FDA vs. Women’s Health, Again

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?


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.

NOW’s Abortion Lawsuit Threatens Freedom of Expression

The fundamental problem with American
politics is that it is largely unprincipled. Groups and lobbies often
seem more interested in getting their own outcome — regardless of the
methods they need to use.

This simple maxim was underscored
with last week’s unanimous Supreme Court ruling that Planned Parenthood
could sue Operation Rescue and other pro-life groups under the Racketeer-Influenced
and Corrupt Organization laws. Planned Parenthood’s “victory”
is nothing less than a stunning blow to the very freedom and choices that
the organization pretends to cherish so deeply.

RICO was passed in 1970 in an effort
to give prosecutors a bigger weapon against organized crime. Congress
wanted to make it easier to go after legitimate businesses that had been
infiltrated and controlled by organized crime outfits.

RICO never did make much of an
impact on organized crime, but prosecutors and other groups were more
than willing to use its provisions for political purposes. The Reagan
administration, for example, encouraged the use of the RICO statutes to
crack down on pornography.

In 1988, The Nation reported
the story of Dennis and Barbara Pryba who owned three adult bookstores.
In 1987 they were charged and found guilty of selling six obscene magazines
and four obscene videotapes. Under RICO, which only requires two criminal
acts to apply, this made the couple an organized crime racket and the
government seized over $1 million in property from the couple.

Reagan’s Attorney General Ed
Meese set up a special anti-obscenity task force whose sole purpose was
to use the RICO laws to drive adult bookstores out of business.

What Meese and Reagan never understood
was that restricting speech can cut both ways.

When a machinists’ union claimed
that Texas Air was violating airline safety rulings, Texas Air promptly
sued the union claming that such criticism constituted “a pattern
of racketeering activity.”

When John Spear, editor of a small
weekly newspaper in New York criticized the way police in West Hartford,
Conn., handled abortion protesters, West Hartford sued him under the RICO
statute, claiming his editorials were an attempt to intimidate West Hartford
police. They argued that Spear’s damaging criticisms constituted
an extortion attempt.

And now the Supreme Court has ruled
that RICO may be used against antiabortion groups.

The National Organization for Women
argued that Operation Rescue had engaged in a conspiracy of racketeering
to run abortion clinics out of business. Operation Rescue concedes it
want to see abortion clinics out of business, but argued that since its
motivation was political and not economic, RICO could not be used against
the organization. The Supreme Court ruled that the motivation of the group
is immaterial to whether or not RICO may be applied.

NOW’s case against Operation
Rescue will now go to trial. If it can convince a jury that blocking entrances
to abortion clinics constitutes a form of extortion, or if it can tie
a couple members of Operation Rescue to other criminal acts, such as bomb
threats, it can probably put Operation Rescue out of business.

This is a horrible application
of RICO and one that will be felt in other areas besides the conflict
over abortion.

“Under this decision, Martin
Luther King Jr. would have been a racketeer,” Randall Terry, founder
of Operation Rescue, told The New York Times. “What I’d
say to the AIDS activists, the anti-nuclear groups, the animal rights
people, is get your affairs in order and line up, because you’re

If abortion clinics can use the
RICO statutes against abortion protesters, what’s to stop corporations
from using it against animal rights protesters?

“Animal rights activists sometimes
use peaceful, non-violent protests … and we’re concerned that this
kind of decisions is going to chill that First Amendment activity,”
Todd Davis, a lawyer for People for the Treatment of Animals, told USA

In fact NOW might eventually find
itself on the other side of the RICO law.

Given the shaky grounds that Roe
v. Wade was construed on, and the clear desire by some Supreme Court justices
to overturn the decision, it’s not inconceivable that the Supreme
Court might turn the issue of abortion back to the states. Operation Rescue
then might find use for this law in going after pro-abortion groups and

By attacking Operation Rescue with
RICO, NOW has demonstrated that achieving its short-term political aims
is more important than preserving the First Amendment protection guaranteed
to all Americans.

Someday, NOW might regret that