FDA to move on approval of over-the-counter sale of "Plan B" birth control

August 3, 2006

The United States Food and Drug Administration has announced that it is moving forward in approving over-the-counter (OTC) sale of the emergency contraceptive pill, "Plan B" to women above 18 years of age. The delayed approval of this drug has been raised in the Senate confirmation hearings for President Bush's nominee for the head of the FDA, Dr. Andrew C. von Eschenbach.

Emergency contraceptives, also known as "morning-after pills" are used to prevent an unintended pregnancy, after unprotected intercourse has occurred. They usually contain high doses of the same drugs that are used in regular contraceptive pills.

While they are considered as contraceptives by the medical establishment and by law, and classified as such by the FDA, some abortion opponents object to ECs as they believe that they constitute abortion. Some groups object to emergency contraception believing that it encourages sexual exploitation of young girls and some religious conservatives object to it as they believe that it promotes promiscuous behavior. Proponents of its use contend that it is merely a form of contraception, and point out that other forms, such as condoms or birth-control pills are widely used and that its use serves an important purpose, in cases where other contraceptives have failed (eg. a condom is torn) or to prevent conception in a rape victim. Approval for OTC sale would make the drug more easily available, which is considered important as the drug must be taken within 72 hours of intercourse to be effective.

The FDA's approval process for the Plan B pills, which contain the drug Levonorgestrel and are manufactured by Duramed, a subsidiary of Barr Laboratories has been mired in controversy since at least 2000, when the American Medical Association announced support for OTC availability. Last year, the FDA rejected the manufacturer's request to approve the pill for OTC sale, citing concerns over "potential behavioral implications for younger adolescents". The decision was criticised by advocates of EC as being based on political considerations rather than scientific reasons. The Government Accountability Office, a congressional watchdog also faulted the decision process. The FDA has also revised the minimum age of customers from 16 to 17 to now, 18.

Currently, the Senate Health, Education, Labor and Pensions Committee is holding hearings on the confirmation of the FDA Commissioner nominee, Dr. von Eschenbach. Senators Patty Murray(D) and Hillary Clinton(D) have held up the approval pending progress on the pill's approval process. Plan B was endorsed by a F.D.A. committee three years ago but had been denied approval for OTC sale by higher officials in the FDA. During the nomination of the last FDA Commissioner, Dr. Lester M. Crawford, Senators raised the issue and went ahead with the nomination after getting assurances that the drug's approval would be given in a timely manner. The deadlines set then were not met.

Senator Clinton was reported as saying: "Like so much of this government in the past five and a half years, it has been turned into a political football, and you're on the field. This is not just about Plan B. Once we start politicizing the F.D.A. there is no stopping. It is essential that we draw a line, and we are drawing a line right here."

In the confirmation hearings, Dr. Von Eschenbach said he would not take political orders on scientific matters. "No one told me what I could or should do," he said.

The FDA statement said that its latest decision was to approve OTC sale was "the result of a thoughtful and comprehensive scientific and public policy process undertaken by the Agency to resolve the novel and significant issues presented by the Sponsor's amended application."

Sale of oral contraceptives otherwise continues to require prescription by a state-licensed doctor, according to FDA regulation.