There is only one drug to treat monkeypox. Good luck getting it.

Doctors wishing to prescribe tecovirimat, or Tpoxx, must navigate a gauntlet of bureaucratic hurdles that experts say could be quickly cleared.

The only drug available to treat monkeypox is so difficult to access that only a fraction of the nearly 7,000 patients in the United States have received it.

Health officials have designated tecovirimat, also known as Tpoxx, an "experimental drug," which they say means it cannot be released from the national strategic stock without a series of complicated bureaucratic steps. But most doctors don't have the time or resources to complete the required 27-page application or provide the detailed patient information.

doesn't have to be that way, experts say: No law prevents federal authorities from changing these rules and making the drug more widely available.

La Food and Drug Administration approved tecovirimat as a treatment for smallpox in 2018, based on safety data in humans and efficacy data in primates – which, for the purposes of the trial, were actually infected with monkeypox. The so-called animal rule allows the agency to approve drugs when testing them on people would be unethical.

Until the current outbreak , tecovirimat was rarely given to patients with monkeypox. As a treatment for smallpox, its use against monkeypox is considered experimental. But vaccines developed for smallpox were assumed to be effective against both diseases. Why not the treatment?

Experts say F.D.A. are a political choice that can be quickly changed.

"The bureaucracy to access Tpoxx is excessive given the crisis the United States is facing with monkeypox said Larry O. Gostin, public health law expert and 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 drugs that can help them," he added.

The Department of Health and Human Services declared monkeypox a national health emergency on Thursday. But Secretary Xavier Becerra failed to take an extra step that would have allowed the F.D.A. to grant emergency use authorizations for vaccines and treatments, as the agency did during the coronavirus pandemic.

In a article published Wednesday in the New England Journal of Medicine, federal health authorities have defended their decision to treat tecovirimat as an investigational drug.

While acknowledging that the animal data were promising and the drug appeared to be safe in healthy patients, they wrote that, without large clinical trials, "we will not know whether tecovirimat would benefit, harm, or have no effect in people monkeypox."

"At this time it is not known if or how well this drug works for patients with monkeypox," said said Kristen Nordlund, spokesperson for the Centers for Disease Control and Prevention.

To provide Tpoxx only as an investigational drug with data from patients who use this drug,” she said. "This will ultimately help us understand who will benefit the most, what the real benefits are, and what potential risks there might be."

Restrictions on tecovirimat were even more complicated early in the outbreak, and — after numerous complaints from doctors — the C.D.C. relaxed some rules. But the system remains cumbersome.

Doctors with...