Ebola has killed thousands, alarmed millions and left the world scrambling to control the outbreak. Sadly, Ebola has been largely ignored by drug makers because there’s little profit potential for a drug that primarily treats people in poor countries.
But there is a law on the books that offers financial incentives to drug makers to develop treatments for 16 other neglected diseases. And there is a window now open to add Ebola to that list.
In 2006, colleagues Jeff Moe, and Henry Grabowski and I proposed in a paper that incentives be provided to pharmaceutical companies
Our proposal became law a year later, and as a result the Food and Drug Administration now rewards manufacturers with priority review for drugs that address neglected diseases and with a bonus priority review voucher they can sell.
However, while dengue, leishmaniasis and 14 other neglected diseases are eligible for a voucher, Ebola is not because it was not a public health emergency when the law passed in 2007.
It is possible for Congress to amend the law to include additional neglected diseases and to fix the voucher law in other ways. Members of Congress are currently considering the 21st Century Cures initiative, which aims to accelerate the pace of medical breakthroughs. Fixes to the voucher law could – and should – be a major component of the initiative.
Under the current voucher program, the developer of a novel drug for a neglected disease receives an expedited, six-month review at FDA and a bonus priority review voucher that can be sold to another company for use on a different drug. One of those vouchers was sold this year for $67.5 million.
To improve the program, Congress should add other infectious diseases for which the burden of disease is great and the profit potential is small. Ebola, which has already killed more than 3,000 people in 2014, is one obvious example, but so is Chagas, which killed an estimated 8,000 people in 2012, mostly in Central and South America.
Second, Congress should increase the value of the voucher by making it more useful for the bearer. Multiple transfers of the voucher should be allowed. The time required for notifying FDA of the intention to use a voucher should be reduced from one year in advance to three months.
And the voucher fee paid by a manufacturer should be refunded if the drug wins priority review on its own merits.
Third, Congress should increase patient access to drugs for neglected diseases. For example, Congress could require the company earning the voucher to report on affordability of its neglected-disease drug. And manufacturers should consider licensing the drug to generic manufacturers in poor countries, as the biopharmaceutical company Gilead has done with Sovaldi, which treats hepatitis C.
Finally, Congress should restrict eligibility for the voucher to novel products that have not been approved in other countries more than two years prior to FDA submission.
Congress created a useful tool in the war on diseases like Ebola. With the 21st Century Cures Initiative, Congress now has an opportunity to enable the voucher program to save more lives.
David Ridley is faculty director of the Health Sector Management program at Duke’s Fuqua School of Business.