I’ve never been a morning person, but on this particular autumn morning I was up with the sun. I woke my boyfriend who was sleeping next to me, and told him to get up and get ready. I wanted to be at the University Health Clinic as soon as it opened its doors. The condom broke the night before and at 2 a.m. there wasn’t much we could do but try to get some sleep. Fortunately, the clinic accepted drop-in visits; but only on a first-come, first-serve basis, and I wasn’t going to risk not being seen that day. Also fortunate was the Federal Drug Administration’s decision to put an emergency contraceptive on the market in December of 2000.
After a long wait and about a five-minute meeting with the resident gynecologist, I was handed a prescription for Plan B, or the “morning after pill.” I took it around the corner to the University’s pharmacist and breathed a sigh of relief as I ripped open the little blue box I was given and was handed a bottle of water.
This was five years ago, and Plan B had only been on the market for nine months. The FDA’s decision to offer Plan B in the United States gave women like me a safety barrier between complete abstinence and the risk of having to confront the dreaded a-word, or m-word. But for women without insurance and the money to pay for a doctor’s visit, Plan B was not readily available.
That is officially changing nationwide – Plan B can now be purchased in nine states, including California, from a pharmacist by anyone over the age of 18, regardless of gender. The American Medical Association has been in support of the FDA’s approval of over-the-counter (OTC) availability of Plan B since it was approved for use in the United States in 2000.
On Aug. 24 the FDA announced its approval of Barr Pharmaceuticals’ (the manufacturer of Plan B) 2004 petition for OTC sale of Plan B. Currently it is only available with a pharmacist’s consultation in Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Vermont and Washington. The other states won’t offer it through a pharmacist until the end of the year, according to an FDA spokesperson, but do offer Plan B with a doctor’s prescription.
The Web site www.ec-help.org lists local pharmacies that now sell Plan B.
Although organizations like Planned Parenthood are applauding the decision, concerns remain for the demographic left out of this decision – women under 18.
“Last year alone, Planned Parenthood provided more than one million women with emergency contraception to prevent unintended pregnancy,” Planned Parenthood president Cecile Richards said in a statement in response to the decision.
“While we are glad to know the FDA finally ended its foot-dragging on this issue, Planned Parenthood is troubled by the scientifically baseless restriction imposed on teenagers,” Richards said. “The U.S. has one of the highest rates of teen pregnancy in the western world – anything that makes it harder for teenagers to avoid unintended pregnancy is bad medicine and bad public policy.”
“We’re trying to make it easily available for women,” said Harriet Fukushima, an advice nurse at the Tang Center. She said students, regardless of age, can call the advice nurse and obtain a prescription over the phone after answering a series of questions. Students may then go to the Tang Center’s pharmacy to fill their prescription. Fukushima said the prescriptions include a backup dose.
“Basically, women should not be shy about asking for Plan B,” Fukushima said. She said the student insurance plan offered through Mills covers 80 percent of the cost and the information given to the Tang Center is confidential. If parents are billed by the Tang Center, the charges are not detailed, Fukushima said, so Plan B would not be listed on the statement.
According to the FDA, Plan B is most effective if taken within 72 hours of intercourse. “We do give it out for up to 5 days after intercourse,” Fukushima said, but it the probability of it working decreases the longer you wait. “It’s probably less effective, but still worth trying,” Fukushima said.
According to Barr, Plan B is 89 percent effective if taken in the first 72 hours after intercourse. The dosage consists of two pills and is taken orally.
The FDA released a statement on Aug. 23 explaining that there was no reason to guarantee Plan B would be used “safely and effectively” by women under 18 without “the professional supervision of a practitioner licensed by law to administer the drug.” This was their reason for making it available OTC only to women over 18.
“While we still feel that Plan B should be available to a broader age group without a prescription, we are pleased that the Agency has determined that Plan B is safe and effective for use by those 18 years of age and older as an over-the-counter production,” said Bruce L. Downey, Barr’s chairman and CEO in a press release. Downey said Barr will continue to work with the FDA to reduce the age restriction of Plan B.
Fukushima said the Tang Center has not yet decided how it will handle the FDA’s decision.
As part of Barr’s agreement with the FDA, the company will implement a Convenient Access, Responsible Education (CARE) program before the emergency contraceptive will be available OTC without a pharmacist’s consultation. The program will limit the sale of Plan B to pharmacies with professional healthcare supervision, educate customers and distributors about how Plan B should be used responsibly and “monitor the effectiveness of the program.” Barr has also agreed to work with distributors to ensure the FDA’s age restriction is enforced.