[Ip-health] NIH and HHS get 'march-in' request for Astellas' Xtandi

Claire Cassedy claire.cassedy at keionline.org
Thu Jan 14 10:11:41 PST 2016


NIH and HHS get 'march-in' request for Astellas' Xtandi

Feds for the second time this week asked to take extraordinary action

January 14, 2016 | By Emily Wasserman

Less than a week after lawmakers asked the federal officials to take
"extraordinary" action against rising drug prices, the National Institutes
of Health (NIH) and the U.S. Department of Health and Human Services (HHS)
are getting a similar request from a nonprofit and cancer patient group.
The latest target? Astellas' prostate cancer drug, Xtandi.

Washington, DC-based nonprofit Knowledge Ecology International (KEI) and
the Union for Affordable Cancer Treatment (UACT) sent a letter to the NIH,
HHS and U.S. Department of Defense (DOD), urging the NIH to use its
"march-in right" to open up Xtandi to generic competition by using a tactic
that goes around patent protection for drugs developed with federal
funding. The way the organizations see it, prices for Xtandi in the U.S.
are "far higher than any other country in the world, despite the fact that
the critical research benefited from U.S. taxpayer funded grants from the
NIH and DOD," they said in their note.

The Bayh-Dole Act in the Constitution allows the government to adopt a
march-in policy to "protect the public against nonuse and the unreasonable
use of inventions," according to a part of the law cited in the letter. And
Xtandi's high prices in the U.S., as well as its cost to Medicare, should
prompt the agencies to act, KEI and the UACT said.

The move comes a few days after Rep. Lloyd Doggett (D-TX) and a group of
more than 50 members of Congress called upon the NIH to implement similar
measures. In the past, the NIH has said that using march-in rights is an
"extraordinary remedy" that should only be used in extreme situations. But
the recent surge in drug prices justifies this action, the congressional
reps argue. "Too many families and providers are facing an extraordinary
challenge from unreasonably priced pharmaceuticals" and "too many drugs"
are not available to the public at reasonable prices, the lawmakers said.

Still, the NIH is keeping quiet about a potential plan of action. "We can
confirm we received the letter," the agency told FiercePharma in an email
earlier this week. "A response will be sent directly to Members of

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