Pharmalot: How political was the decision in this your view? Zuckerman: I should qualify my remarks by saying that I haven’t seen the actual research, but my understanding of the data was that the vast majority of the girls were able to follow directions appropriately… but I don’t know the ages (of the girls who had problems understanding the directions) and I don’t know what the definition was for appropriately. So it’s possible there’s something in the data that’s particularly problematic, but I don’t know.
But assuming the data showing girls have the ability to follow directions is comparable to an adult’s ability to follow medication directions – we all know that not all adults can follow directions – then the scientific decision would have to be based on a scientific fact. And you’d have to conclude this was a political decision going into a tough election year. The FDA commissioner is supposed to make decisions on the real and appropriate reading of the science and apparently did so. And Secretary Sebelius, either on her own or at the direction of White House, decided to revoke for political reasons.
Pharmalot: And what’s your take on the politics and the precedent? Zuckerman: Anything that could be called abortion - even though Plan B is not an abortion pill – and anytime you deal with anything to do with abortion, it becomes a hot potato politically. I don’t think that's going to be likely with other products, so I am not so concerned about the precedent. The other side of the story was an FDA advisory panel meeting on (the safety of) Yaz and other birth control pills (back story) which, in my opinion, showed the opposite kind of bias about not caring what the science showed (the panel voted that more risk info is needed)… The reversal is unprecedented and that’s always dangerous where you have a situation where a secretary overrules. The truth is that should never happen and it’s probably not the first time (it as happened). It’s more likely that this is only the first time (a Secretary's overruling) has been made public.
Pharmalot: What will this mean for girls? Zuckerman: Any reasonable person could say it makes me nervous to think of 11- and 12- year olds taking Plan B without a doctor’s supervision and a prescription. It’s understandable that a lot of people would feel uncomfortable. But then again, I think a lot of people would be uncomfortable with girls that age having unprotected sex and getting pregnant. Hopefully, not a lot (of girls that young) are having unprotected sex. Nobody wants those girls to get pregnant and it’s dangerous for them to get pregnant – more so than for 17-or 18-year olds – and some (young girls) will be victims of rape by family members. We should be particularly concerned that the most vulnerable young girls who need this the most will be unable to get it, and that’s the tragedy.
My guess is there‘ll be some kind of black market if there isn’t already, so teenagers can get it if they need it - People who get it will sell it to somebody else. It’s likely to happen even more now because of all of the attention. Had this decision gone the way the FDA initially planned it, or how they determined how it should go, we would have much easier access and I would certainly rather young girls buy this over the counter at the local drugstore the way they sell condoms, than having them buy it from somebody else who may be selling a product that’s counterfeit or out of date or left in a car when it was 105 degrees in the summer.
Pharmalot: What did you make of the reasoning the FDA gave for ultimately rejecting greater access to Plan B in response to the Citizen’s Petition from Family Planning and Health Organizations? They explained the data were for Plan B One-Step, but the application was for access to regular Plan B, which has a different dosing regimen. Zuckerman: It’s important to distinguish between the decision that Dr. Hamburg made regarding Teva’s application for OTC sales of Plan B One-Step, which Secretary Sebelius overturned, vs. the FDA decision regarding the Citizen’s Petition for OTC access for regular Plan B. FDA’s decision regarding Plan B One-Step was based on the data that Teva provided on the ability of girls under 17 to understand how to appropriately and safely use Plan B One-Step. Commissioner Hamburg determined that the data indicated that Plan B One-Step could be safely used by girls under 17 without a “learned intermediary” (a prescription), but Secretary Sebelius overturned that decision.
The Citizen’s Petition is a different matter, because in that case the 60 women’s health groups asked the FDA to allow OTC access to regular Plan B, but they based that petition on the same data that Teva provided, which was on Plan B One-Step. Woodcock’s letter explained that the FDA would not grant the petition because the data did not support the use of regular Plan B by girls, but rather supported the use of Plan B One-Step. Although the 2 Plan B products have the same ingredients, the One-Step provides the total amount in one dose, while the regular Plan B requires two different doses 12 hours apart.
I don’t think it is unreasonable to deny approval of any product on the basis of data for another, albeit very similar product. But Dr. Woodcock’s letter is somewhat disingenuous. I say that because, presumably, even if the Citizen’s petition had provided research evidence of safe use for the exact same version of Plan B, it would have been rejected anyway because of Secretary Sebelius’ decision. So the distinction made in the letter is, in my opinion, a valid research concern but the Petition would have been denied anyway. You might wonder why the Petition asked for OTC for regular Plan B when they did not have the data to support the use of regular Plan B. The reason is that the FDA was responding this month to a very old petition that was submitted years ago, before Plan B One-Step was available.
Pharmalot: How concerned are you that FDA decision making will now be open to second guessing? Zuckerman: Look, I don’t think anybody wins in this. I think Commissioner Hamburg made a decision based on science. Janet Woodcock (who heads the FDA Center for Drug Evaluation & Research) offered a reasonable explanation for why the Citizen’s Petition was rejected, but because of Secretary Sebelius’ decision, some believe that Dr. Woodcock made a political decision, which is what she was accused of several years ago regarding Plan B. I think that CDER’s decision regarding the Citizen’s Petition, juxtaposed with the FDA’s meeting on Yaz in the same week – which seemed biased in favor of Bayer -- is a very good illustration of why there’s controversy about CDER and Dr. Woodcock among public health and women’s health advocates. Whether CDER decisions are influenced by politics or industry, they don’t seem to be as rooted in science as we want from the FDA.
photo thx to Terry Popkin