CM – Op-Ed: The FDA may be in the process of making the abortion pill more accessible

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In a matter of weeks, the US Supreme Court has tried two cases of access to abortion. The first, SB 8, is a Texas law that prohibits abortion as early as the sixth week of pregnancy. The second, Dobbs vs. Jackson Women’s Health Organization, is a Mississippi law that bans abortion after the 15th week of pregnancy. In both cases, the possibility of access to abortion as federal law could be ended.

While the constitutional battle continues in court, the federal government will have another option in the coming days to maintain access to abortion: by allowing people to do so To get abortion pills when they need them.

The lifting of federal restrictions and the prescription of mifepristone by all healthcare providers, the first drug used in drug abortion, would allow more patients to access abortion care sooner . It would also recognize the reality that abortion is and should be treated as health care.

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In the 21 years since mifepristone was approved by the Food and Drug Administration for terminating early pregnancy, it has been subject to severe restrictions preventing its use by those in need. The FDA allows the drug to only be dispensed by a certified prescriber in certain healthcare facilities.

This means that it cannot be dispensed via telemedicine, mailed, or offered via a pharmacy prescription. Clinicians need to keep it in stock and only those who advertise as abortion providers usually do so. For patients who want a drug abortion, it means they have to travel to a specialized abortion clinic – sometimes hundreds of miles away – to easily get pills that have an extremely low risk of complications, even lower than Tylenol or Viagra. However, in April the FDA announced that it would temporarily waive the requirements for personal dispensing of mifepristone during the COVID pandemic. This was followed by an announcement by the Biden government that the agency would review the drug’s dispensing policy, part of a Chelius vs. Becerra lawsuit that challenged FDA restrictions. In a status report, the agency announced that it would complete its examination of whether the personal requirements should be permanently waived and the way for the pharmacy dispensing of this drug should be cleared by mid-December.

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A federal judge agreed to suspend a rule requiring women to go to a hospital, clinic or doctor’s office to get an abortion pill during the COVID-19 pandemic.

The April ruling opened one Window of opportunity. In some states, vendors began prescribing mifepristone for abortion using telemedicine – helping fill the void for people who cannot or do not want to travel. This model includes remote advice and delivery of medication via a mail order pharmacy. My team at UC San Francisco has explored this innovation in abortion care, and while our research continues, our latest results show that it is safe and effective.

However, the use of telemedicine may not be the only solution. For one, 19 states prohibit telemedicine for abortion, either specifically or indirectly, by requiring the doctor to be physically present when the drug is taken. In addition, hundreds of thousands of people in the US don’t have reliable internet connections – telemedicine is another hurdle to care for them.

The FDA’s final waiver could open up more opportunities. Patients could get prescriptions for abortion pills from their own GP instead of traveling to a specialized clinic. This would give them more privacy, less work free time, and allow them to have a trusted local doctor to assist. People could get medication abortions from nurses. Rural patients could go to local health clinics. College students could get prescriptions from their student health centers instead of leaving campus. This expansion would improve patient-centered care as many patients would prefer to have their abortions performed by their GP.

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Of course, such a transformation would not happen overnight. Even if the FDA lifted the restrictions, expanded access would still require the fight against state-imposed abortion restrictions – including mandating that only doctors administer abortion drugs – that hinder patients’ ability to receive the drugs.

Nonetheless, the FDA’s decision could represent an important opportunity in rights-protecting states to provide wider access to abortion. This move would also make it a little easier for patients from restricted access states who need to travel outside of the state to receive abortion treatment if Roe vs. Wade is downed.

The FDA should treat the abortion pill as it does treating other drugs that have been shown to be safe, effective, and beneficial for patient care – by following science and making them available to all who need them.

Ushma Upadhyay is an Associate Professor and Social Scientist of Public Health at Advancing New Standards in Reproductive Health at UC San Francisco. She is co-director of the Center of Expertise on Women’s Health, Gender and Empowerment at the UC Global Health Institute. @UshmaU

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