The standard of safety

In defending the Plan B decision yesterday, President Obama said the following:

“And as I understand it, the reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old, going to a drugstore, should be able, alongside bubble gum or batteries, be able to buy a medication that potentially if not used properly could end up having an adverse effect,” Obama said. “And I think most parents would probably feel the same way.”

So let’s examine that statement. It seems pretty reasonable on its face. Sure, the FDA may have evidence that the drug, when used properly, is safe and effective. But how can we be assured that adolescents will not go crazy and start popping Plan B like candy. If only someone had studied that possibility.

If only the administration had read their FDA commissioner’s statement:

The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step.  Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.

See, as part of the review process for making a drug over the counter, the CDER specifically investigates whether that would be a problem. They study whether patients can understand how to use the drug properly without a healthcare provider being involved. They check if patients understand the labeling. They examine whether patients understand how often to take it. And, in this case, the CDER did all of this with adolescent girls.

If Secretary Sebelius, and President Obama, feel that this CDER review was improperly done, they should say so. If they feel the investigation was flawed, or incomplete, it is up to them to explain why. But in their response, they seem to be pretending that it never occurred.

Moreover, this is the process by which all over-the-counter drugs are approved. All drugs, when improperly used, carry significant effects. In 2009, there were over 70,000 calls to poison control centers for concerns about acetaminophen and more than 88,000 for ibuprofen. More than 30,000 calls were made for diphenhydramine, and 4 of those cases resulted in deaths. Just looking at kids 5 years of age and under, there were more than 130,000 calls for analgesics, 53,000 for vitamins, 48,000 for antihistamines, and 45,000 for cough and cold preparations. And yet, no one seems to be too concerned that these medications could be purchased “alongside bubble gum and batteries”. And, for the record, battery ingestions killed 4 kids in that age group that year.

All drugs are potentially dangerous. I don’t think that 11 year olds should be buying Tylenol, or Ibuprofen, or Benadryl any more than I think they should be buying Plan B. Maybe we should set age limits for the purchase of all over-the-counter drugs; but we don’t do that. We have set rules as to what is considered safe for over-the-counter sales, and we have determined that the societal good of having those drugs available without a prescription outweighs the very real and known harms that they pose. If the current administration is going to take the unprecedented step of over-ruling the FDA for this one drug, I would hope that they have a compelling reason to believe that it is more dangerous than all those that came before it. I would hope they have some data behind them.

Otherwise, this administration is letting politics trump science. And while it may make campaigning in some ways easier next year, it will remove a significant amount of credibility that they are the ones who will shield science from politics.


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