FDA should end delays on Plan B sales
The shameful political games over the Plan B emergency contraceptive are well into their third year, but there is some hope that the bickering over this vital subject may soon be at an end.
It would be folly, however, to assume we’ve reached the endgame. We’ve been led down this road before.
The latest arena is a Senate committee confirmation hearing for now-acting director Dr. Andrew von Eschenbach, nominated to head the Food and Drug Administration.
The FDA, in what is seen by some as a bid to influence von Eschenbach’s nomination process, said it was moving toward endorsing sale of the pill without a prescription for women 18 and older. The desire to keep the drug out of the hands of underage girls is commendable. Surely, a way can be found to do this without keeping Plan B prescription-only for women of all ages and without appearing deliberately obstructionist.
There are still many possibilities that approval could stall. The FDA still wants to have direct talks with Barr Pharmaceuticals Inc., which has already developed a program to restrict sales. But the FDA could find fault with Barr’s plans, and we’d be back at Square One. Or President Bush could push von Eschenbach through via another one of his recess appointments.
Senate Democrats could still put a “hold” on a floor vote to approve a nominee. Sens. Hillary Rodham Clinton, D-N.Y., and Patty Murray, D-Wash., said they would block a floor vote until the FDA made a final decision on the drug’s sale.
Plan B was approved for prescription use in 1999. Since 2003, the Women’s Capital Corp., and then the pharmaceutical company, have sought to sell it over the counter. The pill consists of 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 risk of pregnancy by up to 89 percent.
Barr has gone through all the regulatory hoops with its morning-after anti-pregnancy pill, but the Bush administration seems determined to box it up.
“We all know what’s going on here,” said Sen. Tom Harkin, D-Iowa, a committee member. “This is a disregard for science out of ideological concerns.”
Opponents fear the contraceptive would promote promiscuity. But studies showed that its availability did not lead to an increase in sexual activity. It is sold without a prescription in 45 countries and nine states.
This drug’s effectiveness and safety have been certified again and again by the FDA’s medical staff. The pill prevents fertilization from occurring in the uterus after intercourse if taken within 24 hours, often longer. It is most effective when taken soon after intercourse, the reason its supporters want it available without prescription.
It is estimated that Plan B could prevent up to 1.5 million unintended pregnancies and 600,000 abortions a year in the United States. The evidence of its safety and value is too high to dither any longer.
Enough political tricks and procedural shenanigans. Plan B should be available without a prescription.
It would be folly, however, to assume we’ve reached the endgame. We’ve been led down this road before.
The latest arena is a Senate committee confirmation hearing for now-acting director Dr. Andrew von Eschenbach, nominated to head the Food and Drug Administration.
The FDA, in what is seen by some as a bid to influence von Eschenbach’s nomination process, said it was moving toward endorsing sale of the pill without a prescription for women 18 and older. The desire to keep the drug out of the hands of underage girls is commendable. Surely, a way can be found to do this without keeping Plan B prescription-only for women of all ages and without appearing deliberately obstructionist.
There are still many possibilities that approval could stall. The FDA still wants to have direct talks with Barr Pharmaceuticals Inc., which has already developed a program to restrict sales. But the FDA could find fault with Barr’s plans, and we’d be back at Square One. Or President Bush could push von Eschenbach through via another one of his recess appointments.
Senate Democrats could still put a “hold” on a floor vote to approve a nominee. Sens. Hillary Rodham Clinton, D-N.Y., and Patty Murray, D-Wash., said they would block a floor vote until the FDA made a final decision on the drug’s sale.
Plan B was approved for prescription use in 1999. Since 2003, the Women’s Capital Corp., and then the pharmaceutical company, have sought to sell it over the counter. The pill consists of 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 risk of pregnancy by up to 89 percent.
Barr has gone through all the regulatory hoops with its morning-after anti-pregnancy pill, but the Bush administration seems determined to box it up.
“We all know what’s going on here,” said Sen. Tom Harkin, D-Iowa, a committee member. “This is a disregard for science out of ideological concerns.”
Opponents fear the contraceptive would promote promiscuity. But studies showed that its availability did not lead to an increase in sexual activity. It is sold without a prescription in 45 countries and nine states.
This drug’s effectiveness and safety have been certified again and again by the FDA’s medical staff. The pill prevents fertilization from occurring in the uterus after intercourse if taken within 24 hours, often longer. It is most effective when taken soon after intercourse, the reason its supporters want it available without prescription.
It is estimated that Plan B could prevent up to 1.5 million unintended pregnancies and 600,000 abortions a year in the United States. The evidence of its safety and value is too high to dither any longer.
Enough political tricks and procedural shenanigans. Plan B should be available without a prescription.
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