The U.S. Senate has failed to remedy serious loopholes within the PRV program for neglected diseases, leaving the law open to abuse from pharmaceutical companies throughout the nation and the world.
Even though the Senate added the Zika virus to a list of illnesses that qualify for the U.S. Federal Drug Administration (FDA) Priority Review Voucher (PRV), the law needs fixed to fully allow innovation against Zika virus infections.
“When we faced the deadliest Ebola epidemic ever, Doctors Without Borders was trying to treat patients virtually empty-handed,” Judit Sanjuan, Doctors Without Borders/Médecins Sans Frontières’ (MSF) U.S. access campaign manager and legal policy advisor, said. “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.”
The vote allows companies to register vaccines or treatments for a disease. After registration, the companies are closer to being approved for a voucher to speed the FDA’s evaluation of products. This can be done without proving that the new product is an innovation to prevent or treat the disease.
The goal of the PRV was to develop incentives that would help researchers create vaccines and treatments for neglected patients and diseases. In contrast, now the PRV gives incentives to companies that do not show innovation for new products that are desperately needed for neglected illnesses; the PRV goes to the highest bidder rather than the best innovator.
"As this bill now moves to the U.S. House, our government representatives must take this opportunity to immediately fix the critical flaws with the program,” Sanjuan said. “They must ensure that companies rewarded with a voucher are actually creating new products that are available and affordable to patients and treatment providers. This program should help people suffering from fatal neglected diseases, instead of companies just looking to rake in huge profits.”