[Ip-health] The US prize for neglected diseases: the FDA priority review
voucher
James Love
james.love@keionline.org
Tue Apr 22 18:11:31 2008
Given the full page IPI/AUTM ads, g8 statements and the general hysteria
over prizes, it is interesting to note that the US adopted a US prize
program for neglected diseases last year, as a new section 524 of the
FDA act.
Based upon an amendment by Senators Brownback and Brown, the law
provides for a transferable voucher that can be used to obtain an
priority FDA review. The proponents estimate its value may be as much
as $300 million. To get the voucher, you have to register a new drug
for a globally neglected disease, including any of the following:
*Tuberculosis.
* Malaria.
* Blinding trachoma.
* Buruli Ulcer.
* Cholera.
* Dengue.
* Dracunculiasis (guinea-worm disease).
* Fascioliasis.
* Human African trypanosomiasis.
* Leishmaniasis.
* Leprosy.
* Lymphatic filariasis.
* Onchocerciasis.
* Schistosomiasis.
* Soil transmitted helmithiasis.
* Yaws.
* Any other infectious disease for which there is no significant
market in developed nations and that disproportionately affects poor and
marginalized populations.
The sponsors credit the proposal to Henry Grabowski, Jeffrey Moe, and
David Ridley in their 2006 Health Affairs paper: "Developing Drugs for
Developing Countries.
This prize is clearly a "complementary" prize, as it does not require
anything from the company regarding the licensing or prizing of the
invention.
I believe there is some effort to get the FDA to limit the
transferability of the voucher, which would benefit big pharma and hurt
small firms.
Here is some more info:
http://www.fda.gov/oc/initiatives/HR3580.pdf
http://www.bvgh.org/documents/Brownback-BrownanalysisFINAL.pdf
https://www.iavi.org/file.cfm?fid=3D47963
http://brownback.senate.gov/pressapp/record.cfm?id=3D283848
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2007/05/fdara_priority_=
.html
http://content.healthaffairs.org/cgi/data/25/2/313/DC1/1
http://content.healthaffairs.org/cgi/reprint/25/4/1186.pdf
http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=3DbioWorl=
dHeadlines_article&forceid=3D46926
http://healthaffairs.org/blog/2007/10/02/global-health-the-impact-of-a-heal=
th-affairs-paper/
"SEC. 524. Priority review to encourage treatments for tropical
diseases.
"(a) Definitions.=E2=80=94In this section:
"(1) Priority review.=E2=80=94The term =E2=80=98priority review=E2=80=
=99, with respect to
a human drug application as defined in section 735(1), means review and
action by the Secretary on such application not later than 6 months
after receipt by the Secretary of such application, as described in the
Manual of Policies and Procedures of the Food and Drug Administration
and goals identified in the letters described in section 101(c) of the
Food and Drug Administration Amendments Act of 2007.
"(2) Priority review voucher.=E2=80=94The term =E2=80=98priority revi=
ew voucher=E2=80=99
means a voucher issued by the Secretary to the sponsor of a tropical
disease product application that entitles the holder of such voucher to
priority review of a single human drug application submitted under
section 505(b)(1) or section 351 of the Public Health Service Act after
the date of approval of the tropical disease product application.
"(3) Tropical disease.=E2=80=94The term =E2=80=98tropical disease=E2=
=80=99 means any of
the following:
"(A) Tuberculosis.
"(B) Malaria.
"(C) Blinding trachoma.
"(D) Buruli Ulcer.
"(E) Cholera.
"(F) Dengue/dengue haemorrhagic fever.
"(G) Dracunculiasis (guinea-worm disease).
"(H) Fascioliasis.
"(I) Human African trypanosomiasis.
"(J) Leishmaniasis.
"(K) Leprosy.
"(L) Lymphatic filariasis.
"(M) Onchocerciasis.
"(N) Schistosomiasis.
"(O) Soil transmitted helmithiasis.
"(P) Yaws.
"(Q) Any other infectious disease for which there is no
significant market in developed nations and that disproportionately
affects poor and marginalized populations, designated by regulation by
the Secretary.
"(4) Tropical disease product application.=E2=80=94The term =E2=80=98=
tropical
disease product application=E2=80=99 means an application that=E2=80=94
"(A) is a human drug application as defined in section
735(1)=E2=80=94
"(i) for prevention or treatment of a tropical
disease; and
"(ii) the Secretary deems eligible for priority
review;
"(B) is approved after the date of the enactment of the Food
and Drug Administration Amendments Act of 2007, by the Secretary for use
in the prevention, detection, or treatment of a tropical disease; and
"(C) is for a human drug, no active ingredient (including
any ester or salt of the active ingredient) of which has been approved
in any other application under section 505(b)(1) or section 351 of the
Public Health Service Act.
"(b) Priority review voucher.=E2=80=94
"(1) In general.=E2=80=94The Secretary shall award a priority review
voucher to the sponsor of a tropical disease product application upon
approval by the Secretary of such tropical disease product application.
"(2) Transferability.=E2=80=94The sponsor of a tropical disease produ=
ct
that receives a priority review voucher under this section may transfer
(including by sale) the entitlement to such voucher to a sponsor of a
human drug for which an application under section 505(b)(1) or section
351 of the Public Health Service Act will be submitted after the date of
the approval of the tropical disease product application.
"(3) Limitation.=E2=80=94
"(A) No award for prior approved application.=E2=80=94A sponsor=
of a
tropical disease product may not receive a priority review voucher under
this section if the tropical disease product application was submitted
to the Secretary prior to the date of the enactment of this section.
"(B) One-year waiting period.=E2=80=94The Secretary shall issue=
a
priority review voucher to the sponsor of a tropical disease product no
earlier than the date that is 1 year after the date of the enactment of
the Food and Drug Administration Amendments Act of 2007.
"(4) Notification.=E2=80=94The sponsor of a human drug application sh=
all
notify the Secretary not later than 365 days prior to submission of the
human drug application that is the subject of a priority review voucher
of an intent to submit the human drug application, including the date on
which the sponsor intends to submit the application. Such notification
shall be a legally binding commitment to pay for the user fee to be
assessed in accordance with this section.
"(c) Priority review user fee.=E2=80=94
"(1) In general.=E2=80=94The Secretary shall establish a user fee pro=
gram
under which a sponsor of a human drug application that is the subject of
a priority review voucher shall pay to the Secretary a fee determined
under paragraph (2). Such fee shall be in addition to any fee required
to be submitted by the sponsor under chapter VII.
"(2) Fee amount.=E2=80=94The amount of the priority review user fee s=
hall
be determined each fiscal year by the Secretary and based on the average
cost incurred by the agency in the review of a human drug application
subject to priority review in the previous fiscal year.
"(3) Annual fee setting.=E2=80=94The Secretary shall establish, befor=
e the
beginning of each fiscal year beginning after September 30, 2007, for
that fiscal year, the amount of the priority review user fee.
"(4) Payment.=E2=80=94
"(A) In general.=E2=80=94The priority review user fee required =
by
this subsection shall be due upon the submission of a human drug
application under section 505(b)(1) or section 351 of the Public Health
Services Act for which the priority review voucher is used.
"(B) Complete application.=E2=80=94An application described und=
er
subparagraph (A) for which the sponsor requests the use of a priority
review voucher shall be considered incomplete if the fee required by
this subsection and all other applicable user fees are not paid in
accordance with the Secretary=E2=80=99s procedures for paying such fees.
"(C) No waivers, exemptions, reductions, or refunds.=E2=80=94Th=
e
Secretary may not grant a waiver, exemption, reduction, or refund of any
fees due and payable under this section.
"(5) Offsetting collections.=E2=80=94Fees collected pursuant to this
subsection for any fiscal year=E2=80=94
"(A) shall be deposited and credited as offsetting
collections to the account providing appropriations to the Food and Drug
Administration; and
"(B) shall not be collected for any fiscal year except to
the extent provided in advance in appropriation Acts.".
_____________________________
James Love, Knowledge Ecology International (KEI)
http://www.keionline.org, mailto:james.love@keionline.org
voice +1.202.332.2670, fax +1.202.332.2673, US mobile +1.202.361.3040,
Geneva mobile +41.76.413.6584
When everyone thinks the same, no one thinks. Bill Walton remix of
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