Girl with post Kala Azar Dermal Leishmaniasis, a recurrent but non-fatal form of Kala Azar that affects 5-10 per cent of patients between six months to three years after cure. Photograph by Matthew Smeal
Press release |

US Congressional Committee advances legislation that fails to fix FDA PRV program for neglected diseases

Photograph by Matthew Smeal
Girl with post Kala Azar Dermal Leishmaniasis, a recurrent but non-fatal form of Kala Azar that affects 5-10 per cent of patients between six months to three years after cure. Photograph by Matthew Smeal

House Energy and Commerce Committee advances, without fixing key problems, legislation on program intended to incentivize new drugs and vaccines to fight neglected diseases

New York, 8 June 2017 — This week, the US House’s Energy and Commerce Committee passed legislation that fails to fix the Food and Drug Administration’s Priority Review Voucher (PRV) program for neglected diseases. An amendment included in the FDA Reauthorization Act (FDARA) of 2017 makes changes to the neglected disease PRV program, but it doesn’t fix the major problems that prevent it from working the way it was intended. This version of FDARA must still be passed by the House, and a different version of the bill passed the Senate’s Committee on Health, Education, Labor and Pensions (HELP) but has yet to pass the Senate, so there is still an opportunity for lawmakers to fix the program.

Nearly ten years after the program was created and three years after Doctors Without Borders/Médecins Sans Frontières’ (MSF) and other global health groups and innovators first wrote to Congress to ask for key loopholes to be closed, the House bill of the FDARA includes a provision on the PRV program, but this change will not effectively close key loopholes.

Under the neglected disease PRV program, when the FDA approves an eligible neglected disease product, the company that submitted the product application is awarded a voucher. This voucher can be used to accelerate FDA review and approval of any of the companies’ drug or vaccine applications or sold to other drug developers. Pharmaceutical corporations have sold these vouchers for as much as $350 million.

If the incentive worked properly, innovators would be rewarded for bringing forth new neglected disease products and people affected by neglected diseases would benefit from urgently-needed new treatments and vaccines. Unfortunately, we’ve seen time and time again pharmaceutical companies reap the rewards without creating new or affordable products. Due to the way the program’s rules work, a PRV is awarded for simply registering a product in the US; It does not have to be a new product, and the company does not have to ensure that the treatment or vaccine is accessible and affordable for people and medical treatment providers like MSF. In fact, to date, none of the PRVs awarded were given for a treatment or vaccine that is both new and accessible and affordable to everyone, everywhere.

As a neglected disease treatment provider, MSF sees every day the consequences of not having the appropriate tools to fight neglected diseases. Globally, neglected diseases affect more than one billion people, yet despite representing more than a tenth of the global disease burden, barely 4 percent of new treatments and vaccines created were for neglected disease over a decade. By fixing the neglected disease PRV program that has never worked as it was intended to work, lawmakers would better incentivize the creation of new medical tools that people and treatment providers urgently need. “The Energy and Commerce Committee’s passage of this legislation does not align the NTD PRV program with its intent and will not stop the program from being misused. It is disappointing that the changes put forth won’t help ensure that PRVs are only awarded for neglected disease products that are new, accessible and affordable for people affected by neglected diseases and treatment providers like MSF.”

"In order to get a voucher worth hundreds of millions of dollars, companies should have to answer: Does this actually offer something new to people affected by neglected diseases? And how will you ensure it reaches them? It is concerning to see that ten years later, these proposed changes do not address those questions. They may pay lip service to improving the program, but this will not meaningfully reform the program. Congress still has a real opportunity to deliver for neglected disease patients and innovators right now by making effective reforms to the program, and we urge them to take it.”

—Jennifer Reid, MSF’s Access Campaign advocacy and research officer

Read the letter to the US Congress, co-signed by MSF