FDA EC-OTC DECISION DELAYED to study the medical research regarding Emergency Contraception [EC] more carefully.
Following is a letter sent to FDA from a member of AAPLOG: I am a board certified internal medicine physician in Amarillo, TX. I have spent 10 years working in Indigent Care. I do NOT support the idea of allowing Emergency Contraception (EC) to be dispensed over the counter. How can the low dose OC be regulated by prescription, but allow the higher dose of the same medicine be allowed to be sold OTC? EC is a serious medicine, with serious related medical implications. If EC is available OTC, who will be responsible for following the patient? Who is liable if the patient has a serious health consequence?
“At what point did giving a potent reproductive related medication without having an established chain of responsibility become good medicine? A significant market for this EC would be assumed to be youth. If a girl is under 18 and trying to hide her consumption of and need for birth control, this OTC might appeal to her. However, the adverse consequences could be significant. It would seem to allow for safer sex, so I assume many women would have sex more frequently. I am very concerned the rate of STDs, including HIV, will rise as a result. As EC would be available with no restrictions, I assume many women would use it repeatedly, and quite possibly continuously. This is a very bad idea that needs to go away
[from AAPLOG, J. DeCook MD, 27Feb04]
FDA FINDS DAY-AFTER CONTRACEPTIVE ADS INACCURATE – Charges Drug Marketing Message Overstates Effectiveness Period & Underplays Risk – Consumer-oriented radio/print ads for the day-after contraceptive, Plan B, are inaccurate & overstate its effectiveness period, according to a U.S. Food and Drug Administration letter to the product’s marketer. Plan B, which has been marketed since 1999 by Women’s Capital Corp., “can work as a contraceptive” if taken within 72 hours after intercourse. The FDA objected to the phrase in a Plan B 60-second radio ad saying both ads imply that the product is as effective 3 days after unprotected sex as it would be if used immediately, and thus does not communicate that “it must be used as soon as possible” for maximum “effectiveness”. The FDA also wrote that both the radio and print ads don’t communicate the drug’s risks with the same level of prominence as the potential benefits. Normally, when the FDA issues a letter of this type, a marketer is forced to pull an ad from circulation. But in this case, the advertising’s 10-week trial run on four radio stations in Seattle and in the Seattle Weekly had been completed with a budget of $167,000. Women’s Capital opted not to submit the ads to the FDA for review after the FDA said it would take up to three months to get a review committee together. The company had planned to launch the ads outside the Seattle test market in Los Angeles, but it found the ads did not provide a worthwhile return on investment to continue. “The really bad news is that we don’t appear to have really increased sales in any substantial way in the Seattle area,” Ms. Camp said. “Doctors don’t market Plan B. They don’t market emergency contraception.” Camp said Women’s Capital, which receives funding largely from nonprofit organizations and fdns, plans to file an application in February with the FDA to switch the product to over-the-counter use. The company hopes to turn its first profit in the second quarter of next year. Plan B can be obtained only by a doctor’s prescription (except in Alaska,
CA, NM and WA where a person can obtain it from a specially trained pharmacist).
[http://www.adage.com/news.cms?newsId=36659,27Nov02; WASHINGTON AdAge.com]
