Each voucher involves two drugs: the voucher winner and the voucher user. Both are subject to limitations. We begin by examining limitations related to the voucher winners.

Limitations for Voucher Winners

  • Rewarding drugs that would have been developed anyway: The program sometimes rewards manufacturers for developing drugs that likely would have been created even without the incentive. In this sense, the voucher program resembles tax breaks for charitable donations that would have occurred regardless of the incentive.
  • Drugs already available abroad: Some awarded drugs were already accessible in other countries but had not yet been registered in the U.S. Registering these drugs domestically offers benefits, such as eligibility for insurance reimbursement and access for U.S. military personnel who may encounter neglected diseases during deployment. To address this issue, some have called on Congress to make drugs ineligible for the voucher, if the drug has been available outside the United States for more than 3 years.
  • Inadequate prize size for high-burden diseases: The financial reward may be insufficient for diseases with significant global burdens. For example, Michael Kremer and colleagues have proposed an Advance Market Commitment that would create a $3 billion market for high-impact neglected diseases like malaria.
  • Lack of access to therapies: The program does not guarantee access to the approved treatments. Fortunately, most of the drugs awarded vouchers are reaching patients. For example, Coartem is registered in more than 80 countries and its manufacturer has distributed more than a billion courses at no profit.

Limitations for Voucher Users

  • Straining FDA resources: Priority review may place added pressure on the FDA. However, the law mitigates this burden by requiring an additional $2 million user fee from manufacturers and a 90-day advance notice before a voucher is used.
  • Concerns about safety and speed: While priority review expedites the review timeline from 10 months to a target of 6 months, it does not bypass safety or efficacy evaluations, nor does it guarantee approval within the shorter timeframe. Nevertheless, concerns persist that the FDA might feel pressured to meet deadlines, potentially increasing the risk of error.
  • Increased costs for payers: Priority review leads to earlier drug availability by about four months, so insurers begin covering the drug sooner. Some of this early market entry merely shifts sales from competitors (Ridley and Régnier 2016), but there is some new spending. While this adds costs, the expectation is that the benefits outweigh them. If not, it raises broader questions about the value of approving any drug under standard review.

This web page is maintained by David Ridley, one of the authors of the priority review voucher program.