Morning After Pill Maker Renews Effort to Get Dangerous Drug in Stores
by Steven Ertelt
July 26, 2004
Washington, DC (LifeNews.com) — After failing in their first bid for over-the-counter sales of the dangerous morning after pill, the maker of the drug is launching a new effort to get the Food and Drug Administration to allow it to be sold to anyone over the age of sixteen.
In May, the FDA denied Barr Laboratories’ request because the pharmaceutical company failed to provide enough data about the impact of the drug on teens.
Barr’s main basis for approval was a study of 585 people who had used the drug. But, the FDA pointed out that only 29 of the subjects were 14-16 years old.
The agency said the drug company could come back with a revised proposal that required women purchasing the drug over the counter to be 16 years of age or older.
Barr’s latest request for approval does just that.
"We are pleased to be responding to the FDA with a submission that we believe will lead to approval of use of Plan B emergency contraceptive," Dr. Carole Ben-Maimon, President and COO of Barr Research, said.
Pro-life groups say it will be difficult to enforce the age requirement and are concerned that adults or friends of teenagers under 16 will purchase the drugs and give them to young teens who should be consulting with a doctor.
The FDA has never before approved such an approach to the sale of drugs in stores.
Pro-life advocates also say the FDA was right to reject the sale of the so-called morning after pill and point to numerous complications that young women can develop by using the drug.
If the drugs, which sometimes act as an abortifacient, are sold without a doctor’s approval, "It is likely that many women, particularly young women, would suffer physical consequences," said Dr. Gene Rudd, associate executive director of the Christian Medical Association.
"These high doses of hormones have not been adequately tested for their effect on teenagers, yet teenagers are a prime market for the drugs," Rudd said.
Cathy Cleaver Ruse, of the United States Conference of Catholic Bishops, added that the morning after pill has been associated with a heightened risk of ectopic pregnancy, a potentially fatal condition.
Under the proposal, send to the federal agency on Thursday, younger teens could still obtain the morning after pill via a doctor’s prescription.