We’ve posted more times than we can count in support of the position that FDA-regulated manufacturers should be able to engage in truthful “promotion” of the off-label uses of their products. Well, on nationwide TV – and in the presence of the Commissioner of the FDA – on March 19, 2010 the President of the United States promoted the off-label use of a prescription drug, hydroxychloroquine sulfate (branded name: Plaquenil), for treatment of COVID-19. See Video at 12:18-14:56. We won’t go so far as to call the promotion “truthful,” because we frankly don’t know, and the President has made numerous other statements in press conferences that have later been clarified, qualified, walked back, or otherwise changed soon afterward by his officials.
Indeed, FDA did clarify that any implication that hydroxychloroquine was approved for COVID-19 was false, although it promised to keep reviewing this, and other drugs as possible COVID-19 treatments. Elsewhere, health experts have widely stated that, despite some interesting in vitro results, there is no evidence that this drug (which has significant risks, including life-threatening cardiovascular disorders) makes a clinically significant difference as an anti-viral in either animals or humans.
Hydroxychloroquine has been around a long time, and is now almost entirely generic, but its FDA-approved labeling has only one intended use:
INDICATIONS AND USAGE
PLAQUENIL is indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax.
PLAQUENIL is indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
FDA labeling at second-third unnumbered page.
The FDA does not regulate the therapeutic use of approved drugs (and medical devices) for conditions other than those for which such drugs are labeled. “[O]ff-label use is generally accepted” under the law as a “necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.” Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 350 (2001). Thus, “[p]hysicians may prescribe drugs and devices for off-label uses.” Id. at 351 & n.5. Indeed, elsewhere in the same press release, FDA also stated:
Disseminating information about promising off-label uses of drugs we already have, investigating their effectiveness, and pursuing other therapeutics will help give American healthcare providers the tools they need to save lives.
We do agree with the President, a rare event, that FDA’s current restrictions on truthful off-label promotion are “outdated rules” (video at 9:16-:18) and create “unnecessary” barriers (video at 9:29-:32) to communication of medical information.
Another drug, remdesivir, was also mentioned (video at 14:46-15:50) as supposedly “essentially approved.” That certainly wasn’t true, as the FDA commissioner later cleared up (video at 23:43-24:20). Unlike an approved drug, remdesivir could be distributed to members of public only through means like FDA’s “compassionate use” program.
The COVID-19 crisis has thus brought into sharp relief the ongoing tension between communications about potentially meaningful off-label uses of approved drugs and the limits the FDA places on what truthful statements a manufacturer can make about its own approved drug. Those who manufacture hydroxychloroquine would not have been allowed to say what the President or even the FDA have stated about this potential off-label use of their product.