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The Pill Comes Under the Spotlight

FDA advisors are planning to review existing birth control pills this week. This decision follows results from clinical studies that show the incidence of pregnancies to// have increased by twice over the last 10 years, while the subjects were on the pill.

Improper use, inferior products and other reasons are considered, as causes for this observation and the panel will discuss whether more stringent guidelines will be needed for safety and efficacy.

The Pill is the most popular method of the birth control in the U.S., accounting for more than 30 percent of all birth control use, according to the Mayo Clinic, while tubal sterilization, or the surgical blocking of a woman's fallopian tubes, is the second-most popular at 27 percent. Male condoms are next, at 18 percent.

Some 19 percent of all American women aged 15 to 44 use The Pill, according to the Centers for Disease Control. But many men and women don't use birth control at all, or they use it without success.

The outcome of these meetings could affect the 13 million-plus women and girls who take birth control pills in America, and the estimated $4 billion market for birth control drugs, dominated by Barr, Watson, Johnson and Johnson and Wyeth pharmaceuticals.

Pills approved in the 1960's allowed less than one pregnancy per 100 women taking the pill for a year. Newer pills allow over two pregnancies in a similar group of women.

Experts say this may be partly because new pills have fewer hormones that could lead to dangerous blood clots and heart disease.

The topics to be discussed by the FDA panel include: Clinical trial design issues, contraceptive efficacy and risk or benefit assessment cycle control (scheduled and unscheduled bleeding and spotting) and other measures of product acceptability to the user, translation of clinical trial findings of efficacy and safety into "real world" effectiveness and safety, extended dosing regimens, ph ase 4 commitments by applicants for further investigation, generally of uncommon but serious safety issues and role and impact of labeling for communication of clinical trial findings including product efficacy, risk, and other benefits.

FDA officials hope to use this information to create a guidance document for the clinical investigation of hormonal contraceptives.

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