united-states medical fda
Does FDA&#39;s &quot;compassionate use&quot; program allow doctors to prescribe drugs to themselves under Emergency Use?
<p>Does the &quot;compassionate use&quot; program allow doctors to prescribe drugs for themselves that have been approved under an FDA emergency use authorization?</p>

<p><strong>TL;DR: Most likely, for certain drugs.</strong> Self-prescribing was never illegal under Federal Law; it is regulated to varying degrees by the states, and discouraged by professional organizations like the American Medical Association. Pharmacists can refuse to fill prescriptions they are uncomfortable filling, and many will not fill self-prescriptions.</p>
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<p>It's not clear if, as originally written, this question is referring to the FDA's <a href="https://www.fda.gov/news-events/public-health-focus/expanded-access" rel="noreferrer">Expanded Access Program</a>, which was created under FDA's regulatory authority (ergo it is not a law) and is colloquially called <em>compassionate use</em>; or the <a href="https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try" rel="noreferrer">Right to Try Act</a>, which was signed into law by President Trump in 2018. I am going to take a few moments to give an overview of both and then get to the question of self-prescribing.</p>
<p>Expanded Access has been around for about 30 years, when it began as a way to make experimental HIV drugs available to patients during the HIV/AIDS epidemic. It has been used since them to make drugs available for a variety of diseases (like <a href="https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/compassionate-drug-use.html" rel="noreferrer">cancer</a>), and most recently for COVID-19.</p>
<p>The Right to Try Act is similar in that it makes experimental drugs available to patients before they have received full regulatory approval. The mechanism for that availability is a different, and it has since it is a law it has the explicit approval of Congress. Here are a <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7081483/" rel="noreferrer">journal article</a> and a <a href="https://triagecancer.org/expanded-access-vs-try-patients#:%7E:text=What%20is%20the%20Food%20%26%20Drug,access%20to%20investigational%20medical%20products." rel="noreferrer">very good table breaking down the differences</a> between Right to Try and Expanded Access.</p>
<p>Neither of these modify the patient/doctor relationship, so they do not effect whether a prescriber can write their own prescriptions either way. <strong>A doctor could probably prescribe COVID-19-related treatments for themselves approved for widespread use under Expanded Access; they would likely be unable to self-prescribe other more medically-complex, higher-risk treatments like chemotherapy.</strong> See below.</p>
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<p><strong>Self-prescribing is legal under federal law.</strong> As noted by the <a href="https://www.ecri.org/components/HRC/Pages/AskHRC111219.aspx" rel="noreferrer">Emergency Care Research Institute</a>:</p>
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<p>Under federal law, physicians in the United States are not prohibited from self-prescribing medications. State laws governing physicians, however, vary greatly, and some may prohibit physicians from prescribing, dispensing, or administering certain medications to themselves or family members.</p>
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<p><a href="https://www.grantsformedical.com/self-prescribing-laws-by-state.html" rel="noreferrer">Restrictions vary by state</a>. Most (perhaps all) states prohibit a prescriber from self-prescribing <a href="https://www.dea.gov/drug-information/drug-scheduling" rel="noreferrer">Schedule II</a> controlled substances, with some providing an exception for an emergency. Many prohibit prescribing of Schedule II drugs to family members. I have found several sources that claim some states outright prohibit self-prescribing, but whenever I follow those back to the actual statute they only apply to Schedule II drugs.</p>
<p>Professional organizations like the American Medical Association strongly discourage their members self-prescribing, stating in their <a href="https://www.ama-assn.org/delivering-care/ethics/treating-self-or-family" rel="noreferrer">Code of Ethics</a> that &quot;treating oneself or a member of one's own family poses several challenges for physicians, including concerns about professional objectivity, patient autonomy, and informed consent.&quot;</p>
<p>The greatest barrier to self-prescribing lies at the pharmacy, where pharmacists are able to refuse prescriptions when they question the medical necessity or standard of care that lead to the prescription.</p>
