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).
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