Although the FDA last week granted emergency use authorization (EUA) for convalescent plasma to treat patients hospitalized with COVID-19, the NIH’s COVID-19 Treatment Guidelines Panel said Sept. 1 there is insufficient data to recommend either for or against its use. In updated treatment guidelines, the panel stressed the need for prospective, well-controlled, adequately powered randomized trials to determine whether convalescent plasma is effective and safe. The panel added that convalescent plasma should not be considered standard of care for treating patients with COVID-19. The update echoed what FDA Commissioner Stephen Hahn said when he announced the EUA. He noted the need for “adequate and well-controlled randomized trials” to definitively demonstrate the efficacy of convalescent plasma and to determine its optimal attributes and the appropriate patient populations. The EUA was not intended to make convalescent plasma the new standard of care for treating patients with COVID-19, Hahn said.
U.S. Rep. Carolyn Maloney (D-N.Y.), chair of the House Committee on Oversight and Reform, said she is issuing a subpoena to North Chicago-based Abbvie Inc. as part of the committee’s ongoing investigation of drug company pricing practices. “After more than 18 months, Abbvie has demonstrated its unwillingness to comply voluntarily with the committee’s investigation,” Maloney said in a Sept. 1 memorandum sent to the rest of the committee. “The volume and quality of Abbvie’s responses are inconsistent with the expected recordkeeping and decision-making processes of a large multinational corporation regarding two of its most profitable drugs.” The response also is “particularly poor” compared with the documents produced by other drug companies targeted in the probe, Maloney added. The committee, in January 2019, opened the investigation into the pricing practices of 12 drug companies that sell 19 of the most expensive medications in the U.S. The committee has requested information from Abbvie on its pricing of arthritis drug Humira (adalimumab), which generated more than $19.2 billion in net revenues last year, and Imbruvica (ibrutinib), a lymphoma drug that had net revenues of more than $4.6 billion.
In its continuing effort to prevent unacceptable levels of nitrosamine impurities in drugs, the FDA published a guidance, “Control of nitrosamine impurities in human drugs,” for immediate implementation. The guidance recommends a comprehensive risk assessment strategy and other actions that manufacturers can take to reduce or prevent the presence of nitrosamine impurities in their drugs.