- A number of drugs to treat COVID-19 have received emergency use authorization from the Food and Drug Administration this year.
- Experts say the emergency authorizations can help quicken the availability of treatments, but they can also put medications into the health system before they’ve been fully tested.
- They added that any time a drug creates health concerns after it’s distributed, that erodes public trust in the process.
During a military, domestic, or public health emergency, the federal government has the power to allow medical treatments to move forward without following the normal regulatory procedures required by the Food and Drug Administration (FDA).
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The EUA process has been back in the news this week with the FDA
In addition, Pfizer officials say they’re preparing to ask for an EUA for their new COVID-19 vaccine.
However, these EUAs don’t come without drawbacks.
The fast-tracking of treatments can lead to nonoptimal therapies being administered and sucking up hospital resources as well as helping widen already existing health inequities, according to a new
For instance, in the case of remdesivir, an antiviral approved for COVID-19 treatment, a news release touting the benefits of the medication was published before any clinical data.
It was
“The news release and distribution of remdesivir, which started on May 5, occurred three weeks before any primary clinical data were published or made publicly available,” the opinion column authors wrote.
“What followed was predictable — hospitals were tasked with providing a limited supply of medication without knowing which patients might benefit most and if the drug actually decreased mortality or other important outcomes,” they wrote.
In the case of remdesivir, while it’s still an approved treatment for COVID-19, a recent World Health Organization study suggested the drug may have little effect on patient outcomes.
All that said, a number of experts say the benefits of EUAs often outweigh the risks.
“Currently, we have no major defenses against the virus, and it is a race against time as the pandemic continues to take more lives and hurt people,” said Dr. Purvi Parikh, an allergist and immunologist with the Allergy and Asthma Network and a co-investigator on COVID-19 vaccine trials.
“Even without death, severe COVID-19 can lead to irreparable consequences such as stroke, lung failure, chronic lung disease, kidney failure, clotting, and neurological problems,” she said.
“The concerns and drawbacks are we do not have the luxury of time to collect more data before it is widely used,” Parikh told Healthline.
Other experts echoed this concern.
“One main concern is the possibility that a medication with an EUA for COVID-19 may later turn out to be not as effective as first thought,” said Christine Cheng, PharmD, a clinical pharmacist at First Databank, which provides drug and medical device databases.
“This is because an EUA is initially granted based on safety and effectiveness data available at the time. In cases where new scientific evidence no longer supports use of the medication for the authorized use, the FDA can revoke the EUA,” she said.
That exact scenario happened with hydroxychloroquine, a malaria drug that a small study touted as an effective COVID-19 treatment, attracting the attention of President Donald Trump.
But that EUA was later revoked, as further research determined the drug wasn’t an effective treatment and the risks of taking it outweighed any benefits.
“It’s important to remember that revocation of the EUA applies only to the authorized use specified in the EUA which, in this case, was treatment of COVID-19,” Cheng told Healthline. “The other FDA-approved uses for chloroquine and hydroxychloroquine were not affected and are still valid.”
Even so, the approval and revocation of a treatment can lead to confusion and mistrust in both the treatment itself and the regulatory process in general.
“My biggest concern is that one bad story will destroy it all,” said Matthew Putman, PhD, CEO and co-founder of the science technology company Nanotronics, which used the EUA process when building a non-invasive breathing device called nHale for COVID-19 treatment.
“If there is any security problem in a factory, or if a supply chain is disrupted, and suddenly people are not getting safe drugs or devices that they know exist, it has the potential to stop everything,” he said.
“This is where we, as companies, need to hold ourselves to higher standards than regulatory bodies would,” Putman told Healthline.
Another issue with EUA-approved drugs and treatments is that they can reflect and exacerbate already existing inequities in the health system, experts say.
For instance, while monoclonal antibody therapy, created by pharmaceutical company Regeneron, could help boost the immune system in fighting COVID-19, its distribution and administration could tax outpatient clinics.
“The currently studied monoclonal antibody preparations require a 1-hour intravenous infusion [and] the hospitals and clinics that can currently provide infusions of therapeutics generally do so in dedicated facilities previously reserved for delivery of immune-suppressing biologic agents and chemotherapy,” the JAMA authors wrote.
On November 30, 2022, the
Meanwhile, unknowns about the drug’s pricing structure could leave uninsured and underinsured patients on the hook for large bills, even if they can receive the therapy.
“Nearly 8 million U.S. residents have lost their employer-sponsored health insurance due to the COVID-19 pandemic, worsening disparities in insurance coverage for Black and Latinx people, and leaving those with the highest rates of infection unable to afford the best possible treatment,” the authors wrote in JAMA.
Cheng agreed.
“Testing and treatment must be made more accessible and affordable, especially for populations most vulnerable to severe COVID-19 infection,” she said.