A text of Health and Human Services Secretary Tommy Thompson and FDA Commissioner Mark McClellan on Tuesday, as transcribed by eMediaMillWorks Inc.:
THOMPSON: First off, let me take this opportunity to thank all of you for coming here today. I appreciate very much this opportunity to make a public health announcement concerning ephedra.
With me today is Dr. Mark McClellan, who is the commissioner of the Food and Drug Administration. Mark has certainly had his hands full with this and other issues.
And I just would like to point out that I think he and the staff at FDA have just done an excellent job of bringing together the scientific evidence, as well as coming up with the conclusions necessary as far as announcing our decision on ephedra today.
And I want to take this opportunity to thank Mark and the whole FDA staff for the job that they've done and are doing and will continue to do.
It was just a few months ago in this very room that a reporter asked me whether we were going to ban dietary supplements containing ephedra. I gave the formal answer that we had proposed then a series of actions against ephedra and that we were still weighing the scientific evidence under the law.
And if I could quickly just capsulize the law for you, under the current law, pharmaceutical companies when they bring drugs to the market have got to prove their safety and their efficacy before they get approved by FDA.
As far as supplements, the other side of the coin comes into play: We have to—the FDA, the government, the department—has got to prove that they are unsafe. And so it's a completely different burden of responsibility, but that's the law.
I gave my strong personal view at that time about dietary supplements with ephedra. In effect, I said, "I don't know why anyone would take ephedra. I wouldn't and I wouldn't want anyone in my family to take it either."
And today, based on the best possible scientific evidence and the reports of the actual experience with these products, in regards to ephedra, we had over 16,000 adverse incident reports that we explored, as well as other scientific evidence.
I can report to you that we're about to ban dietary supplements containing ephedra. FDA is issuing a consumer alert on these products, warning every one of the dangers that they pose. And as we speak, FDA is sending letters to 62 manufacturers telling them as soon as our rule takes effect they must stop selling these ephedra products.
Today's actions tells consumers that the time to stop using these products is now. FDA will soon publish a regulation stating that dietary supplements containing ephedra present an unreasonable risk to the public health.
Dr. McClellan will provide more information about FDA's intended ban momentarily. Before turning this over to him, though, I want to make two additional points.
First, I am pleased that we were able to take the strong action against ephedra. For too long dietary products containing ephedrine alkaloids have been heavily promoted and widely used. They are simply too risky to be used, whether by people who want to lose weight or by elite athletes seeking to enhance their performance, or by youngsters who want to be like these athletes.
Second, the regulation that FDA will be publishing will set a new significant legal precedent. For the first time, we will be articulating the legal standard for protecting the public health under the standards of the dietary supplement law which Congress passed approximately 10 years ago. This is a workable and I think coherent standard that will enable Americans to have access to dietary supplements while enabling FDA to be able to protect consumers from adulterated products.
I am proud that we're taking the action on my watch. And I'm grateful to those at the FDA and elsewhere throughout HHS who have worked so hard and so rigorously to review the evidence and bring us to this well-grounded and productive conclusion.
Before I turn it over to the commissioner, I would like to point out that this, of course, is needed at this particular point in time because, with the holiday season and with the new year coming up with new resolutions, some people have put on some extra weight and they'll be looking for ways in order to lose weight in the coming weeks and months and making resolutions to that effect.
THOMPSON: I want people to eat properly and to exercise and do get their weight under control. But I do not want them to be turning to ephedra products like this in order to think that they will be able to lose weight and then injure their health in the meantime.
That's why it was so important for us to get this out before the new year.
And with that I thank all of you for being here. And now it's my privilege to introduce Dr. Mark McClellan, the commissioner of FDA.
MCCLELLAN: Thank you.
Those of us at FDA, Mr. Secretary, as well as all Americans owe you a debt of gratitude for your passion and your leadership to make sure that dietary supplements are safe.
And I'd also like to thank the FDA's staff who have been working hard to help Americans lead healthier lives.
As the secretary said, today we're announcing an important step to help Americans live healthier in 2004. FDA is issuing a consumer advisory as well as sending letters to manufacturers who market dietary supplements containing ephedrine alkaloids, popularly known as ephedra.
We are notifying consumers and manufacturers of FDA's intent to publish a final rule in the coming weeks that will prohibit the sale of dietary supplements containing ephedra.
The rule states that, "Dietary supplements containing ephedra present an unreasonable risk of illness or injury and are therefore adulterated under the Food, Drug and Cosmetic Act."
Our conclusion that ephedra presents an unreasonable risk to the public health is the result of a long, hard road of seeking out all possible evidence on the potential risks and benefits of ephedra to meet the challenging standard of the dietary supplement law.
Despite the challenges, we have pursued this action for one main reason: our concern about the safety of young people, our sports figures and others who have looked to ephedra for a quick fix for dieting and sports performance. Some have even died.
The dietary supplement law requires FDA to prove that a dietary supplement presents an unreasonable risk after it's on the market, without giving FDA the ability to compel any studies of safety or even to get the safety-related information that companies may have about their products.
In the decade since it was put on the books, the dietary supplement law has never been used to significantly restrict marketing of a dietary supplement on safety grounds.
Under this law, so-called adverse events — when bad outcomes or even deaths occur in people using a product, these adverse events are not sufficient proof. When FDA tried to restrict ephedra before on this basis, the General Accounting Office and many others said that wasn't enough evidence.
So to meet the standard, we've worked hard to obtain and consider scientific studies, adverse event reports not previously available, the science on the way that drugs similar to ephedra work in the body, and expert reviews and analyses, such as a major review of the scientific literature by the RAND Corporation.
We've developed and publicly presented a careful new legal evaluation of our authorities. We have created an extensive public record on the science and the law. And we will respond to an exhaustive record of literally tens of thousands of public comments to make sure that our science-based action gets the legal deference necessary not only to take ephedra products off the market but to keep them off.
Now, we intend to move as quickly as possible to complete the administrative actions required to issue our regulation under the law. When it goes into effect 60 days after publication the rule will have the practical effect of banning dietary supplements containing any significant amounts of ephedra.
Completing this rule on a never-before-used and challenging legal standard has been difficult, but FDA is committed to get it right and to provide lasting protection for the public health.
Along with preparing the forthcoming rule, we've already taken many steps to protect Americans, through a series of enforcement actions and education efforts. Our enforcement actions have included inspections that resulted in voluntary compliance, product recalls, warning letters, seizures and injunctions, criminal enforcements and joint actions with both the Federal Trade Commission and the Department of Justice.
MCCLELLAN: We've also worked to make clear to the public our special concerns about the use of ephedra by people with conditions that place them at higher risk, including people who have high blood pressure and heart conditions, those engaged in strenuous exercise and women who are pregnant.
In conjunction with these actions, use of ephedra has declined and a number of companies have rightly concluded that marketing ephedra is too risky. And now we will be doing much more.
By alerting the public right now we're sending a strong and clear signal that dietary supplements containing ephedrine alkaloids should come off the shelves.
You all know there are companies out there who've profited by misleading Americans about the benefits of ephedra, even as they put Americans' health at risk. Any responsible manufacturer and retailer should stop selling these products as soon as possible.
Everyone involved in marketing ephedra should be on notice that, "As soon as the rule becomes effective, we intend to shut you down."
And we also have a clear message for consumers: "If you haven't done so already, it's time to stop buying and using ephedra products."
"Right now, people are thinking about important goals for the year ahead, as the secretary just told you, including losing weight, including improving their health, and that's just great. There are many ways to take off pounds, but it's (important) to remember that there are no quick fixes.
"We will be taking more steps to help you lose weight and stay healthy in the weeks ahead. But we want to be very clear that if you're resolving to get in better shape in 2004, ephedra is not the answer. Ephedra raises your blood pressure and stresses your system. These effects on the body have been conclusively linked to serious heart problems, strokes and death."
These are exactly the health problems that weight loss is supposed to prevent, but ephedra appears to cause them. There are far better, safer ways to get in better shape. It may take a little longer, it may challenge our motivation but, in the end, we'll be better able to keep off the pounds and enjoy a long and healthy life.
Thank you, all. And we'd be glad to take any questions that you may have.
QUESTION: When do you expect the final action to be out? At that point, will products that are already on shelves be actually recalled?
MCCLELLAN: The final rule is in the final administrative processes of clearance out of the administration. There are a lot of administrative processes that we have to go through to get this exactly right.
We expect it to be out in a matter of few weeks. And it will become effective in the minimum amount of time required under the Congressional Review Act. That's 60 days.
As soon as that time period is up, we will be taking action to get the products that remain on the shelves off the shelves.
QUESTION: Two questions. First, how long did your review take and was there any one piece of evidence that turned the tide toward banning ephedra?
And, two, after this exhaustive review and considering the legal challenges, do you believe that there are changes warranted to the 1994 Dietary Supplement, Health and Education Act?
MCCLELLAN: The review that we have undertaken has been comprehensive, so there's no one single piece of evidence that stands out.
Our staff has spent the past months on top of work over a number of preceding years, scouring all the available adverse event reports, getting access to reports that we didn't have access to automatically, reviewing the science, including reviews by our own staff as well as reviews that we've commissioned by outside experts.
We've also reviewed all of the public comments on this process. That's why we reopened our regulation from 1997 for a period of public comment earlier this year. We wanted all of this brought out for full and complete public discussion to provide the strongest possible and most complete scientific and legal basis for us taking further regulatory action.
So it really is the totality of this whole comprehensive process that led to our decision, not any one specific piece of evidence.
I do want to emphasize, though, that our decision is not based on adverse event reports alone. It's also based on understanding the science of how ephedra works in the body; the so-called pharmacology. It's based on all the clinical studies that we've been able to find of ephedra and similar products in people. And it's been based on expert opinion and review and public comments, as well. So it's really the totality of the evidence that matters.
We have done all we can to fulfill the requirements of the dietary supplement law. We've gone the whole nine yards to collect and evaluate all the possible evidence to reach a conclusion about an unreasonable risk to the public health. So I do think that when FDA reaches a conclusion like this, we ought to be able to carry it out to provide the protection that Americans need.
And we will be doing our best to defend this in court. And if that's not sufficient, it may be time to reexamine the act.
THOMPSON: I'd like to make two points. First off, the sale of ephedra consists of about five percent of the total supplements.
And that's the basis that we're using to move forward to declare the product's adulterated.
THOMPSON: And it has about 45 percent of the adverse incident reports, which indicates the tremendous amount of adverse incident reports that have come in.
But as Mark says, the department went far beyond the adverse incident reports. There were over 16,000 from one company alone in regards to ephedra.
Secondly, as I indicated in my speech, pharmaceutical companies, in order to get drugs to the market, have got to prove first their safety and their efficacy before FDA approves it. We have a tremendous burden of proof in order to take supplements off of the market: We have to prove scientifically that they're unsafe. That's a completely different burden of proof that FDA has. Now, Congress should take a look at We will do as we're supposed to in the department and as a division. We will do everything we possibly can in order to make the law work. And this is the first time that a supplement like this has been taken off the market. It's long, it's an extensive process, but we followed it and we did everything necessary. We crossed the t's and dotted the i's. And we will defend it vigorously in court if need be.
QUESTION: To that point, do you expect lawsuits from manufacturers or retailers?
THOMPSON: I would anticipate lawsuits. I'm not encouraging them, but I get sued every day, so I would presume that — I don't, the department does — but I would presume that more than likely in our litigious society you have to anticipate a lawsuit when you're taking anything off the market, like we are. So I would presume that we will have a lawsuit.
QUESTION: Could you expand on why you think this will meet the definition of an adulterated product, because that's obviously a key to your....
MCCLELLAN: The standard in the dietary supplement law is whether the product presents a significant or unreasonable risk of injury, of harm to the body under the conditions on the label. And if it meets that condition then we can find the product adulterated.
So that gets back to the evaluation of the known risks and suspected risks and the known and suspected benefits of the product that we've just been talking about.
And we conducted this very extensive scientific review with extensive public comment in order to make sure, in doing this calculation of risks and benefits with a very challenging setting, in terms of not having the comprehensive studies that we'd like to see and having to go out and dig up evidence rather than having it come in to us automatically, we reviewed all of this evidence to reach our conclusions under this risk-benefit calculation.
And that's the basis that we're using to move forward to declare the product's adulterated.
QUESTION: So adulterated in the context of the law doesn't mean what it might mean in common English, which is something mixed with something else.
MCCLELLAN: Adulterated in the context of this law means that it presents a significant or unreasonable risk when it's used as labeled. And that's the conclusion that we've reached based on all of the scientific evidence.
THOMPSON: And in our rule, we're going to outline the risks, benefits, statutes and standards that we are using.
QUESTION: Sir, it if poses such a direct danger, why not an immediate recall? Why (OFF-MIKE)
MCCLELLAN: We're working as quickly as we can under the law that Congress has given us and that law requires us to do this very complete evaluation. And in order for it to stand up in court — and I think what is most important is not just that we take the products off for a few days or a few weeks or take action against an individual manufacturer, but have a comprehensive, lasting solution to the problem of ephedra safety. And we're laying the strongest possible foundations to not only take the products off the market but keep them off.
THOMPSON: The worst thing in the world would be is to short-circuit it and then have that be the reason for the judge to throw it out of court. As I've indicated, we are crossing every t, dotting every i. We're doing everything we possible can procedurally to make sure that what we do is going to stand up in a court of law. We have to anticipate that we will get sued and we don't want to short-circuit it and give a reason for a judge to say, "You didn't comply with the statute," and therefore you get it thrown out.
We've done too much work, we've spent too much time getting to this point and we don't want to lose it now. And that's the reason that we're taking every procedural accountability standard into consideration to make sure we don't have anything left to allow a judge to throw it out on basis of procedure.
QUESTION: If the court hearing is still holding up the 60 days effective date of the rule, does FDA have any enforcement options at their disposal while the court hearing is going on?
MCCLELLAN: We expect the rule to go into effect 60 days after it's published, and that's what we're planning for and that's what we'll enforce.
THOMPSON: But we're sending out notices today, which is certainly a strong indication of what people should be doing.
THOMPSON: And this press conference is also going to certainly alert the nation of what ephedra is all about.
QUESTION: So you would anticipate any court hearing would be resolved by the effective date?
MCCLELLAN: We anticipate that we're going to have the strongest possible case to bring to court, as the secretary emphasized, and that's why we've done all this work to lay the strongest possible legal foundation.
My hope is that the responsible companies are going to take their products off the shelves now. They're not going to wait for the 60 days for the regulation to go into effect.
But we are doing everything possible to make sure that we can use all of our authorities to enforce the law and get those products off as soon as possible after the regulation goes into effect.
THOMPSON: And you got to realize that California, Illinois and New York have already banned this. Several companies have already stopped selling it. And so this is really just the next giant step forward to be able to alert the American consumers that they should not be purchasing it, put the companies on notice that it's coming; they'd better get their products off the market.
QUESTION: Mr. Secretary, are you working with members of Congress to repeal this law, that...
QUESTION: You aren't?
QUESTION: Do you plan on trying to do it?
THOMPSON: I intend to lay out the procedure that we have to go through in order to take a supplement off the market.
And that's what we've done. We've complied with the law. We've made the law work, now it's up to Congress to make a decision whether or not they would like to short-circuit it, change the burden of responsibility. That's up to Congress. That is not our prerogative.
QUESTION: It is possible to have the FDA require that dietary supplement companies submit their adverse effect reports to the agency, so that you don't have to go through this whole process?
MCCLELLAN: We do not have that authority under the law.
THOMPSON: It would be nice to have it.
QUESTION: I'm a little confused as to what exactly changed in the way of evidence between March and now, because you had the RAND report in March and you had the 16,000 Metabolife reports in March, so what actually changed between then and now you really were fairly insistent that we needed a law change?
MCCLELLAN: We were at that point insistent on having an opportunity for public comment on all the evidence that had come in. If you will remember, in addition to the RAND report and the adverse events that had been reviewed, we also noted that there had been some studies published since the RAND report that we wanted public comment on.
And we issued what we called a white paper, which was a review of what we thought our legal standard should be under the law and what our thinking was about the evidence that we had seen so far. And we asked for public comment on that.
As you know, regulations have a much better chance of standing up in court when there has been a full opportunity for public criticism and public review of the ideas underlying them.
We got over 10,000 comments in on this regulation from March to now during the period for comment on the regulation that we've been reviewing since then and that we're completing right now.
We are going to respond substantively to all those major comments. And there were a lot of good ideas in there, as well as subsequent reviews and evaluations by experts that have come to bear as well.
So we're in a better position now where I can honestly say that if there's evidence out there that's relevant to this decision, we've made our very best effort to find it, we've made our very best effort to give the public a chance to comment on it. And therefore I think we've got the very strongest conclusions possible about the safety and effectiveness of ephedra underlying our regulatory action.
QUESTION: Having gone through this process with ephedra — assuming that the law is not changing in the immediate future — has FDA learned things that will make it easier and faster to get these products off the market next time before there are so many deaths and injuries and illnesses?
MCCLELLAN: We do. It is a challenging standard under the law because we can't compel studies and we can't even compel the adverse events to be reported to us.
What we have articulated here is a clear framework for applying the dietary supplement law in a way that we think makes sense.
For example, we're interpreting our standard, as we said in our white paper last March, not to require the kind of scientific proof that is required for a drug to be brought to market, a proof of safety and effectiveness, because those large studies just aren't done.
We have to consider evidence that's not quite at that level of proof, but that's still relevant for consideration of the risks and benefits of a product to go under this weighing that the secretary was discussing a little while ago.
So by having this framework in place, we do think it is going to be more straightforward to take action on other dietary supplements where appropriate.
But I do have to emphasize that this is a different kind of framework than for drugs, where they have to be proven to be safe and effective before they come on the market.
MCCLELLAN: We think this framework will make it easier, but it's still challenging.
THOMPSON: And you got to realize that we're doing this for the first time, and any time you do something for the first time you have to be very careful, because more than likely it's going to be reviewed by the courts, and we want to make sure the first time we do it that the courts say we followed the law religiously and that they will be able to uphold our position.
And so the courts will probably give us further discretion and further supervision as it relates to this particular process. And Congress more than likely now will watch this and say, you know, it works but it should be changed in some ways, and posore the end of the year or did it just happen then?
MCCLELLAN: We wanted to let the public know as soon as we have reached these conclusions about the fact that we think ephedra presents an unreasonable risk based on our full evaluation of the evidence. We didn't want to wait while we completed the administrative steps to get the actual final regulation out. That is coming in a few weeks.
We think it's important to let the public know and to let manufacturers know as soon as possible about the conclusions that we've reached.
THOMPSON: And we also want to make sure that people, individuals out there, after the Christmas holidays and have put on maybe a couple pounds, are going to be changing in January to try and come up with new resolutions and start going out and saying, "I got to lose 10 pounds or five pounds quickly," and turn to ephedra. We don't want that to happen, because, as Dr. McClellan has indicated, what happens when you use ephedra, you may have a short-term weight loss, but at the same time it comes with high blood pressure, which is something we don't want anybody to have.
QUESTION: Can I just make sure I understand this then, the answer is no, right; there's no legal significance to this happening during this time of the year?
THOMPSON: No legal, but there's a lot of reasons for it.
MCCLELLAN: We're just trying to work as quickly as possible to protect the public.
QUESTION: Why shouldn't dietary or other supplements be treated like drugs in having to prove that they're safe?
THOMPSON: Because Congress had made the decision they should be different. Congress passed the supplement law about 10 years ago and put down the requirements which FDA and the Department of Health and Human Services have got to comply with. This is a very controversial law that went through Congress, and they made that decision. And we have to follow the law as we have it.
QUESTION: You said it was, sort of, Congress' prerogative as to whether or not they want to revisit this law. Doesn't that, kind of, sidestep the fact that it's also your prerogative to make this a legislative priority, to even send out the....
THOMPSON: I've already indicated that I would like to see the law changed. I said that about three months ago when we had a press conference like this. I've also said that I would like to see FDA to have the authority to be able to receive the adverse incident reports.
So I think the department has been out there. We're saying that the law is there. We've complied with the law. We have now taken ephedra off, based upon the requirements of the statute. And we will continue to work under the statute as we have it.
QUESTION: Are you willing to make that a legislative priority next year?
THOMPSON: I am going to make a report to Congress when I go up and testify.
QUESTION: What's next? I mean, you've set this new legal standard obviously in anticipation of another dietary supplement... So are you looking at any others that are cropping up?
MCCLELLAN: We have, as you know, a very broad set of responsibilities at the Food and Drug Administration. There are more products on the market than ever before, more diverse foods. We've got some important new food safety challenges that we're working to meet right now. More diverse dietary supplements on the market than ever before. And many of these products have important value to Americans: Most Americans take dietary supplements.
So we're going to continue to be vigilant and use our resources as best we can to protect Americans. And setting up this framework does make it possible for us to take further actions more easily as appropriate if there are appropriate reasons for it.
QUESTION: But there aren't any under review right now.
MCCLELLAN: Not any imminent that I want to announce this morning. We're talking today about a very important action on ephedra and we want to educate the public about other steps that they should be taking — alternatives — to keeping their weight down and performing better in sports.
QUESTION: A lot of companies that have already switched from ephedra to other compounds which have ephedrine-like substances in them, bitter orange and that sort of thing, so that one can get the same chemical products with a non-ephedrine product. Is that a worry?
MCCLELLAN: It's definitely something we'll be watching. A number of those products actually do contain some amounts of ephedra.
MCCLELLAN: And to the extent that they are ephedra-containing dietary supplements, they are going to be subject to this regulation.
For the rest, they will be subject to the framework that we're articulating here and that we will be applying in the future. So we will be working just as hard going forward as we have on ephedra to identify when there are safety problems and to take appropriate action. And now we've got a clear regulatory framework for doing it.
QUESTION: Two questions. What are the implications for use of or getting the ephedra over the Internet? As you know, a lot of that's coming from Canada where it would still will be legal and other places. Does the FDA plan to try to keep ephedra from coming into the country that way?
MCCLELLAN: We are concerned about purchases of many unsafe products over the Internet: versions of drugs as well as dietary supplements that we don't regulate and that may not be subject to the same safety standards.
This is an important priority that spans not only FDA but also our partners in consumer protection at the Federal Trade Commission and in some cases the Drug Enforcement Administration and the Bureau of Customs and Border Protection, as well.
So you should look for more announcements from all of us — more actions from all of us working together on this important problem in the weeks ahead.
QUESTION: Would it be fair to say that it will be illegal to import ephedra from abroad?
MCCLELLAN: Yes, these are illegal products. That's right. These will be unapproved, unsafe products in the United States.
QUESTION: Yes, earlier this year, the House provided the FDA some documents related to clinical trials of ephedra. How important were those documents?
MCCLELLAN: The clinical trials were considered. And, again, for some of the evidence that's developed by private companies with private support and we can't automatically compel that being provided to us.
We did get some help from the House. We've been working closely with members of Congress on a bipartisan basis to try to develop all the scientific evidence that we need to reach the conclusion that we reached today.
So that, along with many other types of evidence, was helpful in the overall process.
THOMPSON: Dr. McClellan and I would like to tell you that you should watch what you eat over the New Year's, pass your resolutions, get healthy, eat properly and exercise. And we're going to change the culture in America.
Thank you very much for coming.
MCCLELLAN: Thank you.