There’s a serious risk that the Biden team will default to their instincts and reimpose a culture of bureaucratic control that restricts new medical advances

See Trump, Biden and Covid Vaccines: Will Joe’s advisers scuttle more rapid FDA approvals?. WSJ editorial. Excerpts:

"This summer the FDA was criticized for granting an emergency use authorization (EUA) for convalescent plasma to treat Covid. More than a dozen non-gold standard studies showed benefits. A Mayo Clinic trial that enrolled some 35,000 patients found seven-day mortality was 44% lower among non-intubated patients under the age of 80 who were treated within 72 hours of diagnosis with plasma containing high levels of antibodies versus lower levels.  

The study didn’t find a difference in survival among all patients and didn’t include a placebo group. “There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19,” a National Institutes of Health panel cavilled.

Yet gold-standard trials can obscure critical benefits among subgroups. Consider a World Health Organization multinational trial, which last month reported no benefit from four antiviral drugs tested including Gilead’s remdesivir. An earlier NIH trial in the U.S. found remdesivir improved recovery time by five days and survival by 27%."

"Yet now some critics claim that the FDA jumped the gun by approving remdesivir and should have waited for supposedly more robust evidence like the WHO trial. Some also say the FDA should have consulted outside experts before granting emergency authorization. These panels are notorious for nitpicking trial designs and shooting down promising therapies that only benefit a subgroup of patients. They allow the FDA to disperse accountability for decision-making. Pressure is now building on the FDA to revoke the remdesivir approval and, barring that, for the feds to cut reimbursement for the drug."

"The Trump FDA’s Covid innovation has been providing real-time feedback and clear guidance to drug and vaccine makers about its expectations. This has helped therapies and vaccines advance and cut Phase 3 trials from three years to a few months. These reforms are one of the success stories of the federal Covid response. But there’s a serious risk that the Biden team will default to their instincts and reimpose a culture of bureaucratic control that restricts new medical advances."