FDA misses deadline for the ‘morning after pill’

Jessica Sprowl

The Federal Drug Administration missed its deadline for the proposal of Plan B becoming an over-the-counter drug Jan. 21.

The Plan B contraceptive, also known as the “morning after pill” or the emergency contraceptive pill, may become easier for women to obtain if the FDA approves the contraceptive to be distributed over-the-counter.

Since the FDA missed the deadline, officials do not know when the decision will be made, said R. Duane Satzger, director of the organic branch with the FDA’s Forensic Chemistry Center.

Since 1998, women have had to receive a prescription first from a doctor before being able to take the emergency contraceptive pills, Satzger said.

In December 2003, the FDA started to discuss changing Plan B to an over-the-counter drug, but the committee had concerns pertaining to adolescents 15 years old and younger being able to properly take Plan B without professional supervision of a licensed practitioner, Satzger said.

The FDA came back after the second proposal for Plan B to be distributed over-the-counter with a “not approvable” letter stating the proposal did not reveal enough information that adolescents 15 years old and younger could safely use Plan B without a licensed practitioner, Satzger said.

This does not mean Plan B will not become over-the-counter, but that it must obtain the new guidelines set forth by the FDA, Satzger said.

“Right now, the time constraint for the pill is pretty severe. If it became available over-the-counter, it would become much more accessible for women,” said Roberta Aber, executive director of Planned Parenthood of Summit, Portage and Medina counties.

For now, women have to go see a physician to receive the prescription and then go to the pharmacy, which takes away from the 72 hours women have to take the pill.

Aber also said there is much speculation that the FDA’s hesitation to make Plan B over-the-counter is more of a political matter than a scientific one.

“Research does not support the claim that females 15 years old and younger would not be able to use the pill correctly,” Aber said. “The FDA doesn’t have any reason not to approve it.”

Plan B contraceptive pills have proved to reduce the risk of unwanted pregnancy up to 89 percent when taken as directed. It has also been estimated that Plan B would prevent 1.7 million unintended pregnancies and about 800,000 abortions annually if given over-the-counter, according to www.go2planB.com.

“I have taken the emergency contraceptive pill three times,” said one female student, who asked to remain anonymous. “I was really scared the first time, and I said I never wanted to take it again, but I don’t regret taking it.”

The student said she had mixed feelings about the Plan B pill becoming available over-the-counter. She said younger girls may take advantage of using the pill.

There are already limited pharmacies throughout Alaska, California, Hawaii, Maine, New Mexico and Washington taking part in distributing Plan B over-the-counter through a pharmacy access program.

Plan B uses a higher dosage of levonorgestrel, which is an ingredient many traditional oral contraceptives use.

Plan B is the only FDA-approved emergency contraceptive and should be taken within the first three days of intercourse. It is best when used within the first 24 hours after the intercourse. The pill is then followed by another pill 12 hours later.

This emergency contraceptive does not work like the abortion pill, RU-486, and will not work on women who are already pregnant. There is also no evidence Plan B will impair a pregnant woman or a developing fetus.

Sara Kimball, of Communications Strategies with Barr Pharmaceuticals, Plan B’s distributor, said the most important thing is that women know the pill will still continue to be available whether or not the FDA approves the drug to be administered over-the-counter.

For more information on the Plan B contraceptive, go to www.go2planb.com

Contact social services reporter Jessica Sprowl at [email protected].