Mixed Messages

They call it "Emergency Contraception" but the advertising on this bus in Vancouver, Washington says you can "take it within 5 days" to prevent pregnancy. Sounds like plenty of time to find another phamracist if they one down the street doesn't want to fill it.

The consent form a woman must sign to get the drug says, "New information shows that EC may sometimes prevent pregnancy up to five days after sex, but EC works batter [sic] the sooner you use it."

According to the World Health Organization's study on the effectiveness of Plan B, the drug was found to be significantly more effective the earlier it was used with in a 72-hour interval. The efficacy of levonorgestrel (i.e. Plan B) was only 58% when begun within 49 to 72 hours after unprotected intercourse.

If the efficacy is only 58% at the 49 to 72 hour interval why are they advertising it as effective up to 5 days? So what's its efficacy after 72 hours? Where's this "new information" coming from? Is there a study we can see? What exactly does Planned Parenthood tell women seeking Plan B about its efficacy?-- Try it, if you're still pregnant come back for an abortion? Does this sound like bait-and-switch to you? What about false advertsing?

The FDA seemed to think so. When Planned Parenthood pulled the same thing in their Seattle advertising campaign rolling out Plan B, they received a warning letter from the FDA .

Prescription drug ads are false or misleading if they suggest that a prescription drug is more effective than has been demonstrated by substantial clinical experince (21 CFR 202.1(e)(6)(i)).

If there is substantial clinical experience we'd sure like to see it.

Please write to:
Joan Hankin
Consumer Promotion Analyst
Food and Drug Administration
Division of Drug Marketing, Advertising, and Communications
HFD-42, Rm 8B-45
5600 Fishers Lane
Rockville, MD 20857

Refer to matter: MACMIS ID# 11214 and NDA 21-045