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FDA Seeks Your Input on Morning-After Pill 9/30/2005 Abortion groups press to make controversial drug available without prescription. 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.
Concerned Women for America (CWA) has raised numerous objections to this scheme, including that easy access would create a health hazard to women and the public. It appears that some within the FDA are listening. Pro-abortion groups and politicians have conducted a full-on political and media campaign to demand that the FDA make Plan B, a morning-after pill, available without a prescription.
In an effort that could be seen as an attempt to increase its sales, the drug’s original owner, Women’s Capital Corporation, hired a public relations firm that placed disturbing ads in college newspapers. The ads advocated that young women have multiple sex partners, and then pop Plan B pills in the morning to reduce the fear of pregnancy.
The firm, Bass & Howe, says that its services go beyond advertising to include lobbying public officials and convincing media to run stories promoting its client’s products or policies.
This trumped-up campaign created the impression that there is consensus (at least among political and media elites) for Plan B to be easily available.
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.
[*Note: Links to the research cited above follow this article.]
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.
Then Barr Labs filed a second application, arguing for a marketing scheme that would make it available without a prescription for anyone over 16 years old. Those under 16 would need a prescription.
CWA pointed out the plan’s obvious flaws: The person who buys the drug may not be the person who will take it. An 18-year-old could buy it and give it to a 13-year-old girl. A restriction on who buys the drug does not address the FDA’s concerns about adolescents who would take the morning-after pill.
Barr has not bothered to research what happens to adolescents who take Plan B – particularly those who would take it multiple times, as has been the experience in other countries. Some females come to rely upon the morning-after pill on a regular basis, with every case being an “emergency.”
Further, Barr’s label comprehension study to determine how well women understand the instructions on the drug label (essential for a drug to receive over-the-counter status) found that a full one-third of those surveyed did not understand it is not to be used as a regular form of birth control. The number increased among younger women and those with low literacy, including Spanish-speakers (and other non-English speakers), the illiterate and medically illiterate.
Making Plan B available without a prescription also raises parental-rights issues. It is another attempt at using the government to bypass parents, keeping them out of important decisions in their daughters’ lives. Parents should have a say if the FDA is going around them to make a drug – which has not been adequately tested for safe use by adolescents – available to their children.
The FDA’s request for public comments is a wise one. While Plan B advocates exerted pressure on the FDA, they didn’t count on Americans having a chance to weigh in. This has caused one activist in the FDA to quit in protest – a clear sign that some Plan B activists (who believe that pregnancy is to be shunned at any cost) are working from within the FDA and don’t care for losing control of the process.
The FDA has asked for comment on three issues:
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:
Submit written comments in the following ways: Division of Dockets Management 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 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.
* Research cited:
Swedish study showing an increase in teen abortion rates: click here.
For further information from the FDA, click here. |
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