Two Big Pharmaceutical Companies Sell Monoclonal Antibodies to Federal Government Only, Refuse to Sell to Hospitals or States

 

Officials with two pharmaceutical companies who produce monoclonal antibody treatments said Wednesday that the U.S. government distributes the currently-available supply of those treatments and that those companies may not sell them to hospitals or state governments.

A spokesman for the New York state-based Regeneron, who identified himself only as Alex, said the U.S. government owns the currently available supply of REGEN-COV, which is the company’s monoclonal antibody treatment. The U.S. government allocates that product to state governments.

“We do not sell the medicine commercially at this point,” Alex said.

Monoclonal antibodies, according to the U.S. Food and Drug Administration’s website, are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. Houston Methodist said monoclonal antibody infusion treats COVID-19 and can help prevent hospitalizations, “reduce viral loads and lessen symptom severity.”

Another spokesperson for Regeneron, Tammy Allen, cited the U.S. Food and Drug Administration’s Emergency Use Authorization (EUA). Per that EUA, the U.S. government is responsible for distributing the product.

The Tennessee Star asked Allen Wednesday under which circumstances would her company sell monoclonal antibody treatments to the states and to private hospitals. She did not answer, but she did say why her company delivers the treatments only to the feds.

“Regeneron cannot utilize other distribution channels unless the EUA is revoked or terminated – as in, the circumstances have changed (we’re no longer in a pandemic and the ); the U.S. government changes the scope of authorization under EUA (as they’ve done with other COVID-19 monoclonal therapies) or a full FDA approval, etc.,” Allen told The Tennessee Star via email Wednesday.

Eli Lilly spokeswoman Allison Howell also said hospitals cannot purchase monoclonal antibody treatments directly from her company.

“As long as [the] supply of neutralizing antibodies is constrained, we believe the only way to ensure equitable access is for Lilly to contract directly with governments and pan-national philanthropic organizations,” Howell said via email.

“These institutions are best positioned to direct our antibody treatments to the patients who need them most.”

The Star emailed Tennessee Governor Bill Lee’s office Wednesday. We asked that he or his staff members comment on what, if anything, the governor is doing to help Tennesseans who may need the treatment but cannot get it from the federal government. Members of Lee’s staff did not reply before Wednesday’s stated deadline.

Forbes reported Tuesday on Tennessee’s need for monoclonal antibody treatments.

“Tennessee and Alabama are among a group of Southern states whose heavy reliance on antibody treatments prompted the federal government to introduce new limits on distribution earlier this month,” the website reported.

“Texas, Florida, Mississippi, Tennessee, Georgia, Louisiana and Alabama, most of which have vaccination rates below the national average, were using up 70 percent of the country’s supply of the treatments, Politico reported. A senior Department of Health and Human Services official told Forbes the country had to temporarily move to a system where it was allocating the treatments to states to stave off shortages while the government worked to increase supplies.

Tennessee Department of Health officials said this week that only the unvaccinated should take monoclonal antibody treatments.

Tennessee State Representative Scott Cepicky (R-Culleoka), discussed monoclonal antibody treatments at a rally last week. There, hundreds of Tennesseans expressed their displeasure with COVID-19 mandates and the lack of a special session of the Tennessee General Assembly to fight them.

“We have reached the point in escalation where the federal government is targeting the great state of Tennessee,” Cepicky said.

“They are rationing our monoclonal antibodies that can save Tennesseeans. They are telling you what you have to do to your body. It’s time to say enough.”

The Epoch Times reported Tuesday that Tennessee health officials recommend that only the unvaccinated get monoclonal antibody treatments because of federal government rationing.

In May, the FDA granted Emergency Use Authorization (EUA) to a monoclonal antibody product used for treatment of COVID-19 manufactured by GlaxoSmithKline and Vir Biotechnology.

Tennessee State Senate Majority Leader Jack Johnson (R-Franklin) is scheduled to appear on The Tennessee Star Report with Michael Patrick Leahy radio program Thursday morning to discuss the issue.

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Chris Butler is an investigative journalist at The Tennessee Star. Follow Chris on Facebook. Email tips to [email protected].
Photo “Lab Testing” by Regeneron.