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FDA shifts stance on morning-after pill

The Plan B contraceptive could soon be available without a prescription for those over 18.

By TIMES WIRES
Published August 1, 2006

WASHINGTON - A three-year effort to allow at least some women unrestricted access to the morning-after pill could end in just weeks.

The Food and Drug Administration told Barr Pharmaceuticals Inc. on Monday that it wanted to meet within seven days to discuss how to allow women 18 and older to walk into pharmacies and buy Plan B without first getting a doctor's prescription. Minors would still need a prescription for the emergency contraceptive, and the contraceptive still would be available only from behind pharmacy counters.

The announcement came just 24 hours before President Bush's nominee to lead the regulatory agency, Dr. Andrew von Eschenbach, was to appear before a Senate committee.

Sens. Patty Murray, D-Wash., and Hillary Clinton, D-N.Y., called the FDA announcement a delay tactic and said they would continue blocking von Eschenbach's nomination pending a final decision on the contraceptive.

The morning-after pill was expected to be the focus of today's hearing.

FDA officials said they hoped to wrap up talks with Barr within weeks.

"We think this is a positive development. We will see how the meeting goes and move forward from there," company spokeswoman Carol Cox said.

However, the FDA held out the possibility it could keep Plan B prescription-only if Barr's plan to restrict over-the-counter sales to adult women wasn't "sufficiently rigorous," von Eschenbach wrote the company.

"We sincerely hope the FDA is not bending to a political ploy and that they are definitely going to do what they said they would do in the past, and that is make a decision based on science regarding the over-the-counter availability of Plan B," said Dr. Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America.

The morning-after pill is a high dose of the most common ingredient in regular birth control pills. When taken within 72 hours of unprotected sex, the two-pill series can lower the chance of pregnancy by as much as 89 percent.

The pills prevent ovulation or fertilization of an egg. It's possible they also prevent the egg from implanting into the uterus, considered the medical definition of pregnancy, although recent research suggests that's not likely.

Laws in nine states allow pharmacists to dispense Plan B without a doctor's prescription under certain conditions.

Contraceptive advocates and doctors groups say easier access to Plan B could halve the nation's 3-million annual unintended pregnancies. Opponents say wider access to the pill could promote promiscuity.

Kirsten Moore, president and CEO of the Reproductive Health Technologies Project, called the FDA's announcement a step in the right direction, but said: "Barr is being asked to jump through hoops that are probably impossible and clearly more politically than scientifically motivated."

Jennifer Wu, an obstetrician and gynecologist at Lenox Hill Hospital in Manhattan, said she gave many of her patients who use condoms for contraception Plan B prescriptions to keep in their purses.

"Really having Plan B over the counter will help those patients who don't necessarily have an ob-gyn at the time," Wu said.

Wu said that having the drug available over the counter would also increase education about the drug. "Some women do not know about it," she said.

Several religious and conservative organizations voiced opposition to the plan to make Plan B available without a prescription.

"There's clearly no way that the FDA or Barr Labs could put a gender restriction on who buys the drug," said Wendy Wright, president of Concerned Women of America. "You could have a statutory rapist buy the drug in order to cover up his abuse."

Advocates for Youth, a national nonprofit organization, said it was concerned that many sexually active teens would not have access to the emergency contraceptive.

"We are gravely concerned that once again politics, rather than science, is at play and the most vulnerable women - teens - will be penalized," said the group's president, James Wagoner.

The FDA's scientists say the pills are safe, and in December 2003 a panel of independent advisers backed nonprescription sales for all ages.

The FDA rejected that recommendation, citing concern that young teens could use the pills without a doctor's supervision. Barr reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription and setting up a program for pharmacists to enforce the age rule - just as stores now bar cigarette sales to minors.

Last August, FDA's then-chief, Lester Crawford, postponed a decision indefinitely. Crawford said the agency needed to determine how to enforce those age restrictions - a process that required writing new regulations.

Monday, the FDA reversed itself and said a review of about 47,000 comments from the public convinced it new rules weren't needed.

Before the FDA can reconsider Barr's application, the company must make the following changes:

"We already said that we would only sell to pharmacies - to places where there was a pharmacist, not to convenience stores," Cox said.

Asked why the FDA was moving forward now, 11 months after delaying a decision, FDA spokeswoman Susan Bro said von Eschenbach wanted to spend less of Tuesday's hearing on this contentious issue and more on his own plans for the agency, if confirmed as its chief.

"He knew it was critical that he be able to provide tomorrow a thoughtful approach to resolving what has been one of the most divisive issues the agency has faced in order for him to present his broad and ambitious vision for the FDA," Bro said.

Clinton and Murray had allowed Crawford to be confirmed after receiving a pledge from Mike Leavitt, the secretary of health and human services, that the FDA would decide on Barr's Plan B application. Crawford resigned in September, a month after he put the application on hold.

On Monday, Leavitt said the FDA announcement "demonstrates a good faith effort on the part of Dr. von Eschenbach to help resolve the issues surrounding Plan B."

Clinton and Murray disagreed, saying in a joint statement, "Rather than moving this process forward and doing right by the American people, the administration is continuing to play a game of smoke and mirrors."

Barr shares rose 93 cents, or 1.9 percent, to close at $49.76 Monday on the New York Stock Exchange.

plan b history

- July 1999: Plan B approved by the FDA for prescription use.

- December 2003: An FDA panel recommends Plan B be sold over the counter.

- May 2004: FDA denies over-the-counter use, citing concerns about minors.

- July 2006: FDA allows new application to seek nonprescription sales.

WHAT'S NEXT

Barr Pharmaceuticals and the FDA to meet within a week to discuss over-the-counter sales.

Q&A

Q. What is Plan B?

A. The Plan B contraceptive, also known as the morning-after pill, is a high dose of the most common ingredient in regular birth control pills. When taken within 72 hours of sex, the two-pill series can lower the chance of pregnancy by as much as 89 percent. They have been sold by prescription in the United States as an emergency contraceptive since 1998.

Q. How do the pills work?

A. The pills prevent ovulation or fertilization of an egg, and some experts say they prevent the egg from implanting into the uterus, although that has not been confirmed.

Q. Who could get the contraceptive?

A. If approved, the pills would be available over the counter for women 18 and older. Those younger than 18 would still need a prescription. The contraceptive would be behind a pharmacy counter. To buy it, women would have to show photo identification to prove their age.

Q. When would the pills be approved, and when would they be available over the counter?

A. On both questions, it remains unclear. The FDA has said it would like to meet with the drug's maker, Barr Pharmaceuticals, within the week. In a statement Monday, the FDA said it hoped "the process can be wrapped up in a matter of weeks."

[Last modified August 1, 2006, 02:10:34]