Despite early denials, Health Canada has confirmed that it is currently reviewing an application for the abortion drug, RU-486. On Nov. 25, the same day that a commentary in the Canadian Medical Association Journal claimed such an application existed, Deputy Health Minister George Da Pont told the Standing Committee on Health that “to date, no company has applied to market the product in Canada.”
Matt Wojciechowski of Campaign Life Coalition submitted an access to information request to Health Canada. An unsigned Jan. 2 email from Health Canada’s Bureau of Metabolism, Oncology and Reproductive Services confirmed that there is in fact an RU-486 application, stating “an application has indeed been filed with Health Canada and is under review.”
“All new drug applications are required to meet evidentiary standards demonstrating safety, effectiveness, and quality, including that the benefits outweigh any risks …. currently, in Canada, no health product has been authorized for the termination of intrauterine pregnancy,” the email stated. Wojciechowski is now following up to get information about when the application was submitted and which pharmaceutical company is seeking to distribute the drug.
The Health Canada website states that “the process for the review of a drug takes an average of 18 months from the time that a sponsor submits a New Drug Submission until the Therapeutic Products Directorate makes a marketing decision.”
Da Pont, however, said on Nov. 25 before the Standing Committee that if a submission for RU-486 was received, it would “go faster than normal applications” given mifepristone’s “widespread use” and “lots of data from other countries.”
iPolitics reported that five applications for mifepristone, one of two drugs used as part of the RU-486 abortion cocktail, were approved in 2013 under Health Canada’s Special Access Program permitting doctors to dispense unapproved or restricted drugs to patients with serious or life threatening illnesses. Three of the requests were to treat a patient with brain cancer and the other two were for serious eye disease and higher stress hormone levels due to cancer.
CLC currently has a petition urging Minister of Health Rona Ambrose “to immediately intervene with Health Canada to ensure that the RU-486 application is definitively rejected.” The text of the petition cites evidence of the health risks associated with mifepristone, as well as its designer’s ties to gas used in Nazi death camps.
Wojciechowski commented to The Interim that it is shocking that Canadians are “being kept in the dark” about such an “important” and “controversial” issue.
CLC has been “exposing this ever since we found out,” he said, and has fought against the abortion drug as early as the ‘80s. It will continue to seek more information about the RU-486 application and keep Canadians informed about the process.
Health Canada said it will not reveal the name of the company that is requesting approval of RU-486.