June 21, 2013
FDA Approves Over-The-Counter Emergency Contraceptive For All Women Of Child-Bearing Age
Lawrence LeBlond for redOrbit.com - Your Universe Online
Less than two weeks after the Obama Administration announced it would not dispute a federal judge’s order to remove age limitations on emergency contraceptives for women, the US Food and Drug Administration (FDA) said it is now approving the use of Plan B One-Step as a nonprescription product for all women of child-bearing age.
The FDA action complies with an April 5, 2013 order by the US District Court in New York to make emergency contraceptives containing levonorgestrel available as an over-the-counter (OTC) product without age or point-of-sale restrictions.
Plan B One-Step is intended to reduce the chance of pregnancy following unprotected sex or a suspected failure with other contraceptives, such as condoms. To be effective, the 1.5 mg tablet must be taken as soon as possible after intercourse – within three days.
The FDA notified the District Court on June 10, stating it would comply with the April 5 ruling. But in order to comply, the FDA asked Teva Women’s Health, the maker of Plan B One-Step, to submit a supplemental application seeking approval of the emergency contraceptive to be made without any restrictions. The request was fulfilled by Teva and the FDA has since completed its commitment.
“Over-the-counter access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
News of the FDA’s action was happily welcomed by reproductive rights groups.
“It's about time,” Chris Iseli, a spokesman for the Center for Reproductive Rights, said in an interview with Monte Morin of Los Angeles Times. “It's taken too long to bring emergency contraception out from behind the pharmacy counter.”
According to the Times, the center represented plaintiffs in a lawsuit against the government charging that the access to the drug was being unfairly blocked. It argued that the drug was proven to be as safe as aspirin and should be available to all women.
While the plaintiffs had hoped for a win for all versions of the drug, particularly cheaper generic versions, Iseli said they were happy with Thursday’s approval, calling it a “significant victory.”
While the FDA has officially removed the age restrictions on OTC sales of the drug, it noted the action is not immediate. Packaging on the product must be changed to reflect the new rules and old stock must be sold under the old rules. It could be weeks or months before the new Plan B One-Step boxes hit store shelves, and it is likely that there will be some initial confusion among consumers and sales clerks.
The FDA initially appealed the order to remove age restrictions, but did approve use of the emergency contraceptive as an OTC product to girls as young as 15 years old. That move dropped the age restrictions for OTC sales from women as young as age 17, first approved in 2009.
However, the court demanded that age restrictions be removed for all women of child-bearing age.
US District Judge Edward Korman, who ordered the removal of age restrictions in his ruling, voiced concern that the FDA might now grant “marketing exclusivity” to Teva, giving the manufacturer a three-year monopoly on the sale of the non-prescription drug. Federal law does allow the FDA to grant exclusive agreements to drug firms under certain conditions, conditions that Teva falls under.
Such exclusivity would "only result in making a one-pill emergency contraceptive more expensive and thus less accessible to many poor women," Korman wrote.
Still, the FDA has complied fully with the ruling and soon Plan B One-Step will be available for all.
Plan B contains higher levels of a hormone found in other types of daily-use oral contraceptives and works in a similar way by stopping ovulation and preventing pregnancy. While the one-time emergency contraceptive achieves the same results as daily-use contraceptives, it will not stop a pregnancy if the woman is already pregnant and there is no evidence that the product will harm a developing fetus.
There are some side effects associated with use of Plan B One-Step. The most common effects are nausea, vomiting, stomach pain, headache, dizziness and breast tenderness. These are similar side effects to those associated with daily-use contraceptives.