HEALTH
No Plan B
On Friday, the Food and Drug Administration indefinitely postponed its decision on whether the emergency contraceptive Plan B, more commonly known as the "morning-after pill," could be sold to women without a prescription. Nearly two years have passed since the drug was approved for over-the-counter (OTC) use by an independent panel of experts, then rejected by FDA partisans catering to the president's right-wing base. With this latest delay, the Bush administration has fundamentally undermined its claim to represent the "culture of life." Top medical groups believe that fully half of the nation's annual 3 million unintended pregnancies and 1.3 million abortions could be prevented if Plan B were available without a prescription. President Bush's FDA is again putting politics over science, women's health, and responsible abortion prevention.
ANOTHER BROKEN PROMISE: The FDA's latest delay is especially aggravating since the agency's current commissioner, Lester Crawford, was confirmed for his position only after promising Senators Hillary Clinton (D-NY) and Patty Murray (D-WA) that a decision on Plan B would be made by September 1. (Clinton and Murray are now calling for additional Plan B hearings.) The September deadline was itself a delay. "Under federal regulations, the Food and Drug Administration was required to reach a decision on Plan B by January," the New York Times reports. Now even some former Bush administration officials are alarmed. "At some point, the statute requires that the agency make a decision," Dr. Eve E. Slater, an assistant secretary of health from 2001 to 2003, told the Times. "You can't just delay forever." The Plan B decision has become "overly politicized, and it shouldn't be," Dr. Slater added.
SCIENCE IS "OVERWHELMING": The safety and effectiveness of the Plan B pill has not been seriously questioned since 1999, when the drug was first approved for prescription use. "More than 70 leading medical and public health groups, including the American Academy of Pediatrics and American College of Obstetricians and Gynecologists, say it's safe and should be available without a prescription or any age restrictions." (Why without a prescription? Primarily because the pill needs to be taken within 72 hours of sex, and it is often impossible for women to get an appointment and a prescription from a doctor in that time.) Moreover, a study by the University of California of more than 2,000 California women concluded easy access to the emergency contraceptive "did not lead them to engage in more risky sexual behavior." Panel drug expert Alastair Wood said "the science was overwhelming" on Plan B. Another expert said the FDA's decision not to approve over-the-counter status was "blatantly contrary to the science and the facts."
AGE CHECK NO ARGUMENT: In USA Today, the director of a cultural conservative group, Family-Pac Federal, cheered the FDA ruling, saying that if Plan B were approved for OTC purchase by adults, "Hard-working and over-stressed pharmacists would be turned into bartenders trying to determine a woman's age and identification. Welcome to the world of teenage fake IDs, Walgreens." Except Walgreens and other pharmacies already inhabit that world. In a report earlier this month, the Associated Press noted that if OTC sale of Plan B was approved, "Cash registers could be programmed to block purchase pending an age check. That's doable: Walgreens, the nation's largest drugstore chain, just last month took that step to prohibit sales to minors of cold medicines containing a sometimes-abused ingredient."
DO AS WE SAY (THEN WE'LL REJECT YOU ANYWAY): The FDA justified the latest delay by claiming that the application submitted by Barr Laboratories Inc., the makers of Plan B, had "raised complicated and unresolved issues about whether current regulations allow a drug to be legally sold by prescription only for teenagers but over the counter for all others." So why did Barr submit an application requesting adults-only OTC sale of Plan B in the first place? Because the FDA told them to. After Barr's first application was rejected in May 2004, "the FDA advised Barr Laboratories to submit another application that allowed over-the-counter sales only to women older than 17. That was the plan that was deemed to be impossible to resolve yesterday," the Washington Post reports.
On Friday, the Food and Drug Administration indefinitely postponed its decision on whether the emergency contraceptive Plan B, more commonly known as the "morning-after pill," could be sold to women without a prescription. Nearly two years have passed since the drug was approved for over-the-counter (OTC) use by an independent panel of experts, then rejected by FDA partisans catering to the president's right-wing base. With this latest delay, the Bush administration has fundamentally undermined its claim to represent the "culture of life." Top medical groups believe that fully half of the nation's annual 3 million unintended pregnancies and 1.3 million abortions could be prevented if Plan B were available without a prescription. President Bush's FDA is again putting politics over science, women's health, and responsible abortion prevention.
ANOTHER BROKEN PROMISE: The FDA's latest delay is especially aggravating since the agency's current commissioner, Lester Crawford, was confirmed for his position only after promising Senators Hillary Clinton (D-NY) and Patty Murray (D-WA) that a decision on Plan B would be made by September 1. (Clinton and Murray are now calling for additional Plan B hearings.) The September deadline was itself a delay. "Under federal regulations, the Food and Drug Administration was required to reach a decision on Plan B by January," the New York Times reports. Now even some former Bush administration officials are alarmed. "At some point, the statute requires that the agency make a decision," Dr. Eve E. Slater, an assistant secretary of health from 2001 to 2003, told the Times. "You can't just delay forever." The Plan B decision has become "overly politicized, and it shouldn't be," Dr. Slater added.
SCIENCE IS "OVERWHELMING": The safety and effectiveness of the Plan B pill has not been seriously questioned since 1999, when the drug was first approved for prescription use. "More than 70 leading medical and public health groups, including the American Academy of Pediatrics and American College of Obstetricians and Gynecologists, say it's safe and should be available without a prescription or any age restrictions." (Why without a prescription? Primarily because the pill needs to be taken within 72 hours of sex, and it is often impossible for women to get an appointment and a prescription from a doctor in that time.) Moreover, a study by the University of California of more than 2,000 California women concluded easy access to the emergency contraceptive "did not lead them to engage in more risky sexual behavior." Panel drug expert Alastair Wood said "the science was overwhelming" on Plan B. Another expert said the FDA's decision not to approve over-the-counter status was "blatantly contrary to the science and the facts."
AGE CHECK NO ARGUMENT: In USA Today, the director of a cultural conservative group, Family-Pac Federal, cheered the FDA ruling, saying that if Plan B were approved for OTC purchase by adults, "Hard-working and over-stressed pharmacists would be turned into bartenders trying to determine a woman's age and identification. Welcome to the world of teenage fake IDs, Walgreens." Except Walgreens and other pharmacies already inhabit that world. In a report earlier this month, the Associated Press noted that if OTC sale of Plan B was approved, "Cash registers could be programmed to block purchase pending an age check. That's doable: Walgreens, the nation's largest drugstore chain, just last month took that step to prohibit sales to minors of cold medicines containing a sometimes-abused ingredient."
DO AS WE SAY (THEN WE'LL REJECT YOU ANYWAY): The FDA justified the latest delay by claiming that the application submitted by Barr Laboratories Inc., the makers of Plan B, had "raised complicated and unresolved issues about whether current regulations allow a drug to be legally sold by prescription only for teenagers but over the counter for all others." So why did Barr submit an application requesting adults-only OTC sale of Plan B in the first place? Because the FDA told them to. After Barr's first application was rejected in May 2004, "the FDA advised Barr Laboratories to submit another application that allowed over-the-counter sales only to women older than 17. That was the plan that was deemed to be impossible to resolve yesterday," the Washington Post reports.
posted by T. Scott Brineman at 6:01 AM
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