[Marxism] FDA approves next-day pill: step forward for abortion rights

Fred Feldman ffeldman at bellatlantic.net
Fri Aug 25 03:48:36 MDT 2006


A retreat from the trend to treat abortion as though it was already
outlawed,. and its legal status was just an irritating technicality. Of
course, the age restriction is outrageous.
 
This backdown by the FDA folliows the setbacks to the attempt to outlaw
abortion in North Dakota and Misissippi. None of these battles is
settled, but botrh signal the impact that a revived women's movement
could have.
 
This will probably also further undermine base among rightists Christian
groups.  
Fred Feldman
 
 
August 25, 2006

F.D.A. Approves Broader Access to Next-Day Pill 

By
<http://topics.nytimes.com/top/reference/timestopics/people/h/gardiner_h
arris/index.html?inline=nyt-per> GARDINER HARRIS

WASHINGTON, Aug. 24 - The
<http://topics.nytimes.com/top/reference/timestopics/organizations/f/foo
d_and_drug_administration/index.html?inline=nyt-org> Food and Drug
Administration on Thursday approved over-the-counter sales of the
morning-after contraceptive pill to women 18 and older, resolving one of
the most contentious issues in the agency's 100-year history.

Nationwide over-the-counter sales of the drug, Plan B, are expected to
start by the end of the year. It will be sold in pharmacies and health
clinics only, and buyers must show proof of age. Anyone under age 18
will still need a prescription. Men may also buy Plan B for a partner. 

The prescription drug now sells for $25 to $40 per two-pill dose, but
the manufacturer, Barr
<http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthto
pics/drugspharmaceuticals/index.html?inline=nyt-classifier>
Pharmaceuticals of Woodcliff Park, N.J., said the price could change. 

The agency's decision, which took three years and spanned the terms of
three F.D.A. commissioners, did little to dampen what has became a
central part of the nation's debate on
<http://topics.nytimes.com/top/reference/timestopics/subjects/a/abortion
/index.html?inline=nyt-classifier> abortion. Abortion rights advocates
argue that the wide availability of Plan B may reduce abortions;
abortion opponents assert that Plan B will cause them. 

Abortion rights advocates hailed the F.D.A.'s decision on Thursday,
although many bemoaned the age restriction.

"We are pleased that a common sense, common ground agenda for reducing
unintended
<http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthto
pics/pregnancy/index.html?inline=nyt-classifier> pregnancy and the need
for abortion finally won out," said Kirsten Moore, president of the
Reproductive Health Technologies Project in Washington.

Abortion opponents threatened political retribution, however, and were
displeased when President Bush backed the agency's decision.

"Let there be no mistake about it," said the Rev. Thomas J. Euteneuer,
president of Human Life International, an anti-abortion group based in
Virginia. "Today's decision lies at the feet of President Bush and has
created a lasting rift with the Catholic faithful who comprise a large
part of his support base." 

In a briefing on Monday, Mr. Bush was asked whether he supported the
intention by Andrew C. von Eschenbach, acting commissioner of the
F.D.A., to approve over-the-counter sales of Plan B.

"I support Andy's decision," he replied, a rare moment when a president
addressed an application pending before the drug agency.

Barr Pharmaceuticals said that sales of Plan B would barely register on
its balance sheet and that it had no plans to advertise the drug on
television or radio. [BusinessDay, Page C1.]

Dr. von Eschenbach wrote that he had decided that 18 was the appropriate
cut-off age because pharmacies already used it for restricted nicotine
and cold medicines sales.

"This approach builds on well-established state and private-sector
infrastructures to restrict certain products to consumers 18 and older,"
Dr. von Eschenbach wrote in a memorandum. 

His predecessor, Dr. Lester M. Crawford, said last year that science
supported giving over-the-counter access of the drug to women at 17, but
that he could not figure out how to ensure that such an age restriction
was enforced. 

The agency has now decided that it will rely on Barr to enforce the
rules. The company's chairman, Bruce Downey, said in an interview that
the company would depend on pharmacists to abide by the restrictions.

Barr will not sell the pills to gasoline stations or convenience stores,
and it will conduct surveys to measure adherence, Mr. Downey said.

The drug agency decided that younger women would benefit by seeing a
doctor before having access to Plan B. It also determined that Barr had
failed to prove that young women would understand how to use the drug as
well as older women. 

The F.D.A.'s approval was widely expected and led to a flood of prepared
press releases from Capitol Hill offices, advocacy and medical groups. 

"This long overdue decision is a victory for women's health and for the
American people who have been waiting for years for the F.D.A. to act,"
Senators
<http://topics.nytimes.com/top/reference/timestopics/people/c/hillary_ro
dham_clinton/index.html?inline=nyt-per> Hillary Rodham Clinton, Democrat
of New York, and Patty Murray, Democrat of Washington, said in a
statement. 

Senator Tom Coburn, Republican of Oklahoma and a family practice doctor,
denounced the decision, saying, "Exposing women to the high-dose
<http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthto
pics/hormones/index.html?inline=nyt-classifier> hormones in Plan B
without the guidance of a physician will put them at risk." 

Studies suggest that both the anti-abortion groups and abortion rights
advocates are wrong in their predictions of the pill's effect on the
number of abortions performed each year and on the rate of
<http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthto
pics/venerealdiseases/index.html?inline=nyt-classifier> sexually
transmitted diseases. Couples in the United States have so much
unprotected sex - half of all pregnancies are unplanned - that even if
the pills were passed out like aspirin, they would be unlikely to cause
a major change in abortion and disease rates.

"Emergency contraceptives don't work if, like condoms, they're left in
the drawer," said Dr. James Trussell, director of the Office of
Population Research at
<http://topics.nytimes.com/top/reference/timestopics/organizations/p/pri
nceton_university/index.html?inline=nyt-org> Princeton University. "And
studies show that even if women have the pills on hand, the drawer is
where they remain."

Still, Dr. Tina Raine, associate professor of obstetrics and gynecology
at the
<http://topics.nytimes.com/top/reference/timestopics/organizations/u/uni
versity_of_california/index.html?inline=nyt-org> University of
California, San Francisco, said that over-the-counter access to Plan B
would help some women avoid becoming pregnant.

"Unintended pregnancy rates have been dropping over the last decade,''
Dr. Raine said. "Lots of things have contributed to that, and this will,
too." 

Plan B's effect on the F.D.A. and its image may well overshadow its
public health impact. 

The agency has regulatory authority over a quarter of the United States
economy. Despite this huge portfolio, three commissioners devoted
countless hours to considering whether to switch Plan B. a
small-selling, decades-old medicine, to over-the-counter status.

"I cannot recall any other issue in my 45 years of watching F.D.A. that
has garnered this much attention at all levels of government," said
Peter Barton Hutt, a former general counsel for the agency who now
teaches drug law at
<http://topics.nytimes.com/top/reference/timestopics/organizations/h/har
vard_university/index.html?inline=nyt-org> Harvard.

The director of the Office of Women's Health at the drug agency resigned
last year to protest what she said was the abortion politics behind the
delay in approving Plan B. An investigation by the Government
Accountability Office concluded that top agency officials had decided to
reject the initial Plan B application months before a scientific review
was complete.

Sworn depositions taken by lawyers from the Center for Reproductive
Rights, a legal advocacy organization, show that some of the agency's
staff members were convinced that no amount of scientific evidence would
have persuaded the F.D.A.'s political appointees to approve the
application.

Dr. John Jenkins, director of the Office of New Drugs at the agency,
said in a deposition that his boss, Dr. Steven Galson, told him "that he
felt he didn't have a choice" but to reject the application, according
to transcripts provided to The New York Times. 

"And he characterized that in a sense that he wasn't sure that he would
be allowed to remain as center director if he didn't agree with the
action," Dr. Jenkins said. Dr. Galson is director of the Center for Drug
Evaluation and Research at the F.D.A. 

Dr. Florence Houn, director of the office that evaluated the Plan B
application, said that she was told by Dr. Janet Woodcock, a deputy
commissioner at the agency, that a rejection was necessary "to appease
the administration's constituents, and then later this could be
approved,'' according to the transcripts.

Drs. Galson and Woodcock said in their own depositions and public
statements that scientific considerations drove their decisions. In an
interview, Dr. Galson refused to address the apparent inconsistencies.

"I'm extremely happy to put this phase of the decision-making process
behind me and to move on to other priorities," Dr. Galson said.

But the issue may not go away. 

Barr will study Plan B's use in young adolescents in hopes of getting
the agency's age restrictions lifted, Mr. Downey said.

"In my mind,'' he said, "if we go back and have an adequate study that
includes the younger group, the basis for any age restriction goes
away." 

Last year, Senators Clinton and Murray placed a legislative hold on Dr.
Crawford's nomination as commissioner to pressure the agency to make a
decision on Plan B. They lifted their hold after Health and Human
Services Secretary
<http://topics.nytimes.com/top/reference/timestopics/people/l/michael_o_
leavitt/index.html?inline=nyt-per> Michael O. Leavitt promised a
decision by Sept. 1 of that year. Dr. Crawford was then confirmed, but
the agency announced yet another delay in a decision on Plan B. 

When Dr. Crawford unexpectedly resigned weeks later, the two senators
refused to let Dr. von Eschenbach's nomination as commissioner advance
without a Plan B decision. On Thursday, they said that they would lift
their hold.

Plan B is made from a synthetic hormone found in regular oral
contraceptives. There are two pills, the first of which should be taken
within 72 hours of unprotected sex and the second 12 hours later. Like
regular contraceptive pills, Plan B generally acts by preventing
ovulation or fertilization, according to the F.D.A.

Plan B may in rare circumstances prevent a fertilized egg from becoming
implanted, something abortion opponents decry. But regular oral
contraceptives do that, too.





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