FDA commissioner to drug middlemen: You're part of the problem

(Ref: CNBC)
  • FDA Commissioner Scott Gottlieb chided pharmacy benefit managers as "complacent participants" in schemes to block the availability of biosimilars, CNBC reported Thursday.

  • Gottlieb noted that restrictive agreements between pharmacy benefit managers and drugmakers in many cases can deter coverage and reimbursement for biosimilars.

  • "While such schemes may have the immediate impact of reducing the costs of these therapies, the net result is a lopsided playing field that disincentives biosimilar developers from making the sizable investment in bringing such products to market," Gottlieb remarked, adding "I am concerned this will lead to reduced competition in the long-run and unsustainable costs for these treatments."

  • "Many of these practices persist because high list prices enable lucrative returns across the drug supply chain as the spread between list and net price is carved up and shared among participants," Gottlieb said, continuing "it's easier to log profits this quarter than to think about what the market will look like in two years' time or five."

  • A Pharmaceutical Care Management Association spokesman stated "pharmacy benefit managers have long been strong supporters of bipartisan legislation that would prevent brand drug manufacturer abuses of risk evaluation and mitigation strategies that block generic competition.

  • Meanwhile, Gottlieb applauded firms that have promised to pass drug rebates directly to some members, commenting "I hope that other insurers, employers and manufacturers follow their lead."

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