Legislation recently introduced in the U.S. House of Representatives would add the Zika virus to the list of diseases in the Food and Drug Administration’s (FDA) priority review voucher (PRV) program. The Senate HELP Committee has also recently advanced similar legislation. This is a positive step that would help incentivize needed research and development (R&D) to fight the disease. However, it also illustrates the fact that the PRV platform could be used far more proactively to help address future pandemics before they strike.
Incentive For Innovation
In 2007 the US government created the PRV as an incentive to drive research into neglected diseases which typically don’t command big commercial markets. Under the program, companies that successfully develop and receive FDA approval for a drug that treats a disease on the PRV list then earn a voucher that entitles them to expedited review for another more commercially promising product. The logic is that the potential value of shortened time to market for a profit-making drug is a significant enough incentive to drive research into diseases that would otherwise not attract enough R&D attention.
The voucher can be used by the company that earns it, or sold to another company at a negotiated price. The PRV model is not perfect; there is space to improve the effectiveness and impact of the program, and other research and access incentive mechanisms are worth exploring. Nevertheless, the PRV model has already shown some success in incentivizing new R&D. Today it holds still greater promise as a potential tool to proactively enhance our readiness to respond to future pandemics.
Prioritizing The Pathogens
The initial 2007 list of diseases covered by the PRV program included 16 so-called neglected tropical diseases (NTDs) as identified by the World Health Organization (WHO) for which new drugs would be a welcome addition to the current medical arsenal. The list of eligible diseases can be modified by Congressional action or directly by the FDA: Congress added Ebola to the list in 2014, and the FDA added Chagas and neurocysticercosis in 2015. While these changes reflect a healthy recognition of evolving pandemic priorities, policymakers can and should go even further to get ahead of the next outbreak by putting other potential pandemic agents on the PRV list before they emerge as significant threats.
One place to look is the December 2015 list published by WHO highlighting “top emerging diseases likely to cause major epidemics.” The list was developed by WHO through consultation with a team of scientific and public health experts, and will inform the WHO’s R&D Blueprint for Action Against Pandemics slated for launch in May of 2016.
Not surprisingly, Ebola—already part of the PRV program—is on that list, but so are a number of other diseases that are not on the PRV list and that are not well known to the public: Crimean-Congo fever virus, Lassa fever, Nipah and Rift Valley Fever, MERS and SARS, chikungunya, and severe fever with thrombocytopenia syndrome (SFTS). (Zika, which very few people had heard of when the list was released, was included on a second tier of so-called “serious” threats.) Policymakers should consider incorporating these diseases into the PRV program, using the list’s annual release as a benchmark for periodic updates to the list of diseases eligible for the PRV. FDA-led reviews of the WHO’s list to evaluate it for potential expansion of the PRV would be consistent with the agency’s intent to seek public input on additions to the diseases covered by the program.
One Piece Of The Puzzle
Preventing and fighting outbreaks is a complex and multidimensional effort involving an array of complementary elements in addition to R&D, such as surveillance, education, health care infrastructure, and overall coordination. All of these factors need to be addressed through the collective efforts of a range of committed public health actors. As one part of the preparedness spectrum, regularly reviewing the PRV list and revising it to include top potential threats would be a simple yet critical step in helping to improve the state of public health readiness to address the next pandemic — before it strikes.
Author’s Note
This views represented in this blog do not necessarily represent the official views of Merck.
from Health Affairs Blog http://ift.tt/1S3kVds
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