Soon no prescription for morning-after pill?
Soon no prescription for morning-after pill?
BY LORI RACKL Health Reporter
August 1, 2006
Copyright by The Chicago Sun Times
Women might soon be able to get the morning-after pill without a doctor's prescription -- a hotly debated plan that seemed to be stuck in bureaucratic limbo until Monday.
After months of silence on the matter, the U.S. Food and Drug Administration told Barr Pharmaceuticals that it wanted to meet within seven days to talk about how to allow women 18 and older to walk into pharmacies and buy the emergency contraceptive Plan B over-the-counter. Minors would still need a prescription, despite independent advisers to the FDA in 2003 overwhelmingly endorsing over-the-counter sales for all ages.
Should be 'listening to women'
The FDA's apparent willingness to widen access to the medication was met Monday with equal parts praise and skepticism by contraceptive advocates. They questioned the timing of the announcement, which came as President Bush's pick to lead the FDA, Dr. Andrew von Eschenbach, was headed into Senate confirmation hearings. Some senators have vowed to block his nomination until the FDA makes a decision on the morning-after pill once and for all.
"We've been waiting for a final ruling from the FDA for 550 days," said Steve Trombley, president of Planned Parenthood/Chicago Area. "In the meantime, that's 2.25 million unintended pregnancies and 1.2 million abortions that could have been prevented. It's time for the FDA to start listening to women and families and stop listening to a small group of extremists who would outlaw sex if they could."
When taken within 72 hours of unprotected sex, Plan B can reduce the risk of pregnancy by up to 89 percent.
The two-pill series, which contains a high dose of the main ingredient in regular birth control pills, prevents ovulation or fertilization of an egg. It doesn't work if a woman is already pregnant.
Concerns about wider access
Philip Karst of the Illinois Catholic Health Association said the church is opposed in general to the morning-after pill, prescription or not. But making it available over-the- counter means "more people would have access to the drug, and we'd be concerned about that."
Opponents worry the move could increase promiscuity and jeopardize a woman's health.
"You might have an 18-year-old girl who decides that rather than practice safe sex and plan responsibly, 'I no longer have to worry about it. I can just go to the pharmacy,' " said state Rep. Ron Stephens (R-Troy), a Downstate pharmacist for 31 years.
Stephens, who is morally opposed to the morning-after pill and refuses to fill such prescriptions, said selling Plan B over-the-counter compromises patient safety by "taking the doctor and the pharmacist out of the equation."
The FDA has asked Barr to update its application to limit nonprescription sales to women 18 and older, not 16 as the drugmaker had wanted. Barr has to spell out how the age restriction would be enforced.
The agency also wants different packaging for the nonprescription and prescription versions of the pill, both of which would be sold from behind the pharmacy counter.
Contributing: AP
lrackl@suntimes.com
THE HURDLES
Barr Pharmaceuticals can get another chance at approval for its morning-after pill if the company:
Restricts sales of the medication to women 18 and older, not 16 as it had sought.
Packages the nonprescription and prescription versions of the pill differently, though both would be kept behind the pharmacy counter.
Provides details on how the age restriction would be enforced and on its plan to restrict sales to certain pharmacies.
AP
BY LORI RACKL Health Reporter
August 1, 2006
Copyright by The Chicago Sun Times
Women might soon be able to get the morning-after pill without a doctor's prescription -- a hotly debated plan that seemed to be stuck in bureaucratic limbo until Monday.
After months of silence on the matter, the U.S. Food and Drug Administration told Barr Pharmaceuticals that it wanted to meet within seven days to talk about how to allow women 18 and older to walk into pharmacies and buy the emergency contraceptive Plan B over-the-counter. Minors would still need a prescription, despite independent advisers to the FDA in 2003 overwhelmingly endorsing over-the-counter sales for all ages.
Should be 'listening to women'
The FDA's apparent willingness to widen access to the medication was met Monday with equal parts praise and skepticism by contraceptive advocates. They questioned the timing of the announcement, which came as President Bush's pick to lead the FDA, Dr. Andrew von Eschenbach, was headed into Senate confirmation hearings. Some senators have vowed to block his nomination until the FDA makes a decision on the morning-after pill once and for all.
"We've been waiting for a final ruling from the FDA for 550 days," said Steve Trombley, president of Planned Parenthood/Chicago Area. "In the meantime, that's 2.25 million unintended pregnancies and 1.2 million abortions that could have been prevented. It's time for the FDA to start listening to women and families and stop listening to a small group of extremists who would outlaw sex if they could."
When taken within 72 hours of unprotected sex, Plan B can reduce the risk of pregnancy by up to 89 percent.
The two-pill series, which contains a high dose of the main ingredient in regular birth control pills, prevents ovulation or fertilization of an egg. It doesn't work if a woman is already pregnant.
Concerns about wider access
Philip Karst of the Illinois Catholic Health Association said the church is opposed in general to the morning-after pill, prescription or not. But making it available over-the- counter means "more people would have access to the drug, and we'd be concerned about that."
Opponents worry the move could increase promiscuity and jeopardize a woman's health.
"You might have an 18-year-old girl who decides that rather than practice safe sex and plan responsibly, 'I no longer have to worry about it. I can just go to the pharmacy,' " said state Rep. Ron Stephens (R-Troy), a Downstate pharmacist for 31 years.
Stephens, who is morally opposed to the morning-after pill and refuses to fill such prescriptions, said selling Plan B over-the-counter compromises patient safety by "taking the doctor and the pharmacist out of the equation."
The FDA has asked Barr to update its application to limit nonprescription sales to women 18 and older, not 16 as the drugmaker had wanted. Barr has to spell out how the age restriction would be enforced.
The agency also wants different packaging for the nonprescription and prescription versions of the pill, both of which would be sold from behind the pharmacy counter.
Contributing: AP
lrackl@suntimes.com
THE HURDLES
Barr Pharmaceuticals can get another chance at approval for its morning-after pill if the company:
Restricts sales of the medication to women 18 and older, not 16 as it had sought.
Packages the nonprescription and prescription versions of the pill differently, though both would be kept behind the pharmacy counter.
Provides details on how the age restriction would be enforced and on its plan to restrict sales to certain pharmacies.
AP
posted by Carlos T Mock at 7:23 AM
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