidance for generic drugs (including tighter ranges for narrow therapeutic index medicines and critical dose drugs)

·      A super effort from the FDA’s new Super Office of Pharmaceutical Quality

·      Aggressive intramural efforts on biomarker development and validation

·      A first quarter meeting on off-label communications

·      Smart efforts on abuse-deterrent opioid PROs

·      Next-step traction for Patient-Centered Drug Development

·      More attention to combination products

·      And IVDs

·      Continued sophisticated thinking (from management) – and action (on the Division level) on adaptive clinical trials

·      Completion of the Generic Labeling Rule

·      Better oversight of compounding pharmacies

·      And drug shortages

·      For-real updating of the PMA and 510k processes

·      Continued sanity on drug importation

·      And medical mobile apps and social media

·      Sharper teeth on dietary supplements

·      21^st Century Cures legislation with both mandates and budget

·      A standardized benefit/risk analysis grid

·      Wider lanes on expedited pathways

·      A potent PDUFA that recognizes that FDA resides at the center of the precision medicine ecosystem.

·      A potent PDUFA that doesn’t use “fast and clean” as it’s sole metric for success.

·      A swift, positive vote for Rob Califf

And Santa, this is only a partial list.