Kauai doctor sues to have abortion pill sold at pharmacies

Dr. Graham Chelius, who estimates he has delivered 820 babies on Kauai over the last nine years, filed a lawsuit Tuesday in federal court in Honolulu against the Food and Drug Administration that he hopes will prevent unwanted pregnancies around the country by giving everyone access to the so-called abortion pill that’s currently unavailable on the Garden Isle.

Chelius, chief medical officer for the Hawaii Health Services’ Kauai region, said it’s unrealistic for many of his low-income patients dealing with an unplanned pregnancy to take time off from work and afford the cost to fly to Honolulu to fill a prescription for the pill known as Mifeprex.

“Getting over to that island is difficult because they may not even have a car to get to the airport,” Chelius said. “For very high-risk families who are trying to access this option, it can be incredibly cumbersome for people whose lives are already complicated. For the island of Kauai, this is a significant problem.”

The American Civil Liberties Union filed the lawsuit on behalf of Chelius and three health care associations.

It targets long-standing restrictions imposed by the Food and Drug Administration that say Mifeprex can be dispensed only in clinics, hospitals and doctors’ offices. The lawsuit contends the drug — used for abortions up to 10 weeks of pregnancy — should be made available by prescription in pharmacies across the U.S.

Chelius said it would be difficult to stock Mifeprex over the objections of conservative members of his staff — and because word would quickly spread about patients who use the drug.

“There are people on my staff who are relatively conservative on their issues,” he said. “We have not pursued stocking this medicine to keep a cohesive team. And if I were to dispense this medicine, everybody would know about it. In a small town everybody knows you and you know everybody else. Confidentiality is a struggle.”

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 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 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.

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 customers of all ages, instead of requiring a prescription for girls 16 and younger.

Graham Chelius, M.D. v. Don Wright, M.D. by Honolulu Star-Advertiser on Scribd

The Associated Press contributed to this report.