Health Canada and RU-486: No More Foot-Dragging!

Melissa Haussman suggests that Health Canada’s recent deliberations on the licensing of RU-486 are reminiscent of foot-dragging politics in the US. 

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Foot-dragging by Health Canada in responding to women’s reproductive health needs is nothing new.  For example, Health Canada did not approve a single contraceptive agent for women between1994 and 2005.

The current controversy is ongoing delays by the agency in licensing RU-486 – a safe and effective alternative to surgical abortion. RU-486 (a patented 600-mg mifepristone pill) was developed by Roussel-Uclaf and first approved for clinical use in France in 1988. Then in 1992, the French government approved the use of RU-486 along with a prostaglandin analog of either 400 µg of misoprostol (preferred), or 1 mg of gemeprost, 36-48 hours later.  In numerous clinical trials, these two possible drug combinations proved to be safe and effective alternatives to surgical abortion, causing fewer side effects and reaching a 95% efficacy rate. To reach the 95% efficacy rate, however, the medications must be given sequentially; neither one alone will work as well.

Those who are against abortion not only want to limit access to surgical abortions, they also want to limit access to the medical abortions that would allow women to have safe and effective terminations at a doctor’s office. Among their successful tactics in limiting the availability of medical abortions have been efforts to bully the maker of RU-486.

Imperial War Museum - The Women's Royal Navy Service, 1943

Imperial War Museum – The Women’s Royal Navy Service, 1943

While there are potentially huge profits to be made from the sale of most women’s reproductive drugs, there can also be huge losses associated with the marketing of controversial drugs.  Fear of such losses has been the case with the pharmaceutical company Hoechst-Roussel and RU-486.  If we look at recent experience in the US, it took President Clinton two presidential terms to get RU-486 approved in the US.  One of the reasons it took so long was disproportionate fear of the anti-choice lobby, on the part of the manufacturer.  A second reason was the delaying tactics used by the Republican majorities in both Congressional houses from 1994-2000.

In the 1990s, Hoechst sequentially bought Roussel and then Uclaf.  Hoechst-Roussel, which had a base in New Jersey, was dissuaded from manufacturing, testing and licensing RU-486 for the US market by the RCR Alliance which threatened to boycott its other drugs around the world.  Meanwhile, in 1995, having recently decided not to “take the risks” associated with RU-486 in the US, Hoechst-Roussel bought the Marion-Merrell-Dow Company – the maker of Agent Orange, the toxic defoliant used by the US army in Vietnam. There were no threats of a backlash that would affect company profits.

In 1994, Hoechst transferred the US rights to sell RU-486 to the Population Council – a think tank often concerned with global demography, formed by John D. Rockefeller III in 1952.  This organization was immune to boycott threats, since it was not a private corporation.  The Population Council began clinical trials in the US in 1983. In the last months of the Clinton Presidency, once the US-based trial data were available, RU-486 was approved in the US.  The FDA Commissioner, Dr. Jane Henney, the first woman to head the FDA, announced the approval on September 28, 2000.

Given parallels between the US and Canadian pharma markets and drug approval processes, it is not at all surprising that the licensing of RU-486 in Canada has been similarly delayed. Back in 1997, when the Roussel sale to Hoechst was complete, Hoechst transferred the non-US rights to sell RU-486 to Exelgyn, a French company.  At the time, it was rumored that Exelgyn would apply for the Canadian distribution rights, but that did not happen.  In 2000, the Population Council began clinical trials in Canada. In 2001, there was an unfortunate death in one of the trials – a death from a secondary infection (and not attributable to the use of RU-486) – as a result of which Health Canada and the federal government backed away from the file. This is problematic insofar as the federal government has responsibilities to the women in this country, a majority of whom are fertile, and some of whom may benefit from early, safe and effective medical abortions.

It is my understanding that there is a foreign company willing to provide RU-486 to the Canadian market and there is a willing Canadian distributor.  The federal government needs to be as bold as its private-sector counterparts and approve this drug for use in Canada.

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Melissa Haussman is an Associate Professor in the Department of Political Science at Carleton University and author of Reproductive Rights and the State:  Getting the Birth-Control, RU-486 and Morning-After Pills and the Gardasil Vaccine to the US Market.

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