June 16, 2020
By Naomi Lopez
While there is no FDA-approved treatment or vaccine for COVID-19, there are FDA-approved treatments for other illnesses that may be helpful in the battle against the virus. Today, there is new hope that there is an already available, inexpensive, and effective treatment that can change the course of this illness.
Dexamethasone is a generic anti-inflammatory steroid and is FDA-approved to treat a broad range of illnesses including osteoarthritis, asthma, and dermatitis. And it’s possible it might have an additional use: Led by researchers at the University of Oxford, a large-scale study conducted in the UK found that this common steroid reduced death by about one-third (35 percent) among seriously ill, hospitalized patients who required oxygen. (It is FDA-approved to be administered orally and intravenously and was administered both ways to the study’s patients.)
If the findings are validated and confirmed with additional clinical evaluations, this will be the most significant advancement in the fight against COVID-19 to date. Importantly, this off-label treatment is now likely to immediately become the standard of care for hospitalized COVID-19 patients who require oxygen.
While more study is needed, this treatment is legal and requires no additional FDA authorization or approval to treat patients today. That is because when a drug is prescribed is written for an indication other than an FDA-approved indication, then it is being prescribed off-label. Roughly 20 percent of all drugs are prescribed off-label. If your child has ever been prescribed amoxicillin for an ear infection, they got an off-label prescription since this antibiotic it isn’t approved for kids.
Unfortunately, federal rules and red tape continue to impede the sharing of truthful and scientific information about off-label treatments. While it is legal for a physician to prescribe a drug off-label, FDA gag rules prevent the manufacturer from sharing truthful and scientific information about off-label uses of that drug or combination of drugs. Under current FDA policy, communicating about an approved treatment for a legal, off-label use can result in criminal prosecution and penalties. Now more than ever, physicians need to understand the treatment needs of patients, but many are being kept in the dark without access to full information about treatment options.
So far, Arizona and Tennessee have both passed laws that protect the sharing of truthful and scientific information with doctors and insurers. More states are turning their attention to these obstacles that, too often, keep information about promising treatments out of the hands of doctors. These FDA gag rules should be repealed.
The full findings of the study released today are yet to be validated and more evaluation will be needed, but this off-label treatment is some of the most hopeful news to date in what is an unprecedented public health emergency.
Naomi Lopez is the Director of Healthcare Policy at the Goldwater Institute.