FDA May Grant Restricted OTC Approval for PlanB

ROCKVILLE, Md., July 31 -- The FDA has suddenly signaled that it is ready, after three years, to move forward on limited over-the-counter status for Plan B, an emergency contraceptive.

The move came the day before Andrew von Eschenbach, M.D., the acting FDA commissioner, is scheduled to testify before a Senate committee that is considering his nomination as permanent FDA chief. Senate Democrats have threatened to block his confirmation over the FDA's long delay on Plan B.

The FDA indicated that Plan B's OTC sales would likely be restricted to "behind the counter" status, a restricted marketing plan first proposed by the drug maker two years ago.

As outlined in a letter to Duramed, a subsidiary of Barr Pharmaceuticals, Dr. von Eschenbach, M.D., indicated interest in a restricting marketing plan suggested by Duramed.

The letter said the FDA would like to learn more about the proposal to restrict OTC distribution of Plan B to certain pharmacies.

"The OTC version of Plan B would not be available at gas stations, convenience stores, etc.," said Dr. von Eschenbach's letter, "but only to those pharmacies agreeing to (1) keep the OTC version of the drug behind the pharmacy counter and (2) dispense the drug only upon the production of a valid photo identification card establishing the age of the consumer."

The company's proposed marketing plan would restrict sales to women age 18 or older, a proposal that has been criticized by many women's reproductive health advocates because it would eliminate sales to adolescents, a population that advocates argue is high risk for unwanted pregnancies.

Plan B has demonstrated efficacy and safety in a number of clinical trials and has been recommended for OTC sale by an FDA advisory committee on more than one occasion, but the FDA has declined to move forward on it-until today.

In addition to the Senate hearings on Dr. von Eschenbach's confirmation, the FDA announcement came just four days before a Federal judge will decide whether the Center for Reproductive Rights can subpoena White House emails and other documents, which are being sought as part of a lawsuit filed as a way to force FDA action on PlanB.

Lester Crawford, D.V.M, Ph.D., who served as FDA commissioner before Dr. von Eschenbach, stated in a deposition that the FDA intended to approve Plan B to women ages 17 and older, but then delayed the decision. The Center for Reproductive Rights claims the White House was behind that delay.

In a statement issued today, the FDA said it "hopes that as both sides are committed to working diligently through these issues, the process can be wrapped up in a matter of weeks."

Senate Democrats, led by Sens. Patty Murray of Washington and Hillary Rodham Clinton of New York, responded to the FDA announcement with a joint statement that called the statement "another delay tactic." They pledged to block Dr. von Eschenbach's nomination unless the FDA issues a final decision on PlanB.

PlanB, which is often called a morning after pill, consists of two pills both of which contain 0.75 mg of a single active steroid ingredient, levonorgestrel [18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17?)-(-)-], a totally synthetic progestogen. The inactive ingredients present are colloidal silicon dioxide, potato starch, gelatin, magnesium stearate, talc, corn starch, and lactose monohydrate.

To obtain optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of intercourse. The second tablet must be taken 12 hours later.

PlanB is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal transport of sperm and/or ova). In addition, it may inhibit implantation (by altering the endometrium). It is not effective once the process of implantation has begun.