National representatives introduced a bill Thursday hoping to force the Food and Drug Administration to decide whether Plan B contraception, or the morning-after pill, can be offered over the counter.
Frustrated with the FDA's indecisiveness on the issue, a bipartisan group of lawmakers introduced the Plan B for Plan B Act of 2005, after the FDA closed a public-comment period on the issue Tuesday.
If passed, the act would automatically approve over-the-counter distribution of Plan B after 30 days of the bill's passage, until the FDA made a decision.
"We're not telling the FDA how to decide on emergency contraceptive pills, but we do want the FDA to make a decision before stalling any longer," said Rep. Carolyn Maloney, D-NY, in a Nov. 3 press release. "It's no secret anymore that politics, not health concerns, is driving the FDA's process.
"The longer we have to wait for a decision on this clear-cut issue, the worse it is for women's health."
The bill would not effect the way the drug is distributed at ASU's Health and Wellness Center, where Plan B is available without seeing a physician, but not over the counter, said Health and Wellness Center Managing Pharmacist Carl Labbe.
Women can receive a prescription directly from the pharmacy after a brief counseling session.
If sexual intercourse occurred within the last 72 hours and the woman has had no major medical problems, she is usually eligible to receive the drug, Labbe said.
Manufactured by Barr Pharmaceuticals Inc., Plan B contains a higher amount of progesterone hormone than regular birth-control pills, and works by blocking the release or fertilization of an egg.
The controversy surrounds regulatory, health and ethical concerns. Proponents argue the drug is safe and effective in reducing unintended pregnancies, while opponents say it will encourage teen sex.
The FDA is currently on its third review of the Plan B application.
So far, the issue has prompted heated political debates and the August resignation of Susan Wood, the FDA assistant commissioner for women's health, because of the agency's refusal to issue a final decision.
Labbe said because Plan B has to be administered within 72 hours of sexual intercourse, offering it over the counter may make it more effective.
"Access to this drug is crucial," he said. "Getting it in a timely manner is crucial to its effectiveness."
Labbe also said that because Plan B has been proven safe to use, offering it over the counter would not be dangerous to women's health.
Nevertheless, over-the-counter availability could also present some disadvantages said Dr. Stefanie Schroeder, chief of the medical staff at the Health and Wellness Center.
"My concern is when it is just over the counter and you can pick it off the shelf, there's no counseling associated with that," she said. "We believe in making it available and as free as possible, but with some kind of counseling. You need to know what you're taking."
Also, there's concern that women might start purchasing Plan B over the counter as their primary form of contraception, Schroeder said.
ASU's health center dispenses about 80 prescriptions of Plan B each month. Research done during the 2003-04 school year showed 70 percent of women received the prescription only once.
"There's not a lot of repeat use," said Labbe.
As far as the FDA is concerned, Labbe said, Plan B should not be made available over the counter, but should be distributed through pharmacists, similar to ASU's prescription method. This way, women wouldn't have to meet with their physicians to get prescriptions, but they would receive some counseling through the pharmacist.
The FDA is currently sifting through over 10,000 comments received during its two-month public-comment period about the controversial issue.
Reach the reporter at ann.censky@asu.edu.
