Monday, December 10, 2012

Should emergency contraception — the “morning-after pill” — be available without prescription to females of all ages, including those under 17?

This frame grab from video shows a box of Plan B, the “morning-after” pill. (AP - AP)
The American College of Obstetricians and Gynecologists (and its companion organization, the American Congress of Obstetricians and Gynecologists, both of which shorten to ACOG) thinks it should. Along with the American Academy of Family Physicians, the American Academy of Pediatrics and eight other health-care professional associations, ACOG has renewed its efforts to make emergency contraception more readily available to all who need it.
In a letter to Kathleen Sebelius, Secretary of the Department of Health and Human Services on Dec. 7, the organizations ask that she reverse her decision made a year ago to uphold the requirement that girls under 17 have a prescription in order to purchase emergency contraception. You can read the letter here.
Sold under the brand name Plan B One-Step, the emergency contraceptive greatly reduces the risk of pregnancy if taken within 72 hours after sex. The product’s Web site, along with the agencies advocating for its prescription-free availability, note that it’s not meant to be used as a routine contraceptive; it’s for isolated instances in which unprotected sex has occurred or when a birth-control method has failed (i.e. when a diaphragm slips out of place or a condom ruptures).
Last December Sebelius rejected a request from Teva Women’s Health Inc., which manufactures Plan B One-Step, to make the drug available over the counter to all consumers. Even as FDA Commissioner Margaret Hamburg supported such a change, she followed her boss’s directive to reject the request. In a statement issued at that time, Hamburg argued that there’s plenty of research showing the drug to be safe and effective — and that even young teenagers are capable of following directions for its use.
But Sebelius disagreed with that last part, saying there’s not enough evidence to demonstrate that girls as young as 11 are equipped to responsibly use emergency contraception without consulting a health-care professional. In her statement, she wrote, “The science has confirmed the drug to be safe and effective with appropriate use. However, the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. I do not believe that Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use.”
In November 2012, the American College of Obstetricians and Gynecologists issued a statement that included the suggestion that pediatricians offer sexually active teen patients information about and even advance prescriptions for emergency contraception.
Where do you stand on this matter?
By   |  09:37 AM ET, 12/10/2012

Tags:  morning after pillemergency contraception

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