Health Canada has set an internal deadline of mid-January to finally make a decision on the abortion pill, a drug that is already available in 60 countries but has been stuck in Canada’s drug-approval pipeline for more than three years.
The pro-choice advocates and researchers who have been helping a small European drug company with its Canadian application say they have encountered an unusual amount of antipathy from the regulators who will decide if Canadian women get access to mifepristone, a pill that can end an early pregnancy when combined with a drug that is already sold in this country.
More than 700 days have passed since the company resubmitted its application at the request of Health Canada in October, 2012 – that is more than twice as long as the regulator’s 300-day standard for a first decision on a new drug.
The lag occurred even though the department’s deputy minister told a House of Commons committee in November of last year that mifepristone “would go faster than normal applications,” because of its widespread use.
Despite the delay, the leader of the organization that represents abortion providers in the United States and Canada believes Health Canada is poised to approve the drug. The decision could significantly expand access for women who live far from the urban centres that have most of Canada’s abortion facilities.
“Canada is the only developed country in the world without the gold standard for medical abortion care. It makes no sense,” said Vicki Saporta, the Washington-based president of the National Abortion Federation (NAF.) “We have responded and the manufacturer has responded to every concern [the regulators] have raised ... we do expect that they will approve it in January.”
Health Canada would say virtually nothing about the mifepristone application, citing confidentiality policies. It refused to divulge internal deadlines, the date the application was filed or the name of the drug company.
But The Globe and Mail has learned the applicant is Linepharma International, a small manufacturer based in France and the United Kingdom that makes only two drugs: mifespristone and misoprostol, the second drug required for a medical abortion.
One of Linepharma’s advisers and board members is André Ulmann, a French doctor and one of the fathers of medical abortion. He was the international project leader for the development of RU-486 – as mifepristone was originally known – at the French pharmaceutical giant Roussel-Uclaf in the 1980s.
The company donated the U.S. rights to mifepristone to a U.S. non-profit organization called the Population Council, which got the drug approved there in 2000.
At the time, the director of the organization’s reproductive health program was Beverly Winikoff. She is now the president of Gynuity Health Projects, a U.S. not-for-profit research group that has been providing pro bono support to Linepharma for its Canadian application.
“There seemed to be a lot of negativity toward this drug in some of the meetings I attended,” Dr. Winikoff said. “I’ve been in a lot of regulatory meetings and the Canadian one was unusual in that people were attacking in a way I wouldn’t have expected in a regulatory meeting.”
A spokesman for Health Canada declined to address that characterization directly, but said in a statement that, “Health Canada undertakes a rigorous review of every drug submission, holding companies accountable for providing detailed and scientifically defensible information.”
In October, 2011, Linepharma International filed a new-drug submission for its Mifepristone Linepharma 200 milligram tablet, which it aims to sell in combination with misoprostol, according to Marion Ulmann, the company’s chief operating officer.
After Health Canada requested more “quality documentation,” Linepharma resubmitted its application in October, 2012, Ms. Ulmann said by e-mail.
In an earlier interview, she called the Health Canada process “very smooth,” and said she had no complaints.
Ms. Saporta, on the other hand, echoed Dr. Winikoff’s concerns.
Asked about complaints that the review has been slow and difficult, Health Minister Rona Ambrose said: “I think if you talk to any drug company on the drug approval process, they might say the same thing. I’m not involved in any drug approvals. What I hear from drug companies is the process is very rigorous. But I think it needs to be. Drug safety is very important.”
Safety concerns have been raised about mifepristone. A 27-year-old Quebec woman died during a Canadian clinical trial of it in 2001, which anti-abortion activists have raised in their campaign against the pill.
“It’s anything but perfectly safe ... it’s a deadly cocktail for the baby certainly, but also for the mother,” said Mary Ellen Douglas, a national organizer for the Campaign Life Coalition, which puts on the massive National March for Life at Parliament Hill every year. Last year’s theme was keeping RU-486 out of Canada.
The U.S. Food and Drug Administration has identified at least 14 deaths after medical abortions in the United States.
In six of the most concerning cases, the women died of septic shock after they were infected with an unexpectedly lethal strain of a bacteria called Clostridium sordelli. But the U.S. Centers for Disease Control and Prevention found that strain also killed women during other reproductive events, including surgical abortions, spontaneous miscarriages and births.
Clostridium sordelli was responsible for the Quebec woman’s death, and brought an end to the Canadian trials of mifepristone.
“A lot of smart people worked so hard trying to figure this one out and decided that there had been a mutation in the bacteria,” said Ellen Wiebe, the Vancouver doctor who led the Canadian trials. “It was one in a million, but still, there’s a lot more than a million people around, and so we had those deaths. There haven’t been any recent ones.”
On the whole, mifepristone is considered extremely safe. A review of 45,000 medical abortions published last year in the journal Contraception found serious complications in just 0.4 per cent of cases.
“Every other developed country in the world has this drug,” Dr. Winikoff said. “Why not Canada?”Report Typo/Error