Wow, Here's An FDA Shocker!
It's possible that the FDA turned down the morning after pill for availability sans prescription without hearing all the scientific evidence. Jeez...yuh think? Lauran Neergaard writes for the AP:
Congressional auditors reported that the Food and Drug Administration's May 2004 decision on emergency contraception deviated from 10 years of agency practice in evaluating over-the-counter sales of prescription drugs - and was unusual in several respects.Critics in Congress declared their suspicions confirmed and urged the FDA's boss to intervene to assure that a still pending reconsideration of the pill's fate isn't based on ideology.
"We are deeply opposed to this subversion of science," Rep. Henry Waxman, D-Calif., and 17 other lawmakers wrote Health and Human Services Secretary Mike Leavitt on Monday. "It appears that the decision ... was preordained from the outset."
Also, the lawmakers asked Leavitt to probe whether the FDA illegally destroyed documents from the office of then-Commissioner Mark McClellan, now the government's Medicare chief, that might have shed more light on the controversial decision.
Leavitt's office didn't return phone calls seeking comment.
But in a statement, the FDA stood by its rejection and said the independent Government Accountability Office "mischaracterizes facts."
"We question the integrity of the investigative process that results in such partial conclusions," the agency said.
Monday's report is the latest blow to the credibility of an agency that by law is supposed to base decisions on science, not politics or industry pressure. Top-ranking FDA officials have acknowledged they overruled their own scientists' decision that nonprescription sales of emergency birth control would be safe - and the agency's women's health chief resigned in protest.
A high dose of regular birth control, the morning-after pill lowers the risk of pregnancy by up to 89 percent if taken within 72 hours of unprotected sex. The sooner it's taken, the better it works, but it can be difficult for women to get a prescription in time.
In December 2003, FDA 's scientific advisers overwhelmingly backed over-the-counter sales of one brand, Plan B, for all ages. They cited assessments that easier access could halve the nation's 3 million annual unintended pregnancies.
Conservatives who consider the pill tantamount to abortion intensely lobbied the Bush administration to reject nonprescription sales, saying they would increase teen sex.
In May 2004, FDA leaders rejected the nonprescription switch, saying there was no data proving anyone under 16 could safely use the pills without a doctor's guidance.
Maker Barr Laboratories reapplied, seeking to sell Plan B without a prescription to women 16 or older, much like the way cigarettes are sold with age restrictions, while younger teens would still have to get a doctor's note. In August, FDA leaders postponed that decision indefinitely, saying it wasn't clear how to enforce an age limit.
The GAO probed the FDA 's initial rejection, and cited "unusual" practices - including conflicting accounts of whether the decision was made months before scientific reviews were completed.
No data proving anyone under 16 could use the pills without doctor's guidance? Lemme tell you, the directions are pretty damn simple: "Take the first tablet as soon as possible within 72 hours of having unprotected sex." There's no data proving anyone under 16 can use mascara without guidance either, but somehow, somehow...they manage! (It's the part about not letting the first coat dry before you apply the second coat that always gets me.)
I find it curious that they use the term "unprotected sex". Odd, that is. Perhaps because it is so ... specific. There are a lot of ways to have sex that will prevent pregnancy, but "protected" equals "condom".
Also, the part about not being able to restrict it to persons 16 and over - how stupid is that statement? Have these people tried to buy cold medicine lately? They have cards in the aisle that get redeemed for the actual product after the pharmacist records every bit of personal info possible.
I hope the GAO perserveres.
_Jon at November 16, 2005 5:24 AM
Two coats of mascara? NOW I'll find a man!
rebecca at November 16, 2005 1:50 PM
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