Aug. 10, 2022 – Federal officials declared monkeypox a national public health emergency on Aug. 4, following similar announcements from the World Health Organization and leaders in California, Illinois, and New York.

But that's apparently not enough to ease access to the FDA–approved antiviral drug tecovirimat known as TPOXX, according to Garrett Wilkinson, a government relations and policy officer with the nonprofit Partners in Health.

Tecovirimat was developed and approved to treat smallpox, and the United States has 1.7 million courses in the Strategic National Stockpile. It is available free of charge to treat the related virus monkeypox through the CDC, which has said tecovirimat may be considered for people who have or are at risk for severe disease.

Despite that, the drug can be hard to access, according to news and social media accounts of patients and advocates. The CDC requires health care providers who want to prescribe the drug to provide extensive paperwork through what’s known as an expanded access investigational new drug (EA-IND) protocol.

Though the agency simplified the protocol (also called "compassionate use") in late July, it is still more work for providers than if tecovirimat were available from pharmacies.

The result has caused delays and sometimes even outright lack of availability.

"Physicians are able to prescribe medication off-label. The only reason they're having to do an investigational drug protocol to access TPOXX is because it's being held entirely in the Strategic National Stockpile," Wilkinson says.

He is among a number of activists and researchers who have urged the federal government to ease access.

"It's absurd to make doctors fill out mountains of federal paperwork during a public health crisis to prescribe a drug the FDA has fully approved and deemed safe," Wilkinson says.

HHS Secretary Xavier Becerra can declare that an emergency use authorization for the drug is appropriate. Having an emergency authorization for tecovirimat would ease the burden on providers.

Instead, Becerra declared a public health emergency..

That is a different action and does not allow the FDA to declare an EUA.

The US marked its first case of monkeypox on May 18.. As of Aug. 3, there have been 6,617 U.S. cases.

Plenty of Tecovirimat -- for the Government

New York City–based SIGA developed tecovirimat after the 9/11 attacks, says chief scientific officer Dennis Hruby.

With safety data in hundreds of healthy adults as well as efficacy data for monkeypox in nonhuman primates, the drug earned FDA approval in 2018 for the treatment of smallpox.

The U.S. has stockpiled the drug since 2013, Gomez says, and the company is resupplying the national stockpile as the oldest batches hit their 7-year expiration date. The company delivered 363,000 courses to the U.S. in 2020-2021, he said, and it can increase that number to more than 500,000 courses a year.

Now, the company is starting up clinical trials and is ready to ramp up production as needed, Hruby said.

But despite being FDA-approved and abundant, the drug remains a challenge for providers and patients to access. This isn't the case in other countries. The drug was licensed in 2022 by the European Medicines Agency to treat monkeypox and is also approved for monkeypox in the United Kingdom.

Hruby said SIGA also supplies Canada and is working to respond to "inquiries from around the globe" for compassionate-use courses of the drug.

The company is well aware of the U.S. bottlenecks.

"I think there's a lot of frustration in the impacted communities," Gomez says. "They haven't been able to access the drug as fast and as speedy as they would have liked."

TPOXX was always intended to be sold to governments to hold in the event of an outbreak, Gomez says.

'Loyalty to Bureaucracy'

There is precedent for easier access to medications during outbreaks — including those without FDA approval, says Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health, who spoke.

Paxlovid is not FDA-approved, but its emergency use authorizations allows doctors to prescribe it for COVID-19. Moreover, during the 2009 H1N1 influenza outbreak, unapproved peramivir was made readily available under an EUA. 

"The bottleneck is not supply of TPOXX. The bottleneck is the requirements that government has put in place in order to prescribe it," Adalja says.

On July 15, a group of concerned experts sent a letter to HHS, CDC, and FDA. The signers included representatives from the HIV advocacy organization PrEP4ALL, Partners in Health, and researchers and doctors at New York University and Weill Cornell Medicine.

In the letter, the signers asked that CDC rescind its protocol requirement to release TPOXX from the national stockpile — or that FDA authorize TPOXX for monkeypox through the emergency use authorization process.

Neither appears to have yet occurred.

An FDA-approved version of injectable artesunate is available, and the CDC will no longer be providing non-FDA-approved artesunate as of September 30.

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