News

By John-Henry Westen

WASHINGTON, November 15, 2005 (LifeSiteNews.com) – A US Government Accountability Office (GAO) Report on the Food & Drug Administration’s handling of the over the counter application for the abortifacient morning-after pill Plan B found the FDA’s actions “unusual”. However, Concerned Women for America has praised the FDA in light of the GAO report findings and commended the FDA for treating the application with great concern.

“Making Plan B over-the-counter would needlessly expose adolescents to risks and reduce access to health care to those in need of it,” said Wendy Wright, CWA’s Executive Vice President. “The debate is whether it should be available without a prescription. Barr Labs never bothered to adequately research whether it could be taken safely by the full population who would purchase it from drugstore shelves. And proponents make false claims – which their own studies refute – that it would halve the number of pregnancies and abortions.

“Thankfully, the FDA’s leadership did what others refused to do – consider whether a drug’s easy availability would present unique health risks to women and girls.

“The FDA was asked to make a high dose of a drug available OTC when the low dose requires a prescription. Doctors screen women for medical conditions before prescribing the morning-after pill and check for conditions that a woman may not realize she hasÂacquired which can lead to infertility and death.

“The FDA should consider that its decision to make a drug as easy to get as toothpaste could lead to a proliferation of deadly sexually transmitted diseases.”

Wendy Wright testified at the FDA Advisory Committee hearing on OTC for Plan B. CWA filed an extensive report earlier this month with the FDA, which argued that it lacks the authority to approve Plan B with an age restriction and that OTC status for Plan B would put women at medical risk.

See the GAO report online here:
https://www.gao.gov/new.items/d06109.pdf