Hahn Vows Regulatory Independence From Operation Warp Speed

FDA Commissioner Stephen Hahn assured House lawmakers yesterday that the agency will maintain its regulatory independence in reviewing COVID-19 vaccine candidates, staying at arm’s length from the Trump administration’s Operation Warp Speed, which aims to have an effective  vaccine by year’s end.

Asked about reports that Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, left Operation Warp Speed because of concerns over political pressure, Hahn told the House Energy and Commerce committee that the agency will assess a vaccine candidate based strictly on science and data.

Hahn said the agency “drew a bright line” between Operation Warp Speed and sponsors seeking to develop COVID-19 vaccines and treatments. Although the agency provides technical assistance to sponsors, it does not make any decisions regarding the initiative, he said.

Hahn also said the FDA continues to meet its goals for reviewing product applications during the pandemic. He said the agency has maintained the same pace for reviewing product applications over the past six months as it has in recent years. The agency is on track to take action on 90 percent of brand, generic and similar drug applications, Hahn said.

“The work has continued at a time when the number of applications received in some centers is substantially higher than pre-COVID-19 times,” he said.

Hahn was joined at the hearing on the administration’s response to the pandemic by National Institutes of Allergy and Infectious Disease Director Anthony Fauci, Centers for Disease Control and Prevention Director Robert Redfield and Assistant Secretary for Health Brett Giroir.

Fauci said he remains “cautiously optimistic” about having a vaccine by the end of the year. But he cautioned that having a vaccine in that time, even by means of an Emergency Use Authorization, depends on how quickly safety and efficacy data can be obtained from large-scale, randomized, placebo-controlled trials.

 “I would be very disappointed if we jumped to a conclusion before we knew that a vaccine is truly safe and truly effective,” he said. — Jordan Williams