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FDA Avandia news conference: 2010 rosiglitazone restrictions

Transcript of 9-23-2010 FDA Avandia news conference / media briefing / Q&A

Moderator: Karen Riley

September 23, 2010

11:30 am EDT


Coordinator: Welcome and thank you for standing by, at this time all participants are in a listen only mode. During the question and answer session please press star 1 on your touchtone phone.


Today’s conference is being recorded, if you have any objections you may disconnect at this time. Now turning the meeting over to Ms. Karen Riley, ma’am, you may begin.


Karen Riley: Thank you very much and welcome to today’s media briefing. My name is Karen Riley in FDAs office of Public Affairs. This is an FDA teleconference for credentialed media only to announce FDA’s decision on Avandia.


With me here to discuss this topic, our FDA Commissioner Margaret Hamburg, FDA Principal Deputy Commissioner Joshua Sharfstein and Janet Woodcock, Director of the Center for Drug Evaluation and Research at FDA.


After the speakers make brief remarks, we will move to the question and answer segment. Reporters will be in a listen only mode until we open the call up for questions.


Now before we get started, you should know that we have a wealth of information we’ve just posted on the Internet, a press release, a question and answer document and CDER’s extensive supporting documents on this issue.


And you’ll find that if you just go to the FDA homepage, it’s available there. So without further ado, I will now turn the call over to Dr. Hamburg.


Dr. Margaret Hamburg: Thank you very much and good morning, we are very glad that you can join us. Today, because of concerns about cardiovascular safety, FDA is announcing regulatory action on medications containing rosiglitazone.


FDA is significantly restricting the use of these products by requiring the drug sponsor to submit a Risk Evaluation and Mitigation Strategy or REMS. Under the Food and Drug Administration Amendments Act of 2007, FDA can require a drug sponsor to issue a REMS to impose certain restrictions so that the benefit of the drug can continue to outweigh its risks.


Under the REMS for rosiglitazone, the drug will be available to patients not already taking it only if they are unable to achieve glycemic control on other medications and, in consultation with their health care professional, decide not to take pioglitazone for medical reasons. Pioglitazone is the other drug in this class of diabetes medications.


Current users of rosiglitazone will be able to continue using the medication if they appear to be benefiting from it and they acknowledge that they understand these risks. Doctors will have to attest to and document their patients’ eligibility.


Patients will have to review statements describing the cardiovascular safety concerns. The agency anticipates that the REMS will limit use of rosiglitazone significantly. FDA’s taking this action after careful consideration of the risks and benefits of rosiglitazone.


Today FDA is also directing the Avandia (or rosiglitazone) sponsor, Glaxo Smith Kline, to conduct an independent review of the results of its large scale clinical trial of Avandia called RECORD. We believe this review may provide additional clarity about this trial and the safety of rosiglitazone.


FDA is also stopping the trial known as TIDE, a comparison study between Avandia and Actos. FDA reached the conclusion that this study does not meet the criteria recommended by an Institute of Medicine committee for safety studies at this time.


Before we take questions, I want to turn to Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research to explain to you in greater detail the scientific basis for all the decisions we’re announcing today.


And I then want to comment on the decision today by the European Medicines Agency or EMA to suspend marketing of Avandia. I’ll point out that both the FDA and the EMA have evaluated the same evidence and reached similar conclusions about this evidence.


Our different approaches in part reflect differences in the tools that we have available to manage the risks and benefits of medications. And then I want to ask Dr. Sharfstein, the Principal Deputy Commissioner, to discuss what this decision means for health care professionals and their patients, Dr. Woodcock?


Dr. Janet Woodcock: Thank you, well there were concerns raised in 2006 and 2007 about rosiglitazone from some meta-analyses — a set of meta-analyses showing an increase in myocardial ischemia and trends in increased cardiovascular death or all cause death.


There were – meta-analyses were — from trials that were pulled together, that were efficacy trials of rosiglitazone comparing the drug to standard diabetic drugs or placebo.


Subsequent to that time, there were some observational studies published that made the same comparison and did not really find any consistent findings on myocardial ischemia or death.


Also around the same time the RECORD study was ongoing. The RECORD study is – was — a study comparing rosiglitazone to two standard anti-diabetic drugs, sulfonylurea or metformin.


And it was a very large cardiovascular safety study, in other words, directed at the very question that was raised in the meta- analysis. Are there (excess) cardiovascular events in rosiglitazone or in the other arm?


And this study went on for five years, in RECORD as published did not show any overall cardiovascular finding although it did not have enough myocardial infarction events to rule out an increase in myocardial infarction.


In 2010, recently, FDA did another meta-analysis incorporating additional studies that continued to show a signal for – particularly for — myocardial ischemia. All this was discussed then at our advisory committee (in July 2010).


At the advisory committee that we had recently, RECORD was presented, the RECORD trial and there were questions raised about RECORD’s results because it was open label and because of some features of the study design, it was determined that we cannot at this time rely on these results, which as I said did not show an overall cardiovascular finding.


Therefore the question originally raised by the meta-analysis has really not been answered. In addition there have been several studies done of the other drug in the TZD class, pioglitazone.


And these studies have not shown a (signal) of cardiovascular harm. These have included some large observational studies that compare rosiglitazone to pioglitazone and there was no evidence that pioglitazone had any excess cardiovascular problem in those studies.


Now within and outside the agency, there’s – most agreement on the fact all these scientific data and evidence but not on the weight of the evidence and how to weigh the evidence from meta-analyses, observational studies and randomized trials.


And this has resulted in different conclusions by the experts both within FDA and outside the FDA, not only our advisory committee but other external experts. And this reflects the level of uncertainty in the science that is – whether it’s able to tell us whether or not rosiglitazone actually causes these problems.


Therefore as a matter of prudence, we are restricting access. We are not withdrawing the drug at this time because there is considerable uncertainty about this signal and whether or not it is valid.


We are also though not instituting a label change (Note: clarifies she means only a label change later), which other experts have recommended, because we know that label changes are often not read. This signal of cardiovascular risk has not been refuted by any evidence that we have.


And so we think it is most prudent to restrict access, make sure that doctors and patients using this medication or prescribing the medication are very aware of the fact and make that overt choice to continue on this medication for example.


For the same reason we are halting the TIDE trial at this time. In this REMS situation, prescribers and patients will have full knowledge of the risk data. And thus will be able to make an individual decision on whether to continue on rosiglitazone or to take other medication.


We hope that the re-adjudication of the RECORD study will add more scientific information and help inform us after that is completed. Dr. Hamburg?


Dr. Margaret Hamburg: Thank you let me take a moment now to comment on the action today by the European Medicines Agency to suspend marketing rosiglitazone products. FDA and EMA have conducted their own independent reviews of the science.


While we have done so, we have coordinated throughout the evaluation of the data. We’ve shared information, observed each other’s scientific advisory meetings and had technical discussions.


One difference is that FDA conducts analyses on the raw data and EMA does not. EMA and FDA knew in advance what regulatory decision the other agency was going to take today and had discussed their decision with each other.


While each agency operated on its own in making the decision, they were not made in isolation. In our view and in the view of the EMA, there is substantial alignment between the agencies on the interpretation of the scientific data and the assessment of the risk to the public health.


The difference in our regulatory action reflects differences in how each agency is managing the risk based on the regulatory tools available at its disposal. EMA is suspending the marketing authorizations but not revoking approval.


As new data becomes available, EMA may reconsider. FDA is substantially limiting access to rosiglitazone through the use of a Risk Evaluation and Mitigation Strategy. This is not a tool that the EMA utilizes for a case like this.


The actions announced today underscore the FDA’s commitment to robust scientific debate, transparency in our decision making process and our dedication to continually monitor the relative risks and benefits of all drugs for as long as they remain on the market.


The evaluation of the risks and benefits of Avandia have sparked equally passionate discussion both inside the agency and throughout the community of scientists and clinicians who look to FDA to make well-reasoned, science-based decisions on drug safety.


As FDA commissioner, my job would be infinitely easier if we had consensus and full scientific clarity on this issue. In this case, we have an evolving view of the scientific evidence and the responsibility to continue to assess current decisions and the risk-benefit balance as we gain greater clarity.


We also have a commitment to use all the tools available to us to support clinical care. So at this time I’d like to ask Dr. Sharfstein to discuss what FDA’s decision means for doctors and patients.


Dr. Joshua Sharfstein: Thank you, I’m first going to talk about the situation for patients currently taking rosiglitazone and their health care professionals. If you’re a patient currently taking rosiglitazone, you should continue taking your medication and consult your health care professional.


Your doctor or other health care professional and you may choose to select an alternative medicine without the concern for cardiovascular ischemia. It is very important that patients with type 2 diabetes continue to control their blood sugar.


The rosiglitazone REMS does not take immediate effect at the time of this announcement, rather it will take several months to put the REMS into place. Once this REMS program is in place, current users of rosiglitazone will only be able to continue using the medication if they acknowledge and document that they understand the risks associated with the drug.


FDA believes it is important for patients to fully understand the risks and benefits associated with their medication. And we will be providing further information on the specifics of the REMS program in the coming couple of months.


For health care professionals who have patients currently taking rosiglitazone, FDA’s decision allows your patients to continue using this medication if they appear to be benefiting from it and they acknowledge they understand these risks.


However because of concerns for cardiovascular ischemia, physicians and other health care professionals may want to consider switching patients to a different medication. The rosiglitazone REMS will not immediately take effect at the time of this announcement.


It will take several months to put into place. Once it is in place, physicians will need to enroll their patients into the REMS in order for them to continue receiving rosiglitazone. Now let me turn to patients who are not at this time receiving one of the rosiglitazone products.


If you have type 2 diabetes, you should discuss the appropriate treatment with your health care professional. Once the REMS for rosiglitazone is in place, only patients who cannot achieve control of their blood sugar on other medicines and who decide not to take the alternative medication pioglitazone for medical reasons will be eligible for rosiglitazone.


And for their health care professionals, health care professionals will have to attest to and document their patient’s eligibility once the REMS is in place if they believe that their patient is a candidate for rosiglitazone.


And as part of that process, patients will have to review statements describing the cardiovascular safety concerns with rosiglitazone to assure that they understand the REMS.


Karen Riley: Okay and this concludes our opening statements. At this time ladies and gentlemen, we will begin the question and answer portion of the briefing. When asking a question, please state your name and affiliation. Also we’re asking that you please limit yourself to one question and one follow up.


We’ve got a lot of people on the line and we want to get to as many questions as we can. So operator, we’ll take that first question.


Coordinator: Our first question comes from Meredith Wadman from “Nature,” your line is open.


Meredith Wadman: Good morning, can you tell me in your view are European type 2 diabetics going to be safer once these regulations come into effect than American type 2 diabetics?


Dr. Margaret Hamburg: You know, I believe that, you know, we are taking somewhat different strategies and both strategies are designed to try to ensure the goals of safety. We heard very clearly from both providers and patients that some patients felt that they were unable to tolerate other diabetes medications and that this drug was effective for them.


We believe that this more limited use approach will enable both health care providers and their patients to be fully informed about the data and the concerns about increased cardiovascular risk, make informed decisions if they wish to remain on the rosiglitazone medical product.


Meredith Wadman: My follow up is you mentioned something about patients needing under the REMS to sign something saying they fully acknowledge the risks, does that take away their right to sue if there is an untoward event?


Dr. Margaret Hamburg: You know, the REMS is being developed at the present time, the specifics but I don’t believe that that is an issue in terms of the REMS itself.


Dr. Joshua Sharfstein: Yes, I would just say – this is Dr. Sharfstein that the reason for that is so that people when they – if they choose to go on the medication are fully informed. There’s a, you know, a good policy reason to have that and I don’t think we can comment on any implications like that. I don’t think we have a single lawyer in the room.


Dr. Janet Woodcock: Well, I – this is Janet Woodcock, the signing of this – receiving risk information is not exculpatory. Right now the patients receive a Medication Guide for this product, which has this – has information about cardiovascular risk in it as well.


And obviously drug labels have various risk information in them. So this is not intended to have anything to do with medical liability, the intent of this as Dr. Sharfstein said is to make sure that people are making informed choices. If they want to choose to make this drug, that they have received important information about the drug.


Karen Riley: Okay, thank you, next question please, operator.


Coordinator: Our next question comes from Susan Heavey from Reuters, your line is open.


Susan Heavey: Hi, thank you. So when you were trying to make your final decision here, what was it that precluded you from actually taking the drug off the market? I mean why did you decide that that was not the choice that you needed to make here?


Dr. Janet Woodcock: This is Janet Woodcock. We still feel that there is considerable uncertainty about whether or not this – the magnitude and the existence of this cardiovascular risk.


And we feel the next step should be to while prudently restricting the drug to limit any risk, to re-adjudicate the RECORD study, which directly addresses this risk.


Susan Heavey: And then just for my follow up, when you’re talking about making sure these patients if they aren’t taking it now, if they’re eligible, how are you actually going to enforce all of those provisions. It seems like there’s a lot of patients out there, how’s the FDA going to keep track?


Dr. Janet Woodcock: This is a requirement – this is Janet Woodcock again, a requirement that would be put on the sponsor. We have this, we do this for other products. And we – there are methods by which, you know, basically patients have to be enrolled in these programs to get the drug.


So there is a process that has to go through that a prescriber would have to go through to enroll a patient. And then there is a restriction on dispensing at the pharmacy. So pharmacists do not dispense these drugs that are under this type of a REMS unless there is verification that the patient has been enrolled in the program.


And then under the Amendments Act, sponsors now have to evaluate the success of their program. How well is it restricting and all sorts of things like that. So it’s quite a tight – there’s quite a tight control over who gets the drug and making sure that these steps are followed.


Karen Riley: Thank you, next question please.


Coordinator: Our next question comes from Alicia Mundy from the Wall Street Journal.


Alicia Mundy: Hi. Thank you for taking my question. These are fairly significant restrictions. And certainly it seems that doctors who have already complained about all of the paperwork they do are probably going to really think twice about having to do this.


My question is how often have you put out restrictions like this on other widely used drugs and have you had any concerns expressed by the company that the way these restrictions are worded that very few doctors might risk actually continuing to prescribe this?


Dr. Janet Woodcock: This is Janet Woodcock, again. We have experience with various drugs. Many of them that are under restrictive REMS do not have huge markets. And we believe this action will considerably limit the number of people who are on this drug because partly because of what you alluded to that there are extra steps.


This means people will have to think twice before they continue patients on rosiglitazone or initiate a new patient on rosiglitazone. So there will be restrictions and that will be in effect and they will limit the number of people who would be taking this drug.


Alicia Mundy: Has the company expressed any concerns about that?


Dr. Janet Woodcock: These are the conditions upon which we have put for marketing rosiglitazone in the United States.


Alicia Mundy: Okay, thank you doctor.


Karen Riley: Thank you, next question please.


Coordinator: Our next question comes from Matt Perrone from the Associated Press. Your line is open.


Matt Perrone: Hi, thanks guys for taking our questions. So just going back to Dr. Woodcock’s comments at the top, nothing is changing on the labeling. So there’s no new information that the FDA has about the actual cardiovascular risk profile here.


Dr. Joshua Sharfstein: No, no. This is Josh. Let me, I think I understand why you maybe as part of the confusion. What Dr. Woodcock was saying there is we are not solely changing the label.


But in fact, the label will change and along with the label change will be the restricted access program. Janet, I don’t know if you want to add anything to that.


Dr. Janet Woodcock: Yes, that’s correct. All of these will have to be worked as part of the REMS program and we typically do that as part of the program. So yes, I’m sorry if I confused anyone.


Some individuals advocated for only label changes without this – these restrictions and that is not the course we are taking. But with the restrictions, there will be additional label changes that will be done.


Matt Perrone: And how is the description of the risk, how is it going to change from 2007? Do we know more is this a more real risk? Is it more certain?


Dr. Janet Woodcock: Again, I – This is Janet Woodcock again. I believe that various experts both inside and outside the agency weigh the evidence differently and come to different conclusions about this risk. We will have to – we will work out what will be said in the label as part of the REMS program.


Dr. Margaret Hamburg: But obviously, we are taking this action today to further restrict the use of these products because additional data that emerged in the time since the last action and the last advisory committee. And the information and data and studies that were discussed at the most recent July 2010 advisory committee increased our level of concern.


You know, you may recall from the advisory committee discussions, deliberations and recommendations, that 18 members of the advisory committee found significant concerns for an increase in ischemic cardiovascular events for rosiglitazone relative to the other diabetes medications not in that class compared to six who did not.


Twenty-one members felt that the cardiovascular safety concerns for rosiglitazone was significant compared to the other drug in the class pioglitazone.


Three members did not reach that conclusion. So there was a 21 to 3 vote that reflected recognition that available evidence on pioglitazone including a well designed trial on high risk (individuals) doesn’t show a signal for cardiovascular ischemic risks.


So taking all of that into consideration, in terms of the relative risk balance of the use of one drug or another, it did lead us to this course of, you know, really strongly suggesting that health care providers and their patients be fully informed of the increased concern in cardiovascular risk with the rosiglitazone product as compared to the use of the other product in its class.


Karen Riley: Thank you, next question please.


Coordinator: Our next question comes from Richard Knox with the National Public Radio. Your line is open.


Richard Knox: Yes, thanks and I appreciate the chance to ask. On the review of RECORD that FDA is mandating, can you clarify who you’re asking to do that? Will it be GlaxoSmithKline, will it be the FDA, who chooses the members? And also is FDA reserving the possibility of lifting the REMS restrictions based upon the outcome of that review?


Dr. Janet Woodcock: The review – this is Janet Woodcock. We will ask the company to commission an independent review. And we’ll look, we will look at what they’re doing and make sure it meets our criteria for an independent review all right.


And that review, we call it re-adjudication, will occur at the patient record level because there is concern – the main concern is about referring to events to the adjudication committee. Since that’s what – that’s how that – and then we would review the results ourselves of the re-adjudication effort after we’re done.


We can’t really comment on what will happen in the future. What we are going – the next step here is we’re restricting rosiglitazone as has been described and we are having RECORD re-adjudicated. And some time we will have more information, we will certainly make that publicly available.


Karen Riley: Thank you, next question please.


Coordinator: Our next question comes from Steve Usdin from BioCentury. Your line is open.


Karen Riley: Did we lose you Steve? Let’s see if Steve can get back on the line. Can we take the next-


Steve Usdin: I’m back. I’m sorry I hit the wrong button. Some of my questions might have been partially answered, but there’s two things. One is you say that there’s new CV data that’s going to be presented to physicians and to patients.


Exactly – and at the same time Dr. Woodcock says there’s a lot of disagreement about that data, so exactly what will they be told? And then the follow up question is since you’ve decided not to continue with the TIDE trial, how will you ever actually get more definitive answers (doesn’t that preclude) actually ever really finding out what’s happening?


Dr. Janet Woodcock: This is Janet Woodcock. Think what we have now is we have a situation where we have data from particularly from meta-analyses that raised a cloud of concern over the drug.


We do not have any data that is randomize trial data that addresses that one way or another. And we expect to, we hope that re-adjudication of the RECORD will help us address that one way or another.


In the meantime, though the data suggested by the meta-analysis do not meet the safety standard that we’ve set forth in our guidance for marketed diabetes drugs.


And so we are taking this restriction and we will explain the information that we have available on cardiovascular safety to patients and of course, to the medical community.


Steve Usdin: So is it – to sum that up then, you’re saying you’re making the decision based on the meta-analysis, but your saying that meta-analysis is solid enough to make regulatory decision?


Dr. Janet Woodcock: We’re saying that we have a standard of demonstration of cardiovascular safety, all right, that exists in our guidance. And we have a signal from a meta-analysis and we have no trials that demonstrate that this drug, rosiglitazone achieves this standard of safety.


Karen Riley: Thank you.


Steve Usdin: I’m sorry. About TIDE, if, you know, without having TIDE if you the results from RECORD are equivocal does that mean you’ll really never know?


Dr. Janet Woodcock: TIDE addresses a different question of – addresses a comparative question of rosiglitazone vs. pioglitazone and so we’re focusing right now is what can the RECORDs study show us about the cardiovascular safety of rosiglitazone directly relevant to the signal seen in the meta-analysis which was rosiglitazone vs. placebo or background anti-diabetic drug.


Karen Riley: Thank you. And let’s take the next question and let me remind reporters that you can ask one question and one follow-up question. Okay, operator, next question.


Coordinator: Next question comes from Rita Rubin from USA Today. Your line is open.


Rita Rubin: Hi, thanks for taking my question. I wonder if you could please clarify the time frame here because it sounds like there’re going to be no changes at least for I think Dr. Sharfstein mentioned several months.


I don’t know, are we talking not until the first quarter of next year? You know, what’s the timeframe here and so basically it does sound like for a few months there’s going to be no change.


Dr. Janet Woodcock: Well, this is Janet Woodcock. Rita, we are making this announcement today and I think this will be broadly available to the medical community and prescribers and patients will realize.


And we’ll have a lot of information out there about what we recommend that they do. And right now we’re saying that we believe patients should talk to their prescribers and make a decision now.


I mean if there’s going to be a decision for them to transition to other anti-diabetic therapies. However, for those who – the REMS itself will take some time to put into place. That’s just the nature of these things.


So this is giving folks, I think, time to say I’m going to transition to another therapy or if they really wish to remain on rosiglitazone then they are prepared when the REMS comes – when it’s put into place.


Rita Rubin: And so, there will be no label changes until that time?


Dr. Janet Woodcock: This will all happen at once.


Rita Rubin: And are we – when several – I mean is that two months, three months, do you know?


Dr. Janet Woodcock: We will do this as rapidly as we can given the logistics that is required.


Dr. Joshua Sharfstein: It’s a logistical question. Let me also say that not only are we doing this press call and making a lot of information available, but we are also hoping to be relatively soon publishing an explanation of the decision in leading medical journals.


So our goal is really to educate the medical professionals as much as possible starting now as, you know, the logistics work themselves out on their own.


Karen Riley: Thank you, next question please.


Coordinator: Next question comes from Sherisse Pham from ABC. Your line is open.


Sherisse Pham: Hi, my question is for to that was voiced by “USA Today” about the timeframe. Are you guys specific for the acknowledgement are they being drafted right now, everything is going to come out at once?


Dr. Janet Woodcock: You know, as was indicated, we want to move forward, you know, swiftly to get the REMS out there, but we want them to be as clear and as effective as possible so we want to do it right.


So we’ve already begun to think about, you know, how it would be structured and the language and all of that. But it will take time for us to get it up and in place.


And of course, as we get it in place we again will be providing information to health care providers and patients so that they can most effectively follow the REMS requirements and guidelines.


Sherisse Pham: And you touched upon the language and the structure there which because on my follow up question which is will this be a language that patients can understand. Like you said don’t want to change the labels on the medicine bottle because people often don’t read them. Isn’t it also true for these REMS?


Dr. Janet Woodcock: It’s extremely important that the language be clear, understandable real English. And so, you know, we were working hard to make sure that that is the case as well.


Karen Riley: Okay thank you. And operator now we have time for two more questions.


Coordinator: Our next one comes from Kris Hundley from “St. Petersburg Times”. Your line is open.


Kris Hundley: Hi, thank you for taking my call. I didn’t hear any numbers discussed as far as how many patients you think are going to be effected by this decision. Do you have any estimates?


Dr. Janet Woodcock: Well, we know that there are about 600,000 people currently taking these products. I, you know, think that the numbers will go down very, very significantly with these new requirements.


Kris Hundley: Okay. And I also heard the question asked but I’m afraid I didn’t hear an answer about how many other drugs the FDA has under REMS programs. Can you give me an idea, even a ballpark idea of the number? I know that they’re very few, but…


Dr. Margaret Hamburg: Well, people are looking at each other to try to figure out who has the best information.


Dr. Janet Woodcock: We – there are more than 30 drugs that have these restrictions. Okay there are many more that have other requirements such as the MedGuide or something like that.


But we have a fair amount of experience with putting various types of restrictions. A restricted access, restricted programs on drugs. And there are quite a few out there.


Kris Hundley: Okay thank you very much.


Karen Riley: Thank you and the last question please operator.


Coordinator: Comes from Jennifer Couzin-Frankel from Science Magazine your line is open.


Jennifer Couzin-Frankel: Hi thanks very much for taking my question. I was wondering if you could tell me how many other drugs are currently in the REMS program. And whether drugs have tended to remain in the program long term or been removed, been removed from the market?


Dr. Joshua Sharfstein: You know, one thing that might be helpful since this question comes up. I’ve actually been on the FDA Web site on REMS and it really explains each of the different…


Woman: Right.


Dr. Joshua Sharfstein: …so and there are no two REMS that are exactly the same. They are designed for the unique circumstances of the medication just like this one will be. As Dr. Woodcock said there are about 30 that have these types of restrictions on use.


But they’re all a little bit different, you know, I believe, you know, some of them may require pregnancy tests for example because of the concern over potential (sporadic) birth defects.


So everyone’s a little bit different and it’s hard to speak generalities about REMS. But you can actually see the whole plan on the FDA Web site if you go there and you type in REMS.


Jennifer Couzin-Frankel: Okay, thank you and I was just wondering if I could throw in a quick follow up question although it’s a bit of a cheating one because it’s not directly related to the first question.


In terms of the re-adjudication of RECORD I know that in addition to concerns about how events were adjudicated in that trial there was also quite a lot of concern about the trial design and whether it would even capture events properly.


I was wondering how you may have considered that issue in deciding that re-adjudicating RECORD was the way to go here.


Dr. Janet Woodcock: Actually I think there was not concern about the adjudication. We inspected that group and they did a very good job. There was concern about whether all events were referred for adjudication which…


Jennifer Couzin-Frankel: Okay.


Dr. Janet Woodcock: …is a different issue. So what we are going to request is that there be an independent review at the patient record level, all right. So that would catch events that might have occurred but hadn’t actually been referred appropriately to the adjudication committee that’s the concern that exists.


Jennifer Couzin-Frankel: Thank you.


Karen Riley: Okay, thank you ladies and gentlemen this concludes today’s media teleconference and thank you for participating. A replay will be available in about an hour and will be available for about one week.


And we also plan to post a transcript. And – yes, yes a transcript and an MP3 file in a day or two. And also if I would remind there is a wealth of information on the Web, CDER’s supporting documents, the press release, a question and answer page..


We also have some timeline information if you have some questions about the time line for this drug when it was approved and so forth. And as Dr. Sharfstein said we will shortly be submitting a journal article that will further explain our decision to physicians. Thank you again.


Coordinator: At this time now we conclude today’s conference. You may disconnect. And thank you for your attendance.



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