As Omicron spread, HHS took control of monoclonal antibodies and imposed bad decisions nationwide.
The Biden administration seems to think it knows better than physicians how to practice medicine. But its haphazard micromanagement of monoclonal antibodies to treat Covid-19 has created supply shortages, spread confusion, probably harmed patients, and undermined future treatment.
The Food and Drug Administration granted emergency-use authorizations for three monoclonal-antibody preparations to treat Covid patients who have mild to moderate symptoms and are at high risk of progressing to severe illness. These authorizations covered one treatment developed by Regeneron, one from Eli Lilly and one from GlaxoSmithKline. These laboratory-made proteins provide antibodies to fight Covid faster than our bodies can make them, which reduces the risk of hospitalization and death.
The FDA originally directed manufacturers to provide supplies to the federal government for distribution to hospitals nationwide. The government eventually allowed facilities to order doses directly. But on Sept. 13 the Health and Human Services Department reasserted federal control, citing a surge in Covid cases, and allocated monoclonals to the states rather than allowing hospitals to order doses directly.
At the end of November, as Omicron arrived in the U.S., the federal government paused shipments of GlaxoSmithKline’s medication, sotrovimab, and increased shipments of the more readily available Regeneron and Eli Lilly products. The action seemed contrary to concerns that the more than 30 mutations on the variant’s spike protein would impair the Lilly and Regeneron monoclonals’ effectiveness. Sotrovimab, in contrast, targets a different, less mutable part of the spike protein and was thought to be more likely to retain activity than the other antibodies.
HHS danced around why it did this. The agency initially told one biopharma industry reporter in mid-December that the sotrovimab pause was unrelated to Omicron and was taken because of a surplus of the Lilly product, but then backtracked a few days later, telling the reporter the decision was driven by the variant. When HHS finally acknowledged that sotrovimab was effective against Omicron and resumed shipments on Dec. 17, it still claimed the monoclonal was withheld to “ensure a more balanced portfolio of monoclonal antibody products and to allow more time to assess data regarding the effectiveness of sotrovimab against the Omicron variant.” …
The dizzying turns the Biden administration took on monoclonals shows just how little it trusts physicians and local health officials. Yet local officials and providers are more likely than Washington bureaucrats to be aware of the variants and effective treatments in their region…
The FDA and other agencies should provide accurate, up-to-date information and ensure an adequate supply and variety of treatments. Washington bureaucrats’ micromanagement of Covid-19 treatments that are safe and effective in varying circumstances has to stop.
The full article is available in The Wall Street Journal.
