Senate HELP Committee Fails to Fix Flawed PRV Program Intended to Promote Innovation for Neglected Diseases

Manu Brabo

New York— A Senate committee voted today to add Zika to the list of diseases eligible for the US Federal Drug Administration (FDA) Priority Review Voucher (PRV) program for neglected diseases, but did not fix major loopholes that make the PRV program for neglected diseases ripe for abuse by pharmaceutical companies. The vote, by the US Senate Committee on Health, Education, Labor & Pensions (HELP), means that any company that successfully registers a treatment or vaccine for the disease is one step closer to receiving a voucher that allows the company to accelerate the FDA review of a subsequent product. The Priority Review Voucher was intended to create incentives to develop medicines and vaccines for neglected diseases and patients. Unfortunately, lawmakers have refused to close a loophole in the PRV that has been abused by companies. As a result, the PRV is rewarding companies without helping to stimulate development of urgently needed new products for neglected diseases and make them available and affordable for patients.

In its current form, a company can receive a PRV for simply registering a product in the US; it does not have to be a new product and it does not have to ensure that treatment is accessible and affordable to patients and medical treatment providers. In fact, instead of using these vouchers to motivate companies to bring lifesaving new medicines and vaccines to market, they’re being sold to the highest bidder, diluting the value of the incentive for innovation and leaving people in communities across the world to fend for themselves. The last PRV sold had a price tag of $350 million, which is three and a half times the total amount of money USAID committed to neglected tropical diseases in fiscal year 2015.

“When we faced the deadliest Ebola epidemic ever, Doctors Without Borders was trying to treat patients virtually empty-handed. Nearly two years later, the global health community is facing another epidemic, Zika, without safe and effective vaccines or treatments to help patients. Ebola should have taught us not just about the urgent need for research for neglected diseases, but also that people in affected communities must have affordable access to any new treatments or vaccines that are developed. By adding Zika to the list for which companies can receive a PRV without first ensuring that the program rewards true innovation and that the people most in need benefit from any scientific breakthrough, we are repeating our mistakes. Our lawmakers must stand up and mandate that pharmaceutical companies only receive this reward for new innovations that are available and affordable for patients and treatment providers.

While MSF is not currently treating Zika patients, when there finally is a medical breakthrough, we need assurance that we can access the vaccines and medicines we need to help those who are suffering, regardless of whether or not they’re the people who will benefit the company’s bottom line.”

Jason Cone, Doctors Without Borders/Médecins Sans Frontières (MSF) USA Executive Director 

MSF recently sent a letter with several other organizations to HELP leadership urging them to ensure the PRV program only rewards new innovation and affordable products.

A patient with TB shows the pills for his treatment in a prison in Donetsk, Ukraine, where MSF is helping to treat patients infected with TB. MSF has been running a TB treatment program within the penitentiary system in Donetsk since 2011.
Manu Brabo