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Friday, August 18, 2006

I had an article I wanted to link to, but it's from the Pink Sheet Daily, and I doubt any of you have subscriptions. I would mirror it, or cut and paste the article, but the Pink Sheet's security is so advanced, that I cannot hack it. So, I'll type out a few excerpts for this post, which I have titled:

"Uptight America"

...The agency [FDA] sought to determine how Barr would ensure sales would be restricted to "only those pharmacies agreeing to...keep the OTC version of the drug behind the pharmacy counter and...dispense the drug only upon the production of a valid photo identification card establishing the age of the consumer," Acting Commissioner Andrew von Eschenback noted in the July 31 letter requesting the meeting.

Barr's proposed Convenient Access, Responsible Education (CARE) enforcement and education plan that would accompany OTC sale of the drug also would not allow stores without pharmacies, such as convenience stores or gas stations, to carry the OTC version of Plan B, FDA's letter indicates...

...The acting commissioner's letter requested information about Barr's "plan to routinely monitor these pharmacies to make sure they comply with the restricted distribution plan," and how the firm plans on enforcing the restrictions in any non-compliant pharmacies...

...Sen. Hillary Clinton (D-N.Y.) expressed concerns that FDA would be holding Barr "to an unusual standard...to police and enforce age restrictions on the sale of Plan B" during an Aug. 1 Senate Health, Education, Labor & Pensions committee hearing on von Eschenbach's nomination...


Please don't misunderstand me, I am all for this mythical "third class of drugs" that would be available without a prescription from your friendly neighborhood pharmacist (only). (Actually, I suppose this third class of drugs already exists...it's just kind of empty right now). But seriously, how many meetings are the FDA and congress going to be having about how to prevent minors from buying this drug? Why don't we let 7-11 sell the stuff? They already know how to card for cigarettes.

I guess I should have a Plan B link somewhere, in case anybody wants to read about Plan B. Interesting bit of (pre) Plan B trivia: the FDA was requesting that drug companies market a morning after pill (the technology has been around for 50 years, the morning after pill is just a high dose oral contraceptive) in the mid to late 90s (those crazy, freewheeling Clinton years), but nobody in the pharmaceutical industry wanted to touch the product for fear of alienating Middle America. A new company (Gynetics) was created, and quickly received FDA approval to sell Preven (4 high dose birth control pills and a pregnancy test, if memory serves). Gynetics and Preven are both gone...we'll see how this Plan B thing works out.

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