2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC572
Submitter : Mr. John Naughton Date & Time: 10/12/2005 06:10:42
Organization : Mr. John Naughton
Category : Individual Consumer
Issue Areas/Comments
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
Why approve OTC use of a drug which is generally ineffective?

Morning-after pill access fails to cut pregnancy rate - January 5, 2005

By Cheryl Wetzstein

Women's health care advocates have been urging the federal government to allow easy access to "morning-after" pills as a way to dramatically reduce unintended pregnancies.
However, a study released today undercuts that argument by showing that young sexually active women who were handed packages of "morning- after" pills had pregnancy rates six months later that were virtually the same as women who had to go to drugstores or clinics to get the pills.
"That was definitely a disappointing finding," said Tina R. Raine, lead researcher of the study of 2,117 women, which appears in today's Journal of the American Medical Association (JAMA).
A core hypothesis, she said, was that two groups of women with easy access to "emergency contraception" (EC) would have half as many pregnancies as women who had to see a health provider to get the pills. Instead, all three groups of women had pregnancy rates of around 8 percent.
Nevertheless, EC should still be available without a prescription, said Dr. Raine, a professor at the University of California at San Francisco.
That's because the study also showed that when women had easy access to EC, they used the pills more often, but they didn't take more sexual risks or get more sexually transmitted diseases (STDs), as some have feared.
Given these findings, "it seems unreasonable to restrict access to EC to clinics," Dr. Raine and her colleagues wrote.
Concerned Women for America analyst Wendy Wright, an opponent of EC, disagreed.
"Why make [EC] easily available and put women's health at risk if it doesn't even reduce what the women fear, which is pregnancy?" she said.
Emergency contraception refers to high-dose birth-control pills taken within 72 hours of unprotected sexual intercourse. The pills, used by 4 percent of women, can interrupt ovulation, fertilization or implantation. All but six states require a prescription to get EC.
Most women's health advocates believe that half of the nation's estimated 3.5 million unintended pregnancies could be prevented if EC were widely available, especially to teens and college-age women. They believe the pills are safe and effective, and they have launched campaigns urging the federal Food and Drug Administration (FDA) to allow the nation's primary EC product, Plan B, owned by Barr Pharmaceuticals Inc., to be sold without a prescription.
Opponents of EC, such as Miss Wright, worry that easy access to EC will encourage irresponsible sexual behavior and STDs.
Studies of EC in Britain show easy access to the pills causes "an increase in STDs and no decrease in the number of abortions," she said.
In 2003, two FDA advisory panels recommended that the FDA approve Plan B for over-the-counter sales, but in May, the FDA declined, saying it was concerned about teens using the product without medical supervision.
A spokeswoman for Barr Pharmaceuticals yesterday said they have resubmitted Plan B paperwork and are expecting another FDA response this month.
The Raine study, conducted between 2001 and 2003, divided 2,117 sexually active women, aged 15 to 24, into three groups. One group received free packages of Plan B, another group was told how to get Plan B for free at drugstores and a third group was told how to get Plan B by appointment from a health clinic.
A key hypothesis was that, six months later, women in the two groups with the easiest access to EC would have 5 percent pregnancy rates, compared with a 10 percent pregnancy rate expected for women who had to go to a clinic to get Plan B.
But the three groups still got pregnant at about the same rate: Eight percent of the women with Plan B at home became pregnant, as did 7.1 percent of women with "pharmacy access" and 8.7 percent of women with "clinic access."

A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
Why approve OTC use of a drug which increases the risk to women's health - abortion?

Nonprescription EC Linked to Rise, Not Drop, in Abortion Rates
--Yet Advocates Continue to Push for Over-the-Counter Sales

Newly published figures on the number of abortions taking place in Britain show that the abortion rate has increased despite the availability of so- called "emergency contraception" (or, as critics call it, the "morning after abortion pill") which can be purchased without a prescription.
The abortion rate has increased each year since Britain introduced nonprescription EC in Jan. 2001, with 2.1 percent more abortions taking place in England and Wales in 2004 than in 2003.
EC is a high dose of contraceptive hormones that can act as an abortifacient if the woman has already conceived.
U.S. abortion advocates have claimed that it will reduce the abortion rate by half. However, studies in Scotland and the U.S. (including a study of more than 2,000 young women that was published in the Journal of the American Medical Association this past January) have shown that selling EC over the counter has not reduced pregnancy and abortion rates, even when women are given the drugs in advance and are therefore more likely to use it. In addition, the teen pregnancy rate increased 31 percent in Sweden after nonprescription EC became available there.
While abortion advocates have claimed that the rise in abortion rates in Britain is due to other factors, critics say EC leads people to engage in more risky sexual behavior because they falsely think they are protected from pregnancy, leading to higher rates of unintended pregnancies, abortions, and sexually transmitted diseases. In addition, EC does not abort ectopic pregnancies and therefore women who use it may not realize they are still pregnant, putting their health and lives at risk.
The new figures come as the Food and Drug Administration announced it is delaying a decision on whether it will allow nonprescription EC sales in the U.S, citing a lack of data on the drugs' effect on teens and an inability to enforce regulations limiting nonprescription sales to women over the age of 17.
Seven states currently allow nonprescription EC sales. Barr Laboratories, which markets EC under the name "Plan B" says it is planning to urge other states to allow the sales. The Planned Parenthood Federation of America has also said it will file a lawsuit against the FDA if over-the- counter EC sales are not approved.
According to memos released as part of a lawsuit filed against Planned Parenthood in California, the organization stands to make considerable profit from over-the-counter sales of EC because of a deal the group struck with Barr allowing them to purchase the EC kits at a price below that of other retailers. Planned Parenthood's price on the EC kits averages below that of the competition, and Planned Parenthood watchdog group STOPP, the organization could make $100 million or more in profits over the next five years if EC was made available over the counter.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No comment
C. If so, would a rulemaking on this issue help dispet that confusion?
No comment
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
No comment.
B. If it could, would it be able to do so as practical matter and, if so, how?
Absolutely not. Older teens will buy the pills for younger teens.