Health Canada drags feet on abortion pill
UPDATE: On July 29, 2015 Health Canada confirmed that it had approved the drug for use here.
It's known as mifepristone, or RU-486. Sometimes it's simply called "the abortion pill."
It's been used by women in the U.S. since the year 2000, and in France since 1988. In fact, millions of women in more than 50 countries around the world have used it. But it hasn't yet been approved for use in Canada.
Dr. Rebecca Gomperts, for one, wonders why that is. She's the founder of Women on Waves, an organization that sails a ship to countries where abortion is illegal to perform early medical abortions for women who need them. She's been using the abortion pill -- mifepristone -- with patients for more than 15 years.
It's safer than Viagra , it's safer than penicillin, and it's safer than driving a car. So it's quite interesting to learn that there has been, again...an application process has been delayed again because it's really, especially in Canada, mifeprestone can make such a difference to women's lives and health.- Dr. Rebecca Gomperts
The drug, mifepristone, or RU-486, has been awaiting approval from Health Canada for two years, since 2012. Normally the maximum wait time for any drug to be approved is about 300 days.
And now, just this week, Health Canada announced it was delaying its decision once again, likely until this fall. No other drug has ever had a longer approval process in Canada.
When it comes to RU-486 this is not a new drug. This is something that's been used for decades. It's used in multiple countries around the world. so it's hard to imagine that there's a need for more information about how it works or how safe it is. That information should be readily available based on previous experience.- Dr. Joel Lexchin , Professor at York University in Toronto
We did request someone from Health Canada to speak to us about RU-486, but no-one was made available. It did send a statement, which reads, in full:
"Health Canada does not disclose timelines for specific drug submissions. We cannot comment on whether Health Canada will accept or refuse the application; however we will say that Health Canada makes all drug approval decisions based on a detailed scientific review.
Re: The process
The timelines for the review of drug submissions will depend on the submission class of the drug as outlined in Health Canada's Management of Drug Submissions Guidance Document: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/mgmt-gest/mands_gespd-eng.php. For a New Drug Submission, it is possible that a final decision may not be issued for two or three years if the sponsor receives a notice of deficiency (NOD) and/or notice of non-compliance (NON). The NOD and NON are considered to be interim decisions and provide the sponsor with the opportunity to respond to Health Canada's questions.
The decision on RU486 will be made public in a manner consistent with the processes in place for all drug authorization decisions made by the Department. When there is a positive decision, a notice of compliance is currently posted on the Health Canada website (http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/index-eng.php). The scientific rationale for positive decisions for new drug submissions for new active substances is also made public in a Summary Basis of Decision document (http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/index-eng.php). With the passing of Vanessa's Law on November 6, 2014, regulations are being developed to expand Health Canada's current practices to publish a broader range of regulatory decisions, including negative decisions, in order to support Canadian doctors and patients in making informed decisions about the medications they prescribe and use."
Mifespristone's effectiveness as an abortion pill was studied right here in Canada in the early 2000s. Dr. Sheila Dunn was a part of that research team. She's a family physician at Women's College Hospital in Toronto, and an Associate Professor of Family and Community Medicine at the University of Toronto.
Mifepristone has been available for medical abortions in the United States since 2000. But that's not to say that there's no debate over the drug there. In fact, some U.S. doctors don't feel that mifepristone is safe.
Dr. Donna Harrison is the executive director of the American Association of Pro Life Obstetricians and Gynecologists. She was in Eau Claire, Michigan.
This segment was produced by The Current's Sarah Grant, Pacinthe Mattar and Julian Uzielli.