WASHINGTON — The Food and Drug Administration on Monday revoked its already controversial emergency use decision for the malaria drug hydroxychloroquine — an eyebrow-raising reversal that has sweeping implications for how America responds to Covid-19.

The decision, which flies in the face of President Trump’s own touting of the medicine as a treatment for Covid-19, is more than just a stunning rebuke of a president by his own administration. In fact, the decision is likely to impact everyone from governors who scrambled to assemble stockpiles of the drug for their states, to patients asking their family physician for a chance to try the drug.

And though it seems to settle scientific questions about the drug — mounting evidence has already shown the drug is not effective at treating either patients already infected with Covid-19 or as a preventative treatment— it’s worth noting that there are still over 100 active and recruiting clinical trials meant to test hydroxychloroquine as a treatment for the disease caused by the novel coronavirus. The FDA warned that the drug is “unlikely to be effective in treating Covid-19,” and highlighted “serious side effects,” but the decision could have a lasting impact on public confidence in the agency and its independence.

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Below, STAT answers some of the burning questions arising out of the surprise decision.

What does the FDA’s decision actually mean?

It means that the FDA no longer has confidence that hydroxychloroquine is an effective treatment for Covid-19.

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The FDA, in deciding to revoke the authorization for hydroxychloroquine and chloroquine, is saying loud and clear that the drug no longer meets the approval criteria for an emergency use authorization. Those criteria require that it “is reasonable to believe that the product may be effective” and “the known and potential benefits outweigh the known and potential risks.”

“Probably the most important thing it does is the message [it sends],” said Jessie Goodman, a former FDA chief scientist who now is a senior scholar at Georgetown University. “It should make hospitals, doctors, patients and families really think twice.”

From a policy perspective, Monday’s news means that the Strategic National Stockpile will no longer distribute doses of hydroxychloroquine and chloroquine to hospitalized patients being treated for Covid-19.

Hospitals are also being encouraged to wind down using any of those drugs that they have on hand for Covid-19 patients. In an FDA frequently-asked-questions document, the agency said that hospitals who have already begun treating existing patients with hydroxychloroquine provided from the stockpile can continue doing so, but that treating new patients with these drugs is no longer “authorized.” It remains to be seen, however, how the FDA will force hospitals to not begin new patients on these drugs.

“Chloroquine and hydroxychloroquine no longer remain authorized for emergency use if such treatment was not initiated prior to FDA’s revocation of the EUA for these products. FDA recommends against the use of hydroxychloroquine for new hospitalized patients to treat COVID-19 outside of a clinical trial,” an FDA spokesperson told STAT in a statement.

Importantly, FDA’s decision to revoke the emergency authorization does not revoke the drug’s approval for other treatments, including lupus and malaria.

My state has its own stockpile, what happens to that?

More than 20 states have created their own stockpiles of hydroxychloroquine. Those are now in limbo.

Technically speaking, there may not be any legal reason for states to abandon their stockpiles, so long as they relied on donations of FDA-approved versions of these drugs or purchased FDA-approved versions of the drugs directly from manufacturers.

It remains to be seen, however, whether states will still want to stand behind hydroxychloroquine. STAT reached out to nearly a dozen states for comment on the FDA’s decision on Monday. A spokesperson for North Carolina told STAT that the state “is making an assessment about what [to] do with the supplies that we have on hand.” Spokespeople for Texas and New York said similar, but noted that their states have not distributed any doses from their stockpiles since late April. And a spokesperson for Louisiana said it is contacting manufacturers to see if they can send the drug back.

Can a patient who wants to take hydroxychloroquine still take it?

Yes, so long as they can find a doctor who will write them a prescription. The FDA doesn’t police so-called off-label prescribing, where a doctor uses an FDA-approved drug to treat a condition or other ailment that the drug isn’t approved to treat. Since hydroxychloroquine is approved  to treat malaria and lupus, doctors can use it to treat any condition they want, including Covid-19. The FDA’s decision to revoke this authorization doesn’t take that right away.

“Withdrawing the emergency use authorization may have relatively little practical impact,” said Rachel Sachs, an associate professor of law at Washington University in St. Louis, citing the fact that doctors can still prescribe hydroxychloroquine off-label.

It remains to be seen, however, whether the FDA’s decision will make doctors more reluctant to indulge patients who demand the treatment. After all, the FDA already warned doctors in April that the drug shouldn’t be used outside of a clinical trial because of potentially serious side effects, but that didn’t stop some doctors from prescribing it. The question remains: If that warning did not dissuade doctors, will something as seemingly obscure as revoking an “emergency use authorization?”

Is this a political nightmare for Republicans?

Democrats certainly hope so.

Hydroxychloroquine has become a focal point in a number of congressional races, with Democrats criticizing several Republican lawmakers and hopefuls for being enthusiastic about the drug before there was evidence to support it as a treatment for Covid-19. Already there are signs that Monday’s decision from the FDA is only likely to bolster that criticism.

The Democratic Congressional Campaign Committee has issued press releases slamming Republican congressional candidates Mariannette Miller-Meeks and Rich McCormick, both of whom have been targeted by the Democratic campaign arm for supporting hydroxychloroquine. 

“As FDA Ends Emergency Use Authorization for Hydroxychloroquine, Will Miller-Meeks Finally Apologize for Touting It?” one press release states.

Trump, who has repeatedly pushed the drug and even took it himself for two weeks is taking flak too. Congressional Democrats pounced on the president Monday.

“America: Do not listen to President Trump on any medical advice. His own FDA is rejecting his advice on hydroxychloroquine,” Senate Minority Leader Chuck Schumer of New York tweeted.

Whether these criticisms stick, however, depend on voters’ minds being changed by the FDA’s announcement. Already there are signs that FDA warnings aren’t enough to convince voters that hydroxychloroquine doesn’t work. A May poll from Morning Consult and Politico found that 24% of voters strongly supported or somewhat supported use of the drug, despite the FDA’s warnings that it shouldn’t be used outside of a clinical trial. Another 31% were unsure.

Should the FDA be chided or celebrated for today’s decision?

It depends on who you ask.

The FDA’s decision to issue the emergency ruling in March was widely condemned by public health experts, who said the authorization implied the FDA was giving its stamp of approval, despite a dearth of evidence. Now those experts are split on whether Monday’s news was good or bad for the agency.

Goodman, the former FDA chief scientist, applauded Monday’s decision.

For FDA boosters like Goodman, Monday’s decision is a clear sign that the agency is willing to stand up to political pressure and do what’s right for public health. “I’m hopeful that this reassures the public and sends a strong message of [the FDA’s] independence,” Goodman said.

But not everyone sees it that way.

Peter Lurie, a former FDA associate commissioner who now leads the Center for Science in the Public Interest, previously called for the emergency use ruling’s retraction. While he said Monday’s news was welcomed, he called it “a black eye for the agency.”

“It was a mistake,” Lurie said. “Large numbers of patients were not benefited by the drug and some subset of them were actively harmed. The whole thing when you look back on it is a very regrettable episode.”

Lurie noted that this isn’t the first time the agency has been forced to walk back a decision it made during Covid-19. In March, the agency told manufacturers of Covid-19 antibody tests that they didn’t need an emergency authorization to market their products, only to change its mind three months later, he noted. For those critical of the FDA, this is the latest in a series of missteps in responding to Covid-19.

Is hydroxychloroquine-mania over?

Enthusiasm seems to be waning, but it’s too soon to say it’s over.

For weeks there have been mounting signs that hydroxychloroquine was not the “game changer” that many, including Trump, had hoped it would be. In recent weeks a preprint of a U.K.-government study found “hydroxychloroquine does not reduce the risk of death among hospitalized patients” and another study published in the New England Journal of Medicine, the first double-blind randomized, placebo-controlled trial of hydroxychloroquine, found the drug doesn’t protect people who’ve been exposed to Covid-19.

But it remains to be seen how conservatives, who have touted the drug in recent days despite mounting evidence that it does not work, will respond to Monday’s news. Conservative commentators and some of Trump’s biggest high profile backers were largely silent over the news Monday.

Interest in the drug could also grow again as more clinical trials readout. There are still over 100 active or recruiting clinical trials testing hydroxychloroquine as a Covid-19 treatment, according to clinicaltrials.gov. FDA’s decision has no impact on those clinical trials, and if one or more have positive results, that could reignite interest over the drug.

  • The HCQ debate is far from over & not one the liberal media here can silence. The simple fact is that the trials that have been referenced for discrediting it’s use to reduce satuation of COVID-19 in the lungs have not followed any where close to guidelines defined in the anecdotal reports of it’s successful usage. Those reports from nations like France led to massive petition drives (100-500K signatures) in many nations lobbying their governments to make HCQ readily available for COVID-19 treatment.

    What’s worse is that the trials in question for discrediting HCQ treatment of COVID-19 saturation in the lungs have used what many consider “lethal” doses of the drug. Pres Trump is taking just 200mg of HCQ & other combinants to prevent the saturation of COVID-19 in his lungs should he become infected with SARS-V2. These trials used over 2000mg of HCQ daily. I’m not aware of a single anecdotal report of successful usage of HCQ
    using any where close to that dosage. That is medical malpractice & a waiver is not going to protect the parties involved. When the families of the dead in these trials learn about these lethal doses there will be protests & calls for class action lawsuits against the physicians that conducted them.

    Liberals were caught with their pants down over the Brexit movement & this
    HCQ movement is showing similar signs. While the FDA has discredited mainly based on trial data where lethal doses & other irresponsible behavior occured, both the number of clinical trials & stockpiles continue to grow.
    This has the potential to devastate the DNC & other parts of the liberal establishment world over both now & in the near future. If I were them I would at least leave the door open as to the promise of HCQ vs COVID-19 in the lungs when used RESPONSIBLY.

  • This drug DOES work and there have been hundreds of patients in the US alone who were very sick with Covid and within 2 days they were remarkably better. So, for the FDA to come out this with statement is such a political move by the Liberals; shame on the FDA for playing the politics game. Very disappointed in you.

  • I am 81 yo and am not presently infected with the CoVid-19 Corona Virus. There seems to be two schools of thought on the efficacy of using the drug hydroxychloroquine as a preventative drug used to treat this Corona Virus due to politics entirely. I.e. Whether the FDA is caught up inthi political hysteria is
    caught up in this political argument is in many minds of concern to people such as myself.
    Can you say in good conscience and without a conflicted political influence/opinion that this drug-Hydroxychloroquine has been cleared for the general public to take without dangerous side-effects without your decision being affected with the recent political arguments posed by both the Democratic and Republican Parties?
    Your answer will be greatly appreciated as I am truly concerned for my health at my very critical and susceptible age.

  • Am George Donald God bless Dr. Okasi for his marvelous work in my life, I was diagnosed of HERPES 6 years ago and I was taking my medications, I wasn’t satisfied i needed to get the HERPES out of my system, I searched out some possible cure for HERPES i saw a comment about Dr. Okasi, how he cured HERPES,DIABETES,HIV,EX_LOVER BACK and CANCER with his herbal medicine, I contacted him and he guided me. I asked for solutions, he started the remedy for my health, he sent me the medicine I took the medicine as prescribed by him and 14 days later i was cured from HERPES, Dr. Okasi truly you are great, do you need his help also? Why don’t you contact him through his EMAIL: okasiherbalsolution @ outlook. com or his website: okasisolutiontemple. webs. com.

  • Uhh, the actual letter for which this FDA revocation is based, from RADM Denise Hinton (the chief scientist at the FDA), literally states that early studies/observations related to the use of Hydroxychloroquine showed “decreased viral shedding”. In the context of a public health emergency in which 2 million Americans were expected to die, initial studies that looked promising lead to the emergency authorization in the first place. Democrats have been, and still are, arguing that this wrong. Had Obama been on the Hydroxychloroquine bandwagon, they’d be passing the stuff out on every street corner.

    The excellent summation by Dr. Abeles below shows the power of this medication, and the flaws of the studies that were used to issue this revocation. The fact that numerous clinical trials are still underway is important…at least the author did not exclude the fact that studies are ongoing…so some credit given there for trying to be unbiased, but this whole FDA issue is messy, and political pundits/mouthpieces are attempting with all their might to reduce this evolving situation into scoring cheap political points. The drug is safe…has been for six decades. It has antiviral properties. It showed promise in initial studies. The President was expressing optimism about it being a valuable option for treatment. At the time, all of that was true. It may STILL be true, and until the clinical trials are complete, we won’t know for sure.

    But when it comes to political posturing, selective hindsight is always 20/20.

    • Brian,

      With all due respect. Why worry about “decreased viral shedding” at all? If anyone was tested to be positive and begins to show symptoms, quarantine the heck out of them. Just give them remdesivir (if available and affordable) to slow down viral replication, immunosuppressants such as dexamethasosne, actemra (IL-6 inhibitor) to reduce cytokine storm or hyperinflammation, then observe and hope for a good outcome.

      After all, we are supposed to be the most advanced nation in the world about health care right?

      Trump, Republicans, Obama, Democrats. Who the heck cares! With the election coming, do you really expect both sides not to politicize the entire covid-19 pandemic?

      Why not redirect the money saved from defunding the WHO and give it to Gilead to donate more remedesivir? Or alternatively stockpile HCQ and let every covid-19 testing sites to give them out free with every test kit? Better yet to buy up Rutgers University’s amazing saliva test kits for home use for every9ne suspected of exposure and exhibiting symptoms, focusing on the elderly, those with underlying medical complications such as type 2 diabetes, heart conditions, obese, undergoing chemotherapy, etc.?

      Merely arguing on the merits of initial HCQ studies and objecting to the FDA revocation absolutely do not do anything on this topic and would not affect public health in any way, shapte, or form.

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