FDA rejects nonprescription sales of morning-after birth control

Officials express concern about young teens' use of pills without guidance

May 07, 2004|By Kathleen Kerry | Kathleen Kerry,NEWSDAY

Amid considerable political maneuvering, the Food and Drug Administration yesterday rejected a controversial plan to sell emergency morning-after contraceptive pills without a prescription, citing their potential effect on teen-age girls.

The FDA told Barr Laboratories of Pomona, N.Y., that it had not approved nonprescription sales of the company's morning-after pills, Plan B, because there wasn't enough proof that girls under age 16 could safely use them without medical supervision.

The decision came despite the recommendation of an FDA advisory panel to approve such sales. However, the agency left room for reconsideration of Barr's proposal.

"I would say basically we were disappointed to get a nonapprovable decision," Barr spokeswoman Carol Cox said.

But Cox said the FDA left open two options: selling Plan B over-the-counter only to women age 16 and older and studying effects of the pills on girls under 16, as well as how they use it. Cox said the company will pursue those options.

Barr's Plan B, a two-pill regimen to be taken within 24 to 72 hours after unprotected sex, is available with a prescription. Simply a higher dose of hormonal birth control, Plan B can prevent ovulation and the implantation of a fertilized egg. It does not abort a pregnancy.

Dr. Scott Spear, a pediatrician and chairman of Planned Parenthood's national medical committee criticized the FDA's decision, saying: "I think these pills would be very helpful to teen-age girls, and it's unfortunate that politics was allowed to corrupt good medical science."

Spear said Plan B could prevent pregnancy in teen-age girls afraid to seek medical care after unprotected sex.

Barr Laboratories learned of the FDA's decision as the American Life League, a Stafford, Va., anti-abortion group, was shipping 20,000 petitions to the White House opposing nonprescription sales of Plan B. The petitions characterized Plan B as an abortion pill, and urged President Bush to prevent the switch to over-the-counter status.

The FDA's decision was not unexpected given recent conservative lobbying against nonprescription sales of Plan B. The agency had postponed action on Barr's proposal since its original February deadline. But the FDA's action was unusual because an agency advisory committee of experts had recommended approval in December. The FDA rarely ignores recommendations of its advisory panel.

Some conservative groups have argued that Plan B pills may not be safe for over-the-counter use by teen-age girls and that more testing is needed. They also argue that some people may abandon use of condoms if Plan B becomes easily available and become promiscuous, leading to sexually-transmitted disease.

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