priority review voucher

The U.S. Government has recently taken a number of steps to reinvigorate its support of medical countermeasure development. In particular, by pursuing new methods of contracting, updating regulatory frameworks, and establishing additional incentives for capital investment, the U.S. Government has confirmed that countermeasure development remains a critical component of public health preparedness.

Now, over the past two weeks, a two-part congressional hearing has suggested that recent efforts may soon be accompanied by key legislative changes, including much needed funding authorizations and incentives. As a result, the upcoming reauthorization of the Pandemic and All-Hazards Preparedness Act (“PAHPA”), and its prior reauthorization, may present a critical opportunity to continue to improve public-private relationships in countermeasure development.

Continue Reading Recent Support of Countermeasure Development Poised to Continue in Reauthorization of PAHPA

On January 19, 2018, FDA announced the availability of a new draft guidance, titled “Material Threat Medical Countermeasure Priority Review Vouchers.” FDA’s publication of the draft guidance, which was issued by FDA’s Office of Counterterrorism and Emerging Threats (OCET) without a statutory mandate – reflects the commitment of FDA leadership to the development and approval of medical countermeasures (MCMs). In a question and answer format, FDA provides details about the Agency’s interpretation and implementation of the MCM priority review voucher (PRV) program, which was established in December 2016 by the 21st Century Cures Act (Section 565A of the Federal Food Drug, and Cosmetic Act (FD&C Act)). That provision, intended to incentivize the development of MCMs, requires FDA to award a PRV to the sponsor of a successful marketing application that meets certain statutory criteria.
Continue Reading FDA Commitment to MCM Development Reflected in New Draft Guidance on Medical Countermeasure Priority Review Vouchers