[Ip-health] Stat News: In bid to lower prices, Gottlieb says FDA will take new action to speed approval of biosimilars

Thiru Balasubramaniam thiru at keionline.org
Wed Mar 28 08:15:34 PDT 2018



In bid to lower prices, Gottlieb says FDA will take new action to speed
approval of biosimilars

By ADAM FEUERSTEIN @adamfeuerstein

MARCH 28, 2018

FDA Commissioner Scott Gottlieb is interviewed by CNBC's Meg Tirrell.

NEW YORK — Scott Gottlieb, the commissioner of the Food and Drug
Administration, is a free-market proponent in a fervently anti-regulatory
administration who is trying to lower drug prices by expanding the
regulatory reach of the agency.

Speaking Wednesday at CNBC’s Healthy Returns conference, Gottlieb
criticized branded drug companies, distributors, and pharmacy benefit
managers for practices that reduce competition and restrict market access
to generic drugs, including biosimilars.

The FDA cannot regulate drug prices, but the agency is enacting new
policies to speed the testing and approval of generic drugs, which in turn,
should lead to lower overall drug prices.

“We can bring more competition to the market,” said Gottlieb.

As an example, Gottlieb said the FDA will be introducing new initiatives to
make it easier for makers of biosimilars to demonstrate that their products
are equivalent to the branded biologics they seek to compete against.

“There is no silver bullet here that will make the biosimilar market go
gangbusters. It’s going to be a slow build. The policies we’re introducing
will move the ball in that direction,” he said.

But even if more biosimilars are approved, market access is still often
artificially restricted by the rebate schemes between branded biologic
makers and PBMs, Gottlieb said. He used the term “kickbacks,” then laughed.

Gottlieb took over as FDA commissioner in May 2017. Coming up on his
one-year anniversary, he called the FDA “one of the highest-performing
agencies in Washington” that has accomplished a lot of the objectives he
set out to implement when he took the job.

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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