FDA Moving Towards Plan B Over the Counter?
I wake up this morning and it seems all of a sudden, Plan B is making progress towards becoming approved for over-the counter use!
FDA weighs over-the-counter Plan B sales - Yahoo! News:
You may ask why all of a sudden is this happening now? I think this quote shows why:
Asked why the FDA was moving forward now, 11 months after delaying a decision, FDA spokeswoman Susan Bro said von Eschenbach wanted to spend Tuesday’s hearing less on this contentious issue and more on his own plans for the agency if confirmed as its chief.
“He knew it was critical that he be able to provide tomorrow a thoughtful approach to resolving what has been one of the most divisive issues the agency has faced in order for him to present his broad and ambitious vision for the FDA,” Bro said.
I truly hope this is indeed the case. I am very much looking forward to hearing what exactly his vision is and hope he is able to clearly explain what he wants to accomplish.
I would point out that Mark over at Eye on FDA has a good post about the upcoming confirmation hearings tomorrow (Tuesday, Aug 1, 2006). I think he definitely has a point about the possibility of a recess appointment and I seriously think that’s why the FDA made the announcement just the day before the confirmations. It doesn’t give much time to absorb what exactly the FDA means by this. It may be a play to get Dr. Eschenbach approved without committing to a decision on Plan B. The announcement only says the FDA wants to meet with Barr Labs to have further discussions. That’s a good positive step forward as long as it isn’t just another delaying tactic to get Dr. Eschenbach approved. The FDA could still have reservations and prevent it at a later date.
Bottom line, (and I’l admit this is somewhat cynical) I bet the announcements was made in order to get senators to go along and approve Dr. Eschenbach but that the FDA won’t do anything with Plan B after the nomination goes through. Here’s one case where I sincerely hope I am wrong.
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July 31st, 2006 at 1:53 pm
FDA promote STD’s…
The FDA announced their support of people spreading Sexually Transmitted diseases with the new soon to be approved ‘morning-after pill’….
July 31st, 2006 at 6:46 pm
That’s like saying the fact that I have had a tetanus shot for lockjaw makes me want to go out and step on rusty nails! Behavior is not controlled by availability of certain drugs.
Also, all drugs of this type are clearly labeled as NOT preventing sexually transmitted diseases. The same is true of birth control pills and drugs for erectile dysfunction as well as the recent Gardasil vaccine to prevent cervical cancer.
For example, see bullet point #5 under “What other key information about GARDASIL should I know?” from the patient information for Gardasil:
• GARDASIL also will not protect against other diseases that are not caused by HPV.
Here’s the link to the site: http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf