The FDA is commissioning a panel to discuss setting higher standards for new birth control pills after reports show newer pills are less effective than older ones.
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.
FDA officials want to know if the reduced risk of clots outweighs the increased risk for pregnancy. They also want to know how birth control pills work in every woman often those who smoke, are obese or have risks for blood clots are excluded from studies.
The FDA will also be questioning whether study results can apply to "real world" situations, women who participate in studies are sometimes paid and keep a daily journal, while real women taking the pill don't. They hope to use this information to create a guidance document for the clinical investigation of hormonal contraceptives.