Monday, March 23, was a Big Day for Plan B!


The Decision

Judge Korman of the U.S. District Court for the Eastern District of New York ordered the FDA to reconsider its decision to limit the OTC sale of Plan B to 18 years of age and older.
It also ordered the FDA to act within 30 days to extend over-the-counter access to every-one 17 years of age and older.
This was an amazing victory pursued by the Center for Reproductive Rights.
Further, it is one that I am particularly excited by because my daughter and I were plaintiffs.

    I Followed, Aliza Led

My daughter Aliza was one of the three teenagers involved in bringing the suit. In that Aliza was 16 when the motion was filed and turned 17 before the motion was fully briefed, she played a key role in the decision. (The other two teenagers were both 13.) Part of the text of the Summary Judgment stated:
“Aliza will turn 17 before this motion is fully briefed, and thus falls into the category of women (who all scientists at FDA agreed could safely and appropriately use Plan B as an OTC drug, but are barred from doing so by the BTC regime), which imposes an age cut-off of 18.”
The significance of Aliza’s age was explained by Nan Strauss of the Center, in April 2007:
“Being 17, she [Aliza] cannot access EC OTC, based on the final FDA decision. However, prior to that last decision setting the age limit at 18 (on 8/26/06), during 2005 and the beginning of 2006 Steven Galson, the director of the Center for Drug Evaluation and Research, had placed the age restriction at 17…”
“No one at FDA has indicated any problem w/ the data showing that 17 year olds can use Plan B safely and appropriately. The only basis for the restriction on women 17-18, is that the FDA wanted to set the age limit so that it would be in accordance with already existing age limits on products like tobacco and nicotine replacement products. So it’s helpful to have someone in that in between group, for whom the added year of the restriction (the shift from 17 to 18) is significant, and totally unrelated to health, medicine, or science.”
“Only Aliza falls into the group of women for whom everyone at FDA says can safely use the drug, but can’t have OTC access because pharmacies are already accustomed to restricting certain products to people over 18.”

To read the decision:

0 Responses to “Monday, March 23, was a Big Day for Plan B!”

  1. No Comments

Leave a Reply

Comment guidelines: No spamming, no profanity, and no flaming. Inappropriate comments will be deleted outright.


- site5 - web7