Can POTUS make FDA approve a drug (such as hydroxychloroquine), or make it available over the counter?
<p>President Trump is known to have taken hydroxychloroquine (HCQ) as a prophylactic against COVID-19.</p>
<p>Some prominent medical scientists also <a href="https://www.newsweek.com/key-defeating-covid-19-already-exists-we-need-start-using-it-opinion-1519535" rel="nofollow noreferrer">came out in support of HCQ for outpatients</a> (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.</p>
<p><a href="https://i.stack.imgur.com/sR0Xb.png" rel="nofollow noreferrer"><img src="https://i.stack.imgur.com/sR0Xb.png" alt="enter image description here" /></a></p>
<p>The FDA initially authorized HCQ for <em>in</em>patients, but later revoked this authorization. It's currently prescription-only for certain diseases other than COVID-19 (malaria, rheumatoid arthritis, lupus)</p>
<p>The issue has been politicized and beset by controversy and <a href="https://www.theguardian.com/world/2020/jun/03/covid-19-surgisphere-who-world-health-organization-hydroxychloroquine" rel="nofollow noreferrer">fraud</a>.</p>
<p>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?</p>

<p><strong>No.</strong> Congress, in the <a href="https://www.law.cornell.edu/uscode/text/21/chapter-9" rel="nofollow noreferrer">Federal Food, Drug and Cosmetic Act</a>, 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.</p>
<p>For example, the FDA could grant its <em>Emergency Use Authorization</em> for HCQ because a <a href="https://www.law.cornell.edu/uscode/text/21/360bbb-3" rel="nofollow noreferrer">statute</a> -- <em>21 USC § 360bbb-3 Authorization for medical products for use in emergencies</em> -- gives it the power to do so.</p>
<p>FWIW, interbranch conflicts over FDA decisions are quite common.</p>

united-states medical president covid-19 fda