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Regulatory Focus™ > News Articles > FDA Finalizes Guidance on Tropical Disease PRVs, Offering a Number of Clarifications

FDA Finalizes Guidance on Tropical Disease PRVs, Offering a Number of Clarifications

Posted 05 October 2016 | By Zachary Brennan 

FDA Finalizes Guidance on Tropical Disease PRVs, Offering a Number of Clarifications

The US Food and Drug Administration (FDA) on Wednesday finalized guidance on tropical disease priority review vouchers (PRVs), clarifying when a voucher can be used, whether drugmakers are “guaranteed” a six-month review when using a voucher and whether FDA can remove a tropical disease from the list of considered diseases (it can’t).

This finalization of the 2008 draft guidance includes 25 questions and answers and includes the following substantive changes based on public comment:

  • The procedure for FDA to add diseases to the list is described: FDA can designate by order “any other infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations.”  
  • Clarification on when a voucher can be used: sponsors redeeming vouchers must notify FDA of its intent to use the voucher at least 90 days before submission of a drug application for which it will be used.  
  • A statement was added to say that FDA may provide a preliminary nonbinding opinion, before approval, that an application appears to meet the criteria for voucher eligibility.
  • Clarification on the eligibility of combination products to receive a voucher: Drug-drug combinations are eligible
  • Clarification on the timing of payment of the PRV user fee: It’s due upon submission of the application for which the PRV is used.

FDA also gives itself a little wiggle room (the agency has said that PRVs can often disrupt the agency’s focus on public health priorities) in terms of if sponsors are guaranteed a six-month review when a voucher is used.

“The definition of priority review in section 524(a)(1) refers to the 2007 PDUFA [Prescription Drug User Fee Act] goals letter,” FDA says. “We believe the intent of this section is that a human drug application for which priority review vouchers are used should be treated as if it were any other priority review human drug application under the 2007 goals. The 2007 goals letter committed the FDA to a goal of completing 90 percent of priority reviews within the prescribed time frames.”

Rare Pediatric PRV Extension

The finalization of the tropical disease PRV guidance follows President Barack Obama’s signing into law an extension of the rare pediatric PRV program through the end of the year. Congress is still trying to work out some tweaks to that program as it’s likely to be extended even farther into the future.

Negotiations may focus on how to amend both PRV programs to ensure the programs are actually incentivizing the research and development of novel products. To read more on PRVs, check out the Focus explainer.

Tropical Disease Priority Review Vouchers Guidance for Industry

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