Did the FDA Really Stop Side Effect Reporting for Abortion Drugs?

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<p>At the end of January, I watched the <a href="https://www.finance.senate.gov/hearings/hearingto-consider-the-nomination-of-robert-f-kennedy-jr-of-california-to-be-secretary-of-health-and-human-services" target="_blank" rel="noreferrer noopener">senate hearing</a> for the confirmation of Robert Francis Kennedy, Jr. (RFK Jr.) to be Secretary  of Health and Human Services (HHS),  the department responsible for overseeing health agencies like the Food and Drug Administration (FDA).</p>
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<p>While there were many contentious moments, one left me scratching my head. Senator James Lankford (R-Oklahoma) posed the following question, seemingly referring to mifepristone, a drug commonly used to induce abortion:</p>
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<p><em>The FDA, under the Biden administration, changed the rules for the chemical abortion drug and said you no longer need to see a physician … But they also changed an area that has been — something that’s been very particular you talked about a lot, that’s transparency. They changed the position and said, ‘Don’t tell us if there’s a side effect on this drug unless she dies. But other than that, don’t tell us anymore.’ Literally. ‘Don’t give transparent information to the American people or to the women who take this drug anymore. We don’t want that reported.’ My question to you is: Will the FDA move to be able to actually give transparency to the American people and to say this drug is no different than any other drug?</em></p>
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<p>Kennedy’s response seemed to confirm that doctors and patients were no longer informing the FDA of side effects. He said: </p>
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<p><em>It’s against everything we believe in this country, that patients or doctors should not be reporting adverse events. We need to know what adverse events are… We need to understand the safety of every drug, mifepristone, and every other drug…President Trump has made it clear to me that… he wants me to look at safety issues, and I’ll ask NIH, FDA to do that.  </em></p>
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<p>I wondered under what circumstances the FDA would ever tell people to stop reporting side effects, so I reached out to <a href="https://phlr.org/expert/adrienne-ghorashi-esq" target="_blank" rel="noreferrer noopener">Adrienne Ghorashi</a>, Esq., Lead Law and Policy Analyst at Temple University’s Center for Public Health Law Research, to ask what the two were talking about, and what the requirements are for reporting side effects of mifepristone. </p>
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<h2 class="wp-block-heading">How Does the FDA Monitor the Side Effects of Approved Drugs?</h2>
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<p>The FDA maintains the <a href="https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program" target="_blank" rel="noreferrer noopener">MedWatch</a> database, where <a href="https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/medical-product-safety-educational-resources" target="_blank" rel="noreferrer noopener">patients and doctors</a> are encouraged to <a href="https://medshadow.org/about-fda-drug-development-process-risk-of-side-effects/#:~:text=Whether%20a%20drug%20receives%20a%20phase%2D4%20study%20or%20not%2C%20the%20FDA%20continues%20to%20monitor%20public%20databases%20that%20collect%20reports%20of%20possible%20adverse%20events.%20These%20include%20MedWatch%C2%A0and%20the%20FDA%E2%80%99s%20Adverse%20Event%20Reporting%20System%20(FAERS)%2C%20along%20with%20its%20counterpart%2C%20a%20Vaccine%20Adverse%20Event%20Reporting%20System%20(VAERS)." target="_blank" rel="noreferrer noopener">report suspected side effects</a> of any drug in as much detail as possible. The agency monitors and compares the data as it comes in, and if experts identify concerning side effects or a pattern of similar reactions, the FDA launches an investigation to determine whether the drug is the cause.</p>
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<p>If a drug is found to be responsible for newly reported side effects, the FDA may update warning labels, adjust prescribing guidelines, or, in severe cases, remove the drug from the market.</p>
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<h2 class="wp-block-heading">How is Mifepristone Different?</h2>
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<p>Mifeprex (the brand name of mifepristone) was first approved by the FDA in 2000 to end dangerous or unwanted pregnancies up to 7 weeks gestation, with specific prescribing restrictions in place, because the clinical trials were conducted only by doctors with particular qualifications. In 2011, the FDA approved a <a href="https://pubmed.ncbi.nlm.nih.gov/24505829/#:~:text=Implementation%20of%20REMS%20began%20in,remain%20underexplored%20by%20academic%20study." target="_blank" rel="noreferrer noopener">Risk Evaluation and Mitigation Strategy</a> (<a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation" target="_blank" rel="noreferrer noopener">REMS) program for mifepristone</a>.</p>
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<p>REMS programs are designed for drugs that are considered potentially “dangerous,” and require doctors and patients to be extra careful in weighing the risks and benefits, says Ghorashi. REMS programs are rare, and typically reserved for particularly risky drugs such as opioids, she adds.</p>
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<p>The REMS program for mifepristone <a href="https://www.fda.gov/media/164648/download?attachment" target="_blank" rel="noreferrer noopener">established</a> specific prescribing requirements, including restricting its prescription to certain qualified healthcare providers. Ghorashi further explains that the program established a separate side effect reporting system, distinct from the MedWatch database.</p>
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<h2 class="wp-block-heading">Easing Mifepristone’s ‘Reporting Burden’ Doesn’t Mean Ignoring Side Effects</h2>
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<p>To this day, mifepristone remains on its REMS program, but the requirements of that program have been updated several times. </p>
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<p>“There were changes in 2016, including a reduced reporting burden and increasing the use of mifepristone for pregnancies from seven weeks to 10 weeks. And then in 2021, the in-person dispensing requirement was temporarily lifted, and then it became permanent in 2023,” notes Ghorashi. </p>
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<p>The 2011 REMS guidelines required prescribers to report any hospitalization, transfusion, or other serious event to Danco Laboratories. However, the 2016 REMS update revised this requirement, stating that doctors only needed to report deaths occurring within 15 days of using Mifeprex, regardless of whether the drug was the cause.</p>
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<p>Ghorashi emphasizes that reducing reporting requirements under mifepristone’s REMS program does not mean doctors and patients are being told to stop reporting side effects. Everyone is still encouraged to report their experiences through the standard MedWatch database. </p>
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<p>“The reason that [the FDA] decided to reduce that reporting burden was because the <a href="https://medshadow.org/abortion-pill-side-effects/" target="_blank" rel="noreferrer noopener">safety profile</a> was sufficient,” adds Ghorashi. </p>
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<p>By 2016, mifepristone had been on the market for 16 years, with the FDA closely monitoring reported side effects, allowing the agency to develop a clearer understanding of the drug’s rare risks. “The normal channels of reporting side effects are [now] sufficient because of how <a href="https://medshadow.org/is-mifepristone-a-drug-used-in-medication-abortions-dangerous/" target="_blank" rel="noreferrer noopener">safe</a> mifepristone is,” Ghorashi continues. </p>
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<p>So, while the REMS program <em>did</em> change reporting requirements for mifepristone’s side effects — that’s only part of the story. It’s unclear whether Senator Lankford and Kennedy knowingly relied on distorted facts during their discussion on the Senate floor, but in this case, their political soundbites misrepresented reality, giving the American public an inaccurate understanding of the issue.</p>
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