FDA allows some nonprescription sales of the morning-after pill

Women can buy the morning-after pill without a prescription, the government declared Thursday, a major step that failed to quell the politically charged debate over access to emergency contraception.

The manufacturer, lawmakers and other advocates said they will press the government to allow minors to purchase the pills over the counter.

The Food and Drug Administration said that women 18 and older -- and men purchasing for their partners -- may buy the Plan B pills without a doctor's note, but only from pharmacies.

Girls under 18 still will need a prescription to buy the pills, the FDA told manufacturer Barr Pharmaceuticals Inc., in ruling on an application filed in 2003.

The compromise decision is a partial victory for women's advocacy and medical groups, which say easier access could halve the nation's 3 million annual unplanned pregnancies.

"While we are glad to know the FDA finally ended its foot-dragging on this issue, Planned Parenthood is troubled by the scientifically baseless restriction imposed on teenagers. The U.S. has one of the highest rates of teen pregnancy in the Western world -- anything that makes it harder for teenagers to avoid unintended pregnancy is bad medicine and bad public policy," president Cecile Richards said.

Opponents say that nonprescription availability could increase promiscuity and promote use of the pills by sexual predators.

Plan B contains a concentrated dose of the same drug found in many birth-control pills.

Locally, pharmacies have not changed their policies in deference to the ruling.

Schnucks Pharmacy at 19 S. Kingshighway does not stock or fill the prescription, but directs those seeking it to other pharmacies that do.

Walgreens on South Kingshighway said store policy is that prescriptions for the pill are routinely filled.

Ben Tally, owner and manager of Medicap Pharmacy at 1020 N. Kingshighway, chooses not to stock Plan B. He says the choice is in line with his beliefs, and he has no plans to change.

"I feel that if it's not taking a life, then it's awfully close," Tally said. "In our church we believe life begins at conception. And the way I understand it, the pill keeps the child from attaching to the mother's umbilical cord. That is just not something I want to be a part of, although I cast no judgments on those who do."

No intent to change

Tally believes pharmacies in town that don't stock the prescription will continue not to and the ones that do stock it will distribute it over the counter. No pharmacy contacted stated intentions to change store policy.

Tally, whose pharmacy carries birth-control pills, said he feels the ability to have a say on what his pharmacy does not carry is important. "We ought to all be able to make our own decisions and live with the consequences. If people think we're being too high and mighty and they don't come back, well, at least I got to make a decision that I can live with," he said.

Legislatively there has been something of a divide over the issue between Missouri and Illinois. In Illinois, Gov. Rod Blagojevich declared his desire to introduce legislation that would make Plan B available over the counter. The FDA ruling now makes this unnecessary.

In 2005 Blagojevich issued an emergency rule ordering pharmacies to accept and fill contraceptive prescriptions including Plan B without delay. Illinois is the only state with such a policy.

But Missouri has taken a more conservative approach. Gov. Matt Blunt pledged to support a state law that would allow pharmacists to decline to fill prescriptions for Plan B. A law to that effect introduced by state Sen. Jason Crowell, R-Cape Girardeau, was not approved by the state legislature, though.

If a woman takes Plan B within 72 hours of unprotected sex, she can lower the risk of pregnancy by up to 89 percent. Plan B is different from the abortion pill: If a woman already is pregnant, Plan B has no effect.

Barr hopes to begin nonprescription sales of Plan B by the end of the year. The pills will be sold only from behind the counter at pharmacies, but not at convenience stores or gas stations. Pharmacists will check photo identification.

Staff writer TJ Greaney contributed to this report.

The earlier the pills are taken, the more effective they are. Allowing nonprescription sales mean women won't have to hustle to get a prescription, something especially difficult on weekends and holidays, advocates said.

The FDA's long delay in deciding on Barr's application ensnared President Bush's nominee to head the regulatory agency. On Thursday, two senators said they would lift their block on Dr. Andrew von Eschenbach, making it likely he will win confirmation as FDA chief, perhaps next month.

In recent weeks, anti-abortion groups, angered that approval was imminent, had urged Bush to withdraw von Eschenbach's nomination. Bush said Monday he supported the doctor's decisions.

Barr hopes to begin nonprescription sales of Plan B by the end of the year. The pills will be sold only from behind the counter at pharmacies, but not at convenience stores or gas stations. Pharmacists will check photo identification.

There isn't enough scientific evidence that young teens can safely use Plan B without a doctor's supervision, von Eschenbach said in a memo. Over-the-counter use is safe for older teens and adults, the acting FDA commissioner added in explaining the age cutoff.

"This approach should help ensure safe and effective use of the product," wrote von Eschenbach.

Barr and others were disappointed that FDA imposed the age restriction. Bruce L. Downey, Barr's chairman, pledged to continue working with the agency to try to eliminate it.

The age restriction remains controversial even inside FDA, agency drugs chief Dr. Steven Galson told The Associated Press. Galson has acknowledged overruling his staff scientists, who concluded in 2004 that nonprescription sales would be safe for all ages.

"Let me be frank, there still are disagreements," Galson said in an interview. "There were disagreements from the first second this application came in the house."

The Center for Reproductive Rights said a lawsuit filed last year to do away with all age restrictions would continue.

As a condition of approval, Barr agreed to use anonymous shoppers and other methods to check whether pharmacists are enforcing the age restriction.

"I'm sure the FDA will follow through on that and make sure these important conditions are established and enforced," said White House spokeswoman Dana Perino.

Barr hasn't said if it will raise the price of the pills, which now cost $25 to $40 in prescription form.

Planned Parenthood, the largest dispenser of the pills, expects some insurers to continue covering prescription sales. Whether that would be cheaper will depend on a woman's insurance.

Nine states -- Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Washington and Vermont -- already allow certain pharmacies to sell Plan B without a doctor's prescription to women of any age.

Minors won't see any change in those states, because the pharmacist already technically writes the prescription, the American Pharmacists Association said.

The FDA approved prescription-only sales of Plan B in 1999. The quest to change its status began in 2003. That year, agency advisers endorsed nonprescription sales for all ages, and FDA's staff scientists agreed.

Higher-ranking officials rejected that recommendation, citing concerns about young teens using the pills without oversight. Barr reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription. Then last August, the FDA postponed a final decision indefinitely, saying the agency needed to determine how to enforce the age restrictions.

FDA's handling of Plan B sparked a firestorm, with allegations of political meddling, high-profile resignations, lawsuits and congressional investigations.

The controversy appears to have helped Plan B sales, which are up an estimated 30 percent this year, according to IMS Health Inc., a health care consulting company. Barr estimates pharmacists dispense about 1.5 million packs a year.