Plan B drug wins approval from FDA

After much speculation, the U.S. Food and Drug Administration (FDA) yesterday announced the approval of much anticipated Plan B, a morning-after contraceptive drug, as an over-the-counter (OTC) option for women aged 18 and older, without a doctor's prescription. Prescription remains required for those 17 and under.

Plan B (0.75mg levonorgestrel) is often referred to as emergency contraception or the "morning after pill." Unlike other birth control pills, morning-after pills are taken after sex, and if used as directed, Plan B effectively and safely prevents pregnancy. The approved Plan B could be ready for over-the-counter sale by late fall.

Each Plan B tablet contains 0.75 mg of a single active steroid constituents, levonorgestrel (18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17?)-(-)-), an overall synthetic progestogen. The inactive elements present are colloidal silicon dioxide, potato starch, gelatin, magnesium stearate, talc, corn starch, and lactose monohydrate. Levonorgestrel has a molecular weight of 312.45.

The FDA's move permits Duramed, a subsidiary of Barr Pharmaceuticals, based in Woodcliff Lake, N.J., to sell Plan B to anyone 18 and older without a prescription. The company will make Plan B available with a strict labeling, packaging, education, distribution and monitoring program.

Under the CARE (Convenient Access, Responsible Education) program Duramed committed to:

(A) Provide customers and healthcare professionals with labeling and description about the appropriate use of prescription and OTC Plan B, including an informational toll-free number for questions about Plan B;

(B) Ensure that distribution of Plan B will only be through licensed drug wholesalers, retail operations with pharmacy services, and clinics with licensed healthcare practitioners, and not through convenience stores or other retail outlets where it could be made available to women under 17 without a prescription;

(C) Packaging designed to hold both OTC and prescription Plan B. Plan B will no be displayed on the counters rather it will be stocked by pharmacies behind the counter because it cannot be dispensed without a prescription or proof of age; and

(D) Watch the effectiveness of the age restriction and the safe distribution of OTC Plan B to consumers 18 and above and prescription Plan B to women under 18.

Plan B slashes chances of pregnancy by 89 percent if taken within 72 hours of unprotected sex, and it is most effective if taken within 24 hours. Plan B delivers a high dose of hormones that keep an egg from becoming fertilized or, if that's already happened, abandon it from implanting in the uterus.

Out of the 3 million unplanned pregnancies which are happening each year in the U.S., some 850,000 are in teens.

However, some opponents of recently approved Plan B predicted ominous social consequences from the FDA's move.

"Does anybody really believe that people under 18 won't be able to obtain Plan B? I think it's going to lead to situations that devalue human relationships and increase promiscuity," argues Robert Gilligan, executive director of the Catholic Conference of Illinois.

On the other hand, advocating the sale of drug completely without age restrictions, Vicki Saporta, president of the National Abortion Federation said, "By allowing the over-the-counter sale of Plan B, more women will now be able to prevent unintended pregnancies. Yet it is extremely disappointing that age restrictions will create medically unjustified barriers for teens."

In India the Plan B drug is sold by the Chemical, Industrial & Pharmaceutical Laboratories (CIPLA) under the brand name of Pill 72 which comes in blister pack of two tablets.