FDA Commissioner Stephen Hahn said yesterday that he was “optimistic” that more than one COVID-19 treatment could be available by the fall in addition to Gilead Sciences’ remdesivir, which has already received Emergency Use Authorization from the agency.
Hahn told the Senate Committee on Health, Labor, Education and Pensions that one potential therapy, convalescent plasma, was found to be safe in more than 20,000 patients. Those patients were tested as part of the agency’s expanded access program with the Mayo Clinic.
He said the data on convalescent plasma could help multiple sponsors in developing monoclonal antibodies as treatments, and that safety and efficacy data on the antibodies should be available by the fall.
Hahn also noted that the U.S. dependence on China for the pharmaceutical supply chain has become a problem during the pandemic, and said the agency wants to encourage domestic manufacturing as a way to diversify the supply.
Other FDA officials have previously warned of U.S. over-reliance on foreign manufacturers. Center for Drug Evaluation and Research Director Janet Woodcock, who is temporarily reassigned to the Trump administration’s Operation Warp Speed, last year called for an overhaul of American drug manufacturing to offset the nation’s dependence on active pharmaceutical ingredients (APIs) made in China, India and elsewhere. Woodcock warned that the U.S. reliance on these countries for APIs is increasing (DID, Nov. 14, 2019). — Jordan Williams