The U.S. Food and Drug Administration is backing a fast-track approval process for a drug used to treat Chagas disease, but some say this approval process has a history of making drugs too expensive to help those who need it most.
The California-based company, KaloBios, announced earlier this month that the FDA had given it the green light to use safety and efficacy data from previously conducted studies. If approved, the drug would be eligible for a priority review voucher (PRV) – a step Doctors Without Borders (MSF) said would be “egregious.”
“Awarding KaloBios a PRV for this product would be a complete misuse of the program’s intent and undermine the PRV program’s ability to deliver the new treatments and vaccines people affected by neglected disease and treatment providers like MSF still urgently need,” Jennifer Reid, advocacy and research officer for MSF’s access campaign, told Humanosphere.
MSF estimated the current cost of a single treatment course at around $100, which is already too high a price for many people who need it. If KaloBios is granted a priority review voucher, which companies have been awarded and then sold for hundreds of millions of dollars, the company would be able to sell the drug at any price without having to report on its affordability.
For years, MSF and other health advocates have called on Congress to revise the priority review voucher system to include caveats for affordability, which has been a problem since the program began in 2007. Out of the four products that have been awarded a priority review voucher for neglected diseases, at least three – bedaquiline for tuberculosis, miltefosine for kala azar and Vaxchora for cholera – were for products with access challenges, according to MSF.
The priority review voucher program was created to offer incentives for developers to come up with new drugs for neglected diseases, offsetting low demand and weak earning potential that companies say would make it impossible for them to recoup development costs. The voucher fast-tracks drugs through the regulatory process, helping companies get the drugs to market faster.
The incentive was intended to help to bring new treatments to people affected by neglected diseases while rewarding innovators for their investment. However, as Reid explained, “it doesn’t require that the treatments be made available and affordable to those who need it, and it doesn’t require that the products even be new.”
Indeed, benznidazole is already used as a treatment for Chagas disease, which affects between 6 million and 8 million people in the most impoverished regions of Latin America. Benznidazole is the most widely used drug for Chagas disease despite severe side effects and lengthy treatment.
Ideally, health experts say researchers would quickly develop a new, more affordable drug to treat Chagas disease. But according to tropical disease researcher Rick Tarleton at the University of Georgia, the process needed to compare the efficacy of current drugs to newly developed ones is a long one.
“One simply can’t wait for 10 years (as current protocols require) to determine if a new drug is better than the existing ones,” Tarleton said in a press release.
The priority review voucher has also been criticized for not requiring companies to even sell the drug, and has raised questions around whether the voucher system actually creates incentives for development versus just giving away bonuses to companies that would have made the new drugs anyway.