Healthy Skepticism Library item: 7859

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Publication type: news

Dooren JC.
FDA Told to Hone Steps for Testing Birth-Control Pill
Wall Street Journal 2007 Jan 24D5

Full text:

WASHINGTON — The Food and Drug Administration should require companies to include more overweight women in studies used to approve birth-control pills, amid concerns lower-dose pills now on the market might be less effective for that group, a panel of medical experts said.
The FDA is considering revamping the standards it uses to approve birth-control pills and is calling on an outside panel of medical experts to make recommendations about the standards during a two-day meeting that ends today.
The FDA said it appears the pregnancy rate in clinical trials of newer, lower-dose pills has increased, compared with an older generation of drugs with higher doses of the hormones used to prevent pregnancy. The FDA noted lower doses of hormones could also carry fewer risks, such as of blood clots.
The agency said that it isn’t entirely sure why the pregnancy rate is rising, but that the increase may be caused by lower hormone doses and “heavier subjects.” Women considered obese typically have been excluded from studies the FDA uses to approve the pills.
The FDA said it wanted advice on an acceptable “failure,” or pregnancy, rate for approving new birth-control pills going forward. Over the years, many manufacturers have reduced the amount of hormones in the pills in an effort to lower side effects. Any changes in FDA standards would affect future, proposed birth-control pills, not pills now on the market.
In the 1960s and 1970s, the FDA said, pregnancy rates guiding approval of the pills were less than one per 100 women taking the pill per year. But in recent years, the FDA said, it has approved some products with a pregnancy rate higher than two.
Even with the higher pregnancy rates, Scott Monroe, acting head of the agency’s reproductive-drugs division, said the products are 98% effective at preventing pregnancy when used according to instructions.
Dr. Monroe said the agency is divided on the need for a cutoff or an upper limit for pregnancy rates, and the panel yesterday couldn’t reach a consensus on whether the FDA should set an upper limit. But the panel suggested the FDA discard its method for measuring the rates, saying it was outdated.
Today, the panel is expected to address standards affecting the so-called extended-dosing pills designed to reduce the number of, or eliminate, women’s monthly periods. One product pending FDA approval is Wyeth’s Lybrel; it could be affected by any new FDA standards.

Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com