Plan B Decision Ignores solid science, said FDA Head

13:32
Plan B Decision Ignores solid science, said FDA Head -

The Obama administration took power with the promise that the policy would not trump science, but many say now that he has not always lived up to this commitment.

Fallout continues today to yesterday's announcement of emergency contraception by Kathleen Sebelius, head of the US Department of Health and Human Services (HHS). For the first time anyone could remember, HHS annulled a decision of the Food and Drug Administration (FDA).

Specifically, Sebelius said she would not allow Plan B, the emergency contraceptive to be sold without prescription to those under 17 years, a step that the FDA had approved. (Currently, it is available over the counter only to 17 and over ;. Teens and tweens younger need a prescription to access) In a statement, Sebelius said that 10% of the younger cohort could use the Plan B are barely 11 years old and can not use the drug correctly. These girls have "significant behavioral and cognitive differences" compared to older teens, she explained.

The decision was immediately attacked by health groups of breeding, who said the argument Sebelius is contrary to science. in a carefully worded statement, FDA Commissioner Margaret Hamburg has also resisted Sebelius. Hamburg noted that "I reviewed and thoughtfully considered the data, clinical information and analysis provided by the "drug experts from the FDA," and I agree ... it is adequate and reasonable, well supported, and the scientific evidence that Plan B One-Step is safe and effective and should be approved for a nonprescription use for all females of childbearing potential. "

Plan B has been the source of much controversy during the presidency of George W. Bush. Then, the FDA has been accused of putting politics before science and resist movement to provide Plan B over the counter to adults and teenagers alike. critics now see something similar in the current administration. As the new York Times noted in a news story, "the Obama administration takes a socially conservative position on Plan B, one closer to that of the Bush administration than many of his own liberal supporters. "

many professional groups, including the American Academy of Pediatrics ( . AAP) approve making Plan B available over the counter to anyone partly, this is because time is of the essence: for Plan B to prevent pregnancy, ideally it should be taken within 72 hours unprotected sex, although some studies say it can work up to 0 hours. In a 05 document without order approving Plan B for girls, AAP lamented that pharmacies often do not store the drug and only 35% of surveyed 320 pharmacies Pennsylvania said they could fill an order the day it requested.

President Barack Obama, asked at a press conference today if politics had trumped science in the Plan B decision, walked a delicate line. He defended Sebelius and said he agreed with his decision, but noted that he had stayed out of the process. Sebelius, he said, "could not be sure" that preadolescent girls know how to use a drug that "may end up having a negative effect. ... When it comes to 12 or 13 years, the question is," can we have confidence that they could use Plan B properly? And his judgment was that there was not enough evidence "for this. (The former head office FDA Women's Health Susan Wood, was quoted elsewhere as saying that many other much riskier medications, such as acetaminophen, are widely available without a prescription.)

This is not the first time the Obama administration reversed the scientists, including his own. In September, President Obama rejected the new air pollution standards proposed by the Environmental Protection Agency. In late 09, faced with an outcry, Sebelius refused to approve the recommendations of a working group that challenged the value of donated mammograms before age 50.

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