[Ip-health] Health Groups Ask Senate for Changes to FDA Priority Review Voucher Program for Neglected Diseases

Jennifer Reid Jennifer.Reid at newyork.msf.org
Thu Nov 19 13:09:01 PST 2015


Health Groups Ask Senate for Changes to FDA Priority Review Voucher 
Program for Neglected Diseases
November 19, 2015
Program meant to promote research for neglected diseases seriously flawed
On November 17, 2015, Doctors Without Borders/Médecins Sans Frontières 
(MSF), the American Thoracic Society, the Drugs for Neglected Diseases 
initiative (DNDi), the Global Alliance for TB Drug Development, the IDSA 
Center for Global Health Policy, the Sabin Vaccine Institute, and the 
Treatment Action Group sent a letter to the US Senate Committee on Health, 
Education, Labor, and Pensions (HELP) leadership asking for amendments to 
fix critical flaws in the US Food and Drug Administration’s Priority 
Review Voucher (PRV) program for neglected diseases.
The US FDA PRV is supposed to reward innovation for companies that invest 
in research for neglected diseases. Under the program, companies that 
successfully register a product to treat certain neglected diseases are 
rewarded with a voucher that allows them to fast-track any of its products 
or medicines through the crucial FDA review process.
This voucher can be used or sold to another entity, offering an 
accelerated FDA review with a targeted decision time of six months. To 
date, three PRVs for neglected diseases and five PRVs for rare pediatric 
diseases have been issued. Four of these vouchers have been sold, 
increasing in value, with the most recent PRV sold for $350 million in 
August 2015.
In spite of this clear and growing value of the incentive, the program has 
so far failed to ensure that neglected disease medical products are 
appropriately incentivized and are accessible to the patients and health 
care providers who urgently need them.
This is due to two key flaws in the design of the PRV program for 
neglected diseases:
The PRV program should have a novelty requirement. A PRV for neglected 
diseases can still be awarded even when new R&D investments have not been 
made by the entity receiving the award or even when the medical product 
awarded a PRV for neglected diseases is not new.
The PRV program should require an access strategy. The PRV program for 
neglected diseases does not include any mechanism to ensure patients, 
governments and health care providers will have affordable and appropriate 
access to products for which a PRV has been awarded.
As a result, two of three PRVs for neglected diseases were awarded for 
drugs already in use for a long time in other countries, and in some cases 
the products earning a PRV are not affordable or even accessible to the 
people and health care providers who urgently need them.
Now, as the US Senate is preparing to introduce a bill on biomedical R&D 
legislation there is an opportunity to include amendments to this program. 

Click Here to Download the Letter

Jennifer Reid
Researcher, MSF Access Campaign
Doctors Without Borders/Médecins Sans Frontières (MSF)
333 Seventh Avenue, 2nd Floor, New York, NY 10001
Phone:  +1-212-763-5714
Email: jennifer.reid at newyork.msf.org

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