Barr CEO says amending Plan B drug bid
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Barr Pharmaceuticals Inc. will amend its plans to limit nonprescription sales of its morning-after contraceptive by age, but cannot be held responsible if pharmacists disregard the restrictions, Chief Executive Bruce Downey said on Wednesday.
Downey said the drugmaker would incorporate ideas from the U.S. Food and Drug Administration, which has said the Plan B drug could be made available without a doctor’s note for women at least 18 years old if kept behind pharmacy counters.
The FDA said Barr, in order to win agency clearance, must come up with a rigorous plan for making sure younger girls cannot buy the product without a prescription.
“Ultimately we can’t prohibit a pharmacist from not living up to his ... or her obligations,” Downey said in an interview with Reuters. “I am confident most pharmacists are responsible people, and they will abide by the law.”
Barr had been seeking approval for women age 16 and older. Downey said the company has not made any decision whether to raise the age to 18 in its new bid.
His comments come one day after the drugmaker met with FDA officials to discuss wider access to Plan B, an emergency contraceptive that has stirred debate and held up the confirmation of the FDA’s top official.
Last week the agency said it would take another look at the long-delayed application, which was first filed in 2003 seeking easier access for all women.
Downey said he disagreed with the FDA over any age restrictions for Plan B, which can prevent pregnancy if taken within 72 hours of sexual intercourse.
“That need doesn’t discriminate on the basis of age. If you’re 17 and need it, you need it just as quickly as someone who is 31 and needs it,” he said.
He added the company and the FDA would “have to come to some resolution” to make available nonprescription versions of the drug, approved as a prescription in 1999.
Nine U.S. states already allow wider Plan B sales through pharmacists for all women, and the company said earlier this year sales of the drug have grown.
If Barr wins wider FDA approval “it would double sales,” Downey said. He previously has said Plan B accounts for about 3 percent to 3.5 percent of Barr’s total sales.
The campaign to broaden state access will continue, he added, but would be less aggressive if the FDA eases access.
The company would have to change the packaging for its nonprescription product, making it available a couple of months after approval, Downey said.
Supporters and critics of the drug have lobbied the FDA intensely over the decision, which the agency has said should be wrapped up within weeks.
Downey rejected charges from opponents, who argue wider access will promote promiscuity or liken the drug to a medical abortion.
The FDA has said Plan B—a high dose of a hormone used in birth control pills—works mainly by blocking the release of an egg from an ovary. It also may prevent an egg and sperm from uniting or prevent a fertilized egg from attaching to the womb, the FDA says.
“There’s a lot of misinformation about the product,” Downey said. “It works in exactly the same way, has the same mechanism of action as other oral contraceptives.”
“If it were widely available, you’d have fewer unintended pregnancies and fewer abortions, and I think that’s a good thing,” he said.
Supporting Downey’s position are women’s groups and medical associations, which have said dropping the prescription requirement is critical for women to get the product in time.
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