In today's press conference (3/19/2020) the President is touting the FDA's approval of using (for example) an anti-malarial as a treatment for COVID-19. This drug has been in widespread use and has been approved by the FDA for years. HOWEVER, the FDA required drug information on this drug does NOT mention COVID-19, so it's use as a pharm for COVID-19 would be considered off-label.

Physicians commonly order these off-label applications, however they assume the risk and liability by ordering off-label pharms for their patients.

Considering today's assertion that FDA has now approved certain pharms, does it follow that these prescriptions are no longer "off-label", but rather are indicated uses.

  • 1
    To clarify: Chloroquine has not been approved for treatment of COVID-19. In that same press conference, the FDA commissioner clarified that the FDA has expedited a clinical trial but, contrary to what the President claimed, has not approved the use of Chloroquine for treatment of COVID-19
    – divibisan
    Mar 19, 2020 at 19:36
  • @divibisan AHA, that will teach me to wait until the FDA commissioner to contradict the president. Unfortunately, I was only able to listen to the first 15 minutes or so of the press conference, so I missed the correction. DJT's assertion of a treatment drug that we will make available almost immediately (due to FDA's recent 'approval') completely fooled me.
    – BobE
    Mar 19, 2020 at 23:08

2 Answers 2


Considering today's assertion that FDA has now approved certain pharms, does it follow that these prescriptions are no longer "off-label", but rather are indicated uses?

No. The president is not the FDA, and the president's statements about FDA actions are not FDA actions. The only official source of information about drug approvals is the FDA's list of approved drugs. See 21 CFR 314.3:

Listed drug is a new drug product that has been approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act for safety and effectiveness or under section 505(j) of the Federal Food, Drug, and Cosmetic Act, which has not been withdrawn or suspended under section 505(e)(1) through (5) or section 505(j)(6) of the Federal Food, Drug, and Cosmetic Act, and which has not been withdrawn from sale for what FDA has determined are reasons of safety or effectiveness. Listed drug status is evidenced by the drug product's identification in the current edition of FDA's “Approved Drug Products With Therapeutic Equivalence Evaluations” (the list) as an approved drug. A drug product is deemed to be a listed drug on the date of approval for the NDA or ANDA for that drug product.


The FDA doesn't regulate off-label use per se, but does [well, try to] regulate the advertisements for off-label use. Basically manufacturers are not "allowed" to do the latter, even though clinicians can still prescribe off-label. As an FDA document explains:

the modern Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations prohibit manufacturers from introducing new drugs and most class III medical devices into interstate commerce for any intended use that FDA has not determined to be safe and effective. These authorities also prohibit manufacturers from introducing into interstate commerce devices subject to premarket notification requirements under section 510(k), which includes most class II and some class I devices, for any intended use that is outside FDA’s substantial equivalence determination (clearance) for such devices. Devices that are exempt from premarket notification requirements, generally because they are low risk, may be introduced into interstate commerce for the specifically exempt intended use(s) without obtaining FDA clearance. To establish a manufacturer’s or distributor’s intended use for the product, FDA is not bound by the manufacturer’s or distributor's subjective claims of intent, but rather can present objective evidence, which may include a variety of direct and circumstantial evidence.

Under the FD&C Act, an approved new drug that is accompanied by written, printed, or graphic matter that suggests an unapproved use may be an unapproved new drug with respect to that use. Furthermore, an approved prescription drug that is intended for an unapproved use (whether referenced in labeling or not) would be considered misbranded, because the drug does not meet the regulatory exemptions from the requirement that its labeling bear “adequate directions for use.” Similarly, a medical device that is intended for an unapproved use is considered adulterated and misbranded.

It then goes on into a pretty long discussion of Section 401 of FDAMA and how it was challenged in courts on First Amendment basis. However that provision sunset in 2009. So the FDA now has pages and pages of guidance (like the document I linked to) what the "best practice" for the manufacturers is with regards to off-label information, e.g. what off-label claims they can make in scientific journals, textbooks etc. For example, if you are a manufacturer and pretend to put out a "textbook" that is mostly advocating some off-label use for your product, you fall foul of FDA's guidance.

It's not clear to me what the implications are for falling foul of these, other than something like "the FDA is really pissed off with you, [so] your next new drug application might take 250 years to complete".

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