FOR IMMEDIATE RELEASE
July 19, 2018
July 19, 2018
Contact: HHS Press
Office
202-690-6343
media@hhs.gov
202-690-6343
media@hhs.gov
HHS
Secretary Azar Directs FDA to Establish Working Group on Drug Importation to
Address Price Spikes
As part of the Trump
administration’s efforts to lower drug prices and put American patients first,
Health and Human Services Secretary Alex Azar requested today that FDA
Commissioner Scott Gottlieb establish a working group to examine how to safely
import prescription drugs from other countries in the event of a dramatic price
increase for a drug produced by one manufacturer and not protected by patents
or exclusivities.
“We look forward to
working with Commissioner Gottlieb and the FDA to explore how importation could
help address price hikes and supply disruptions that are harming American
patients,” said Secretary Azar. “We have seen a number of both branded and
generic examples in recent years where a single manufacturer dramatically hikes
the price for a drug unprotected by patent or exclusivities. In the 2015 case
of the drug Daraprim, we saw the list price of a drug approved by the FDA in
1953 increase by more than 5,000 percent.
“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.
“Importation may well fit
that bill in some instances. We look forward to working with Commissioner
Gottlieb on this issue, and appreciate the voluminous work FDA has done to
increase competition in America’s drug markets.”
Further Background
Why is the Trump
administration launching this working group?
President Trump and
Secretary Azar have consistently maintained that HHS is willing to
explore allways to tackle the soaring price of drugs while
protecting incentives for innovation and maintaining standards of patient
safety and access. The working group will examine importation of drugs that
have seen significant price increases or significant access challenges for
patients.
How does this compare
with other importation proposals?
This working group will
examine the potential to promote competition for drugs that are off-patent or
off-exclusivity and produced by one manufacturer. This stands in contrast to
proposals to import a broader range of drugs, which raise additional questions
about how to protect American patients.
The working group will
consider drugs unprotected by patents or exclusivities, which will allow other
manufacturers to introduce new competition.
Because the drugs being
considered for importation are off-patent and have no exclusivity remaining,
the proposals contemplated by the working group would not dilute intellectual
property rights or affect incentives for innovation. Rather, they would provide
a new avenue for competition to drive down prices for American patients.
Is safe importation
possible?
The Food and Drug
Administration’s gold standard for safety and effectiveness is unimpeachable,
and will guide the working group’s efforts. Importation will be limited to
cases where drugs can be imported with adequate assurances of safety and
effectiveness.
Putting American
patients first, as President Trump aims to do, means not just delivering lower
prices, but also ensuring that all Americans can expect that the drugs they
purchase are safe and effective.
Haven’t administrations
traditionally rejected proposals like this?
President Trump has
called for action on drug prices, and HHS under Secretary Azar has answered
with aggressive legislative proposals and sweeping potential regulatory reforms
of drug pricing. The Secretary remains committed to receiving input from
stakeholders and will continue to implement the President’s American Patients
First Blueprint. The FDA working group is only one portion of a larger reform
package being coordinated by HHS.
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