Union sues FDA for access to abortion pill in pharmacies

consult pharmacy pharmacist patient consultation medication prescription

American women can currently only get the drug from a clinic, medical office or hospital

The American Civil Liberties Union (ACLU) has filed a lawsuit this week that could allow US pharmacies to dispense the abortion pill RU-486 (mifepristone), according to media reports.

The suit is being brought against the Federal Drug Administration (FDA) on behalf of a Hawaii-based doctor who says he was motivated after his female patients that were seeking abortions had no options.

Under current FDA regulations of mifepristone, doctors who carry out abortions must dispense the drug themselves or send women to a clinic, medical office or hospital that carries it.

Some doctors have difficulty stocking the abortion drugs, the ACLU said, and called on the FDA should loosen restrictions on mifepristone access.

“Once a woman has been prescribed [mifepristone], there is no medical benefit to requiring that the pill be handed to her at a medical office, clinic, or hospital rather than handed to her at her local pharmacy or via a mail-order pharmacy,” the suit states.

But pro-life advocates disagree, arguing that the drug is risky enough for women without further easing of restrictions.

“The marketing spin is to repeat the mantra of ‘safe’ over and over again when the reality is, these are dangerous drugs,” Donna Harrison, executive director of the American Association of Pro-Life Obstetricians and Gynecologists, told Samantha Gobba from the World News Service.

ACLU of Hawaii director Mateo Caballero called the drug a “safe, proven method to end a pregnancy,” and said the FDA’s requirements were “politically motivated.”

In Australia, access to mifepristone is relatively recent – prior to 2013 use was severely restricted.

In 2012 the TGA put mifepristone/misoprostol on the Australia Register of Therapeutic Goods, and it went onto the PBS in 2013.

A composite pack of mifepristone and misoprostol, which was made available in 2015, remains prescription only.

Pharmacies must register with MS Health before it can stock and dispense the composite pack (MS 2-Step) to those with a prescription.

“Medical abortion with mifepristone/misoprostol requires at least two visits to a doctor’s office or abortion clinic,” explains Children by Choice.

Women in most states can access the drugs to terminate a pregnancy. They can even access the procedure via a phone service with GP referral, up to eight weeks.

However some states require abortions have to be performed in a hospital.

“As a result of law reform in six of eight Australian jurisdictions, abortion can be performed lawfully subject to various conditions in these jurisdictions but it has been fully decriminalised only in the Australian Capital Territory,” say Associate Professor Kirsten Black and Dr Deborah Bateson of the Discipline of Obstetrics, Gynaecology and Neonatology at the University of Sydney.

“Abortion remains a crime in NSW and Queensland and can only be performed lawfully at all as a result of case law permitting abortion where it is necessary to prevent serious risk to the life or health of the woman.

“Practitioners report that the current complex and varied legal status of abortion across Australia has a significant impact on service provision and compromises patient care.”

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