[Ip-health] Senators Alexander and Harkin to introduce bill expanding the priority review voucher to Ebola

Jamie Love james.love at keionline.org
Wed Oct 29 07:24:34 PDT 2014


We have written to Senator Alexander's staff, telling them

"We would like to see language in the bill that required an applicant for
the PRV to disclose (1) what they invested in the new treatment (2) how
much it will cost and (3) how much they received in consideration if they
transferred the PRV to a third party."

Here is the Senator's press release.


http://www.help.senate.gov/newsroom/press/release/?id=fe1d1c2f-7e7c-4bdc-8c7f-4c939db7dbbf

Harkin, Alexander Will Introduce Bipartisan Bill to Speed Development of
Ebola Treatments

Tuesday, October 28, 2014Liz Wolgemuth 202-224-8584

WASHINGTON, D.C. —Today, Senator Tom Harkin (D-IA), Chairman of the Senate
Health, Education, Labor, and Pensions (HELP) Committee, and Ranking Member
Lamar Alexander (R-TN) announced their intention to introduce a bill to
speed the development of treatments and vaccines for Ebola by adding Ebola
to FDA’s priority review “voucher” program, a program at the Food and Drug
Administration (FDA) designed to incentivize the development of new drugs
for neglected tropical diseases. Currently Ebola is not listed as a
qualifying tropical disease. The Harkin-Alexander bill, which will be
introduced when Congress reconvenes, will seek to add Ebola as a qualifying
disease under the program.

“In Iowa and around the country, families are counting on their leaders to
ensure the U.S. is taking every step possible to contain Ebola and keep
Americans healthy and safe. To help accomplish this, I plan to introduce a
bill that will help FDA incentivize the development of new Ebola
treatments,” Harkin said. “When enacted, as I hope it will be, this
legislation will strengthen our response to Ebola and help innovators to
continue their work to develop Ebola treatments and vaccines. I urge my
colleagues to join me in passing this bill and continuing to invest in the
public health agencies on the frontlines of the U.S. response to Ebola.”

“The world is in desperate need of a vaccine to prevent Ebola and a drug to
treat it,”  Alexander said. “This bill will help fight Ebola with a tool
that encourages the development of necessary but unprofitable
drugs—offering a reward for drug makers who invest the time and resources
to develop drugs to treat, and hopefully cure, Ebola.”

The bill would add Ebola to FDA’s priority review voucher program, which
Congress first authorized in 2007 to promote the development of new
treatments and vaccines for neglected tropical diseases. Under the program,
a developer of a treatment for a qualifying tropical disease receives a
voucher for FDA priority review to be used with a second product of its
choice, or this voucher can be sold.

However, Ebola is not considered a qualifying disease under current law, so
developers of Ebola treatments and vaccines currently do not qualify for
the program. This bill would change that and immediately add Ebola to the
program – a step that should be taken given that we need our full arsenal
of tools at work.

On September 16, Senator Harkin convened a joint hearing entitled “Ebola in
West Africa: A Global Challenge and Public Health Threat,” as chair of both
the HELP Committee and the Labor-HHS Appropriations Subcommittee. This
joint hearing was the first hearing in the U.S. Senate regarding Ebola.

Alexander has hosted two Ebola fact-finding roundtables in Memphis and
Nashville and will hold a third event Friday in Chattanooga to learn more
about the threat of the epidemic and Tennessee preparedness.

###

-- 
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love



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