2consists of one pill containing 1.5 mg of levonorgestrel. Studies have shown that combining thetwo 0.75 mg doses of the hormone into one pill does not decrease its effectiveness; indeed, thetwo Plan B pills may be taken simultaneously, fewer than 12 hours apart, or up to 24 hours apart,without any adverse consequences. Both Plan B and Plan B One-Step are most effective whentaken immediately after intercourse and preferably no later than 24 hours later, though they mayretain some effectiveness if taken within 72 hours. Neither drug has any known serious or long-term side effects, though they may have some mild short-term side effects, such as nausea,fatigue, and headache.Levonorgestrel-based emergency contraception “interferes with prefertilization events. Itreduces the number of sperm cells in the uterine cavity, immobilizes sperm, and impedes furtherpassage of sperm cells into the uterine cavity. In addition, levonorgestrel has the capacity todelay or prevent ovulation from occurring.” U.S. Gov’t Accountability Office, GAO-06-109,
Food and Drug Administration: Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual
at 12 (November2005), Case No. 05-cv-366, Doc. No. 68-2 (hereinafter “GAO Report”).
These contraceptives“have not been shown to cause a postfertilization event—a change in the uterus that couldinterfere with implantation of a fertilized egg.”
at 13. Indeed, Diana Blithe, the biochemistwho supervises research on contraception at the National Institutes of Health (“NIH”), opinedthat the possibility of levonorgestrel-based emergency contraceptives having an effect onimplantation of fertilized eggs should “definitely” be taken off the labels for those drugs. Pam
Citing H.B. Croxatto et al.,
Mechanismof Action of Hormonal Preparations Used for Emergency Contraception: AReview of the Literature
, 63 Contraception, 111 (2001); H.B. Croxatto et al.,
Pituitary-Ovarian Function Followingthe Standard Levonorgestrel Emergency Contraceptive Dose or a Single 0.75-mg Dose Given on the DaysPreceding Ovulation
, 70 Contraception 442 (2004); A.L. Muller et al.,
Postcoital Treatment with LevonorgestrelDoes Not Disrupt Postfertilization Events in the Rat
, 67 Contraception 415 (2003); H.B. Croxatto et al.,
Mechanismsof Action of Emergency Contraception
, 68 Steroids 1095 (2003).
Case 1:12-cv-00763-ERK-VVP Document 85 Filed 04/05/13 Page 2 of 59 PageID #: 2127