FDA Seeks Your Input on Morning-After Pill
by Wendy Wright, Concerned Women for America

The Food and Drug Administration (FDA) has announced it needs guidance on whether the controversial morning-after pill should be available without a prescription but with age restrictions. Since the FDA has never approved over-the-counter status for a drug based on the buyer’s age, it has asked for advice on whether the agency has the authority to do it, and if an age restriction could be enforced.

Citizens have until November 1, 2005, to submit comments.

Barr Labs, which bought Plan B from Women’s Capital Corporation, has argued that making Plan B easily available would reduce pregnancies and abortions. They have run into a problem, though, in that studies show just the opposite. Where the drug is available without a prescription, pregnancies and abortions do not go down. In fact, several studies show that the number of abortions increase.

And, since the drug does not prevent or treat sexually transmitted diseases (STDs), the STD rates skyrocket.

The FDA originally declined to make Plan B available to anyone without a prescription, citing concerns that Barr had not proven that adolescents can safely use it.

The FDA has provided a unique opportunity that will affect families throughout America.

You can help ensure that the FDA does not rely solely on the unsubstantiated assurance by abortion advocacy groups (which would lose customers if it were true) that easy access to the morning-after pill would reduce pregnancies. Nor should it rely upon a drug company that will make huge profits if the drug is easy to buy, even if its promises prove to be untrue. Parents can step in to ensure that a government agency does not make a drug available to any adult, including molesters seeking to cover their crimes against girls.

Take Action:
Here is how to send comments to the FDA. Note: All submissions must include the agency name (Food and Drug Administration) and either the Docket Number 2005N-0345 or Regulatory Information Number (RIN) 0910-AF72.

Submit written comments in the following ways:

1. Fax: 301-827-6870.

2. Mail/hand delivery/courier (for paper, disk, or CD-ROM submissions):

Division of Dockets Management
5630 Fishers Lane, Rm. 1061
Rockville, Maryland 20852

3. E-mail: To ensure more timely processing of comments, the FDA is no longer accepting comments submitted to the agency by random e-mails. However, electronic comments can be submitted using the Federal eRulemaking Portal http://www.regulations.gov or the agency Web site http://www.fda.gov/comments.html. (Keyword: 2005N-0345)

All comments received will be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided.

Docket: For access to the docket to read background documents or comments received, go to http://www.fda.gov/ohrms/dockets/default.htm. Insert the docket number into the "Search'' box and follow the prompts, and/or go to:

Division of Dockets Management
5630 Fishers Lane, Rm. 1061
Rockville MD 20852.

For further information, contact the FDA at 301-827-0002 or by e-mail at pcomments@fda.gov. This phone number and this e-mail account have been set up to address questions relating to this notice.

9/22/05