A new bill by Representative Hakeem Jeffries (D-NY) would add the novel coronavirus to the list of diseases eligible to receive a special incentive known as a Priority Review Voucher.
The FDA has several incentive programs at its disposal meant to incentivize drug development in otherwise neglected areas. For most products, these incentives include things like extra marketing exclusivity or unlocking tax credits. However, Congress granted the FDA authority under the FDA Amendments Act of 2007 to award companies a special incentive to accelerate regulatory reviews that can be either used or sold. That incentive is known as a Priority Review Voucher and allows the recipient of the voucher to have any drug reviewed under a “priority review” timeline instead of a “standard review” timeline.
However, as AgencyIQ has previously explained, companies that successfully develop a treatment for SARS-CoV-2 or COVID-19 are not currently eligible to receive a priority review voucher. That’s because the virus and disease hasn’t been added to the list of eligible diseases, and because the FDA doesn’t believe it meets the statutory authority to receive a voucher.
A new bill by Representative Hakeem Jeffries (D-NY) would add the novel coronavirus to the list of diseases eligible to receive a voucher. The “Cure the Coronavirus Act” would specifically add “the 2019 novel coronavirus (COVID-19)” to the statutory list of diseases eligible to receive a voucher under the Tropical Disease Priority Review Voucher program.
“The Coronavirus is now an international public health crisis,” Representative Jeffries told POLITICO in a written statement. “Congress must do the most we can to reduce the regulatory hurdles for discovering and launching a new drug or vaccine that can treat the Coronavirus Disease 2019 before more lives are lost.”
The bill is currently under consideration by the Energy and Commerce Committee, where it awaits mark-up and review. Jeffries’ bill has precedent. Congress has previously added Zika Virus Disease and Ebola Virus Disease to the list of eligible diseases following outbreaks in 2016 and 2014, respectively. That approach—of selectively adding diseases in the midst of an outbreak—may be ripe for change. For example, under the Material Threat Medical Countermeasure Priority Review Voucher program, HHS’ Assistant Secretary for Preparedness and Response can add an “Emerging Infectious Disease” to the list of product eligible to receive such a voucher. A similar statutory change might, for example, allow the FDA to add any disease to its list if HHS has declared it a public health emergency or if the WHO has declared it a pandemic.
As written, the bill would not apply to any other types of coronaviruses, of which there are many. For example, the Middle-East Respiratory Syndrome coronavirus (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS) coronavirus, which previously caused deadly outbreaks, are not eligible for a voucher.
COVID-19 would be the first disease to be added to the list that has been classified as a global pandemic. The widespread need for a treatment for a disease—which has touched every continent except Antarctica—means major market potential in addition to the added bonus of the PRV. As noted in our earlier analysis, even if a company doesn’t earn a voucher, the fact that they could be eligible for one may help companies to raise capital to sustain investment in clinical development programs.