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More Stupid Excuses from the FDA
2005.09.01 (Thu) 14:36
We saw yesterday that the FDA has once again failed to make the morning after pill available without a prescription. According to ABC News:
The FDA on Friday postponed indefinitely its decision on whether to allow the morning-after pill, called Plan B, to sell without a prescription. The agency said it was safe for adults to use without a doctor's guidance but said young teenagers still needed a prescription and that it couldn't determine how to enforce an age limit a decision contrary to the advice of its own scientific advisers.
The morning-after pill is a high dose of regular birth control that, taken within 72 hours of unprotected sex, can lower the risk of pregnancy by up to 89 percent.
Plan B opponents, who consider the drug tantamount to abortion and have intensely lobbied the Bush administration to reject over-the-counter sales, praised [FDA Commissioner Lester] Crawford's move, saying easier access to emergency contraception may encourage teen sex.
But contraception advocates called Friday's action a case of politics trumping science, saying easier access to the pills could halve the nation's 3 million annual unintended pregnancies. FDA's scientists say the pills are safe, used by more than 2.4 million Americans and millions more women abroad with few side effects, and in December 2003 the agency's scientific advisers overwhelmingly backed over-the-counter sales for all ages.
FDA rejected that recommendation, citing concern about young teens' use of the pills without a doctor's guidance. Maker Barr Pharmaceuticals reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription while younger teens continue to get a doctor's note saying an age limit could be enforced just as it is for sales of cigarettes.
The drug has no effect if a woman already is pregnant. It works by blocking ovulation or fertilization, or possibly by interfering with implantation of a fertilized egg into the uterus, the medical definition of pregnancy.
Let's break this down. Reasonable people can disagree about whether minors should have access to this medication without a prescription. So, setting that aside for a moment, why the hell wouldn't the second application — which asked for a scenario in which adults can buy the medication over-the-counter and minors would still need a doctor's permission — be granted? The FDA's own science advisors are clearly saying that the pill is safe for all ages, so what's the problem?
Of course, the "problem" for opponents of the pill isn't physical, but rather spiritual. Some of them seem to view taking this pill to be the same as an abortion. However, the fact that the pill does nothing if pregnancy has already occurred makes their point not only irrelevant to an FDA policy decision (since abortions are legal), but also patently incorrect.
Then there are those who seem to think that, like other birth control devices such as condoms, access to this pill will incite teens to have sex. Wake the fuck up, people. Minors are having sex, and will continue to do so no matter what forms of birth control are or are not available to them. Instead of living in a world of denial, how about we focus on reality? For example, the reality that since minors are already having sex, access to this pill could prevent them from also becoming pregnant.
Look at it this way: if a prescription was required to buy condoms, do you think the use of condoms would increase or decrease? We're willing to bet that fewer people would go through the trouble, expense, and/or embarassment of asking their doctors for condoms. And if the use of condoms decreased, we're willing to bet that instances of unwanted pregnancies would increase as a result. Continuing to mandate prescriptions for the morning after pill perpetuates a similar situation.
In addition, you only have a 72 hour window from the time that you perform the horizontal bop in which to take this pill. Which is more likely to fit within such a window: walking into a pharmacy and buying the pill, or scheduling an appointment with your doctor and getting a prescription, then walking into the pharmacy and buying the pill? This can be further complicated by the jungles of red tape and bureaucracy that many health care providers now make people wade through in order to fill a prescription. For example, some providers make it prohibitively expensive to get prescription medications in person, and instead push their users to order online. All of these factors just make it harder for a woman to procure and use in a timely manner a medication that has been deemed to be both safe and effective.
Now, reasons such as these for stifling methods of birth control are old hat to us — we've heard them from the religious nutbags for years now. However, the FDA is breaking out a new excuse — they can't determine how to enforce an age limit. They can't determine how to enforce an age limit?! Is it just us, or is that the most pathetic load-of-crap excuse imaginable?
There are currently age restrictions in place for both tobacco and alcohol products. If we're trying to stop minors from purchasing this medication without a doctor's authorization, why wouldn't the same system be put in place for this pill? And before someone reminds us that the age restrictions for tobacco and alcohol are far from perfect in their application, we'll remind that imaginary person that such lapses haven't caused those products to be pulled from the market until a foolproof system is designed. We'll also throw in the fact that, since this pill has been determined to be medically safe, it is certainly less harmful than both tobacco and alcohol, so lapses in the pill's age restriction policy wouldn't be nearly as harmful as allowing minors to purchase beers and butts.
Due to this frustrating stance by the FDA, Susan Wood, the Director of the FDA's Office of Women's Health, has resigned her position. Her statement said:
"I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," wrote Wood, who also was assistant commissioner for women's health. "The recent decision announced by the Commissioner about emergency contraception, which continues to limit women's access to a product that would reduce unintended pregnancies and reduce abortions, is contrary to my core commitment to improving and advancing women's health."
While we certainly support Susan Wood's decision, we can't help but be depressed that the net result is the loss of a voice of reason within the FDA.
So, to recap, the morning after pill has been tested and deemed safe for all ages by the FDA's science advisors. It isn't the same as an abortion, which is a legal procedure anyway, since it doesn't work after conception has taken place. Minors are having plenty of sex without access to this medication, and they will continue to have sex no matter what the future holds for this pill. This pill has an 89% effective rate which could put a huge dent in the three million annual unwanted pregnancies. Such a step would certainly lower the demand for actual abortions, which are more invasive and more costly. Similar age restrictions already exist for alcohol and tobacco products, so determining a system to restrict sales to minors is not an issue. The use of this medication is time-senstive, and removing the need for a prescription would result in more women getting the medication in time to prevent pregnancy.
Given all this information, the FDA has still decided to cozy up with the religious right by denying an effective and valuable medication to American women, and in the process, they have forced out their own Director of Women's Health.
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[ Filed under: % Civil Liberties % Government & Politics % Religion ]
Grendel, 2005.09.01 (Thu) 21:17 [Link] »
Mongrel, 2005.09.02 (Fri) 04:25 [Link] »
Grendel, 2005.09.02 (Fri) 08:11 [Link] »
Rockstar, 2005.09.02 (Fri) 09:50 [Link] »
MBains, 2005.09.02 (Fri) 14:19 [Link] »
Rockstar, 2005.09.02 (Fri) 15:23 [Link] »
Tom from the Two Percent Company, 2005.09.02 (Fri) 18:07 [Link] »
Grendel, 2005.09.02 (Fri) 19:00 [Link] »
God's Personal Contraception Consultant, 2005.09.04 (Sun) 11:33 [Link] »
Fan-man, 2005.09.07 (Wed) 16:53 [Link] »
Grendel, 2005.09.07 (Wed) 20:47 [Link] »
Fan-man, 2005.09.07 (Wed) 22:21 [Link] »
Grendel, 2005.09.08 (Thu) 17:32 [Link] »
Fan-man, 2005.09.08 (Thu) 22:13 [Link] »
Mongrel, 2005.09.12 (Mon) 07:57 [Link] »
Fan-man, 2005.09.12 (Mon) 11:01 [Link] »
Mongrel, 2005.09.13 (Tue) 04:37 [Link] »
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