The Food and Drug Administration will pull out all the stops when it comes to approving treatments for COVID-19, President Donald Trump said Thursday, but it is unclear what policy changes are being pursued outside of the agency’s existing procedures.
FDA Commissioner Stephen Hahn said the agency hoped that drugs already approved for other uses might be safe and effective in treating the novel coronavirus, and he encouraged doctors to consider the FDA’s “compassionate use” process to treat patients with experimental products.
The FDA didn’t reply to questions about Trump’s comments that potential treatments would be made available “almost immediately” or how data collected in foreign countries might inform the FDA’s decisions.
Trump gave an optimistic timeline for the deployment of two treatments: remdesivir, an experimental HIV and antiviral drug that has not yet been approved by the FDA, and hydroxychloroquine, a drug approved to treat malaria and arthritis.
“Clinical trials are already underway for many new therapies, and we are working on scaling these to allow many more Americans to access different drugs that have shown good progress,” Trump said.
But Hahn suggested that both products would only be available through some of the FDA’s current protocols until they were formally approved. Remdesivir, from drug company Gilead, is currently being tested in patients in Phase 3 clinical trials in the United States and China, and Hahn said he hoped clinical trials would be pursued to find out if hydroxychloroquine is effective.
Hahn also said the agency was looking at how to accelerate development of so-called “convalescent plasma.” He described it as a method of collecting blood from previously infected patients who have recovered, then concentrating that blood and using it to treat other patients.
Hahn said he hoped these tools might provide relief for COVID-19 patients and provide a bridge for three to six months before anything is officially approved.
Trump said hydroxychloroquine “has shown very encouraging early results” in treating COVID-19 and that his administration would “make that drug available almost immediately.”
Trump said he talked to governors about making the drug available to states, including a discussion with New York Democratic Gov. Andrew M. Cuomo on Wednesday night.
Yet Hahn wouldn’t commit to any timing for when hydroxychloroquine would be approved for treating COVID-19 or made available for that purpose. He said he wanted a clinical trial, which typically takes years.
“We want to be sure this is done well and right for the American people,” Hahn said. Because it’s a drug that has been around for a long time, he said, “We do have a lot of information about the side effects of the drug, so that really helps in terms of expediting it.”
But while he said that “we are working as quickly as we can,” he wouldn’t speculate on a timeline.
Fourteen companies make generic hydroxychloroquine, according to the FDA, and Sanofi makes a branded version marketed as Plaquenil. At least 14 companies make generic chloroquine, which is more toxic than hydroxychloroquine.
CQ Roll Call asked half a dozen companies if they were in discussions with the administration to ramp up supply, but none immediately responded.
Asked when remdesivir might be ready to come to the market, Hahn said that was proprietary information he could not share. Hahn said Gilead would supply more information to the public “relatively soon.”
But he encouraged practitioners to consider using the FDA’s compassionate use process to acquire remdesivir and treat patients. Those requests depend on the drug companies to cooperate and provide the drug, and while Gilead says it is considering requests, it appears to be prioritizing the most severely ill people.
“Gilead is currently assessing requests on an individual basis and require, at a minimum, that the patient be hospitalized with confirmed COVID-19 infection with significant clinical manifestations,” Gilead’s website says. The company didn’t reply to questions about how many compassionate use requests it has received or fulfilled in the U.S., nor did the FDA.
Trump likened the FDA’s approach to “Right to Try,” an approach championed by conservatives and libertarians that allows for patients with fatal illnesses to be treated with unapproved therapies. The key difference between “Right to Try” and FDA’s compassionate use is that doctors, patients and drug companies that participate don’t need to get the FDA to approve the individual course of treatment.
The “Right to Try” law signed by Trump in May 2018 came after years of opposition by the pharmaceutical industry, which was afraid that more liberal distribution of experimental drugs outside of controlled clinical trials could result in lawsuits or make it harder to win FDA approval if a patient’s condition did not improve or there were adverse side effects.
The final law provided protections for participating drug companies. But since it was implemented, there have been only a handful of instances of “Right to Try” being used, and most drug companies prefer to use the FDA’s compassionate use process. The agency says it typically approves the vast majority of requests expeditiously.
And the “Right to Try” policy was intended by lawmakers as a last resort for patients with a rare, lethal disease. Epidemiologists project that as much as 70 percent of the U.S. population could eventually be infected with the novel coronavirus, making the circumvention of typical safety standards more risky.
Hahn appeared to walk back the idea that “Right to Try” was the FDA’s desired approach in this case, arguing that the FDA needed the patient use data to make an informed decision about whether the drugs would ultimately be safe and effective for the broader population.
Trump also signaled some willingness to make greater use of trial research conducted in other countries in the FDA approval process but did not provide specifics about how that would work.
“We’re reviewing drugs that were approved abroad or approved here for other uses,” Trump said.
“If treatments that are known to be safe in Europe, Japan or other nations are effective against the virus, we’ll use that information to protect the health and safety of the American people,” he said.
Some of the president’s critics said the remarks were confusing and betrayed a lack of knowledge about how medicines come to market.
“At the White House press conference today, President Donald Trump continued to spew misleading, overly optimistic and often incoherent statements about potential treatments for the coronavirus that may be on the horizon,” Michael Carome, health research group director at the liberal consumer advocacy group Public Citizen, said in a statement.
It’s common for clinical trial data reviewed by the FDA to be conducted in foreign populations, so it was unclear what Trump meant by how the FDA would “use that information.” The FDA didn’t respond to questions about whether Trump meant that approvals made by foreign regulators would result in a U.S. approval.
Although hydroxychloroquine is an approved drug, Trump is promoting it for a use that hasn't been tested to treat COVID-19 using the FDA's gold standard for approval, a randomized clinical trial. There is some limited evidence that in combination with other therapies, it can be effective against other coronaviruses like SARS, and some early attempts to use it against COVID-19 have been promising enough for authorities in other countries like China and South Korea to recommend using the drug for treatment.
The White House did not respond to a request for more details, such as what research officials are studying to support the idea that hydroxychloroquine or chloroquine could be an effective therapy for COVID-19.
FDA is collaborating with other agencies and universities to investigate whether chloroquine can be used to treat some COVID-19 patients with mild to moderate symptoms. The drug may reduce the duration of the symptoms, the agency said.
There is evidence that chloroquine can treat COVID-19, Chinese researchers with the Wuhan Institute of Virology have found, but they say global production of chloroquine is more limited than hydroxychloroquine.
So far, there's little evidence yet supporting the use of hydroxychloroquine to treat COVID-19, according to the researchers.
Another study showed hydroxychloroquine in combination with another drug could be helpful, but the researchers only studied 42 people and the study was not a randomized clinical trial. An author of that paper was featured on Tucker Carlson Tonight on Fox News on Wednesday night, several conservative news outlets reported.
Sanofi, which makes the combination drug used in the French pilot study, said more research is needed.
"Keep in mind it is very important to highlight that to date there is insufficient clinical data to draw any final conclusions over the clinical efficacy or safety of hydroxychloroquine (or chloroquine) in the management of COVID-19," said spokesperson Ashleigh Koss.