You may have seen
this diary a couple days ago, pointing out that the FDA is now taking public comments regarding Plan B, and the drug manufacturer's application to make that medication available over-the-counter.
As noted in the diary, I e-mailed the FDA and, surprisingly, got a response that was more than simply a "Thank you for taking the time to comment, your input is very important to us" form e-mail, like you usually get.
The FDA's response follows. My response to their response? There is no "there" there.
Here's their e-mail to me:
Dear [LegalSpice],
Thank you for your message to the Division of Drug Information in the Center for Drug Evaluation and Research (CDER).
The goal of the FDA is to protect the health of Americans by assuring that drug products are safe and effective while promoting health by making new treatments available. Thank you for your comments concerning the Morning After Pill. They are much appreciated and have been noted.
The Food and Drug Administration (FDA) has issued a "Not Approvable" letter to the sponsor of an application to make the Plan B emergency contraception product available without a prescription. In its letter to the sponsor, FDA outlined the additional information that would be required to gain approval to market Plan B over-the-counter.
FDA based its action primarily on the lack of data concerning OTC use of the product among adolescents younger than 16 years old. The sponsor's application contained no data in subjects under 14 years of age and very limited data in adolescents 14 to 16 years old.
FDA's letter to the sponsor notes that the application does not provide adequate data to support use of Plan B by young adolescent women without the intervention of a physician. The letter also points out that the sponsor's March 11th amendment of its application to allow marketing of Plan B by prescription only to young women under 16 years of age was not complete. As a result, the agency was unable to do a complete review on that amendment during this review cycle. You may find more information at http://www.fda.gov/cder/drug/infopage/planB/default.htm.
To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic or written comments. You may submit comments, identified by Docket No. 2005N-0345 and/or RIN number 0910-AF72, by any of the following methods:
1. Electronic Submissions
Submit electronic comments in the following ways:
link: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/getDocketInfo.cfm?EC_DOCUMENT_ID=750&S
ORT=STARTD&MAXROWS=15&START=1&CID=&AGENCY=FDA
or, goto http://www.fda.gov/bbs/topics/news/2005/NEW01223.html
and clink on 'Online Comment Form' at the bottom of the page.
2. Written Submissions
Submit written submissions in the following ways:
- FAX: 301-827-6870.
- Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]:
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852
You may find more information at:
http://www.fda.gov/bbs/topics/NEWS/2005/cd0584.pdf
Thank you for your comments.
Sincerely,
Palm
Division of Drug Information
BS-100, Rockville, MD 20857
***This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
I'm not even sure what this response means, that there is "inadequate data to support use of Plan B by young adolescent women without the intervention of a physician". Seems to me that if they really wanted to tell the manufacturer what was missing or wrong with their application they would be a lot clearer than this.
Are they talking about the health and safety of young adolescent women? Because that should be the sole province of the FDA. And of course this response seems to simply sidestep the alternative that was suggested - that Plan B be available OTC for persons age 16 and up, similar to "carding" for cigarettes or alcohol, and on a prescription-only basis for younger women. Application "incomplete", so not processed.
This looks to me like the continuation of a stonewall on a drug that has been overwhelmingly approved by the FDA's own advisory panel, for reasons that are threadbare at best.
Please contact the FDA as indicated above, and voice your opinion.