Health Canada has taken longer to issue a decision on the abortion pill than on any other new drug approved in recent years, according to a Toronto professor who studies the federal drug regulator.
Joel Lexchin, a professor in the school of health policy and management at York University, reviewed the time it took Health Canada to approve 41 new drugs in the two years leading up to March 31 of this year.
The longest took 644 days. More than 750 days have elapsed since a small European drug company re-submitted its application to sell mifepristone, a pill that can terminate an early pregnancy when combined with a drug that is approved in Canada for other uses.
“It’s pretty unusual,” Dr. Lexchin said of the delay.
The Globe and Mail reported on Tuesday that Linepharma International applied to have its 200 mg mifepristone tablet approved in October, 2011. The company refiled its application in October, 2012, at the request of Health Canada, which was seeking more “quality documentation,” Linepharma’s chief operating officer said.
Dr. Lexchin said the delay is especially confounding because mifepristone is already approved in 60 countries, including the United States, Australia and most of Europe.
“The more data that’s available from outside of Canada, the easier it should be to make a decision, especially if you’re looking at safety data,” he said.
Health Canada has an internal service standard of 300 calendar days to issue a decision on a new drug – which can be an approval, a rejection or a request for more information.
A spokesman for Health Canada would not comment on the mifepristone application, citing confidentiality policies.
However, he said some new drug applications can take as long as two or three years if Health Canada asks the manufacturer for more information.
The National Abortion Federation, which represents abortion providers in Canada and the United States, has been pushing for years to see mifepristone approved in Canada in hopes that the pill would make first-trimester abortions more discreet and widely available.
NAF and Linepharma say they are expecting Health Canada to issue a ruling by mid-January.
“The difference that mifepristone could make is that all of a sudden any family physician across Canada … will be able to offer this to women and girls with unintended, unwanted pregnancies,” said Wendy Norman, a family physician and professor in the department of family practice at the University of British Columbia. “This then can happen within the privacy of the relationship you have with your primary care provider.”
Dr. Norman co-authored a recent survey that found, in 2012, less than 4 per cent of abortions performed in Canada are done using drugs, a process known as medical abortion.
Although mifepristone is not approved in Canada, doctors can use the chemotherapy drug methotrexate off-label to kick-start a medical abortion that is completed using misoprostol, the contraction-inducing drug that would be used with mifepristone.
However, abortion providers generally consider methotrexate inferior to mifepristone. It takes longer to work, is less predictable and can lead to birth defects if the abortion fails.
Ellen Wiebe, the director of the Willow Women’s Clinic in Vancouver, is a strong supporter of mifepristone. But she doubts general practitioners will take up the drug as enthusiastically as some of her colleagues hope.
“Theoretically, it could make a huge difference,” she said. “But why didn’t methotrexate do it if it’s just a matter of people not having the surgical skills or the surgical clinic available?”Report Typo/Error