The US Food and Drug Administration (FDA) is set to increase the fee it charges users of a special, transferable voucher meant to reward developers of tropical disease treatments with an expedited review process for any subsequent drug product.
The voucher, known as a tropical disease priority review voucher, was established under the FDA Amendment Act of 2007 (FDAAA). Under the law, companies that receive approval for a tropical disease treatment are eligible to receive a transferrable voucher that allows the bearer to receive priority review status for any future product. Products undergoing priority review are generally given an approval decision—positive or negative—within six months after the applicant's filing date instead of the standard 10 months.
The legislation was enacted to spur development of treatment options for tropical diseases, which FDA notes have been remarkably stagnant over the last half century. "Because these diseases are found primarily in poor and developing countries, existing incentives have been insufficient to encourage development of new and innovative drug therapies," explained FDA in a 2008 guidance document on the subject. FDA said it was taking an interest in the topic given the needs of other countries and the ability of those diseases to affect Americans in an increasingly globalized economy.
Under normal circumstances, FDA only grants priority review status to products which fill a treatment void or would otherwise represent a significant advancement compared to existing treatments.
However, there are caveats which limit the worth of the tropical disease voucher. Per FDAAA, companies must notify FDA at least 365 days in advance that they plan to use the voucher—a major problem for companies, which often wait until just after a drug has successfully cleared late-stage trials before submitting an application. In the seven years the voucher system has been on the books, no vouchers have yet been sold, and only one has been used (unsuccessfully).
In contrast, FDA's pediatric rare disease priority review voucher has just a 90-day limit and recently saw its first sale for $67.5 million. The pediatric voucher program has only been in existence for two years.
Fee Set to Rise
But even once a company possesses a priority review voucher, it still must pay to use it.
In the last few years, tropical disease priority review voucher fees have plunged downward, and are now less than half the cost of what they were in 2013.
|Tropical Disease Priority Review Voucher Fees|| || |
|Fiscal Year||Voucher Fee||Change from Previous Year ($)|
|FY 2011||$4,582,000|| |
|FY 2012||$5,280,000||+ $698,000|
|FY 2013||$3,559,000||- $1,721,000|
|FY 2014||$2,325,000||- $1,234,000|
|FY 2015||$2,562,000||+ $237,000|
But for the first time since FY 2012, the cost of using FDA's tropical disease priority review voucher is set to rise. In a Federal Register notice on 26 August 2014, FDA indicated that it plans to charge $2,562,000 to use each voucher—a premium of $237,000 above what it charged in FY 2014.
FDA said its fee was based on its estimation that priority reviews take 67% more resources than a traditional review.
Drug application sponsors must still pay a fee to process the actual new drug or new biologic application as well, FDA noted.
Federal Register Notice