Doctor SUES the FDA to get abortion pills sold in stores

A doctor in Hawaii has sued the US government in a desperate bid to get early-stage abortion pills sold in pharmacies.

In a lawsuit filed on Tuesday, Dr Graham Chelius said his patients have to fly 300 miles to other states if they wish to end an unwanted pregnancy. 

He is imploring the Food and Drug Administration to give permission for stores to sell Mifeprex, which is used for abortions for up to 10 weeks of pregnancy. 

Currently, it can only be issued by clinics. But Dr Chelius said his attempts to order the drug have been vetoed by his pro-life colleagues.

The situation is not unique: on the heels of Dr Chelius’ lawsuit, a first-of-its-kind study by the Guttmacher Institute was published showing how far some women have to travel if they want an abortion. 

Dr Graham Chelius (pictured) said patients have to fly 300 miles to end a pregnancy as his coworkers refuse to stock the drug for abortions up to 10 weeks of pregnancy

In New York, the average distance is about three miles (five kilometers). At the other end of the scale, the average distance in Wyoming is about 168 miles (271 kilometers).

‘The abortion pill is safe, effective and legal. So why is the FDA keeping it locked away from women who need it?’ said Julia Kaye, an attorney with the ACLU Reproductive Freedom Project, which endorsed the lawsuit. 

‘The FDA’s unique restrictions on medication abortion are not grounded in science – this is just abortion stigma made law.’

FDA WARNS THE ABORTION PILL IS LINKED TO DEATHS – BUT LAWYERS SAY PREGNANCY CARRIES A HIGHER MORTALITY RISK

The restrictions have been in place since the drug was approved for use in the U.S. in 2000. They stipulate that Mifeprex may not be sold in pharmacies and that all providers of the drug undergo a special certification process.

The FDA issued new guidelines for the use of Mifeprex last year, and said at the time that the restrictions continue to be necessary to ensure safe use of the drug.

The FDA confirmed this week that the agency’s position has not changed since then. Regarding the lawsuit, it said the agency does not comment on pending or ongoing litigation.

The suit was filed on behalf of three health care associations and a physician, Graham Chelius. He works on the Hawaiian island of Kauai, which currently has no abortion providers.

Chelius, a family medicine doctor, says he is qualified and willing to provide medication abortion, but is unable to stock the abortion pill at the hospital where he works because of objections from some colleagues. 

As a result, he says, his patients must carry an unwanted pregnancy to term or make a 300-mile round trip flight to another island to get an abortion – boosting costs and sometimes delaying the procedure by several weeks. This could be avoided if the pill were available at pharmacies on Kauai.

The lawsuit is supported by the American Congress of Obstetricians and Gynecologists. Its CEO, Dr. Hal Lawrence, said there is no medical justification for the FDA restrictions.

According to a commentary earlier this year in the New England Journal of Medicine, 19 deaths have been reported to the FDA among the more than 3 million women who have used Mifeprex in the U.S. since 2000, a mortality rate lower than for pregnancy-related deaths among women.

The commentary suggested that lifting the FDA restrictions would likely increase the number of doctors willing to prescribe Mifeprex, since they would no longer have to stock the drug in their office and no longer have to be on a list of certified abortion providers. 

Easing the rules also might help make medical abortion more available via telemedicine to women in rural areas who live far from the nearest abortion facility, said the 10 co-authors, who included doctors and academics from Stanford, Princeton and Columbia universities.

According to the latest federal figures, medical abortions – generally a two-pill regimen using Mifeprex and the drug misoprostol – accounted for about 22 percent of abortions in the U.S. in 2013. Surgical procedures accounted for nearly all the other abortions.

Women using the pill generally take it in the privacy of their home. Noting that, Kaye said the legal case ‘is primarily about where a woman must be standing when she’s handed the abortion pill that’s been prescribed to her.’

‘The FDA restriction defies common sense,’ she said. ‘There’s no medical issue in whether she’s handed the pill at a pharmacy or at a clinic.’

There is precedent for a federal court to overturn FDA restrictions. In 2013, a federal judge in New York ordered that the most common version of the morning-after pill must be accessible over-the-counter for all customers of all ages, instead of requiring a prescription for girls 16 and younger.

HOW FAR WOMEN TRAVEL FOR ABORTIONS: STUDY REVEALS SOME AMERICANS ARE ALMOST 200 MILES AWAY FROM THE NEAREST CLINIC

The Guttmacher Institute, a research group that supports abortion rights, used 2014 data on abortion clinic locations and U.S. Census population figures. The findings were published online Tuesday by the journal Lancet Public Health.

Nationally, according to the study, half of all women of reproductive age lived within 11 miles (18 kilometers) of an abortion clinic in 2014. 

However, many women in rural areas lived much farther away; the study said one in five women nationwide would need to travel at least 43 miles (69 kilometers) to reach the nearest abortion clinic.

In the states with the longest average distance to travel — Wyoming, North Dakota and South Dakota — at least half of women of reproductive age lived more than 90 miles (145 kilometers) from the nearest clinic providing abortion services. 

Women in Alaska lived an average of nine miles (about 15 kilometers) from the nearest clinic, but 20 percent of women in that state would have to travel more than 150 miles (240 kilometers).

The researchers said the average distance increased between 2011 and 2014 for many women in Texas and Missouri, which imposed restrictions during that period that led to closure of some clinics. At one point recently, there was only one abortion clinic operating in Missouri; there are now two, and abortion-rights advocates are pursuing legal action to expand that number.

In a commentary in the journal, Ushma Upadhyay, a professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco, detailed possible repercussions for women facing the long distances.

‘Increased travel distance means increased costs for transport, overnight stay, lost wages from time off work, and childcare,’ she wrote. ‘For a woman who is economically disadvantaged, having to travel a long distance could put an abortion out of reach, leading her to carry an unwanted pregnancy to term.’

Upadhyay suggested that access could be improved if nurse practitioners and certified nurse midwives were allowed to perform abortions without a physician’s supervision. 

Another step, she wrote, would be for the Food and Drug Administration to lift restrictions on the abortion-inducing drug mifepristone so that women could get it at pharmacies with a prescription. It’s now dispensed only at clinics, hospitals and doctors’ offices.

The American Civil Liberties Union filed a lawsuit on Tuesday challenging those FDA restrictions.

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