FDA Approves Generic Plan B EC for Teens

Yesterday, the FDA approved a prescription-only generic version of the contraceptive Plan B, an emergency contraceptive (EC), for women age 17 and younger. Watson Laboratories Inc has been granted approval from the FDA for its Abbreviated New Drug Application (ANDA) for lthe evonorgestrel tablets. The generic product (levonorgestrel 0.75 mg) will only be available by prescription and will only be sold to women under the age of 18. Watson Laboratories plans to market and launch the product shortly under the trade name Next Choice.

This approval is the latest chapter in the long and EXTREMELY confusing history of the FDA and emergency contraception. Plan B (also known as the morning-after pill), is marketed by Duramed Pharmaceuticals, and has been available over-the-counter to women age 18 and older since 2006 and via prescription-only for those younger than 18.

• In March 2009, a Federal court ruled that the FDA based its age restriction policy on politics rather than science, and ordered the FDA allow 17-year-olds to buy Plan B without a prescription under the same conditions as Plan B was currently available to women over the age of 18 stating, "The FDA repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons.”



• On April 22, 2009, in accordance with the court's order, the FDA announced that Plan B will be available to women 17 and older without a prescription.

HOWEVER, this ruling was very misleading...

According to the FDA press release announcing approval of generic Plan B, 17-year-olds (or younger) would need a prescription-only generic emergency contraceptive because, as of right now, they cannot purchase Plan B OTC and that insurance companies are more likely to cover prescription drugs. In fact, by announcing the approval of OTC sales of Plan B to 17-year-olds, the FDA would basically allow for Plan B’s manufacturer to submit an application for OTC Plan B sales to this age group. The FDA will not confirm or deny whether such an application has been submitted; however, the agency has said that no application for OTC sales to 17-year-olds has been approved. So, at least for the time being, the only way that a person under the age of 18 can obtain this EC (whether brand name or generic) is with a prescription.

The FDA also added that no generic, non-prescription version of Plan B for women 18 and older can be approved until August 24, 2009 – as this is when Duramed 's patents on the product expire.

• How to Use and Obtain Plan B
• EC Quiz

_{Plan B EC Photo © 2009 Dawn Stacey}