Globe and Mail reported that Health Canada is delaying its decision whether to approve the abortion pill mifepristone, also known as the abortion pill RU-486, until the Fall after requesting additional information from Exelgyn S.A, the drug’s manufacturer, “resetting the clock” on the approval process. A decision had been expected last month.
The source of both stories was the National Abortion Federation, which is keeping the media abreast of the importation request for the abortion drug. Both quote NAF president Vicki Saporta extensively as Health Canada will not comment on specific drugs while they are being considered for approval.
There was a request from European drug manufacturer Linepharma International to approve importation of mifepristone in October 2012. Nearly 60 countries have approved RU-486, beginning with France in 1988; the United States approved RU-486 in 2000. If approved in Canada, mifepristone would be available by prescription to abort pregnancies of up to nine weeks.
Canadian pro-life groups, including Campaign Life Coalition, launched petitions against approval of the abortion drug arguing Canada does not need to make abortion access easier and citing its health risks to the mother. Clinical trials in Canada were ceased in 2001 following the death of one woman. In 2011, the U.S. Food and Drug Administration reported 2,200 adverse effects, including 14 deaths, 58 ectopic pregnancies, 256 infections and 339 problems resulting in blood transfusions.
CLC speculated in its February newsletter that the decision to delay either permitting or refusing the request was a political decision, postponing its announcement until after the scheduled October federal election.
Still, CLC is not disappointed with the delay.
Jack Fonseca of Campaign Life Coalition said he was pleased that the decision has been pushed back, saying he hopes the move means that Health Canada scientists are “demanding more data from the manufacturer because they have safety concerns about the dangerous drug.” He told LifeSiteNews “there is no logical reason to lift the existing ban.”
Officially Health Canada decides whether to approve drugs “based on a detailed scientific review.” Fonseca said there seems to be political pressure on the bureaucracy and the government to permit the abortion drug in Canada.
Saporta told the media she is “very optimistic” it will be approved. She said mifepristone is needed in Canada to provide chemical abortions where there are no abortion services, such as in Prince Edward Island, the northern Territories, and remote rural areas. Yet Saporta told the CBC that RU-486 does not increase the total number of abortions in a country once approved.
Pro-lifers are hopeful that Bill C-17, which became law last November, might help keep RU-486 out of Canada. Also known as Vanessa’s law, the private member’s bill requires the mandatory reporting of adverse drug reactions and institutes tough new penalties for unsafe products. CLC’s Johanne Brownrigg told the Catholic Register, “we could trust that Health Canada would follow those guidelines and see that RU-486 is not the miracle drug it’s being marketed as.”