Plan B - Take 2

Aug 02 2006 Published by under Uncategorized

After re-reading my post on the latest Plan B foolishness, I think I might have been too angry to make my point clearly. I'm still pretty damn pissed off, but I'm going to give it another shot. There's little about this thing that doesn't make me mad, but right now I'm angriest about the FDA's latest arbitrary decision in this case: to refuse to allow over-the-counter (OTC) sales of the "Plan B" morning after pill to those under 18 years of age. Here's why:


The primary mission of the branch of the FDA that oversees pharmaceuticals is to ensure that drugs, whether prescription or over the counter, are safe and effective. Period. It is not to ensure that drugs are politically acceptable. It is not to ensure that only those drugs that do not threaten the religious beliefs of a narrow-minded but politically powerful set of Christian fundamentalists get approved. It is to approve drugs that are safe and effective, and refuse to approve drugs that do not meet both those criteria.
With Plan B, senior FDA officials have gone through all sorts of contortions on the issue of OTC safety. According to a GAO review of the FDA's hijinks, the FDA has always assumed that contraceptives work the same in adolescents and adults, and has never demanded extra studies in the younger population. Although the scientific review panel responsible for the original application for OTC status unanimously concluded that Plan B was safe for over-the-counter use, senior officials declined to approve the application, citing insufficient evidence that the drug would be safely used by adolescents. The Acting Director of the Center for Drug Evaluation and Research (CDER) cited concerns regarding the "level of cognitive development" of the younger population. The GAO characterized these concerns as "unprecedented."
But never mind that.
The FDA then essentially said that they would be willing to consider an application to allow the drug to be sold OTC to those over 16 years of age, and by prescription only to those under 16. The manufacturer of the drug submitted an application to do just that. The FDA then appears to have decided that there wasn't enough evidence that the drug was safe for 16-year-olds to use, but that it was safe for those 17 years old and older.
But, again, never mind that.
Instead, let's just look at what happened yesterday. Yesterday, the FDA sent a letter to the drug's manufacturer, informing them that they will not consider switching the drug to OTC status unless the age restriction is increased to 18. They are not trying to claim that the drug cannot safely be used by 17 year olds without the guidance of a doctor. Instead, they are claiming that the latest age change is required because of "enforcement considerations." They do not specify exactly what considerations would require the increase in age, and it is difficult to imagine exactly what difference one year might possibly make in this regard.
Here's what I think is going on: the FDA is once again attempting to stall the decisionmaking process on Plan B. They can't disapprove the application outright, since the science is too clear. The last time they stalled, it was to study whether or not they could approve a drug for OTC use only above a certain age limit. They used that to stall for as long as they could, but the 60-day comment period for that issue ended more than six months ago, so they were really out of time there. By requiring Barr Labs to change the age limit, change the labeling, and discuss assorted other issues, the FDA is doing their damndest to buy more time - I'd guess that they're hoping to push this off until sometime after the mid-term election.
The FDA can trumpet what they are doing all they want, but it is clear to anyone who has been paying attention to this process that all they are really doing is playing games with womens' health to make sure that the conservative Christianists don't get mad at the administration. Or at least not until the mid-terms are past.

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