Excerpt of the Transcript of Press Briefing by Ambassador Randall Tobias, Global AIDS Coordinator, U.S. Department of State

Foreign Press Center Briefing
Washington, DC
May 7, 2004


[snip]

QUESTION: Hi. David Coetzee at Southscan. The U.S. got and has had quite a bad press in the last few weeks or in the last month over the Gabarone conference on treatment drugs. It seemed that the U.S. was taking a position against generics and in favor of big pharma. And that's the way it was written in a lot of the papers in, for instance, Ethiopia or in South Africa.

So I am wondering if you could explain what exactly the position is, vis--vis generics and the label drugs from the big pharma companies.

And as an addendum, really, it's just an add-on to Charlie's earlier question, I wonder if you could let us know what the -- what your perception is of the awareness in the African countries you visited about what is going to happen to their state's capacity as AIDS deaths start to hit their administrations, whether you see an awareness of that coming up.

AMBASSADOR TOBIAS: Let me take the second question first and say that I think it varies from country to country the degree of the awareness of the magnitude that AIDS is going to have. Even as recently as a year ago, I think there were -- when I first came to this, there were government leaders who either didn't recognize or weren't willing to talk about the economic impact, for example, that AIDS was already having on many countries.

I'm seeing more openness and more desire to identify the things that need to be done, much more eagerness to embrace the kinds of help that is coming from what we're doing, what the Global Fund is doing and others. And I think this will feed on itself. I think as more and more African leaders step up and are much more visible and talk about this and talk about the problems, then that will either encourage or, for whatever reasons, motivate those that aren't to be doing the same thing. So I think -- we're not there yet, but I think we're on a path.

Unfortunately, there has been a lot of inaccurate information on the drug issue, and I think it's, in large part, because there have been some very active lobbying on the part of those who have economic interests associated with what are referred to as generic drugs but really aren't.

In this country, when we think about generic drugs, what we are talking about is a prescription that a physician writes that you can take to your local pharmacy and get it filled, and if it is a drug that has availability of both a generic drug and a drug that originally came from a research-based company, whichever you get, the fact of the matter is you know that either one of those drugs are exactly, precisely the same. And the reason that you know they're the same is because there is a process in the United States whereby the Food and Drug Administration approves in exactly the same way, with exactly the same processes, the way in which these drugs are put together, the way in which they're manufactured, all the scientific data that stands behind that, and so forth.

When people refer to generic AIDS drugs, there really aren't any that fit that mold. These are really copies of drugs that have been approved by regulatory authorities, but the copies themselves have not been submitted to any regulatory authority or approved by any regulatory authority.

Now with the relatively limited presence of treatment up to this point in time, the risks associated with that, if there are any, have been relatively containable. But we're about to scale this whole treatment effort up in a very, very massive way, and we have to be sure that we're getting it right. So our position is not that these copy drugs are bad, it's that nobody knows because they have never been reviewed by a stringent regulatory authority.

And so our policy at the moment is that we're requiring that the programs that we fund use drugs that have been approved by a stringent regulatory authority. And I might add that we're having no trouble at all getting adequate supplies of those drugs and getting our programs scaled up, while, at the same time, we're working together with the World Health Organization, UNAIDS, the Southern African Development Community and others to try to identify appropriate processes whereby the people in Africa who will receive these drugs have assurances that these drugs are safe and effective, just as people in the United States do.

I think it's totally inappropriate to have a policy where there are good drugs in the United States and drugs that people view are good enough in other places in the world, that the drugs need to be good and safe and effective every place. It's interesting that this is an issue that, in talking with people in Africa who are involved in these programs, they are much, much more focused on the issues of infrastructure and people and the capacity constraints than they are on the drugs, because right now, they're able to get drugs, for the most part, in the programs that are able to do treatment. But there is so little treatment going on because the capacity doesn't exist. And we've got to do both of these things over time.

The availability of drugs over time is going to become a huge problem. The capacity of the pharmaceutical industry globally to produce the quantities of drugs that are going to be needed, as we scale up this program, is an issue that will need to be addressed.

But right now, our only interest is ensuring the safety and effectiveness of the drugs we acquire, and with that assurance, it will be our policy to acquire the drugs wherever we can get them, at the lowest possible price for which we can get them, but I want to be sure that we're going to do good and not harm.

MR. DENIG: Let's go to this side here, again, please.

QUESTION: (David McAlary, Voice of America) I'd like to follow up on that question. The WHO supposedly has an oversight process that it says ensures quality, safety and effectiveness of these generic drugs. Are you saying you don't have faith in that?

AMBASSADOR TOBIAS: No, I'm saying the WHO -- I think you're misquoting the WHO. I would refer you to the WHO's own website on their so-called prequalification program. It has been characterized inaccurately by some as a regulatory process, and it is not. It was not intended for that purpose. And rather than my tell you what the WHO's process is, I'd just refer you to their website.

But it serves an important function. We're working very closely with the WHO on this. But we need something that is more akin to a regulatory process where we can have assurances and be able to assure patients that these drugs are safe and effective.

[snip]


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