Una victoria para el acceso a cuidados de salud: la FDA suspende barreras al aborto médicamente innecesarias durante la pandemia

WASHINGTON, DC — La Administración de Alimentos y Fármacos de los Estados Unidos (FDA, por sus siglas en inglés) ha notificado a provedores de salud que "ejercerá discreción en cuanto al cumplimiento" de barreras al aborto con medicamentos durante la pandemia del COVID-19 que son medicamente innecesarias. Las restricciones a la mifepristona obligan a los pacientes a recoger los medicamentos directamente de una oficina de un doctor, hospital o centro de salud, en vez de hacerlo de una farmacia o recibir el medicamento por correo, como lo es permitido con otros medicamentos igual de seguros. El anuncio reconoce que las interacciones en persona son innecesarias y exponen a los pacientes al COVID-19.

Declaración de Alexis McGill Johnson, presidenta & CEO, Planned Parenthood Federation of America:

“Esta es una victoria para el acceso a la salud y la equidad reproductivas, y agradecemos al liderazgo de la FDA por basarse en la ciencia al tomar esta decisión. Desde hace mucho tiempo hemos sabido que las restricciones a la mifepristona son médicamente innecesarias. Y, durante la pandemia, se han convertido en un peligro conforme los pacientes han tenido que poner en riesgo su salud al no poder obtener este tratamiento esencial a tiempo. Como era de esperarse, estos requisitos solamente han servido para crear más barreras a cuidados de salud para aquellos ya sufriendo índices más altos de enfermedad y dificultades económicas debido a la pandemia del COVID-19 – entre ellas, personas de la comunidad Latina, residentes de zonas rurales y personas de bajo ingreso. Pero debemos recordar que estas barreras sistémicas existían mucho antes de la pandemia y existirán mucho después de ella. Es crucial que la FDA ahora lleve al cabo un análisis amplio de la totalidad de las restricciones a la mifepristona. Debemos garantizar que todos los pacientes tengan acceso al cuidado de salud esencial que necesitan – durante y después de la pandemia”.

TEXTO DE LA NOTA DE PRENSA EN INGLÉS

WASHINGTON, D.C. — Tonight, the U.S. Food and Drug Administration (FDA) notified medical provider groups that it would “exercise enforcement discretion” regarding a medically unnecessary barrier to medication abortion for the duration of the COVID-19 pandemic. The Risk Evaluation and Mitigation Strategy (REMS) restrictions on mifepristone mandate that patients pick up the medication directly from a doctor’s office, hospital, or health center, rather than from a pharmacy or by mail, as allowed for other equally safe medications. The announcement recognizes that unnecessary in-person interaction exposed patients to COVID-19 risks related to transportation, child care, multiple health center trips, and more. 

Statement from Alexis McGill Johnson, president & CEO, Planned Parenthood Federation of America:

“This is a victory for access to reproductive health care and health equity, and we thank FDA leaders for following the science to come to this decision. We have long known the decades-old restrictions on mifepristone are medically unnecessary. But they have become dangerous during this pandemic, as patients have had to risk their health and the health of others just to obtain essential, time-sensitive health care. Unsurprisingly, these requirements have served only to create more barriers to care for those already suffering from higher rates of illness, and economic hardship due to COVID-19 — people of color, people in rural areas, and people with low incomes. But we must remember that these systemic barriers to care existed long before the pandemic and will continue to exist long after. It’s critical that the FDA now conduct a comprehensive review of the full set of restrictions on mifepristone. We must ensure all patients can access the essential health care they need — during the pandemic and beyond.”

Last month, Planned Parenthood joined a coalition of 55 reproductive rights, health, and justice groups in a letter calling on the administration to immediately remove the medically unnecessary in-person dispensing requirement during the pandemic and to initiate a comprehensive review of the full set of restrictions. More than 200,000 supporters joined the urgent call by signing petitions to the administration. While today’s announcement is an important first step, the FDA must now move to complete the review needed to undo these unnecessary restrictions once and for all. 

Mifepristone is safe, effective, and has been used by more than 4 million people since the FDA approved it more than 20 years ago. Leading medical associations such as the American College of Obstetricians and Gynecologists and American Academy of Family Physicians have maintained that the FDA’s long-standing restrictions on mifepristone are not based on medical evidence and do not benefit patients. In fact, out of 20,000 prescription medications regulated by the FDA, mifepristone is the only one that the FDA requires to be dispensed in person, but permits patients to self-administer at home.

Planned Parenthood is proud to offer medication abortion via telehealth in 21 states. As a leading sexual and reproductive health care provider, Planned Parenthood is committed to making sure all patients receive the high-quality health care they need, when they need it — including safe, legal abortion. By providing medication abortion safely and effectively via telehealth, we can keep patients, providers, and health center staff safer during the pandemic and expand access to abortion for people, no matter where they live. 

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Planned Parenthood es el proveedor y defensor líder del país de una atención médica asequible de alta calidad para mujeres, hombres y jóvenes, como también el mayor proveedor del país de educación sexual. Con más de 600 centros de salud en todo el país, las organizaciones de Planned Parenthood atienden a todos los pacientes con cuidado y compasión, con respeto y sin juzgarlos. A través de centros de salud, programas en escuelas y comunidades y recursos en línea, Planned Parenthood es una fuente confiable de información de salud que les permite a las personas tomar decisiones de salud informadas. Hacemos todo esto porque nos preocupamos de manera apasionada de ayudar a las personas a llevar vidas más saludables.