Energy and Commerce Committee members held a bipartisan teleconference briefing with Food and Drug Administration (FDA) Commissioner Stephen Hahn, M.D., today about the agency’s ongoing response to the COVID-19 pandemic. Commissioner Hahn was joined on the teleconference by Center for Biologics Evaluation and Research (CBER) Director Peter Marks M.D., PhD., and Center for Drug Evaluation and Research (CDER) Acting Director Patrizia Cavazzoni M.D.
Chairman Frank Pallone, Jr. (D-NJ) and Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) released the following joint statement on the teleconference:
“Today, members of the Energy and Commerce Committee took part in a bipartisan teleconference with Commissioner Hahn, Director Marks and Acting Director Cavazzoni on FDA’s ongoing response to the COVID-19 crisis.
“Members of the Committee raised important concerns on today’s call including FDA’s reputation as an independent agency. Today’s call reaffirmed our strong belief that Commissioner Hahn must participate in a hearing in September.
“The American people must be able to trust FDA, but recent events, including misleading claims about the efficacy of convalescent plasma, raise serious concerns that the Trump Administration is increasing political pressure on the agency and interfering with its regulatory independence. An effective long-term response to COVID-19 is dependent on the availability of treatments and vaccines approved by the agency following its long-held standard of safety and efficacy. Politics should not play any role in these decisions.
“We are grateful to Commissioner Hahn, Director Marks and Acting Director Cavazzoni for participating in today’s call and look forward to scheduling a hearing before the Committee in the coming weeks."
During the call, the members discussed several issues with the FDA officials, including:
* Bipartisan member agreement on the need for a public hearing with Commissioner Hahn;
* Questions concerning Health and Human Services’ (HHS) legal determination allowing Laboratory Developed Tests (LDTs) for COVID-19 to come to market without FDA review;
* Questions about the announcement of an Emergency Use Authorization (EUA) for the use of convalescent plasma to treat COVID-19 patients and the impact it may have on participation in ongoing clinical trials;
* An update on continued development of rapid point of care tests for COVID-19 as well as potential for future at-home tests.
