Less than two years after the Food and Drug Administration approved Plan B, the so-called “morning after pill” for over-the-counter access by women 17 years of age and older, the drug’s maker is now seeking to lift the age restrictions on the controversial product.
Teva Pharmaceuticals, Plan B’s maker, submitted data from a study in which girls ages 11 to 16 used the drug to prove its effectiveness and safety. Girls under 17 currently need a doctor’s prescription to obtain the drug.
“Parents should be very concerned that the FDA and the drug company are trying to sell this drug to minor girls without the parent’s knowledge or consent,” Wendy Wright of pro-life group Concerned Women for America told Fox News.
Teva says that the nature of the drug, which must be consumed within three days of unprotected sex to be effective, means many customers won’t have the ability to see a doctor quickly enough for what they deem an “emergency contraceptive,” to work correctly.
The drug uses a massive flood of hormones to prevent a fertilized egg from taking root in a woman’s uterus. Pro-life groups, which maintain that human life begins at conception, say that the drug actually ends pregnancies, rather than preventing them.
“We believe it is important that we remove all the barriers to obtaining Plan B One-Step so that anyone who needs it can get it as quickly as possible,” Teva spokeswoman Denise Bradley said.
Critics of the proposal say that selling the pill to minors over the counter eliminates important safeguards.
“In any case in which a minor girl would be seeking this drug, there needs to be an adult intervention,” said Wright. “There needs to be a doctor involved, who can find out if this girl is being abused.”
The general timeline for a drug to be re-classified from prescription to over-the-counter by the FDA is roughly 10 months, but each case is different. The agency performs a benefit-to-risk analysis and studies whether labeling instructions can be done so that consumers can safely use the drug without the intervention of a medical professional.
Supporters of the drug say the move is long overdue. After a court hearing to expand over-the-counter access for Plan B in November, Suzanne Novak, an attorney for the pro-choice Council for Reproductive Rights said the politicization of the issue needed to end.
"All of the scientific facts are there and FDA experts agree-emergency contraception has proven safe and effective to be sold over-the-counter to all ages," she argued.
Plan B has been a contentious issue for the FDA for some time. In 2005, the FDA official in charge of women’s health issues resigned in protest after the agency delayed a final ruling on whether the drug should be made more easily accessible.