Breakthrough Patient Recruitment

: Can the Ebola Outbreak Improve the PVR Law?

Can the Ebola Outbreak Improve the PVR Law?

Online Media Specialist

As Facebook newsfeeds are flooded with statuses about how, "More people have been married to Kim Kardashian than have Ebola in the US," it would seem sensibility has prevailed over mass World War Z Zombie panic, as I like to call it.  (Side note-WWZ is a great book to read about the mindset behind international disease epidemics.) Although the U.S. population has cooled down in their panic about the few diagnosed patients on the mainland, the disease is still very real in countries like Guinea, Liberia, and Sierra Leone. So, when politicians like Sen. Tom Harkin (D-Iowa) and Sen. Lamar Alexander (R-TN) push to add incentives for Ebola drug development in the United States, who exactly are they looking to help? And, did they miss the window for getting this incentive passed quickly enough to help the most affected countries?

There are 16 deadly conditions that currently fall under the priority review voucher program (PVR) for neglected tropical diseases (NTD).  These conditions affect millions of people in developing countries, but are considered "neglected" in Europe and the United States due to their rare prevalence and lack of potential profit.  The vouchers given out by this program to qualifying pharmaceutical companies developing drugs or medicines to treat one of the 16 conditions allow the companies to have their FDA standard review expedited; there is also a bonus review voucher that can be sold to another company. This year, one of those vouchers sold for $67.5 million. But in 2007, when the law was passed, Ebola was not considered a serious threat.

Politicians have taken various stances on the issue. Some politicians have seemingly tried to take advantage of the epidemic and gain the public's favor by doing things like forcing quarantine on returning nurses, causing them to spend nights in unheated tents without proper bathrooms. Others have pushed for more funding put toward the Centers for Disease Control (CDC) to add Ebola to the FDA PVR program and make it easier to obtain vouchers. Under the current law, it is very difficult to obtain one of these vouchers; only four vouchers have been awarded over the past seven years.

Although the Ebola virus finally making its way to the United States has been tragic, it has caused a surge of pressure on congress and the CDC to pass an amendment on the PVR law to include infectious diseases like Chagas disease and Ebola. While the Ebola hysteria dies down, the window of having the Ebola on the forefront of Congress' collective mind is also closing.  This is important because Ebola remains prevalent in West African nations. Losing this issue in the U.S. Congress may mean we risk losing the ability to treat Ebola in these developing countries, at the disease's core. For information on how you can help urge your local congress representative to take a stand against infectious diseases such as Ebola visit http://www.house.gov/representatives/find/.

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