Medical Countermeasures: FDA Reports on FY2018 Achievements

Regulatory NewsRegulatory News
| 09 April 2019 | By Michael Mezher 

As part of its effort to protect against pandemic disease and chemical, biological, radiological and nuclear (CBRN) threats in FY2018, the US Food and Drug Administration (FDA) approved or expanded the use of nine drugs and biologics and 19 medical devices, according to a report released Tuesday.
The agency also granted two new emergency use authorizations (EUAs) in 2018, one for the first fingerstick diagnostic system for detecting Ebola virus and the other for freeze-dried plasma for use by military personnel to treat battlefield trauma.
In 2018, FDA also approved the first drug indicated to treat smallpox, SIGA Technologies’ TPOXX (tecovirimat), which became the first product to be awarded a material threat and medical countermeasure priority review voucher.
FDA’s MCM initiative dates back to 2010 and encompasses the agency’s efforts to bring products to market to combat threats from infectious disease, bioweapons and other hazards by providing regulatory and scientific advice and facilitating access to investigational products during emergencies.
Over the years, FDA’s MCMs authorities have been expanded through various pieces of legislation such as the Pandemic and All-Hazards Preparedness Reauthorization Act, the 21st Century Cures Act and most recently under Public Law 115-92, which expanded FDA’s authority authorize products for emergency use by the military and allows the Department of Defense to request that FDA expedite review of products intended for use by military personnel.
In the report, FDA details its activities related to its MCM initiative throughout FY2018, including product approvals, emergency use authorizations, new guidances and meetings with sponsors.
FDA’s budget for the program is down slightly from previous years, with $107.3 million in base funding plus another $5.9 million in supplemental funding from earlier “no-year” funding packages for responding to the West Africa Ebola epidemic, H7N9 influenza preparedness and other emerging health threats.
Base funding for the program has declined in each year since peaking in FY2014, when the agency received $129.4 million in base funding. Likewise, the number of staff working on the initiative has dropped from 604.5 full time equivalent (FTE) in FY2014 to 472.7 in FY2018.
Across its three product centers, the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) and Center for Devices and Radiological Health (CDRH), FDA held 104 meetings with product sponsors and applicants in FY2018.
The agency also issued 42 draft and final guidances either expressly dealing with MCMs or with recommendations that can apply to MCMs.
FDA, Report


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