Hospital Pharmacy - May 2017 - 324

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editorial2017

HPXXXX10.1177/0018578717715330Hospital PharmacyBaker

Editorial

For Sale: FDA Priority Review Vouchers

Hospital Pharmacy
2017, Vol. 52(5) 324-325
© The Author(s) 2017
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https://doi.org/10.1177/0018578717715330
DOI: 10.1177/0018578717715330
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Danial E. Baker1

Did you know that the US Food and Drug Administration
(FDA) has a voucher system related to new drug approvals?
The voucher system was implemented to encourage drug
development for "neglected" tropical and rare pediatric disease. Both of these represent markets that may not allow the
pharmaceutical company to recoup its development cost.
Recently, the development of medical countermeasures was
added to the list of drugs covered by the voucher system.1,2
Diseases eligible under the tropical disease priority
review voucher system include blinding trachoma, Buruli
ulcer, Chagas disease, cholera, cuevavirus, dengue/dengue
hemorrhagic fever, dracunculiasis (Guinea-worm disease),
Ebola virus, fascioliasis, human African trypanosomiasis,
leishmaniasis, leprosy, lymphatic filariasis, malaria,
Marburg virus, neurocysticercosis, onchocerciasis, schistosomiasis, soil-transmitted helminthiasis, tuberculosis,
yaws, and Zika virus. The FDA also has the authority to
add other infectious diseases that are defined within the
regulation.2,3 The drugs (also known as orphan drugs) used
in the treatment of rare pediatric disease priority voucher
system include those that affect fewer than 200 000 persons
in the United States.1,2
Unlike a lot of vouchers or coupons a consumer receives
from a business as a reimbursement or "reward," which are
generally not transferable or cannot be sold, these priority
vouchers can be sold. This means that the pharmaceutical
company that submits the product to the FDA that qualifies
for one of these voucher programs and gets FDA approval
can market the new drug in the United States and receives a
priority review voucher. The pharmaceutical company then
has the right to use or sell the voucher to another company. In
addition, if the FDA classifies the drug as an orphan drug,
there are other financial incentives.
A pharmaceutical company with one of these priority
review vouchers can use it to expedite the review of new
drug product. For a pharmaceutical company to use one of
these vouchers, it has to inform the FDA of its intent to use
the voucher on an upcoming submission. When that application is submitted, the FDA accepts the voucher and agrees to
review the data in the drug application within 6 months.2,3 In
addition to surrendering the priority review voucher, the
pharmaceutical company has to pay the FDA the priority
review fee plus the normal new drug user fee. In 2017, the
priority review fee was $2 706 000.1-5
These vouchers can be sold or transferred an unlimited
number of times; they require a 90-day notification prior to

its use and have no expiration date.1-4 Published information
from 2016 indicates that the FDA has distributed 13 of these
vouchers. Fifty-four percent of these vouchers have been
transferred and used by another company. Examples of how
some of these vouchers were used include the use of a tropical disease voucher for the review of canakinumab (Ilaris); a
rare pediatric disease voucher for the review of alirocumab
(Praluent); a tropical disease voucher for the review of rilpivirine, emtricitabine, and tenofovir alafenamide (Odefsey);
and a rare pediatric voucher for the review of basal insulin
glargine/lixisenatide (Soliqua).2,5-7
Use of a voucher does not guarantee that the drug will
be approved, but it does speed up the time of the FDA's
review process, assuming the new drug or biologics license
application is complete and provides sufficient efficacy
and safety data to support the drug's approval. If the drug
is approved, the pharmaceutical company may be able to
market their drug earlier than if it had been reviewed under
the standard process. If that happens, it means the pharmaceutical company may be able to beat to the market a similar product or a different type of treatment for the same
medical condition from another company or they can just
get a head start on generating revenue from the sale of the
drug.2,7
The biggest unanswered question about this voucher system is whether it has accomplished its goal of increasing
drug development for the treatment of these types of medical
conditions or has become a means for a few companies to
make money by selling these vouchers or purchasing these
vouchers to speed up the approval process of other drugs.
There appears to be no answer in sight.
References
1.

US Food and Drug Administration. Rare pediatric disease
priority review vouchers, draft guidance for industry. https://
www.fda.gov/downloads/RegulatoryInformation/Guidances/
UCM423325.pdf. Published November 17, 2014. Accessed
April 7, 2017.

1

Washington State University, Spokane, USA

Corresponding Author:
Danial E. Baker, Director, Drug Information Center, College of Pharmacy,
Washington State University, PO Box 1495, Spokane, WA 99210-1495,
USA.
Email: danial.baker@wsu.edu


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Table of Contents for the Digital Edition of Hospital Pharmacy - May 2017

Editorial, For Sale: FDA Priority Review Vouchers
Current FDA-Related Drug Information; Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals
Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings
ISMP Adverse Drug Reactions: Levofloxacin-Induced Neuroexcitation and Hallucinations Statin-Induced Muscle Rupture Mefloquine-Induced Rhabdomyolysis Methimazole-Induced
Critical Care Pharmacist Market Perceptions: Comparison of Critical Care Program Directors and Directors of Pharmacy
Capecitabine, Oxaliplatin, and Bevacizumab (BCapOx) Regimen for Metastatic Colorectal Cancer
Clinical Pharmacy Discharge Counseling Service and the Impact on Readmission Rates in High-Risk Patients
Mannitol Prescribing Practices With Cisplatin Before and After an Educational Newsletter Intervention
Pharmacists’ Knowledge of the Cost of Laboratory Testing
Adverse Drug Reaction Reporting Practices Among United Arab Emirates Pharmacists and Prescribers
Postoperative Pain Management With Liposomal Bupivacaine in Patients Undergoing Orthopedic Knee and Hip Arthroplasty at a Community Hospital
Formulary Drug Reviews
Hospital Pharmacy - May 2017 - 317
Hospital Pharmacy - May 2017 - 318
Hospital Pharmacy - May 2017 - 319
Hospital Pharmacy - May 2017 - 320
Hospital Pharmacy - May 2017 - 321
Hospital Pharmacy - May 2017 - 322
Hospital Pharmacy - May 2017 - 323
Hospital Pharmacy - May 2017 - Editorial, For Sale: FDA Priority Review Vouchers
Hospital Pharmacy - May 2017 - 325
Hospital Pharmacy - May 2017 - Current FDA-Related Drug Information; Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals
Hospital Pharmacy - May 2017 - Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings
Hospital Pharmacy - May 2017 - 328
Hospital Pharmacy - May 2017 - 329
Hospital Pharmacy - May 2017 - ISMP Adverse Drug Reactions: Levofloxacin-Induced Neuroexcitation and Hallucinations Statin-Induced Muscle Rupture Mefloquine-Induced Rhabdomyolysis Methimazole-Induced
Hospital Pharmacy - May 2017 - 331
Hospital Pharmacy - May 2017 - 332
Hospital Pharmacy - May 2017 - 333
Hospital Pharmacy - May 2017 - Critical Care Pharmacist Market Perceptions: Comparison of Critical Care Program Directors and Directors of Pharmacy
Hospital Pharmacy - May 2017 - 335
Hospital Pharmacy - May 2017 - 336
Hospital Pharmacy - May 2017 - 337
Hospital Pharmacy - May 2017 - 338
Hospital Pharmacy - May 2017 - 339
Hospital Pharmacy - May 2017 - 340
Hospital Pharmacy - May 2017 - Capecitabine, Oxaliplatin, and Bevacizumab (BCapOx) Regimen for Metastatic Colorectal Cancer
Hospital Pharmacy - May 2017 - 342
Hospital Pharmacy - May 2017 - 343
Hospital Pharmacy - May 2017 - 344
Hospital Pharmacy - May 2017 - 345
Hospital Pharmacy - May 2017 - 346
Hospital Pharmacy - May 2017 - 347
Hospital Pharmacy - May 2017 - Clinical Pharmacy Discharge Counseling Service and the Impact on Readmission Rates in High-Risk Patients
Hospital Pharmacy - May 2017 - 349
Hospital Pharmacy - May 2017 - 350
Hospital Pharmacy - May 2017 - 351
Hospital Pharmacy - May 2017 - 352
Hospital Pharmacy - May 2017 - Mannitol Prescribing Practices With Cisplatin Before and After an Educational Newsletter Intervention
Hospital Pharmacy - May 2017 - 354
Hospital Pharmacy - May 2017 - 355
Hospital Pharmacy - May 2017 - 356
Hospital Pharmacy - May 2017 - Pharmacists’ Knowledge of the Cost of Laboratory Testing
Hospital Pharmacy - May 2017 - 358
Hospital Pharmacy - May 2017 - 359
Hospital Pharmacy - May 2017 - 360
Hospital Pharmacy - May 2017 - Adverse Drug Reaction Reporting Practices Among United Arab Emirates Pharmacists and Prescribers
Hospital Pharmacy - May 2017 - 362
Hospital Pharmacy - May 2017 - 363
Hospital Pharmacy - May 2017 - 364
Hospital Pharmacy - May 2017 - 365
Hospital Pharmacy - May 2017 - 366
Hospital Pharmacy - May 2017 - Postoperative Pain Management With Liposomal Bupivacaine in Patients Undergoing Orthopedic Knee and Hip Arthroplasty at a Community Hospital
Hospital Pharmacy - May 2017 - 368
Hospital Pharmacy - May 2017 - 369
Hospital Pharmacy - May 2017 - 370
Hospital Pharmacy - May 2017 - 371
Hospital Pharmacy - May 2017 - 372
Hospital Pharmacy - May 2017 - 373
Hospital Pharmacy - May 2017 - Formulary Drug Reviews
Hospital Pharmacy - May 2017 - 375
Hospital Pharmacy - May 2017 - 376
Hospital Pharmacy - May 2017 - 377
Hospital Pharmacy - May 2017 - 378
Hospital Pharmacy - May 2017 - 379
Hospital Pharmacy - May 2017 - 380
Hospital Pharmacy - May 2017 - 381
Hospital Pharmacy - May 2017 - 382
Hospital Pharmacy - May 2017 - 383
Hospital Pharmacy - May 2017 - 384
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