US Lawmakers Fail to Fix Flawed PRV Program Intended to Promote New Medicines for Neglected Diseases

Key House subcommittee examined bill today that amends neglected disease innovation incentive program without fixing loopholes abused by pharmaceutical corporations

Today the US House’s Energy and Commerce Subcommittee on Health considered changes to the Food and Drug Administration’s Priority Review Voucher (PRV) program for neglected diseases without fixing major problems that prevent it from working the way it was intended. The PRV program was created to incentivize the research and development of new medicines for some of the world’s most neglected diseases, but it has yet to lead to any products that are both new and accessible for people affected by neglected diseases. Congress has had multiple opportunities to make urgently needed changes the PRV program but has consistently failed to do so.

Under the PRV program, a company that introduces an eligible neglected disease product is awarded a voucher, which they can then use to accelerate FDA review of any of their drugs or vaccines. They can also choose to sell their voucher to other companies, as has been done for as much as $350 million.

If the incentive worked properly, drug developers would be rewarded for bringing to market new vaccines and medicines and people affected by neglected diseases would benefit from new products. However, a company can receive a PRV 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 to people and medical treatment providers like Doctors Without Borders/Médecins Sans Frontières (MSF).

“Once again, US Congress is choosing to protect pharmaceutical corporations and others that reap huge rewards without offering new vaccines and medicines to tackle some of the world’s most neglected diseases. Today’s hearing of the Lower Drug Costs through Competition Act is yet another missed opportunity to make sure that companies only get a PRV for products that are new, accessible and affordable for treatment providers like MSF and people affected by neglected diseases.

“When we faced the deadliest Ebola epidemic ever, Doctors Without Borders was trying to treat patients virtually empty-handed. Unfortunately, this situation is all too familiar for our doctors and staff on the ground. Without fixing the program so it only rewards the creation of new and affordable products, we have no assurance that companies that get PRVs are contributing anything new for the treatment of neglected disease or that any vaccine or medicine they create will actually reach those who need it most.

“It’s critical that lawmakers stand up and seize this opportunity to fix the PRV program before it’s too late.”

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