Pharma company seeks over-the-counter Plan B access for minors
WASHINGTON, D.C., February 17, 2011 (Lifesitenews.com) - Girls of any age could obtain the Plan B morning after pill without a prescription, if a request filed by Teva Pharmaceuticals with the Food and Drug Administration (FDA) is approved.
Teva manufactures Plan B One-Step, a form of the drug that the company claims will prevent pregnancy with a single pill if taken within 72 hours of intercourse.
Pro-life opponents of the pill have long pointed out that, like other forms of emergency contraception, Plan B can also act as an abortificient by preventing a fertilized ovum from implanting in the uterus.
“Plan B One-Step works like any other abortifacient drug: It can alter . . . the lining (endometrium) of the mother’s uterus so that the newly-formed baby cannot implant and thus dies,” aid Marie Hahnenberg, director of American Life League’s The Pill Kills project. “Plan B One-Step’s product information itself states, ‘It may inhibit implantation.’ Women should not allow themselves to be misled by sales representatives for Plan B and Plan B One-Step, who claim that these products will not terminate an existing pregnancy.”
Plan B is currently available over the counter to women over the age of 17, but requires a prescription for those under the minimum age.
The company’s request is the latest development in the drug’s embattled history since it was first made available by prescription in 1999.
In response to a lawsuit filed by the Center for Reproductive Rights, the FDA in 2006 made the pill available over the counter to women 18 years of age and older.
In March of 2009, a U.S. District Judge ruled that the FDA’s continued restrictions on the pill were in “bad faith and in response to political pressure.” The Agency was ordered to lower the age of over the counter access to 17, and to reconsider granting full over-the-counter status.
Last November, the Center for Reproductive Rights (CRR) filed a motion for contempt against the FDA, arguing that the agency had failed to comply with the court’s order to reconsider free access to the drug.
Advocates of the pill have expressed hope that Teva’s recent application could provide additional leverage to their efforts.
“The FDA has had enough evidence before it to make a decision . . . since before the lawsuit started. There was no need to wait for another application,” Ian Vandewalker, a CRR legal fellow, wrote in a blog post Monday. “The Teva application may get the ball rolling on a final decision on Plan B, which will likely result in increased access for teens.”
Opponents, however, are raising concerns about the effect that increased access will have on the health and well-being of minors.
“Plan B has been an utter failure at reducing abortions or pregnancies, which was the main argument for making it available over the counter. This senseless obsession with giving it to minors without doctor’s oversight is not in the best interest of children,” Wendy Wright, President of Concerned Women for America, told LifeSiteNews in an interview.
“There’s a good reason why even the birth control pill requires a prescription, which is an even lower dose of the drug. . . . It offers an opportunity for the woman to get a check up, for the doctor to talk to her and check her for sexually transmitted diseases and find out if she is being abused.”
Wright also pointed out that several studies have indicated that many women now rely on Plan B as a substitute for normal methods of birth control, despite the lack of information about the effects of regular use.
“They haven’t done the tests,” said Wright, “They’re not going to do the tests because they don’t want to find out. That’s why it is incredibly irresponsible for the FDA to continue approving these kinds of drugs.”