JULY 19, 2018
WASHINGTON
— The Trump administration is opening up the door to importing prescription
drugs — at least in a limited number of cases.
The
administration said Thursday that the Department of Health and Human Services
will form a working group to look at the idea of importing drugs from other countries in
cases in which there is a dramatic price increase for a drug produced by one
manufacturer and not protected by patents or exclusivities.
And
although the announcement was cast as an early step, health secretary Alex Azar
left little doubt the administration planned to eventually approve a
significant policy change.
“I told the FDA commissioner, I said, ‘I
insist that you find a pathway to make this happen,'” he said in an interview
on the Fox Business Network. “I believe we can do it in a way that is safe,
effective, leading to results, and that preserves innovation. So make it happen
and make it happen quickly.”
The
proposal is one of the boldest the administration has yet floated as it has
laid out a series of ways to bring down the cost of prescription drugs.
Although President Trump said on the campaign trail that he supports importing
drugs from other countries as a way to lower prices for Americans, the notion
has traditionally been more popular among Democrats. Independent Sen. Bernie
Sanders of Vermont, the former presidential candidate, is one of its most vocal
proponents.
Most
Republican policymakers, however — including Azar himself — have long been
opposed to the idea on the grounds that it could jeopardize patient safety.
But Azar
said Thursday there are situations where importation could make sense. He
pointed to Turing Pharmaceuticals’ 2015 decision to
raise the price of the drug Daraprim by more than 5,000 percent, the dramatic
spike that made then-CEO Martin Shkreli a household name.
“Safe,
select avenues for importation could be one of the answers to these challenges.
When HHS released the President’s Blueprint for putting American patients
first, I said we are open to all potential solutions — assuming they are
effective, safe for patients, and respect choice, innovation, and access,” Azar
said in a statement.
The
administration emphasized in its announcement that the proposal will not apply
to a broader category of drugs, the way some legislative proposals have. Broad
importation would “raise additional questions about how to protect American
patients,” HHS said.
In his
own statement, the commissioner of the Food and Drug Administration, Scott
Gottlieb, emphasized just how “narrow” the conditions for such importation
might be.
“Any
policy that involves the importation of drugs would be temporary until adequate
competition enters these categories,” he said. “Furthermore, any resulting
policy would also be narrowly tailored in order not to create the same risks of
counterfeits or other unsafe drugs getting into the U.S. supply chain as a
broader importation policy would present.”
He added
that the administration’s ultimate goal is to have multiple FDA-approved
versions of each medically important drug, and that the working group will
search for a policy that “facilitates near term access, while safeguarding the
incentives that support a safe, stable and high-quality drug supply over the
long term.”
Both
brand and generic drug makers were quick to criticize the idea. The trade group
PhRMA called it a “scheme” that would “circumvent the robust safety
requirements we have in United States, posing a serious public health risk and
jeopardizing our secure medicine system.”
BIO also
lambasted the proposal, saying it was a “dangerous approach that would
undermine the integrity and safety of the American drug supply.”
“It also
offers illusory savings, as the government itself has repeatedly acknowledged,”
the group’s president and CEO, Jim Greenwood, said in a statement. “We will
work to ensure that any HHS actions on importation do not endanger patients or
import foreign price controls on American innovation.”
The
Association for Accessible Medicines, which lobbies for generic manufacturers,
said the policy idea “will not solve the underlying under-reimbursement issues”
for generic drugs.
https://www.statnews.com/2018/07/19/with-a-new-working-group-hhs-opens-door-to-possibility-of-importing-some-drugs/?itx[idio]=8812325&ito=792&itq=d65acd22-4eab-4101-bb20-fdd71be964db
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