The only drug available to treat monkeypox is so difficult to access that just a fraction of the nearly 7,000 U.S. patients have been given it.
Health officials have designated tecovirimat, also called Tpoxx, an “investigational drug,” which they say means it cannot be released from the strategic national stockpile without a series of convoluted bureaucratic steps. But most doctors do not have the time or resources to fill out the required 27-page application or to provide the detailed patient information.
It does not have to be this way, experts say: There is no law preventing federal officials from changing those rules and making the drug more widely available.
The Food and Drug Administration approved tecovirimat as a smallpox treatment in 2018, based on safety data in people and efficacy data in primates.
Until the current outbreak, tecovirimat was given only rarely to monkeypox patients. As a smallpox treatment, its use against monkeypox is considered experimental. But vaccines developed for smallpox have been assumed to be effective against both diseases. Why not the treatment?
Experts say the FDA’s restrictions are a policy choice that can be quickly altered.
“The bureaucracy of gaining access to Tpoxx is excessive given the crisis the U.S. is facing with monkeypox,” said Larry Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University.
“The law gives the agency considerable flexibility to use scientific assessments to ensure those in need get the medication that can help them,” he added.
The Department of Health and Human Services on Thursday declared monkeypox a national health emergency. But Secretary Xavier Becerra did not take an additional step that would have allowed the FDA to grant emergency use authorizations for vaccines and treatments, as the agency did during the coronavirus pandemic.
“At this time, it’s unclear if or how well this drug works for monkeypox patients,” said Kristen Nordlund, a spokesperson for the Centers for Disease Control and Prevention.
Providing Tpoxx only as an investigational drug “ensures we have data from patients who use this drug,” she said. “This will ultimately help us understand who will benefit most, what the true benefits are and potential risks there might be.”
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