james g. keegan jr.
2009-03-30 20:15:12 UTC
A New Day for the Morning-After Pill
A federal court ruling rightly criticizes the FDA's reasons for
limiting sales of the Plan B pill and orders a remedy.
The 40 studies were thorough and conclusive: The morning-after
contraceptive pill is safe and effective, and teenage girls understand
just as much as young women do about how to use it safely. Also well
studied were the Bush administration's attempts to keep the pill out of
the hands of American women and girls, at least for as long as it could.
The conclusion, just as clear, in a 2005 report by the Government
Accountability Office: The Food and Drug Administration abdicated its
duty, overriding and overruling scientists so that it could delay and
limit access to the pill and thus allay the concerns of religious
conservatives.
A federal court ruling this week spared no criticism of the FDA,
saying that the agency's reason for limiting behind-the-counter sales of
the pill to women 18 or older and to minors with a prescription "lacks
all credibility" and was politically motivated. Perhaps most scathing
was the court's order to the FDA: Go back and reexamine the issue solely
on its scientific merits. Within 30 days, the FDA also must make the
pill available to 17-year-olds without a prescription.
The FDA stalled for years with subterfuges that were all too
transparent. First it rejected nonprescription use of the pill, which
was marketed as Plan B. Then it told the manufacturer, Barr
Laboratories, to submit a proposal for allowing the pill for older teens
and adults. Once the company did so, the FDA said it wasn't sure that
limiting use by age was valid. Finally, in 2006, the agency decided to
give women 18 and older behind-the-counter access - but only as a sop to
senators who were threatening to hold up President Bush's nomination of
Andrew C. von Eschenbach as FDA commissioner.
The campaign to make Plan B available without a prescription was
based on solid medical grounds: The pill is most effective when used
within 24 hours of intercourse. The response of the FDA, which the
public relies on to make equally solid medical decisions, was an
embarrassing new low that prompted the agency's director of women's
health to resign. Objections that the pill would entice girls into
earlier and more promiscuous sex were not only unfounded - among the
studies were findings that access to Plan B did not affect sexual
behavior - but irrelevant. It was never part of the FDA's job to monitor
moral behavior among adolescents.
There is justified glee in the scientific community over the
announcement by President Obama that science will be shown due respect
under his administration. As welcome as this new direction is, the
court's review of the FDA's actions provides an even more significant
reassurance that the government will be held to account no matter who is
in power at the moment.
http://www.truthout.org/032709HA?print
A federal court ruling rightly criticizes the FDA's reasons for
limiting sales of the Plan B pill and orders a remedy.
The 40 studies were thorough and conclusive: The morning-after
contraceptive pill is safe and effective, and teenage girls understand
just as much as young women do about how to use it safely. Also well
studied were the Bush administration's attempts to keep the pill out of
the hands of American women and girls, at least for as long as it could.
The conclusion, just as clear, in a 2005 report by the Government
Accountability Office: The Food and Drug Administration abdicated its
duty, overriding and overruling scientists so that it could delay and
limit access to the pill and thus allay the concerns of religious
conservatives.
A federal court ruling this week spared no criticism of the FDA,
saying that the agency's reason for limiting behind-the-counter sales of
the pill to women 18 or older and to minors with a prescription "lacks
all credibility" and was politically motivated. Perhaps most scathing
was the court's order to the FDA: Go back and reexamine the issue solely
on its scientific merits. Within 30 days, the FDA also must make the
pill available to 17-year-olds without a prescription.
The FDA stalled for years with subterfuges that were all too
transparent. First it rejected nonprescription use of the pill, which
was marketed as Plan B. Then it told the manufacturer, Barr
Laboratories, to submit a proposal for allowing the pill for older teens
and adults. Once the company did so, the FDA said it wasn't sure that
limiting use by age was valid. Finally, in 2006, the agency decided to
give women 18 and older behind-the-counter access - but only as a sop to
senators who were threatening to hold up President Bush's nomination of
Andrew C. von Eschenbach as FDA commissioner.
The campaign to make Plan B available without a prescription was
based on solid medical grounds: The pill is most effective when used
within 24 hours of intercourse. The response of the FDA, which the
public relies on to make equally solid medical decisions, was an
embarrassing new low that prompted the agency's director of women's
health to resign. Objections that the pill would entice girls into
earlier and more promiscuous sex were not only unfounded - among the
studies were findings that access to Plan B did not affect sexual
behavior - but irrelevant. It was never part of the FDA's job to monitor
moral behavior among adolescents.
There is justified glee in the scientific community over the
announcement by President Obama that science will be shown due respect
under his administration. As welcome as this new direction is, the
court's review of the FDA's actions provides an even more significant
reassurance that the government will be held to account no matter who is
in power at the moment.
http://www.truthout.org/032709HA?print
--
"You have confirmed my suspicion that those who argue the rights
of the fetus view the woman as a container."
==Muriel Nelson <***@hemlock.cray.com>
"You have confirmed my suspicion that those who argue the rights
of the fetus view the woman as a container."
==Muriel Nelson <***@hemlock.cray.com>