An FDA drug voucher program needs a reboot
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Congress will update the laws governing prescription drugs this summer, including changes to a program designed to spur drug development for neglected diseases like dengue, Ebola, Zika and river blindness.

Unfortunately, the fix as written to the FDA Reauthorization Act does too little to help the millions of people at risk for these diseases.

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A decade ago, Congress used our proposal, “Developing Drugs for Developing Countries,” to create the priority review voucher program to encourage drug development for these diseases.

 

The 2007 law rewards developers of drugs with a voucher for faster review at the Food and Drug Administration for a different drug, regardless of the disease it treats.

The drug using the voucher is reviewed by FDA in about six months, rather than 10 months, but has the same safety and efficacy requirements.

To be clear, two drugs are involved with each voucher: A drug for a neglected disease, such as dengue that wins the voucher, and a second drug, say a cholesterol-lowering medicine that may generate billions in sales, which also uses the voucher for speedier FDA review.

Both the drugs are reviewed quickly by FDA. The neglected-disease drug is reviewed fast because it provides significant improvements over current treatments in the U.S., and the second drug is reviewed quickly because the company used its voucher to receive priority review in the FDA process.

Some companies, especially smaller ones, have sold the vouchers to larger companies. For example, this spring GlaxoSmithKline and Viiv Healthcare bought a voucher for $130 million to speed approval of an HIV combination therapy.

Unfortunately, the 2007 law allows companies to receive vouchers for registering old drugs widely used in other parts of the world. It is time to change the requirements and award vouchers only for new drugs to treat neglected diseases.

We titled our 2006 voucher proposal “Developing Drugs for Developing Countries,” not “Registering Drugs,” because we wanted to reward innovation and access, not just registering old ones.  

First, the law should require that drugs winning the voucher be truly new.

Companies should not win vouchers for products registered outside the U.S. for more than a decade. If we limit vouchers to rewarding only new drugs and vaccines, then we will reduce the supply of vouchers and increase their prices. With higher voucher prices, there is more incentive for drug developers to work on truly new drugs and vaccines. When fewer vouchers were available, voucher prices reached $350 million

Second, the law should require that drug companies be held publicly accountable to make their treatments available to where it is most needed.

Our original proposal required that voucher winners forego patent rights, but that provision did not become law. We propose that the law require drug sponsors to publish an access plan prior to receiving a voucher.

These two changes would reward companies committed to innovation and access. Tighter eligibility would bolster the value of vouchers by reducing the supply.

Most importantly the changes would help people suffering from neglected diseases who are in urgent need of new medicines that are affordable and available regardless of where they live.

David Ridley, Ph.D., is a professor of the practice of business at Duke University. His research examines innovation and pricing, especially in healthcare. Jeffrey Moe, Ph.D., is a professor of the practice of global health at Duke University. Previously, he was an executive in residence at Duke's Fuqua School of Business. His research focuses on incentives for neglected diseases, healthcare delivery innovation and financing and payment reforms in low and middle-income health care markets. 


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