Plan B OK Has Political Ramifications

FDA commissioner Dr. Andrew von Eschenbach with FDA Logo and Morning-After Pills
Thursday's ruling by the Food and Drug Administration ends a three-year effort to loosen restrictions on the pill known as Plan B — and eliminates a hurdle that threatened to sink President Bush's pick to head the agency.

The delay had ensnared Mr. Bush's nominee to head the FDA. On Thursday, two senators lifted their blockade on the nomination, making confirmation of Dr. Andrew von Eschenbach as FDA's commissioner likely next month.

Following the FDA's decision, the morning-after pill can be sold to women over the counter. The emergency contraception is available to those who can prove they're at least 18. Those who are younger still need a prescription, the Food and Drug Administration told manufacturer Barr Pharmaceuticals Inc.

While the FDA delayed this decision, Sen. Patty Murray, D-Wash, was one of two senators who blocked the confirmation of acting commissioner von Eschenbach to head the agency full time, CBS Radio News correspondent Barry Bagnato reports.

"I am still concerned about the age restriction," Murray said.

Talking to reporters Thursday aboard Air Force One as President Bush headed to Kennebunkport, Maine, White House spokeswoman Dana Perino, asked for his reaction, said Mr. Bush "appreciates that the FDA did an exhaustive review, that they recognized the critical distinction between minors and adults and the risks a drug like this could pose."

Noting the restrictions the agency attached to its approval, Perino added, "I'm sure the FDA will follow through on that and make sure these important conditions are established and enforced."

The compromise decision is a partial victory for women's advocacy and medical groups that say eliminating sales restrictions could cut in half the nation's number of unplanned pregnancies. Opponents have argued that wider access could increase promiscuity.

"While we urge the FDA to revisit placing age restrictions on the sale of Plan B, it is real progress that millions of American women will now have increased access to emergency contraception," Murray and Sen. Hillary Rodham Clinton, D-N.Y., who had held up the confirmation, said in a joint statement.

The pills are a concentrated dose of the same drug found in many regular birth-control pills. When a woman takes the pills within 72 hours of unprotected sex, they can lower the risk of pregnancy by up to 89 percent. If she already is pregnant, the pills have no effect.

The earlier it's taken, the more effective Plan B is. But it can be hard to find a doctor to write a prescription in time, especially on weekends and holidays — hence the push to allow nonprescription sales.

Barr has said it 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 — so the pharmacist can check photo identification — but not at convenience stores or gas stations.

There isn't enough scientific evidence that young teens can safely use Plan B without a doctor's supervision, von Eschenbach, the FDA's acting commissioner, said in a memo.

But Barr did prove that over-the-counter use is safe for older teens and adults — and licensed pharmacies are used to checking for proof of age 18 before selling tobacco and certain other products, von Eschenbach wrote in explaining the agency's age cutoff.

"This approach should help ensure safe and effective use of the product," he concluded.

Plan B's maker was disappointed that FDA imposed the age restriction and pledged to continue working the agency to try to eliminate it.