Medical community decries decision to maintain status quo of emergency contraceptive
WASHINGTON — A group of medical associations on Wednesday denounced the government's decision to maintain the status quo with regard to the prescription status of the emergency contraceptive Plan B.
“As advocates for the health and well-being of all young people, the [American Academy of Pediatrics] recommends that adolescents postpone sexual activity until they are fully ready for the emotional, physical and financial consequences of sex,” stated Robert Block, AAP president. “However, as physicians who care for our nation’s children, it is our responsibility to protect the health of our teenage patients, and an unintended pregnancy can have significant implications for adolescents’ physical and emotional health.”
Plan B has long been an industry hot button, even before Barr Pharmaceuticals' subsidiary Duramed first started shipping the first and only dual-status nonprescription/prescription drug in November 2006. Plan B was to be sold from behind the pharmacy counter without a prescription to women 18 and older; and dispensed to women younger than 18 so long as they had a valid prescription. Before gaining that dual status, Plan B was a de facto behind-the-counter medicine in nine states, where pharmacists were allowed to dispense a Plan B course without a prescription under certain circumstances.
Former FDA commissioner Lester Crawford was the commissioner who delayed the FDA decision to approve the prescription-to-OTC switch of Plan B — based on a reluctance to create a dual status class of medicines, according to Crawford. Crawford resigned abruptly in 2005 (for reasons unrelated to Plan B), and the Congressional approval of his proposed successor, Andrew von Eschenbach, was delayed until FDA in essence promised to approve the switch application for the emergency contraceptive.
The medicine was controversial even among pharmacists, many of whom were implored by their peers to practice a refuse-and-refer policy, whereby a pharmacist who was not comfortable adjudicating a Plan B request would be able to refuse the prescription and refer that prescription to a pharmacist who would fill it, even if that meant sending the patient to another pharmacy.
The group of medical associations on Wednesday was particularly concerned that the U.S. Department of Health and Human Services overruled what would have been an approved sale of Plan B with no prescription restrictions by the Food and Drug Administration. “The decision to continue restricting access to this safe and effective product is medically inexplicable,” Block said. “The AAP strongly encourages the use of contraception — including [emergency contraception] by adolescents who choose sexual activity, and recommends that teens receive appropriate counseling on EC use by a pediatrician or other primary care physician.”
The group of medical associations included the AAP, the American College of Obstetricians and Gynecologists (The College) and the Society of Adolescent Health and Medicine. The AAP and SAHM recommend that adolescents be counseled on emergency contraception in the context of a discussion on sexual safety and family planning, regardless of current intentions for sexual behavior. All contraceptive counseling for adolescents should include information on the use and availability of emergency contraception wherever these visits occur, including emergency departments, clinics and hospitals, the associations added.
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