- Margaret HamburgFDA Commissioner
Tell the FDA to End Unnecessary Age Restrictions on Emergency Contraception
The FDA has a long history of standing in the way of full over-the-counter access to emergency contraception (EC) – a safe, effective back up birth control option which can help a woman reduce the risk of unintended pregnancy.
In February 2004, FDA leaders announced a delay in considering a request to make this time-sensitive method available over the counter. You acted.
In May 2004, the FDA took the unprecedented action of refusing an OTC application despite overwhelming scientific consensus. You acted.
In August 2005, the FDA delayed once again. You acted.
Finally, in August 2006, the FDA could not ignore the overwhelming evidence any longer and allowed OTC access to Plan B for consumers 18 and older. We celebrated even though the unwarranted age restriction means every woman must ask a pharmacist for emergency contraception and young women still have to get a prescription for this time sensitive product.
A US District Court ruled on March 23, 2009 that the FDA had “acted in bad faith and in response to political pressure” in imposing the age restriction and urged the FDA to re-review the evidence for over-the-counter access to anyone at risk of unintended pregnancy. (You can find the court decision here: http://reproductiverights.org/en/case/tummino-v-von-eschenbach-ny)
The FDA has had a year to remove the politically motivated age restriction and it has not done so. We have waited long enough. Tell the FDA to comply with the court’s decision and act now so that every woman who needs emergency contraception can get it without embarrassment or delay.
If a woman fears unintended pregnancy and seeks emergency contraception, the last thing she needs is confusion – or worse, refusals – at the pharmacy counter. She needs simple, over-the-counter access to EC to prevent a pregnancy.
This administration must stop using reproductive rights as a bargaining chip and instead take action to improve access to the full range of reproductive health care. An immediate step would be for the FDA to follow the court order and reconsider the scientific evidence on making emergency contraception available without a prescription for consumers of all ages.
- FDA Commissioner
- President of the United States
On March 23, 2009 a U.S. District Court issued Tummino v. von Eschenbach, finding that the Food and Drug Administration’s over-the-counter approval process for Plan B "departed in significant ways from the agency's normal procedures.” The court ordered the FDA to reconsider making emergency contraception available without a prescription for consumers of all ages, citing the overwhelming consensus among scientists at the FDA in support of the switch without restrictions.
It has been a full year since the District Court decision and we are still waiting for the FDA to comply with the judge’s ruling to re-review the evidence for over-the-counter access to emergency contraception.
Emergency contraception (EC) is a safe, effective back-up method of birth control that can prevent pregnancy after unprotected sex or contraceptive failure. As the leader of a government agency “responsible for protecting public health,” it is imperative to embrace comprehensive reproductive health options for women. A woman is healthiest when she can decide the timing and spacing of her pregnancies. Let’s ensure that any woman who needs EC can get it safely and quickly.
Please adhere to your own scientists’ recommendations to make emergency contraception available over-the-counter. Comply with the court’s decision and act now so that every woman who needs emergency contraception can get it without embarrassment or delay.
Thank you for your consideration.
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