Reading Deeper Into The FDA Announcement on Plan B One-Step

On April 30th, the FDA announced it would approve the amended application by Teva Women’s Health, Inc to lower the age requirement for accessing Plan B One Step from 17 to 15. The product will still only be available in retail establishments with an on-site pharmacy, but may now be available in the family planning aisle, and during hours that the pharmacy is not open. The ruling doesn’t apply to the other emergency contraception drugs, Plan B or Ella.

While we laud the decision to make emergency contraception more accessible, the details are problematic. Under the new ruling the label must read “Not for sale to those under 15 years of age. *Proof of age required.* Not for sale where age cannot be verified.” This means a 15 year old will have to provide proof of age in order to access Plan B One-Step. According to an article published on Forbes.com, when asked how a 15 year old can provide identification an FDA spokeswoman replied “a passport or birth certificate.” Per the FDA’s press release, “Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age.” 

This requirement could easily create a situation where a person of any age could be denied the sale if they do not have the proper ID. Marcia D. Greenberger, from the National Women’s Law Center (emphasis added) points out “While an improvement over current policy, today’s announcement is still disappointing. Because all women will be required to show an ID to establish their age, those without IDs could be denied access.”

While any progress towards greater access to emergency contraception can be seen as a victory, this ruling still brings cause for concern.  Emergency contraception is most effective when it’s taken early on after unprotected sex. Therefore, any delays in being able to purchase this contraception can lead to unintended pregnancy. 

On April 4th, 2013, Federal Judge Edward Korman found against the FDA’s current age restriction policies in Tummino v Hamburg, and gave the federal government 30 days to remove all age restrictions on the sale of emergency contraception. In doing so, he stated:

“…she [Secretary of Health and Human Services Sebelius] has failed to offer a coherent justification for denying the over-the-counter sale of levonorgestrel-based emergency contraceptives to the overwhelming majority of women of all ages who may have need for those drugs and who are capable of understanding their correct use.” (pg 12)

The FDA has until May 5th to comply with the federal court ruling to provide all emergency contraception over the counter to anyone, regardless of age. So why approve an amended application five days before a court ruling would have made this matter moot?  National Women’s Law Center Vice President Judy Waxman suggests “This triggers their intention to file an appeal even if they haven’t yet. This decision doesn’t comply with the judge’s ruling.”

We’ll be waiting to see what the fallout of this ruling will be. What do you think? Is this decision a victory or a stall tactic?

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