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November 16, 2009

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Editorial: Setting birth control standards

Friday, Jan. 26, 2007 | 8:45 a.m.

A Food and Drug Administration advisory panel is considering whether standards of effectiveness should be raised for birth control drugs - some appear to be slightly less effective than the first generation of drugs released 30 to 40 years ago.

The Associated Press reported Tuesday the FDA has noted that the birth control pills of the 1960s allowed less than one pregnancy in 100 women who took the pill for a year, while some of the newer drugs allow two pregnancies - or more - per 100 women in a year's time. One reason may be that drug companies have lowered the dosages of hormones that prevent pregnancies.

But the higher hormone levels of the 1960s-era drugs carried high risks of blood clots and cardiovascular problems. So raising hormone levels in new drugs could raise concerns.

The FDA advisory panel also will weigh whether drug manufacturers should include women who are overweight, smoke or have histories of heart problems in the clinical trials of new birth control drugs. These groups routinely are excluded because of health risks, but they more accurately reflect the actual population, the FDA says.

We should note that in a statement released Tuesday the FDA called news reports of lower efficacy rates misleading and said that the newer drugs "are highly effective in preventing pregnancy." Still, the FDA added, the advisory panel has been asked to consider raising minimum efficacy standards for new drugs.

Medical research has come a long way in 40 years. If there is a way to increase the efficacy of birth control drugs while ensuring that they are safe for women in high-risk health categories, then the FDA should carefully, and scientifically, examine those options.

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