FDA wonders if The Pill still works well

NEW YORK (CNNMoney.com) -- FDA advisors will consider on Tuesday and Wednesday if birth control drugs need more stringent guidelines for safety and effectiveness.

The FDA is concerned over the increase in pregnancies over the last 10 years among women participating in clinical trials for birth control drugs. The agency said this could be the result of inferior products, improper use, or other factors.

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 Pharmaceuticals (up $0.18 to $55.70, Charts), Watson Pharmaceuticals (up $0.05 to $26.60, Charts), Johnson & Johnson (down $0.88 to $66.30, Charts) and Wyeth (down $0.80 to $50.10, Charts).

Unlike other advisory meetings it is unclear whether the panel will vote or take any other action.

The advisors will focus on the continued study of drugs after they are approved and enter the market, the effectiveness of drugs, and whether their benefits outweigh their safety risks, according to FDA documents. Much of the discussion will probably center on the success and failure rate of birth control drugs. If the advisors vote, it would be considered by the agency, which follows the advice of its experts most of the time.

Panelists will consider the inclusion of smokers, overweight women, and women with a family history of strokes in clinical trials, as well as the role of non-U.S. studies in the American population, according to documents. Also, panelists will consider whether changes should be imposed on the kind of risk and benefit information that is included on a drug's label.

The Pill, as it is often called, has been on the U.S. market since 1960. The original patents for birth control pills expired decades ago, so the market is dominated by generics, which tend to cost less than brand-name drugs.

Barr and Watson produce generic birth control drugs. In addition, Barr produces the name-brand birth control pill Seasonale, as well as the Plan B "morning-after" pill, an emergency contraceptive that can be taken within 72 hours of sexual intercourse. Plan B was approved by the FDA in 1999 as a prescription drug, and then approved in 2006 for over-the-counter use in women at least 18 years of age. Younger girls require a prescription.

The Johnson & Johnson subsidiary Ortho-McNeil Pharmaceutical produces the name-brand Ortho-Tri-Cyclen birth control pill, as well as the Ortho Evra birth control patch, a relatively new drug that has been on the U.S. market since 2001.

Agency advisors will discuss dosing regimens for contraceptive pills, which are traditionally taken 21 days on as an active pill, and seven days off with a placebo, to correspond with the menstrual cycle. Depending on the outcome of the meeting, this could impact Wyeth because of a new birth control drug it has in the works.

Wyeth has developed a drug that, if approved, would be the first contraceptive pill that is active every day and is not staggered with a placebo. Wyeth is trying to get its drug Lybrel approved by the FDA. The agency issued Wyeth with an "approvable letter," meaning that the company has to do more studies on the drug and fulfill further requirements to become eligible for approval. Lybrel is also under review in Canada and the European Union.

Wyeth spokeswoman Natalie deVane said the FDA advisors are unlikely to affect Lybrel, because the drug is already so far along in the regulatory process.

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 ages 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 CDC says that 49 percent of all U.S. pregnancies were unintended in 2001, the most recent year for that statistic.

Johnson & Johnson is the second-largest drugmaker in the U.S., behind Pfizer (down $0.75 to $26.20, Charts). Wyeth is No. 6.

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