Feminists in the United States
waged a decade-long battle against right wing activists to bring an important
medical technology to the United States only to experience years of foot
dragging from the Clinton administration which recently announced it still
won’t allow women access to a drug that has been available in Europe for
12 years.
The drug, of course, is RU-486
and induces an abortion 95.5 percent of the time when taken within the
first 49 days of pregnancy. Originally developed by Hoechst AG, the drug
first went on sale in France in 1988.
Unfortunately anti-abortion
activists actively campaigned to keep the drug from being available in
the United States. Promising to retaliate against Hoechst AG if the drug
were sold in the United States, the drug company refused to allow Roussel
Uclaf — which held RU-486’s marketing rights for the United States —
to market the drug here.
The anti-abortion groups were
aided by Congress and the Bush administration. In 1989 the U.S. Food and
Drug Administration banned the import of RU-486 for personal use. U.S.
Customs seized a prescription of RU-486 from an American citizen brought
to the United States after a trip to Europe and the Supreme Court refused
to hear the pregnant woman’s appeal of the seizure, allowing the FDA ban
to stand.
But feminists thought that
would all change with the election of Bill Clinton in 1992. In an effort
to court feminist voters, candidate Clinton pledged his support for bringing
RU-486 to this country and after the election the FDA announced that it
could review and approve RU-486 in as little as six months. FDA Commissioner
David Kessler wrote to Roussel Uclaf and encouraged the company to submit
the drug for approval.
Unfortunately Hoechst AG and
Roussel Uclaf still were resistant to selling the drug in the United States,
but agreed to transfer the marketing rights to the nonprofit Population
Council. Finally, on May 16, 1994 the Population Council was granted the
U.S. patent rights to RU-486 and clinical trials began in October 1994.
And almost six years later the drug is still not available in the
United States (so much for that six month speedy approval the Clinton
FDA promised.)
All of the studies conducted
so far indicate the drug is safe and effective, yet the FDA still refuses
to grant it final approval. Just last week, the FDA announced that it
still is not ready to approve the drug, saying that it had concerns about
the manufacturing and labeling of the drug, which is pretty much the same
thing the FDA said in a 1996 letter.
Planned Parenthood spokeswoman
hit the nail on the head when she said, “We think it’s appalling that
for 10 years the world’s most industrialized nation has not had access
to this drug that would benefit women.”
This is a classic example of
the idiocy of the FDA. Although in the 1950s or 1960s, U.S. drug approval
processes might have been said to be superior to Europe’s, today the techniques
for distinguishing between safe and unsafe medications are well known
and practiced by all Western industrial nations. A much better policy
would be to allow any drug approved for sale in Europe to be sold in the
United States with a warning that the drug has been reviewed by European
regulatory agencies but not the U.S. FDA.
Why not let women choose for
themselves what to do with their bodies? Or are we to assume that the
same woman able to decide whether or not to abort a fetus is simply incapable
of making a decision about whether or not to take a drug that has been
approved an in use in Europe for more than a decade?
References:
French
abortion pill falls short of FDA requirements. Fox News, February
21, 2000.
The Fight To
Make RU-486 Available To U.S. Women. From The Feminist Majority Foundation.