Posts Tagged FDA
The FDA has announced it will proceed to make Plan B (the so-called “morning after pill) legally available for 17-year olds to purchase over the counter. This overturns a Bush-era decision politicizing Plan B.
There is some misunderstanding about Plan B. It is not an abortion pill. Unlike the RU-486 pill, Plan B prevents ovulation and fertilization but will not affect an existing pregnancy. If administered within 72 hours after unprotected sex, the Plan B pill reduces a woman’s chance of becoming pregnant by 89 percent.
Making this emergency contraceptive available to young women over the counter is not going to be a cure-all in reducing teen pregnancy, however.
. . . young people in the United States have so much unprotected sex — one in three girls under the age of 20 will get pregnant, with 80 percent of the pregnancies unplanned — that Plan B has been little more than a sandbag on an overtopped flood wall. Even women who are given the medicine free often fail to take it after having unprotected sex.
It is significant to note that the judge’s decision that led to this change in FDA policy repudiates the Bush administration’s political strong-arm tactics with the FDA.
Judge Korman wrote that officials of the agency had repeatedly delayed action on the petition, moving only when members of Congress threatened to hold up confirmation hearings on acting F.D.A. commissioners. Several officials also violated the agency’s own policies, he wrote.
Citing depositions, Judge Korman wrote that agency officials had improperly communicated with White House officials about Plan B. And, he said, F.D.A. employees sought to influence decisions by appointing people with anti-abortion views to an independent panel of experts reviewing Plan B for the agency.
The agency also departed from its normal procedures, the judge wrote, by ignoring favorable conclusions about the drug by an advisory panel as well its own scientists and officials who found that the drug could be safely used by women at least as young as 17.
Such “political considerations, delays and implausible justifications” showed that the F.D.A. had acted without good faith or reasoned decision making, Judge Korman wrote.
Susan F. Wood, a former F.D.A. director of women’s health who resigned in 2005 to protest the handling of Plan B, said Monday that the judge’s decision to send the drug back for reconsideration signaled hope of the agency’s ability to act independently under a new administration.