Mifepristone, also known as RU-486, has been under consideration by Health Canada since December 2012. It usually takes about nine months for pharmaceuticals to work their way through the approvals process, making mifepristone overdue for a decision.
If approved, the drug would be available by prescription to terminate pregnancies of up to nine weeks. It's different from the morning after pill, which is used within a few days after sex to stop a fertilized egg from implanting.
Another drug, misoprostol, is used after mifepristone to complete the process.
While abortion rights defenders await the department's decision, anti-abortion activists are already setting their sights on the drug, making RU-486 a theme for their annual protest on Parliament Hill.
It's all bound to continue the debate among MPs over whether Canadaneeds legal limits on abortion.
'Really, really important'
Advocates say approving mifepristone would be an important step in bringing access to women in rural and remote communities who now have to travel to a clinic that provides surgical abortions.
Dawn Fowler, the Canadian director of the National Abortion Federation, says that's one of the big hopes if the drug is approved. She says it can take a day or two for women in rural and remote communities to travel to a bigger centre to have an abortion.
"It's about delivering safe, quality care," Fowler said.
While there are no legal restrictions on terminating pregnancies in Canada, access to surgical abortions varies across Canada. There are no facilities on Prince Edward Island that terminate pregnancies, for example.
"Having this pill approved, I think is really, really important to a lot of women who need to have access to reproductive choice. There shouldn't be any holdup as far as I'm concerned," New Democrat health critic Libby Davies said in an interview with CBC News.
Fowler says access to mifepristone doesn't increase the rate of abortion in a country, but changes the distribution of surgical versus medical terminations, reducing demand for surgery.
Fowler says the drug has been used safely by millions of women in 57 countries since 1988 when it was first approved in France, including the U.S., the U.K., western Europe, Australia and New Zealand.
Debate over safety
But Mary Ellen Douglas, national organizer for the anti-abortion Campaign Life Coalition, says she's concerned about the drug's side effects. She pointed to a handful of reports of fatal sepsis.
"It's just not something that should be brought into Canada," Douglas said, adding that she's calling on Health Minister Rona Ambrose not to allow the drug in Canada.
The U.S. Food and Drug Administration addressed concerns about sepsis related to mifepristone in 2011 and said sepsis is a risk related to any abortion.
"We do not know whether using mifepristone and misoprostol caused these deaths," the FDA said in a fact sheet posted on its website.
"Reports of fatal sepsis in women undergoing medical abortion are very rare [approximately one in 100,000]."
Douglas says her coalition is making mifepristone a theme for its annual March for Life rally on Parliament Hill, using slogans like "RU-4 life?" to play off the RU-486 name.
"It is pregnancy termination. It is abortion ... and of course we wouldn't want it for that reason," Douglas said.
Health Canada confusion
A spokesman for Ambrose said drug approval decisions "are made by Health Canada scientists — not politicians or ministers."
Ambrose drew criticism in 2012 when she voted in favour of a motion for Parliament to study when life begins. She was then the minister for status of women. Opponents of the motion said it was a backdoor attempt to re-open the abortion debate, a discussion Prime Minister Stephen Harper has repeatedly and emphatically said he won't have.
Health Canada has been reluctant to address the drug, with the department's top civil servant initially telling a House committee that there was no application for mifepristone.
Deputy Minister George Da Pont later had to tell the committee that he was wrong.
A spokeswoman for Health Canada said in an email to CBC News that she couldn't say when the department would decide whether to approve mifepristone.
"Timing for the review of drug submissions varies depending on the information provided by the manufacturer, as well as whether or not requests for additional information or clarification are needed," Leslie Meerburg said.
Another medication, methotrexate, is prescribed off-label for medical abortions, but it's only suggested for ending pregnancies up to seven weeks.
Health Canada says that drug is approved only to treat certain cancers, including breast cancer, Non-Hodgkin's lymphoma and leukemia, and at lower doses, for the treatment of severe psoriasis and rheumatoid arthritis.
Also on HuffPost