FDA Commissioner cites “Kabuki drug-pricing constraints”

In a conference by a leading U.S. health insurer lobbying group (America’s Health Insurance Plans, AHIP), US FDA Commissioner Scott Gottlieb, M.D. criticized “Kabuki drug-pricing constructs” that profit industry at the expense of consumers.  He stated “Patients shouldn’t face exorbitant out-of-pocket costs, and pay money where the primary purpose is to help subsidize rebates paid to a long list of supply chain intermediaries,” . “Sick people aren’t supposed to be subsidizing the healthy.”  Much of the cash flow in patient payments for prescription pharmaceuticals is not disclosed to either patients or physicians, as described in my 2016 article, “What determines how much your patient pays for their medication in the United States” in the American Journal of Ophthalmology.  Note that current U.S. law does not allow the FDA to consider drug pricing in their regulatory actions.  However, FDA’s actions may affect pricing – e.g., speed of review and approval of generic marketing applications (Abbreviated New Drug Applications).

The role of compounding pharmacies for topical ocular medications

There’s a lot of talk and confusion of the issues involved in the role of compounding pharmacies for topical ocular medications (eyedrops).  Please see this interview in EyeWorld in which I am interviewed about regulatory issues.  I address the special role which compounding pharmacies have played in the therapeutic process as physicians tailor therapies to individual patients.  At the same time, I discuss the issues in the use of compounding pharmacies for larger populations crossing state lines.

NDA Partners Quantitative Drug Development Strategies Practice

I’m pleased to be part of NDA Partners Quantitative Drug Development Strategies Practice – providing drug development guidance to Sponsors.

Together with other senior industry and regulatory consultants, we will be providing expertise in quantitative clinical pharmacology, the application of Bayesian approaches in biostatistics and clinical trial design, and clinical trial modeling and simulation.   NDA Partners will support the design and execution of clinical trials that can accelerate development programs and that produce high-quality regulatory packages containing the data needed to secure regulatory approval without delays.