A decision on whether to approve the abortion pill in Canada has once again been delayed, likely until the fall, according to the organization that represents abortion providers in Canada and the United States.
The president of the National Abortion Federation said on Tuesday that Health Canada has asked for more information from the European drug company that has applied to sell mifepristone in Canada, a request that means the federal regulator is unlikely to issue a ruling on the drug until later this year.
"Certainly, we're disappointed with the delay," Vicki Saporta told The Globe and Mail in an interview. "But I'm very optimistic that, at the end of the day, Health Canada will approve mifepristone and it will be available for Canadian women to use next year. We're making forward progress."
The National Abortion Federation, which represents 80 per cent of abortion providers in Canada, has been helping the drug company, Linepharma International, with its application to sell a combination pack of mifepristone and misoprostol, a second drug required to complete a medical abortion that is approved in Canada for other uses.
Ms. Saporta told The Globe last month that Health Canada had set an internal deadline of mid-January to decide on the application, which was submitted in October, 2011, and resubmitted in 2012, according to Marion Ulmann, the company's chief operating officer.
Asked about the decision being postponed, Ms. Ulmann, Linepharma's chief operating officer, said by e-mail Tuesday night that the application has proceeded as expected.
"So far the registration procedure has gone uneventfully along with usual Health Canada procedures and there is no predefined date for the end of the procedure," she said.
Health Canada has an internal service standard of 300 days to issue a decision on a new drug application. However, a spokesman said processing an application can take as long as two or three years if the regulator requests more data from pharmaceutical companies.
Mifepristone is already approved in 60 countries, including the United States, Australia and most of Europe.
More than 750 days have elapsed since Linepharma resubmitted its application.
That is longer than Health Canada has taken to approve any other new drug in recent years, according to a Toronto professor who studies how Health Canada reviews drug applications.
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 last year. The longest application took 644 days.
Mifepristone, when combined with misoprostol, is generally used to terminate a pregnancy between seven and nine weeks. NAF and other organizations that support bringing the medical abortion drug to Canada say it will make ending a pregnancy more discreet and widely available, especially in areas where services are scarce.
But opponents of the drug warn it is not safe for women, a contention NAF says is not supported by more than 20 years of medical evidence.