Food Safety Counterterrorism Initiatives




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So I agree, Mike, that that would be a great topic for discussion. I would like, I would suggest that if we do talk about that, we might expand it in the broader picture of the public health service, and maybe it would be appropriate to have somebody there from CDC, who is very actively engaged, I mean, they have people who are very heavily engaged in obesity as a problem.

We could have somebody from the Surgeon General's Office, we could have somebody from various Institutes of NIH, and if we want to explore how the FDA could be doing more in the context of the Department structure on obesity, that might be a fruitful discussion, as opposed to the brief discussion of saying that, in reality, the FDA is doing some, but not a huge amount. That's the status today.

DR. DOYLE: Does anyone else have any thoughts?

[No response.]

DR. LANGER: Thank you. Great. Okay. We'll get started then.

So the next topic is Pregnancy Labeling/Research & Study Design on Medications Used by Pregnant Women, and Susan Wood is going to lead that, and we'll also have Margaret Miller and Kathleen Uhl speak as well.

Susan?

DR. WOOD: Thank you. Go ahead and have Peggy come up, and when Kathleen Uhl gets here, we'll--

[Interruption to fix microphone.]

DR. WOOD: We'll slightly reorder the presentation today, but we want to talk to you about a number of the activities focused on pregnancy and medication use by pregnant women and what we do and don't know about it, and what we do and don't regulate about it.

So we're going to talk about a couple of different areas throughout the presentation. First, I'm going to briefly do an overview of the Office of Women's Health, and I think a number of you are familiar with this already, what we've been doing around clinical trials in women, and what the problem really is, in a nutshell, around addressing issues of pregnancy and medication use during pregnancy.

If Dr. Uhl is here, we will then move on to discuss revising the pregnancy labeling. If she's not, we'll save that part till the end and move into the research activities, which Dr. Miller will speak about, and then we'll talk to you about some of the issues that we have regarding pregnancy labeling, research, information about medication use and ask your input on where we, as an agency, we, as the Office of Women's Health, need to be going and what are some strategies that we can take on and adopt to try and tackle some of these complicated questions because we know these are both not trivial, and there are no simple answers as well.

The Office of Women's Health is part of the Office of the Commissioner, and we focus no a wide variety of activities in women's health, serving as a champion for women's health, both inside and outside the Agency.

Our activities range from funding a number of research products, including the specific area of pregnancy research, but others as well. We also have an outreach campaign this year focusing on diabetes in women and their families, and we also then get involved in regulatory and policy issues. Again, the pregnancy rule and regulatory activities is a prime example of that type of activity that we're involved in across the Agency involving multiple centers.

As you all know, the clinical trials approval process, we're asking questions about products being safe and effective. We ask for data on proper doses, and we want to know about adverse effects. I think when you take these questions and apply them to pregnant women, we often find that the information is lacking and does lead to questions about are we dosing pregnant women properly to effectively treat whatever the condition is and are we really getting information on adverse effects, both for the mother and for the infant.

In 1993, and continuing through to the present, we work under a guideline on studying gender differences in the clinical evaluation of drugs, and we encourage the participation of women in clinical trials, although it is not required, in terms of numbers per trial. We call for the collection and analysis of data looking for gender differences, and we recommend that there are methodologies that can be used to minimize risk of fetal exposure by eliminating pregnant women from studies through design of the studies at all phases.

But, in fact, that eliminating of pregnant women, although done for very clear and understandable reasons, leaves us with a problem. When we come to looking at pregnant women as patients, pregnant women with health conditions that do require treatment and that how, as more and more effective treatments come on the market, how do really treat, and advise, and label products for use during pregnancy when we know women are taking them?

The problem, as stated on the slide, is that pregnant women are healthy, and I think we know that chronic conditions, in particular, ranging from hypertension, asthma, epilepsy, diabetes, these all require treatment, and women who have these diseases get pregnant and pregnant women have these diseases. So we have to work on these conditions and recognize that medications are taken.

There's also a belief that pregnant women should avoid taking prescription drugs at all, even if they do have conditions that require it, or only use older medications with good safety profiles. That may be sort of where we are, as a reality of where we are, but there is also a reality that some of those older medications may not be as effective, and they may have more adverse events than newer products on the market, not necessarily the ones that have just come on the market yesterday, but ones that are several years old and we have experience with, as opposed to 20-year-old products.

But the fact is, as I mentioned earlier, many pregnant women do need prescription products to maintain their health and to maintain the pregnancy, but these products are not tested in pregnant women, and pregnant women are actively excluded from clinical trials.

What we're going to talk about today is not only the labeling information and what is and is not available and how useful is the information on a label regarding use during pregnancy, but how to go about ethically, safely, and usefully do studies on pregnant women who are taking medications to begin to get the information on the appropriate dosing and efficacy of these products during the various stages of pregnancy and postpartum.

That sort of is laying the groundwork of where we're going to talk about today to lay out this problem, and ultimately we want to ask you questions about how to prioritize our efforts, how do we encourage more research in industry and academia, because FDA is limited, and then what other strategies are out there to actually collect data and other information on drugs that are used by pregnant women.

We'll circle back around to those questions at the end of the presentation, but because of, again, the range of topics and the complexity of some of the questions, we're going to try to go through both the labeling issues in some of the research that we're doing.

And right on cue. So you didn't hear my introduction, Cook, but that's okay. She knows exactly what I said.

So, again, these are the issues for the Board that we're going to be looking at, prioritization, how do we facilitate research and what are some other approaches and strategies.

At this point, I will turn it over to Dr. Cook Uhl, who is a medical officer at CDER. What's the official title?

DR. UHL: Pregnancy Labeling Task Force.

DR. WOOD: Pregnancy Labeling Task Force.

DR. UHL: Thanks, Susan.

Good afternoon. Thank you for the opportunity to speak. What I'm going to do is go through kind of where we are now with the Agency with respect to labeling for pregnancy and lactation, where we are, why we're there, and what we're trying to do. I have about five slides with which to tell you that.

So, currently, in the CFR, the regulations addressed pregnancy labeling in 1979. Prior to that, there was nothing that was required in labeling about pregnancy. The intent of that legislation or that regulation was to assist health care providers when prescribing for women who are already pregnant.

It does not address anything regarding inadvertent exposures. What do we mean by inadvertent exposures? We mean a woman who is pregnant, doesn't know that she's pregnant and is taking a medication and then finds out that she is pregnant.

Why is that a concern? In the United States, 50 percent of the pregnancies are unexpected. That means they're either mistimed or unwanted. As far as numbers go, there are 6 million pregnancies in the U.S. per year and women of reproductive ages of 15 go 45, 10 percent of those women in the United States become pregnant annually. So it's a pretty significant problem about unexpected exposures or unintended exposures in pregnancy.

The current category system focuses specifically on teratogenic risk, and it uses letter categories. I'm briefly going to walk you through what the current pregnancy letter categories are.

The categories are A, B, C, D, and X. A is when there are controlled clinical studies in humans, and A is used very rarely. There are about five products of which currently have a Category A.

Pregnancy Category is B is when the human data are reassuring, but there have been positive findings in animals or the animal studies show that there's no risk.

Pregnancy Category C is a conglomeration, basically, and the majority of our products are labeled as Category C. More than two-thirds of our products are Pregnancy Category C. A Pregnancy Category C can come about when there are no human data, there are no animal studies or the animal studies show some findings. Animal studies are positive.

Pregnancy Category D is when human data show risk, and there's a concern here about benefit outweighing the risk. For example, some of the products that are used for seizure disorder, some of the anticonvulsant medications, where a woman has to be taking this medication for controls of her seizures. However, we know there's a teratogenic risk. Some of those compounds are labeled as D.

Now X is when there are either positive animal or positive human. Another interpretation of X, though, is that these products are contraindicated for use in pregnancy or these are drugs that should not be used during pregnancy.

Now let me give you an example of that. Oral contraceptive products. Oral contraceptive products are obviously not intended for use during pregnancy. They are intended to take to prevent pregnancy. Because they are not intended for use in pregnancy, they have been given a Pregnancy Category X designation.

So, needless to say, there are limitations in our current system. The current pregnancy categories are overly simplistic. The A, B, C, D, X is oftentimes felt to represent a linear continuum of risk, meaning A is better than B, B is better than C, C is better than D, and so on.

From a clinical standpoint, this type of labeling is not very helpful, and it's not very informative. The categories combine different levels of risk assessment. For example, that's the Category C. You could have a Category C because the animal data are positive or because there are no human data.

The current system also combines risk information with benefit, and that's specifically seen in the D and the X. Currently, most of the products have only animal data, and by nature of the way that the studies in animals are done, the findings in animals are commonly positive, and with that a lot of the products then are Pregnancy Category C.

At the current time, there is no requirement or incentive to update these labels with human experience. From the pharmaceuticals standpoint, as well as from the medical-legal standpoint, oftentimes, warnings in labeling are perceived as optimal. It's felt that it's better to just warn don't take these if you're pregnant. Unfortunately, because of that, it's very rare that these labels will be updated with human experience.

Now, despite that or probably because of that, there are changes coming to the Agency. There are changes coming to the current pregnancy labeling, and that's predominantly what my job is. That's what I work on, but what we are working on, there we go, is to have a label that provides clinically useful information and information that's useful to the patient, as well as the physician or other health care provider when making a decision about prescribing drugs in pregnancy or prescribing decisions that had been made prior to pregnancy and pregnancy has occurred.

So what we're in the process of doing is working on revising the regulations. Now the current physician labeling rule addresses pregnancy and lactation as a special population. However, that portion of the labeling rule does not provide the information that should go into that. So we view this as a regulation that just provides the content and format for pregnancy labeling.

What this does, first and foremost, is to get rid of the pregnancy category designation. The intent is to separate out information about risk from information about benefit, and this will use a standardized descriptive text that characterizes risk, has built-in flexibility, but it is not a simple letter categorization.

In addition, this will separate out animal data from human data and risk that's ascertained based on animal or human.

Also, the labeling will distinguish what says here is clinical advice, but actually considerations that should be given in the clinical setting for prescribing in pregnancy or for discussions of inadvertent exposures, and it will separate out that type of information from fetal risk information.

In addition, the label will address the inadvertent exposure, and it will address--it will address it by providing information about dose, duration of exposure or the gestational timing of exposure for which you would be most concerned for fetal risk.

Because there are numerous physiologic changes that occur in pregnancy, the point has been raised about whether the dose that's provided in labeling for an otherwise healthy male is an appropriate dose to give to pregnant women. So information about optimal dosing will be provided, and this will include whether there are any pharmacokinetic or pharmacodynamic changes that occur during pregnancy; in addition, any information about unique maternal adverse events.

Lastly, because the risk information requires looking at all data that are available, there will be a requirement to update the label and to provide clinically relevant information in the label.

With that said, Dr. Margaret Miller, from the Office of Women's Health, will now address some other issues.

DR. MILLER: So as Kathleen said, as we were working through this reformatting exercise, it became clear that having good information to put in the label was going to be critical to improving the health of pregnant women and to helping prescribers make accurate prescribing decisions for the pregnant women.

So what I'd like to do now is talk about some of our efforts that we've been engaged in over the last two years to try and improve the content of information that would go into a label, and in embarking on a discussion about research and pregnant women, I think it's important to mention the ethical concerns and the ethical rules that we have to comply with.

The basic regulations for conducting research in human subjects for federally funded research are contained in 45 CFR Part 46. They are subpart (a), which are the regulations that cover protections for all human subjects. And when you're doing research on pregnant women, you also have to comply with what's known as subpart (b) of those regulations.
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