FDA Experimental Virus Drug Policy Highlights Right to Try Issue

March 19, 2020, 7:35 PM

The FDA’s ability to collect data on whether experimental treatments for Covid-19 are effective spotlights pitfalls in a two-year-old controversial drug law called Right to Try.

The agency is letting patients with Covid-19 try drugs that aren’t approved for it through its “compassionate use” pathway. That lets the Food and Drug Administration cull information about which treatments are effective or have potentially dangerous side effects and gives it a hand in how patients are treated.

That’s crucial as scientists race to fine a viable treatment for Covid-19, according to FDA Commissioner Stephen Hahn.

The desire is to give patients hope “but not false hope” about a treatment for Covid-19, as the disease caused by the new coronavirus is known, Hahn said at a press conference Thursday. Even if a drug could be effective in treating the virus, an incorrect dosage “may do more harm than good,” he said. Some of the drugs the FDA is trying to fast track to treat Covid-19 include a Gilead treatment called remdesivir and chloroquine, a malaria drug.

Right to Try, by contrast, lets patients pursue unapproved treatments—but without FDA oversight. Reporting requirements are also less robust. It was intended to give terminally ill patients access to drugs that hadn’t secured full FDA approval.

An important component of the compassionate use pathway but not Right to Try is that, “We get to collect the information” on the drugs, Hahn said. “One of the things we’ve promised is we will collect the data and make the absolute right decisions about that data on safety and efficacy of these treatments,” he said.

Renewed Push for Right to Try

Groups like the Goldwater Institute, a libertarian policy think tank, lobbied for Right to Try as something that would cut red tape for needy patients lacking other treatment options. On Tuesday, the institute released a statement urging policymakers to expand Right to Try even further amid the new coronavirus outbreak. It’s unclear what such an expansion would look like.

“For patients who have either become infected, are at high risk, or simply wish to inoculate themselves from the COVID-19 virus, patients, under their physician’s care, should be allowed to access treatments and vaccines prior to government approval, if and when they are made available by manufacturers,” the group said in the statement.

Critics say Right to Try is unnecessary and exposes patients to heightened risk.

Holly Fernandez Lynch, a professor of medical ethics at Perelman School of Medicine at the University of Pennsylvania, called Right to Try a “dangerous and unnecessary pathway” because there aren’t any “meaningful” requirements to collect and report safety data.

The FDA’s compassionate use pathway, on the other hand, “adheres to the safety reporting requirements that apply to clinical trials and that’s what we need—both in pandemics and always,” she said.

“Giving patients unapproved products for treatment use is sometimes a reasonable thing to do, but we have to keep a close eye on what happens and try to learn what we can,” Lynch said.

Trump & Right to Try

President Donald Trump was a strong supporter of Right to Try, which he predicted would save “thousands and thousands, hundreds of thousands,” of lives.

“We’re going to be saving tremendous numbers of lives,” Trump said after signing the bill in May 2018. So far, that hasn’t happened. There are reports of patients accessing drugs with Right to Try, but not nearly as many as Trump or other supporters initially suggested.

For now, the FDA is using its own resources to get patients access to potential treatments.

“We need the data, we need the information to make the absolute best decision for the American people,” Hahn said.

—With assistance from Jeannie Baumann

To contact the reporter on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Melissa B. Robinson at mrobinson@bloomberglaw.com

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