FDA Bows to Politics
The FDA came out with a statement and subsequent action this week and it is not in the best interest of the American public. This week the FDA approved the transition of PlanB® to over the counter status for women older than 16 years of age. I am unclear of how this program will be regulated or monitored but in my humble but accurate opinion this is a horrible move by the FDA for both moral and health/scientific reasons.
Explanation
Women older than 16 years of age will now be able to purchase this ‘emergency’ hormone contraceptive (EHC) ‘medicine’ with out a prescription. Women younger than 16 years of age will continue to require a prescription from a medical provider for access to it. The ‘necessity’ for this over the counter (OTC) transition has been purported to be previously hindered access to the ‘medication’ in a timely fashion. If this drug is not acquired and administered within 72 hours, its efficacy is dramatically reduced. If the realization of necessity is Friday night, for instance, and a provider is not consulted until Monday afternoon, it is possible that the 72 hour limit will be breached. This is the reason proponents, such as Planned Parrenthood, have pushed so hard for PlanB® OTC status.
In my humble but accurate assessment, there are at least 3 HUGH problems with this action. (1) Relaxing access to women > 16 and ‘restricting’ access to women < 16 is not likely to happen. Many women will, no doubt, purchase the product under the guise of personal use and then turn around and sell it to ‘ineligible’ patients. Just look at the tobacco market in America. Restrictions have been in place for the sale of tobacco to minors for decades yet the CDC currently reports (year 2004) that as many as 40.2 % of 6-12th graders have or currently use tobacco. The law says that minors may not have access to tobacco. This is obviously not found in practice.
(2) EHC will be used as a primary means of birth control. It is only indicated for ‘emergencies’, not continual use. In my humble but accurate opinion, women who either cannot afford the cost of visiting a medical provider or do not want to take the time out of their schedule will travel from pharmacy to pharmacy acquiring the OTC product. They will go to Walgreen’s the first time, CVS/Pharmacy the second, Wal-Mart the 3rd, Wal-Mart down the road the 4th, and then progress down the never ending list of grocery store pharmacies for each subsequent ‘need’. I guarantee that at each pharmacy visit they will be asked, “When was the last time that you used this product?” The answer will always be, “Oh, I have used it once before years ago.” This becomes a problem because it is unhealthy to consistently expose one’s self to this dose of hormones.
(3) EHC do not cause abortion but they do provide the possibility for terminating (aka ‘killing’ for those not offended by politically incorrect terms) the life of a human. The ease of access to this drug will decrease the time spent in contemplation prior to its use and increase total financial health care burden to society because of the likely side effects caused by continual use and abuse.
The FDA usually acts in the best interest of the American public. This time they gave way to political and health care activists at the cost of harming the public. Let’s be vigilant to watch the ‘post marketing’ research and see how long it takes for the first ‘continual’ user detrimental effects of this decision. It will arrive sooner than later, mark my words.
Explanation
Women older than 16 years of age will now be able to purchase this ‘emergency’ hormone contraceptive (EHC) ‘medicine’ with out a prescription. Women younger than 16 years of age will continue to require a prescription from a medical provider for access to it. The ‘necessity’ for this over the counter (OTC) transition has been purported to be previously hindered access to the ‘medication’ in a timely fashion. If this drug is not acquired and administered within 72 hours, its efficacy is dramatically reduced. If the realization of necessity is Friday night, for instance, and a provider is not consulted until Monday afternoon, it is possible that the 72 hour limit will be breached. This is the reason proponents, such as Planned Parrenthood, have pushed so hard for PlanB® OTC status.
In my humble but accurate assessment, there are at least 3 HUGH problems with this action. (1) Relaxing access to women > 16 and ‘restricting’ access to women < 16 is not likely to happen. Many women will, no doubt, purchase the product under the guise of personal use and then turn around and sell it to ‘ineligible’ patients. Just look at the tobacco market in America. Restrictions have been in place for the sale of tobacco to minors for decades yet the CDC currently reports (year 2004) that as many as 40.2 % of 6-12th graders have or currently use tobacco. The law says that minors may not have access to tobacco. This is obviously not found in practice.
(2) EHC will be used as a primary means of birth control. It is only indicated for ‘emergencies’, not continual use. In my humble but accurate opinion, women who either cannot afford the cost of visiting a medical provider or do not want to take the time out of their schedule will travel from pharmacy to pharmacy acquiring the OTC product. They will go to Walgreen’s the first time, CVS/Pharmacy the second, Wal-Mart the 3rd, Wal-Mart down the road the 4th, and then progress down the never ending list of grocery store pharmacies for each subsequent ‘need’. I guarantee that at each pharmacy visit they will be asked, “When was the last time that you used this product?” The answer will always be, “Oh, I have used it once before years ago.” This becomes a problem because it is unhealthy to consistently expose one’s self to this dose of hormones.
(3) EHC do not cause abortion but they do provide the possibility for terminating (aka ‘killing’ for those not offended by politically incorrect terms) the life of a human. The ease of access to this drug will decrease the time spent in contemplation prior to its use and increase total financial health care burden to society because of the likely side effects caused by continual use and abuse.
The FDA usually acts in the best interest of the American public. This time they gave way to political and health care activists at the cost of harming the public. Let’s be vigilant to watch the ‘post marketing’ research and see how long it takes for the first ‘continual’ user detrimental effects of this decision. It will arrive sooner than later, mark my words.
posted by OS Hopper at Thursday, August 24, 2006
1 Comments:
I read the headline yesterday and just said, "NOOOOOO!!!" There is probably a lack of thinking things through. If they think they can regulate this, they might want to talk to the tobacco industry and find out how THEY managed to keep 15-year-olds from obtaining cigarettes...since it's worked so well for them, it just has to work for the FDA.
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