Plan B pill sets political stage for bitter battle

and Barbara Martinez

The Food and Drug Administration's decision to allow the emergency contraceptive Plan B to be sold to adults without a prescription will boost the use of the drug, but the move may also widen political and societal fault lines around issues of medicine and reproductive rights.

Plan B, made by Barr Pharmaceuticals Inc., has been at the center of a bitter debate both inside and outside the FDA, which for years stalled the manufacturer's application for over-the-counter status. Yesterday, the agency said that people 18 years or older could get the drug without a prescription, if they show identification proving their age. For women younger than 18, Plan B, also known as the "morning-after" pill, will still require a prescription.

Thursday, Democratic Sens. Hillary Rodham Clinton of New York and Patty Murray of Washington said they would remove their hold on the nomination of acting FDA Commissioner Andrew von Eschenbach to be formal head of the agency. They had blocked a Senate vote until the FDA made a decision about Plan B.

Antiabortion groups criticized yesterday's decision and said it wouldn't prevent young teens from getting Plan B without a prescription. On the other side, reproductive-rights groups, which had argued that easy access to Plan B would be a vital tool against unintended pregnancies, applauded the decision but said the age restriction was unnecessary.

Plan B effectively functions like a high dose of birth-control pills. When taken within 72 hours following unprotected sex, the product reduces the risk of pregnancy by as much as 89 percent. Scientists believe the resulting surge of hormones interferes with ovulation and fertilization or may potentially prevent implantation of a fertilized egg in the uterus. The medical community generally doesn't consider this to be abortion, and the FDA doesn't classify Plan B as an abortion-causing drug, though some antiabortion groups do. Plan B isn't the same as mifepristone, sometimes called RU-486, a prescription-only pill that induces an abortion.

The FDA and Barr said that they will take steps to try to enforce the age restriction. Plan B will be sold only in stores or clinics with a medical professional such as a doctor, nurse or pharmacist, not in gas stations or convenience stores, and isn't expected to be available through online pharmacies and other Web sites, Barr said. The company agreed to send "anonymous shoppers" to test whether pharmacies are adhering to the rules. Barr will provide a booklet to be distributed with the drug that will explain how it works and its proper use.

'Adequate Safeguards'

Steven Galson, director of the FDA's drug center, said he believed the agency didn't have enough data about younger teens to approve the use of Plan B for them, and that they "would strongly benefit from consultation with heath-care providers" before getting Plan B. The FDA can't absolutely ensure that people younger than 18 won't get the drug, he said, but the agency had "adequate safeguards in place ... to convince us this drug will be provided as per the labeling." He said other FDA officials within the FDA's drug center, who had endorsed over-the-counter Plan B without an age limit, disagreed with the final decision.

Barr said it expects use of the drug to grow. Currently, it is prescribed about 1.5 million times a year in the U.S. The company declined to project how much revenue would increase over the approximately $30 million a year currently generated by Plan B's sales in the U.S. Barr's version of the drug is only sold in the U.S. and Canada. Other companies sell similar products elsewhere. Will Sawyer, specialty pharmaceuticals analyst at Leerink Swann & Co., predicted that Plan B sales may triple, to $90 million, over the next three to five years. The company said it expected to price the two-pill Plan B regimen at least as high as the current $25 to $40 per prescription.

Bruce Downey, chief executive of Barr, said the company was "very happy" with the FDA's decision but planned to try to "lower or eliminate the age restriction" in the future. Major drugstore chains including Walgreen Co. and CVS Corp. said they would offer Plan B under the new FDA rules. A spokesman for Wal-Mart Stores Inc., which declined to stock Plan B until March of this year, said the company is "still looking at details of what was approved and how the product can be sold ..."