BIO Seeks Additional Voucher Clarity

The Biotechnology Innovation Organization (BIO) says its members would benefit from more clarity in terms of a specific timeframe for when FDA might make a preliminary non-binding opinion on whether an application meets the criteria for priority review voucher eligibility. “We recommend that the preliminary opinion be conveyed in conjunction with other agency communications planned during the review and approval process, such as during the mid-cycle review,” BIO says in a comment letter on an FDA draft guidance on material threat countermeasure priority review vouchers.

The trade group also says it was encouraged to see the agency highlight that, although some medical countermeasures may not be eligible for a priority review voucher, they may qualify for other incentive programs such as other voucher programs, orphan drug designation, statutory exclusivity, tax credits, and exemptions from user fees.

Two specific comments were provided by Emergent BioSolutions.