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President Trump is known to have taken hydroxychloroquine (HCQ) as a prophylactic against COVID-19.

Some prominent medical scientists also came out in support of HCQ for outpatients (as opposed to inpatients, where it's considered ineffective). Yale professor of epidemiology, Dr. Harvey A. Risch stated that he believes that ~100,000 American lives would be saved by HCQ.

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The FDA initially authorized HCQ for inpatients, but later revoked this authorization. It's currently prescription-only for certain diseases other than COVID-19 (malaria, rheumatoid arthritis, lupus)

The issue has been politicized and beset by controversy and fraud.

What I'd like to know is if POTUS has the power to compel the FDA to issue an emergency use authorization or to make HCQ available over the counter?

  • Is HCQ a "controlled substance"? – DJohnM Aug 8 at 21:15
  • @DJohnM I believe it is not a controlled substance. The term "controlled substance" is reserved for substances such as marijuana and morphine, some of which may be available under a prescription, while others are not. But there are plenty of drugs that require a prescription that do not fall under the controlled substances act, such as penicillin. Anyway, for most medications, doctors are already allowed to prescribe them for "off-label" use, so it's probably not necessary for the FDA to "issue an emergency use authorization." – phoog Aug 9 at 13:07
  • @phoog As I understand it, off-label prescriptions are a major liability for the doctor. Many COVID19 patients die. If they die after HCQ, it's a lawsuit. – MaxB Aug 9 at 16:50
  • @MaxB where does Wikipedia say that? See en.wikipedia.org/wiki/Controlled_Substances_Act. Look at the criteria for inclusion in the five schedules. Many prescription drugs exist that meet none of these criteria and are included in none of the schedules. Penicillin is an example. – phoog Aug 9 at 17:03
  • @phoog You're right. Will edit. – MaxB Aug 9 at 17:16
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No. Congress, in the Federal Food, Drug and Cosmetic Act, gave the the power to regulate drugs to the FDA, not the President. In addition to giving the FDA jurisdiction, Congress also set up requirements and procedures that the FDA must use to classify and reclassify drugs. (The FDA, acting under the APA and other statutes, has engaged in further procedural rule-making as well.) These procedures require the FDA to hold hearings, etc. before making decisions. Since the President can only execute laws passed by Congress, he cannot bypass the FDA or these procedures. To do so would violate the separation of powers.

For example, the FDA could grant its Emergency Use Authorization for HCQ because a statute -- 21 USC § 360bbb-3 Authorization for medical products for use in emergencies -- gives it the power to do so.

FWIW, interbranch conflicts over FDA decisions are quite common.

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    Doesn't POTUS appoint the head of the FDA? Can he not replace him with whoever will make the FDA do what he wants? – MaxB Aug 24 at 21:47
  • @MaxB Sort of: 1) The President appoints the FDA commissioner, with the advice and consent of the Senate, so he can't replace the Commissioner at will. That said, Trump so far has had five commissioners, including three Acting Commissioners. 2) The FDA is supposed to follow procedures before approving drugs or devices. As I point out, in an emergency, the FDA can streamline the approval process, as it has recently for Covid treatments. – Just a guy Aug 25 at 3:49

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