Summer 2004- This summer a new application for the OTC status of Plan B was submitted with a novel packaging requirement- the “dual label”. If approved under this requirement, Plan B would be available OTC only for women 16 and older. Younger women would still need a prescription to purchase emergency contraception. This is a policy many public health and women’s rights advocates find completely unacceptable because it prevents responsible yet vulnerable young women from accessing a product that has the potential to powerfully shape their future.
The FDA is scheduled to make its decision regarding this application by late January 2005. Many advocates and health care experts familiar with this issue and the FDA process feel that politics is trumping science, and that this decision will be made purely on political grounds- in accordance with an anti-reproductive rights, right-wing agenda. Right-wing groups and anti-reproductive rights members of Congress have been pressuring the FDA to reject approval of over-the-counter status, but scientific research has overwhelmingly demonstrated the safety, efficacy, and need for emergency contraception over-the-counter for all women. Tell the FDA to stop playing politics with women's lives!
5/7/04 - Food and Drug Administration (FDA) late yesterday decided to reject over-the-counter status for emergency contraception.
We must now make our voices heard, once again expressing our anger that the FDA has allowed right-wing politics to trump women’s health.
The FDA sent a letter late Thursday night to Barr Laboratories, the distributors of the emergency contraceptive Plan B, rejecting its application for over-the-counter status for the drug. This decision is despite the fact that the FDA’s own expert advisory panels voted 23-4 in favor of making Plan B available over the counter.
It is imperative that we send thousands of messages to the FDA expressing our outrage that it has succumbed to political pressure and rejected approval for Plan B over the counter. ACT NOW!
5/6/04 - The Washington Post just reported the alarming news that the distributors of the emergency contraceptive (EC) Plan B do not think that the Food and Drug Administration (FDA) will approve over-the-counter status for EC. A spokesperson for Barr Laboratories, the distributors of Plan B, told the Post that she thinks "an approval is not a likely scenario." ACT NOW!
2/13/04 - *Campaign Update* FDA
delays Emergency Contraception status decision
by 90 days, send an urgent message of support
to the FDA to make EC available over the counter,
without a prescription. See the News
Article and send
a message to the FDA!
2/6/04 - *Campaign Update* The FDA will make its final decision on over-the-counter status for the emergency contraceptive Plan B by Feb 20. Please IMMEDIATELY send a message of support of EC OTC to the FDA today!
1/15/04- *Campaign Update* Thanks to women like you 32,744 petitions were delivered to the FDA on December 16. The advisory committee voted to support over-the-counter sales status for the emergency contraceptive (EC) Plan B. This is a great win for women everywhere. But the FDA has yet to give final approval and the anti-choice community is trying to make the decision a political one.
On April 21, 2003, Women’s Capitol Corporation
(WCC) submitted their petition to the FDA to make
Plan B® - the progestin-only form of emergency
contraception - available over
the counter. The Feminist Majority Foundation
is submitting petitions in support of this important
initiative to expand and protect women's reproductive
rights. The FDA will accept or reject the request
by Spring 2004. The FDA will be holding a hearing
on December 16, 2003.
EC has the potential to prevent half
of the unintended pregnancies and 800,000
of the abortions that take place in the United
States each year. EC works for 120 hours after
unprotected sex, failed contraception, or rape
to prevent pregnancy by interfering with ovulation,
fertilization, or implantation. EC is up to 95%
effective in the first 24 hours and is safer than