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How Will The U.S. Distribute COVID-19 Antibody Drugs If They Get FDA Approval?


The Food and Drug Administration is evaluating two potential drugs that could help keep people healthy after they've been infected with the coronavirus. The FDA has not yet authorized them for emergency use. And so far, there is no clear system for how to allocate them fairly or how to pay for these expensive products. NPR science correspondent Richard Harris reports.

RICHARD HARRIS, BYLINE: There's a lot more to getting a drug on the market than cranking up a factory and getting FDA's stamp of approval. In the case of these drugs, which are called monoclonal antibodies, one of the most urgent questions is to figure out how to allocate scarce supplies.

RENA CONTI: Demand is going too far outstrip supply here.

HARRIS: Rena Conti at Boston University's Questrom School of Business says even though manufacturers are gearing up to produce more than a million doses before the end of the year, millions more newly infected Americans might be clamoring for these medications. President Trump got a dose of one of these drugs and has since told Americans that they, too, could get it at little or no cost, but Conti doubts that.

CONTI: That is unprecedented in its statement. It's not realistic.

HARRIS: The drug itself could be free at first, but Conti says it's expensive to administer. It's given by IV infusion. Even people on Medicare have copays for many infused medicines. If that pattern holds, the copay for these COVID drugs could be many hundreds of dollars, considering Conti's estimate of a price tag around $2- to $10,000 per treatment.

Then there's the question about how to allocate limited supplies. Dr. Jewel Mullen at the University of Texas Dell Medical School suggests using principles she helped develop for the National Academy's study of COVID vaccines. That would mean giving highest priority to health care workers.

JEWEL MULLEN: And first responders because we need them to be well - they're protecting us all the time. They're putting themselves at risk all the time.

HARRIS: Mullen says the drug should then go to vulnerable people who stand to benefit most, keeping the people at highest risk out of the hospital.

MULLEN: Maximize the benefit. Make sure everyone's valued and thought about equally, and address health inequities.

HARRIS: That means making sure populations hard-hit by the pandemic, often poor and people of color, get fair access regardless of the cost of these medications. But equitable distribution has been a huge challenge, with another scarce COVID drug, remdesivir, says Erin Fox, a pharmacist at the University of Utah.

ERIN FOX: You know, I think about all of the problems that we had with remdesivir, and that was for a pretty narrow patient population.

HARRIS: At first, it was reserved for seriously ill people in intensive care units. The antibodies, by contrast, would be given to many more people - those who just got infected and aren't in the hospital. If demand sharply outstrips supply, Fox figures hospitals would be hard-pressed to follow a rubric based on equity.

FOX: If the amount that we get is so small, it's probably very likely that we would just use it for a short period of time and just use it up and not try to make some really difficult rationing decisions.

HARRIS: Another huge challenge is figuring out how to get these drugs to wherever they are needed most, says Nada Sanders, who studies supply chains at Northeastern University. The federal government plans to send supplies to each state.

NADA SANDERS: The answer of simply saying, we're going to leave it up to the state, is not an answer.

HARRIS: Distribution itself is complicated and costly. These drugs must be shipped in temperature-controlled trucks and sent to destinations that are equipped to handle them gingerly. And they need to go to rural areas coping with outbreaks.

SANDERS: At the end of the day, someone has to pay for this.

HARRIS: If the federal government has a plan for that, it hasn't been revealed. And the clock is ticking. The FDA has been considering emergency use applications from Regeneron and Eli Lilly for two weeks now, and there's no saying how soon those deliberations will end.

Richard Harris, NPR News. Transcript provided by NPR, Copyright NPR.

Award-winning journalist Richard Harris has reported on a wide range of topics in science, medicine and the environment since he joined NPR in 1986. In early 2014, his focus shifted from an emphasis on climate change and the environment to biomedical research.

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