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Plan B Will Stay Behind the Counter

Tuesday, December 13th, 2011
It appears efforts to make the emergency contraceptive pill Plan B One-Step available over the counter have been stopped. But if you think these recent developments ended the debate over this controversy you should reconsider you position. Something tells me this isn’t the end of this story!

So what exactly happened anyway? Well, recently the FDA was moving to make the emergency contraceptive pill Plan B One-Step available over the counter with no age restrictions, according to this Fox News story from the Associated Press. The expected transition of Plan B to over the counter status was suddenly halted at the last moment by Health and Human Services (HHS) Secretary Kathleen Sebelius. She effectively over-rode the FDA panel’s decision. The result is that for now, the morning after pill Plan B will remain as a behind-the-counter product sold only to customers at least 17 years old who have proof of age through proper identification.

The decision was a rare reversal of the FDA’s expert panel that took Teva, the manufacturer of Plan B, by surprise. Teva had been gearing up for the product’s conversion to over the counter status. According to CBS News 12, the drug manufacturer had released data from a study it funded showing a vast majority of women between the ages of 11-17 years old could correctly and safely use Plan B without professional supervision. Secretary Sebelius argued that the drug company didn’t sufficiently prove that younger female patients fully understood how to properly use the medication.

This resulted in an unusual situation where the FDA’s experts carefully reviewed a proposal and ruled one way, only to have the HHS Secretary overrule their decision. Typically the government will trust and accept the FDA panel’s decision, even though they are not obligated to do so. The whole debate resulted in no change to the current behind the counter status of Plan B.

So what can we expect now? I would assume a continued fight over Plan B is inevitable. And don’t be surprised if politics, not science, leads this debate forward. There have already been accusations that the FDA’s current placement of Plan B as a behind the counter product with restrictions was driven by political pressure instead of science. So what really did happen here? Did politics win out over science or was this the right decision?

Let’s look at the traditional decision making process for making a drug OTC vs. prescription only. Usually, the FDA has an expert panel that reviews all available data and then makes a final determination based on safety and public health considerations. Factors like monitoring considerations, the public’s ability to properly use a drug, and safety are all taken into consideration. Then a final decision is made, ideally without political pressure getting involved in the process.

But then there is the case of Plan B. Its status in the United States was as much a political decision as it was a public health consideration. While you’d like to leave these decisions purely to science, the inevitable influence from politics, religion, and people’s personal beliefs complicates this issue tremendously. I can’t think of another medication in history that has generated so much political and personal debate other than Plan B. And that all plays into the decision to make this medication over the counter whether that is fair or not.

The problem I have with this issue is that I see the valid points to both sides of this argument. On the one hand, women should have access to a drug that can safely and effectively prevent a pregnancy. And we do have a teen pregnancy crisis in America. But on the other hand, is the general public really able to handle buying a product like Plan B off the shelf and using it properly and for its intended use? It is a classic safety vs. accessibility debate that makes the Plan B status decision a difficult one.

I do have a couple of concerns with simply putting Plan B over the counter with no sales restrictions. First, the age issue that was a main factor behind HHS Secretary Sebelius’ decision to block its OTC conversion. Giving women as young as 11 years old access to this medication without professional supervision or counseling just sounds like a mistake to me. I’d also assume that parents would want to be involved in an 11-year-old’s decision to purchase this type of medication.

Secondly, even now with its behind-the-counter status, Plan B is used as a regular and consistent form of birth control by an alarming number of females. This was not the intended use of Plan B and it shouldn’t be used as a regular means of birth control. I’d worry that more and more women would follow this trend if the drug became available over the counter. I could be wrong here, but I could see many women just using this medication all the time instead of getting a prescription for traditional birth control pills.

Personally, I’ve always argued for removing political influences out of the decision making process and evaluating these sorts of issues on the basis of science, public health and safety, and evidence based medicine. But I recognize that because of the nature of a drug like Plan B, this idealistic focus on science just isn’t possible.

I’d feel a little uncomfortable giving everyone access to Plan B One-Step without any counseling or age restrictions involved. But many, including the drug’s manufacturer, would argue that Plan B would be perfectly safe sold over the counter. So the question remains: did HHS Secretary Sebelius make the right decision here? Do you agree with keeping Plan B One-Step behind the counter? Can women as young as 11 years old handle the responsibility of taking this product correctly and as intended? What do you think?
Blog Info
Blog Description
The Redheaded Pharmacist is a popular blog about pharmacy written from the perspective of a retail pharmacist about his experiences "being a very small part of the huge United States healthcare system."
Author Bio
Through his blog, which he began writing in December of 2009, the Redheaded Pharmacist relates his thoughts, opinions, and stories on the issues that impact the world of pharmacy, from current events and legislative developments to patient safety efforts and the demands placed on pharmacists. Feedback from readers is welcome. He can be found on Twitter at http://twitter.com/Redheadedpharm.
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