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FDA Considers Lowering Acceptable “Failure” Rate on Approved Contraceptive Pills

Chilean President Signs Decree to Permit Hand-Out of Morning After Pill to Young Girls…  

FDA CONSIDERS LOWERING ACCEPTABLE “FAILURE” RATE ON APPROVED CONTRACEPTIVE PILLS. The US Food and Drug Administration is reconsidering contraceptives, but only to make sure they are more effective at preventing – or ending – a pregnancy. The FDA has asked an expert panel whether it ought to ensure higher standards of “effectiveness” of new hormonal contraceptive/abortifacient drugs before approval for the market. The 14 member panel of outside experts met this week to advise the agency on future guidelines for drug manufacturers seeking approval.

The pills approved by the FDA in 1960 contained much higher doses of hormones than modern pills and had a lower “failure” rate, approximately 1 in 100 “woman-years” of use. That is, one woman in one hundred using the drug for a year became pregnant. The dangerous side effects of the high dose drug prompted the development of lower dose versions.

In recent years, the FDA has approved lower doses of the pill, though studies have shown that they allow more pregnancies to occur and also still have serious side effects. The agency has approved pills allowing more than two pregnancies for every 100 woman-years of use.

According to a 2005 study by Planned Parenthood’s Guttmacher Institute, 11.6 million US women use hormonal birth control pills.

The pill has three main actions: to suppress ovulation; thicken the cervical mucus making it difficult for sperm to reach the ovum; and to alter the lining of the uterus so that the developing embryo (blastocyst) cannot implant. The last action is directly abortifacient since the zygote/blastocyst is the first stage of human development.

Low-dose pills are less effective at preventing ovulation and therefore rely more on the remaining two functions.

Possible side effects of low-dose pills, apart from the possible death of already-conceived children, include blood clots and cardiovascular problems. One recent study showed that woman have a 100 per cent increase in risk of heart attack and stroke with the low-dose pill.

A spokesman for the FDA, Karen Riley said the agency considers all the contraceptives it approves to be safe and effective.

Parents Sue After 14-Year-Old Daughter Died with Birth Control Patch
[By Hilary White WASHINGTON, January 24, 2007]
FDA Panel Supports Flexibility in the Approval of Hormonal Contraceptives. Government advisers yesterday recommended against setting specific requirements for the reliability of new hormonal contraceptives, saying that might keep useful products off the market.
The panel did recommend, however, that the Food and Drug Administration ask drug companies to conduct follow-up studies on some new methods after they go on the market to identify any safety or reliability problems missed during initial testing.
The recommendations came a day after the panel called for testing new hormonal contraceptives on women who are more representative of the general population, including, for example, women who are overweight. The panel also urged the agency to require drugmakers to test new approaches on smokers, teenagers, women older than 35, and others to get a better assessment of their effectiveness and risks.
The agency is not required to follow the panel's advice, but an FDA official said it probably would.
"This was very useful," said Scott Monroe, acting director of the FDA's division of reproductive and urologic products. "All the recommendations are recommendations we are likely to implement."
The FDA convened the panel for a two-day meeting to advise the agency on what criteria should be used to decide when to test new hormonal contraceptives, including pills and patches, because it has been more than a decade since the last review.
In that time, a number of changes have occurred. The dosages of hormones in some contraceptives have been lowered to reduce the risk of side effects, and new methods are being developed. Even the user has changed: There are more overweight women, and the lower doses may not work for them.
"We think the studies should better reflect the real world," said Yale University's Charles J. Lockwood, who chaired the panel.
Yesterday, the panel said the effectiveness of each method should be judged individually and weighed against the benefits.
"You might have a product that has a higher failure rate but has all kinds of benefits," Lockwood said. "We were uncomfortable being pinned down to a specific number."
That approach was endorsed by some women's health advocates.
"We think an individual woman might choose a product that's less effective because it has some other quality that she likes, such as fewer side effects," said Amy Allina of the National Women's Health Network. She also endorsed the recommendation to test products on more representative groups of women.
"Given the trends in weight in the population, we're talking about a significant proportion of women in the United States," Allina said.
Lockwood said the panel did not want to discourage drug companies from developing new methods by making expensive follow-up studies mandatory. Instead, it recommended follow-up studies only for specific reasons, such as a new delivery method or a new type of hormone. [R. Stein, Washington Post, 25Jan07; A18;; Comment: What other drug would get a virtual pass on proving "effectiveness" because some patients are overweight, smoke, etc.? N Valko RN]

CHILEAN PRESIDENT SIGNS DECREE TO PERMIT HAND-OUT OF MORNING AFTER PILL TO YOUNG GIRLS. Following through on her threat earlier this month, Chile’s President Michelle Bachelet signed a decree Monday authorizing the distribution of abortifacient emergency contraception to girls as young as 14 without their parents’ consent, the latest move in a drawn-out battle over efforts to legalize the drug in the country.

Distribution of the drug was halted earlier this month when the Constitutional Court ruled that the Health Minister did not have the power to authorize handing out the drug to minors, after 32 legislators petitioned the court to rule on the issue, backed by Catholic Church leaders.

The lawmakers argued that the drug violates the country’s anti-abortion laws by causing early abortions when taken after fertilization of the egg has occurred. They also argued that giving the drug to minor girls without their parents knowledge was a violation of parental rights.

In ruling on the issue, the court avoided the question of abortion and parental rights by addressing the technicality of the executive’s lack of legitimate authority in permitting the drug’s distribution.

Jorge Reyes, attorney for the legislators opposing the drug, said a presidential decree would not end the matter, at the time of the Court ruling earlier this month, saying if a decree was issued, “We will go back to the court to object to other aspects of the program that we consider unconstitutional.”

The decree includes an amendment that requires teenagers to receive counseling when they obtain the pill.

Chilean Constitutional Court Decree Halts Distribution of Abortifacient Plan B

Chilean Court Reverses Its Decision and Allows Abortifacient ‘Morning After Pill’"

Chile Court Suspends Gov’t Plan to Distribute Free Morning-After Pill"

Chile’s Mayors Refuse Morning After Pill Push"

Chilean Supreme Court Orders Sale of Abortifacient Morning-After Pill"

Chilean Health Ministry Defies Supreme Court By Allowing Abortifacient Pills" [31Jan07, G. Schultz, Santiago,]