Birth Control Pills under FDA's Eye

With the decrease in effectiveness of birth control pills, the government is considering setting advanced standards for birth control drugs used by millions, holding that the standards have gone down with the passage of time.

The Food and Drug Administration consulted a panel of experts to ask if it should require new contraceptive drugs to meet a standard of efficiency before they are permitted for the market. The panel meets again on Wednesday.

In a survey conducted in 2005 by the Guttmacher Institute, a nonprofit research group, it was found out that 60% U.S women in the age group of 15-44 use some sort of contraceptive, and out of this, 11.6 million use birth control pills.

The FDA said that the birth control pills available in market these days are less effective than the pills that were manufactured years back and there is a high risk of failure. It blamed the manufacturers for using lower doses of hormones that stop ovulation.

"The very first pills were very high dose and carried risks of blood clots and cardiovascular problems that would be unacceptable to most women," said Amy Allina, program director of the National Women's Health Network. "Today most birth control pills are very safe for the vast majority of women."

FDA said that the pills approved in 1960’s by the government allowed one pregnancy out of the 100 women taking the pills in a year. But in the last decade, the government has approved pills allowing more than two pregnancies for every 100 woman.

The 14 member panel, which primarily consists of gynecologists, obstetricians, a statistician and a neurologist, was asked by FDA if the difference in performance is large enough for concern.

After Tuesday's discussions, an FDA spokeswoman said, “the agency does not believe the effectiveness of different contraceptive drugs can be compared due to the way their clinical trials are designed.”

Moreover, spokeswoman Karen Riley said, “the FDA considers all contraceptives it approves to be safe and effective.”

In order to insure that the pills are effective for a majority of women, FDA has asked the manufacturers to include more representative mix of women in the clinical trials for their new products.

FDA held that during the clinical trials, women who smoke, are overweight, or have a history of heart problems, are excluded, and due to this, it becomes difficult to check the effectiveness of the drugs in the real world.

Heather Boonstra, a policy analyst for Guttmacher Institute, said that FDA is on its heels these days to stay au fait of a number of ground-breaking contraceptive products that are now in development.

One such innovative product is Wyeth Pharmaceuticals' Lybrel. The drug is the first of its kind and can be continuously used all year round. The drug is in the pipeline and is waiting to be approved in US and Europe.