Plan B - Why 18?

Aug 24 2006 Published by under Uncategorized

For those of us who have been wondering why the FDA concluded that Plan B can safely be used by 17-year-olds, but should only be sold to those 18 and over, there is finally an answer: the FDA is afraid that pharmacists and pharmacy cashiers cannot correctly subtract. If you go to the FDA's latest website on Plan B, you will find links to pdf files for two memos, one by Center for Drug Evaluation and Research director Steven Galson, and one written by Acting FDA Commissioner Andrew von Eschenbach.

The Galson memo is largely silent on the 18-year-old age restriction, saying only:

Regarding the restriction on OTC use to age 18 and older, Dr. von Eschenbach decided that this was the appropriate age for OTC use for the reasons described in his memorandum of August 23, 2006. I have read that memorandum and, although I previously concluded that OTC use should be restricted to women 17 or older, I have now determined that for the reasons Dr. von Eschenbach outlines, the approval of this application should reflect a restriction to OTC use for those age 18 and older.

The entire Eschenbach memo is a justification for increasing the age restriction from 17 to 18, and I will not quote the entire rambling thing here. Instead, here are a couple of the low points:

The state regulated pharmacies that will be dispensing Plan B under Barr's voluntary CARE program (as well as society as a whole) are more familiar with 18 as a cutoff age. I understand that in all 50 states, 18 is the age of majority...and retail outlets, including pharmacies, are familiar with using 18 as the age restriction for certain products. ... This approach builds on well-established state and private-sector infrastructures to restrict certain products to consumers 18 and older.

That's right, folks. The FDA decided to use 17 instead of 18 because they were afraid that people couldn't learn to deal with a new age restriction. How's that for full of ....
I guess we should just be happy that they didn't decide to use the 21 year old alcohol restriction instead.

3 responses so far

  • somnilista, FCD says:

    It's because "FDA" stands for Ministry of Vice and Morals.

  • Joseph j7uy5 says:

    "Well-established infrastructures"? That means those little signs with calendars on them, that say, "You must be born on or before..."
    I can see his point. It would cost a fortune to make all new signs.
    Snark aside, it is difficult to understand how we could trust a pharmacist to decipher a doctor's handwriting, but not trust them to figure out how old someone is, given the birthdate.

  • bob koepp says:

    The age at which one gains access to Plan B w/o a presciption is a distraction from the fact that nobody (of any age) has access without going through a pharmacist. OTC, indeed.