Priorities for the Priority Review Voucher
Am. J. Trop. Med. Hyg.
Perspective Piece Priorities for the Priority Review Voucher
David B. Ridley 0 1 2
0 100 Fuqua Drive , Durham, NC 27708-0120
1 Duke University , Durham, North Carolina
2 Author's address: David B. Ridley, Duke University , Durham, NC
The U.S. Congress created the priority review voucher program in 2007 to encourage development of drugs for neglected diseases. Under the voucher program, the developer of a drug for a neglected or rare pediatric disease that is approved by the U.S. Food and Drug Administration receives a bonus priority review voucher for another drug. As of 2016, four vouchers have sold for an average price of $200 million. Recent experience with the voucher program indicates strengths and weaknesses of the program, as well as a need for legislative changes.
The U.S. Congress created the priority review voucher
program in 2007 to encourage development of drugs for
neglected diseases. Congress expanded the program in
2012 to include rare pediatric diseases. Under the voucher
program, the developer of a drug for a neglected or rare
pediatric disease that is approved by the U.S. Food and
Drug Administration (FDA) receives a bonus priority review
voucher for another drug. Thus, two drugs are involved: the
drug that wins a bonus priority review and the drug that uses
the bonus priority review. The drugs need not be from the
same company, because the voucher may be sold. Priority
review typically reduces review time at the FDA by about
4 months.1,2 As of June 2016, 10 vouchers had been
awarded and four had been sold for an average price of
around $200 million.3
Based on their first-hand experience with the voucher
program, industry executives Berman and Radhakrishna
evaluate the priority review voucher program in a recent
paper in this journal.4 They highlight perceived flaws in the
voucher program that could reduce expected returns to
First, Berman and Radhakrishna argue that incentives for
drug development created by the voucher program are
limited by the narrowness and uncertainty of voucher
eligibility. To be eligible to receive a bonus priority review, a
developer’s drug must itself receive priority review. In other
words, there are two drugs with priority review for every
voucher. To be awarded a voucher, the drug for a
neglected or rare pediatric disease must earn priority review
on its own merit by offering a major advance in treatment,
or providing treatment where no adequate therapy exists. If
a competing drug wins a race to market, then subsequent
drugs for that disease are less likely to qualify for a
voucher. The developer does not know prior to submission
whether it will receive priority review. For a marginal drug,
the uncertainty could discourage investment. Another
critique of the eligibility criteria is that previously approved
molecules are ineligible, even if they target new indications.
Fortunately, developers can receive signals from FDA
about the likelihood of receiving priority review. Drugs with
accelerated approval or fast track status are highly likely to
receive priority review. Also, for drugs treating rare pediatric
diseases, the FDA provides a rare pediatric disease
designation early in the development process. Furthermore, while
the eligibility criteria could reduce investment in marginal
drugs, it could also increase investment in innovative drugs.
Because the voucher program is subject to supply and
demand, reducing the quantity of vouchers pushes prices
higher, which encourages development.2 Indeed, Congress
could tighten eligibility even more. For drugs already
available outside the United States, Congress could require that
the manufacturer certify that it conducted new clinical
investigation after the 2007 law.
Second, Berman and Radhakrishna argue that clinical
trial costs are higher for drugs for neglected diseases than
for rare, pediatric diseases, because developers of drugs
for rare diseases are often permitted by FDA to conduct
smaller trials. However, the cost of testing for neglected
diseases such as dengue, malaria, and tuberculosis might not
be so onerous relative to other drugs because of the ease
of identifying patients for a clinical trial. Also, drugs with
greater clinical benefits require smaller trials to prove that
the benefits are real. Indeed, there is evidence that drugs
for infectious and parasitic diseases tend to have lower
development costs than other drugs.5
Third, Berman and Radhakrishna argue that expected
returns are reduced by legislative risk. Investors cannot be
certain that a drug will win a voucher because they do not
know how eligibility might evolve. Indeed, there is some risk
that the rare pediatric program will not be renewed, although
renewal seems likely given the affinity for the voucher
program by members of Congress.
In support of the voucher program, Berman and
Radhakrishna argue that the voucher program imposes little
cost to society or to other products under FDA review. This
is a goal of the program and the reason that the voucher
user must pay an additional FDA user fee of $2.7 million
(in addition to the usual $2.4 million user fee for a total of
$5.1 million). However, even with the additional user fee,
FDA cannot easily hire new staff each time a voucher is
redeemed. FDA needs a steady stream of vouchers to be
confident that it can commit to hiring staff. Furthermore,
FDA struggles to attract new staff given Federal
employment and pay limits.6 Congress should loosen FDA pay
limits. Also, if several vouchers were redeemed every year,
FDA could confidently hire many new staff. For example,
if four vouchers were redeemed each year, then FDA would
receive an extra $11 million each year that could be used to
hire around 22 new reviewers.
PRIORITIES FOR THE PRIORITY REVIEW VOUCHER
Finally, although the voucher program encourages drug
development, the program does not ensure access to the
drugs.1,2,7,8 Congress should require that manufacturers have a
plan for ensuring drug access, especially for drugs for neglected
diseases. This would help motivate developers to work with
international organizations to promote access. Furthermore,
some international organizations might support drug access
through funding such as an advance market commitment.9
The voucher program would benefit from refinement. It is
helpful to have policy makers, regulators, public health-care
advocates, academics, and manufacturers engaged in a
debate about the strengths and weaknesses of the voucher
program to enhance the program for the future.
Acknowledgments: David Ridley was one of the authors of the 2006
paper proposing the priority review voucher program. He thanks
Kathleen Miller for helpful comments on an earlier draft of the paper.
This is an open-access article distributed under the terms of the
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use, distribution, and reproduction in any medium, provided the
original author and source are credited.
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