FDA and the Internet: Advertising and Promotion of Medical Products - Opening Remarks
|VOLUME I:||Remarks||WWW 101||Group 1||Group 2||Presentations||Group 3|
|VOLUME II:||Remarks||Group 4||Presentations||Group 5|
October 16, 1996
Opening Remarks: William B. Schultz
World Wide Web 101: Sandy Desautels
P R O C E E D I N G S
MR. SCHULTZ: My name is Bill Schultz. I am Deputy Commissioner of Policy at the Food and Drug Administration. I want to welcome everybody to this conference, the FDA's conference on advertising and promotion on the Internet.
When I was in law school I had a teacher who always signed up for small classrooms because he felt that if the room was full, and maybe if a few people were standing, there would be a lot of extra energy in the classroom and it would be a much more successful course. If that's any test, I think we should have a very interesting two-day conference.
With the increased popularity of the Internet, it's not surprising that questions would begin to be raised about how the laws pertaining to drug and device advertising apply to the Internet. FDA has no question but that they do apply and, in fact, the Agency has issued a number of warning letters during the past six months. But we also recognize that the Internet raises some new and important and very different issues regarding the regulation of promotion.
Under the Food, Drug and Cosmetic Act, the Food and Drug Administration regulates both labeling on drugs and devices and advertising of prescription drugs as well as advertising of so-called restricted medical devices. Historically, most prescription drug and device advertising has been directed at physicians, so that drugs have been promoted through detailing, through professional meetings and professional journals.
In recent years, we've seen more advertising in newspapers and magazines and some very limited use of television advertising. Those expanded uses raise separate questions that are related to the topic to be discussed today but are not up for discussion today. The basic regulation of promotion and advertising through the statute is designed to prohibit false and misleading advertising. There are principles of balance that sufficient information be given to consumers or physicians so that consumers can make an informed decision about medical products.
The Agency will review advertising at the request of companies but it does not require preclearance of any drug or device advertising. The basic core of the statute was written in 1938. It was amended in the '50s and '60s, obviously long before the Internet. That's why it is particularly important that we air the issues and do a fair amount of thinking before we figure out what the correct rules to apply are.
Before today, the Agency officials have met with representatives from a number of individual companies and there are a lot of questions that have been raised that don't have obvious answers. The one thing the industry I think is very reasonably requesting from the Agency is guidance so that it knows exactly what the rules are. This seemed to us to be a perfect opportunity to have a public meeting such as this one to air the issues.
We intend to mostly listen at this meeting. It has been set up so that there are five topics. There will be five panels run by moderators from the private sector. Very quickly, the first panel will be on Internet Investigational Use Questions. That will be this morning. This afternoon we will have two panels: Internet Chat Rooms and News groups; and General Regulatory Questions. Then, tomorrow, Internet Website Linkage Questions and Internet International Questions.
Most of the day will be taken up by discussion of these topics among the panel members. The panels will sit here. There will be a couple of opportunities for the FDA representatives, who are over at this table, to ask questions and there will be an opportunity for audience questions at the end of each panel.
We see that there really are sort of two focusses to the meeting that I would want to mention. One is we certainly recognize both the utility and the power of the Internet. We view this meeting, again, as an opportunity really for all of us but particularly for the Agency to learn more about how it's used and what the opportunities are and to help us figure out what the right policy and guidance would be.
In saying that, I want to emphasize that the Agency is not here today to answer any questions either about the law or about its plans. We are here much more to listen and are not in a position--and I don't think it would be appropriate and it wouldn't be a good use of this meeting to try and figure out here exactly what the answers are.
The second focus I want to mention is we would like to concentrate on the application of current law. There have been debates on Capitol Hill and debates in a lot of places over the last two years about changing the Food and Drug Act. Those are very important and they are very appropriate. But our focus today is what is the appropriate way for us to apply the current statute to this new method of advertising.
I just want to mention a few things about the logistics. I suppose it is appropriate, since this is a whole new issue for us, that we would try a whole new way of doing a public meeting. As I mentioned, there will be five separate panels that will sit at these tables here. The panel members should not come up until they are called, just before each panel discussion.
There will be a moderator who will present the issues for the panel discussion. We would ask that each panel member or any member of the audience speaking state their name for the reporter. The reporter will much appreciate it if you state your name and, if it has a difficult spelling, I think the reporter would appreciate it if you would spell your name as well.
Because we have so many participants and so much to cover, I would just ask everybody, whether you are asking a question or you are on the panel to try and keep your comments or questions short. We have a lot of ground to cover, a lot of different ideas. If we could all try to do that I think it would be very helpful.
One other matter is that there will be a transcript of this meeting that will be available in about two weeks through the FDA's Freedom of Information Office. We can give you more details on that later.
I would like to introduce our first speaker. What we are going to do before the first panel meeting is have Sandy Desautels give us a 30-minute talk on the Internet so that we can all be familiar with what it is that we are going to spend the next two days thinking about. Sandy is with the National Institutes of Health Division of Computer Research and Technology. We looked around the government to try and find the person who is most knowledgeable and could give the best presentation on this. She was kind enough to come here this morning to do that. So I think I'll turn it over to her and let her give us her presentation.
MS. DESAUTELS: Thank you very much for having me here today. As he mentioned, I work for the Division of Computer Research and Technology at NIH. NIH has been working a great deal with the Internet and the World Wide Web in the last couple of years. I've been there the last two years and pretty much most of what I do is Web- and Internet-related. My job today is just to make sure everybody is kind of starting from the same base.
What I want to cover up here is I'm going to give a little background of how this whole thing got started, where it came from, how do you personally get started and how does the whole thing work? Then I will go over a few terms. Actually, I will cover the terms in my talk and I will just have a list of them to show you.
The Internet was originally started by the Department of Defense, actually, in the '70s with the idea of military use. They wanted to have a reliable system that they could send information back and forth from anywhere in the world. What is the Internet? The Internet is a network of networks. It is a backbone that fiber cables running almost everywhere in the world, through over 160 countries.
How big is the Internet? What I have here is basically a map of Africa to show you. North America, South America, Europe and Australia are pretty much 100 percent covered by Internet. Even in Africa, those countries in the light brown the beige, are about the only countries that don't have any Internet at all. So eve Africa, we're talking about 90 percent coverage, as well as Asia. So it really is, they say World Wide Web, it is pretty much worldwide. There are not too many places you can't go.
It was originally designed using a protocol called TCP/IP. The only reason I mention that particular protocol is it was not common for desktop computers for many years. PCs and Macs just didn't do that. That was a Unix background. So that's why the whole thing started with Unix. What that means is, it was kind of ug It was text-based. It used a lot of really weird Unix terms like grep and L-list an these goofy things that normal human beings don't use. So it was really for the gee the '70s.
When people say Internet, they don't mean any particular system. The Internet is a suite of services. It's a whole bunch of different services. I've li big ones here, what they are. Each service has its own separate programs that do different things. FTP is one you hear a lot. It stands for file transfer protocol. way of getting files from one point to another point easily, transferring files, upl and downloading.
E-mail, electronic mail, the still absolute number one user of Internet volume is E-mail by far. There are a lot of sections of the world where all you hav E-mail really. You don't have a lot of the other stuff. Telnet, that's a real Unix thing. Gopher is a way of searching and retrieving text files. These are just stra texts; no bold, no italics.
The problem with a lot of the FTP and Gopher things is you really have to know where you are going. Somebody has to tell you, "Go to the site. Look here, look here, look here." All you have is a couple of archaic names. There are no explanations. There are no really good search tools, or there weren't for many year So for most of the '70s and '80s, you had to know what you were doing to find this information.
Internet Relay Chats, IRCs; those are chat rooms. I'll show you a couple of things on those in a little bit. That is, it's E-mail, but it's a whole b people in one section all talking at once, sending E-mail messages back and forth an everyone can see everyone else's E-mail. It's like a bulletin board system. News groups; that's kind of the same type of thing, only chat rooms are interactive; you' doing it at the same time. News groups are, think of it as, like a bulletin board t posted somewhere in the world and anybody can go and look at it.
They are broken down into very, very, very specific subject areas so if you are interested in green Jello, there is probably a news group that is specifical designed for green Jello, whether you like it with bananas or not. There are probab people having discussions about that somewhere.
Like I said, through most of the '70s and '80s, it was really ugly to use. You had to use these goofy terminals and type these awfully Unix words. The World Wide Web changed that.
Where does the Web fit in to this whole thing? The Web is a service on the Internet. It's only one small portion of it. It's a lot newer. Tim Berners-Le Switzerland, decided he was sick of all these Unix and text and everything being rea ugly. He wanted to do something a lot neater. So he created the whole philosophy behind the World Wide Web. He created the languages, the interpretation.
What it does is it gives the Internet to real people, people who aren't geeks. You can look at stylized text with graphics and sounds and movies. As I put the definition, an online collection of documents that are interconnected by hyperli forming a virtual web that spans the Internet. That's where the World Wide Web name came from.
Hyperlinks are those lovely little blue text items. If you've ever been on a Web page, you see those little things highlighted in blue. Those are links to oth documents that can be on the same server, they can be in the same building, they can be in the same country, they can be in a completely different country. As far as th user is concerned, it makes very little difference. You can move from looking at so information in Australia to Italy to California to Florida by clicking on little blu Very little do you know where you are in cyberspace.
It was a real leap above because now all of a sudden we could do stylized text. We could put explanations in. We could show people how to get from one place to another. With the other ways, once you got one piece of information, i wasn't a whole lot easier to go get the second piece or the third piece. You had to through the same awfulness. Whereas, on the Web, if there is some connection between documents, just hyperlink to them and you can look at five different documents on the same subject, five different places fairly easily.
Great! You want to get on the Web. What do you do? How do you get started? You need four things to get started. First you have to have a computer; makes sense. It can be a PC; it can be a Mac; it can be a Unix machine. It doesn't matter. You have to have a connection to the Internet. Most government agencies already have this. Home users, it used to be very difficult. Now, I mean, there's Erol's, ten bucks a month. Everybody's selling connections to the Internet. And yo need a modem if you don't have a direct connection or if you need a modem.
You need a Web browser, an application you are going to run on your computer which is going to display Web documents. I am using Netscape Navigator right now to do this presentation. I do most of my presentations on Web pages. Navigator is probably the most popular browser. Internet Explorer is another one. There are a lot of them out there but those are the two biggest ones.
And you have to have a URL homepage. URL; you'll hear this word a lot in the Web. Some people are starting to call it "Url". I haven't gotten used t Url thing. It just sounds a little weird. Uniform resource locator; the address of on the Web.
What I usually like to do at this point is give people a breakdown of what a URL consists of, all the parts, because it is something you see a lot on the and it makes it a little easier if you can break it up and see what it means. There four parts to a URL. The first part is telling you what type of server you are acce The second part is the name of the server. Then the third part is the path on that to get to the file you need, directory structure. Then the last part is the actual the page you are looking for.
For an example, let's use a page that is on an FDA server. So someone gives you the address to go to look at a page that talks about the FDA's new drug approvals. There's the whole address: "http://www.fda.gov/cder/da/da.htm". The way it breaks down is every Web server always starts "http://". It stands for hyper transfer protocol. That is what allows Web servers to talk to the rest of the world Web browsers have the ability to understand more than just Web servers. They can talk to FTP, those file transfer protocol servers. They can talk to Gopher servers. They can talk to news groups. They can do a lot of different kinds of connections. The beauty of a browser is you don't have to get a lot of other progra you can pretty much do everything with your browser. You can also connect to something that says ftp:// or gopher:// but most of them you are going to see are ht because that's Web.
Then "www" is the name of the computer. It has sort of become a very standard thing on the Internet that the main computer, the main Web page for any group, is www.microsoft.com, dot whatever, netscape.com, because that's sort of the way it started and that's the first thing people think of. Fda.gov is saying this i domain.
You'll see most--in the United States--domains end with .gov, .com. That tells you what kind of institution it is: gov, government; com, company; edu, educational for universities; org is organization, like PBS, non-profit organization Those are the big ones. Outside of the U.S., they use actual country codes like fr France, that type of thing. So that's how you can tell. If you look at a URL and i ends .fr for the name of the computer, then you will know that you are looking at a computer in France.
That's really about the only way you can tell, unless it's in French of course. That might help. Although, most everything is in English. It is pretty mu the language of the Web now. There is a registry service that registers domain name Like FDA is pretty much, obviously, taken, but Coca-Cola had to go register for the name cocacola.com.
When you get past that first part and you do a slash, everything after that is the directory structure. You're saying, on the server this is where I want to go find the file I'm looking for. Then the last part, the "da.htm" is the actual file. .htm or .html stands for hypertext markup language. That is the language of the Web That is what you create pages in that you stick on a Web server that people can read So I thought I would just give you an idea of what the whole URL is and how it breaks down. You need some kind of starting point. It's usually considered homepage. A homepage, the definition you hear, is a document that provides a starti point or organizational center for any collection of documents.
Now, that's kind of two different things. There is your personal homepage, which is your starting point. When you start up your browser, what is you first place you are going to go to start your adventure? A homepage for a company i their main page. When you just say www.fda.gov, without adding any kind of directory information, what is the first page you are going to see? It should be something that has got kind of a structure that shows you the different parts, where can go from here, what the sections are. It is their organizational center.
How do you get a starting point? If you work for the FDA, probably your best one is to start with their homepage, www.fda.gov. Or, if you are on Netscape, when you originally buy Netscape Navigator, the first time it connects it connects to Netscape's homepage, which is also a good starting point because it give you a lot of information. Or you could ask a friend. Ask a friend who has been on Net for a while where is a good place to start and they will give you some informati Another place to start is a search engine. I'll talk about search engines in a little bit. It's how you find information on the Web. A lot of times, if that you are going to be doing, is originally trying to find something, your starting poi could be that search, that place to look for things.
Once you get your starting point, from there you're off. Because on that starting page there are going to be links, hyperlinks, to other sites. Then you can all over the place and sort of really get lost because you start clicking and moving moving and moving. So once you get started, you can go anywhere. As I mentioned, links can be to other servers. Very easily you can go from location to location. T can also handle other kinds of services, such as news groups and Gopher. I wanted t back and show you just a picture of a chat room which has been put on a Web page.
This is actually a page I just took off the Web. I just copied it to my machine. It shows you a fairly common chat room. It gives you an area here where you can type your comment and if you want to post it you just click the little butto that says "post text to current room". Then down below it shows you all the things were typed in order. The top is the newest item of what is going on at the time and time.
I happened to do this at 11:30 yesterday so everything is like 11:26, 11:27; they are all fairly running right after each other because it was a conversat that was going on at the time. So there are a whole bunch of comments and at the bottom it will say right now these are the names of the people who are currently onl So there are 63 people who are currently either looking at information on this page typing information. So it is basically a conversation going on between 63 people online.
Just a couple of pointers about what you can do if you are browsing to kind of make your experience a little better. Learning how to navigate; as I said, can be blinking all over the place and after a while you might get lost. You want t back to where you started, because you kind of went off on the wrong kind of tangent [Slide.]
There are a couple different ways you can do that. You can use the back and forward buttons, which take you back to the last screen you looked at and then y can keep going back and back and back. You can use the "go menu" which gives you a listing of all the places you've been since you signed on. So these are basically the slides that I've had in my presentation in the order that I've looked at them, s want to go back three or four or five slides I could look at it.
There is also something called "history" which is the exact same thing. It's just a whole listing of every place I've been since I started up Netscape. So can see where you were. Also, if you were within a particular site, a lot of times person who created the site is going to have some kind of navigational links, to go the table of contents, to go to Section 1, Section 2, to start this part. So as lon are within one site, you can use their navigational links to work your way around.
The easiest way to get started with that is--if you are using Netscape Navigator, anyway--Netscape Navigator has some directory buttons. One of the directory buttons is "Internet search". That takes you to a site on one of Netscape servers that pretty much has just about every major search engine--a listing of it. the top it will have whatever search engine--they kind of switch back and forth--the have a search engine. All you have to do is type something you're looking for in th hit the search button and it will come up and show you all of the different sites th have mentioned what you are looking for.
This is a listing of all the major search engines. You can see there are about 20 of them. I can use all of them. The important thing to keep in mind about search engines is different ones search differently. Some of them have little robot go out into the Web and just search through, drill down into servers and look for information themselves. They'll have tons and tons of information--they might have too much information. Sometimes, if you are looking for a very broad subject and yo look for something in the search engine like that, it will give you 50,000 hits. Yo not going to look at 50,000 hits. You're going to look at ten, maybe.
Other sites are a little more selective. Somebody has to basically fill out a form and submit it to the search engine saying this is what I've created; this is whole purpose behind it. So, therefore, there is a little more control. If you are looking for a major subject, it is probably better to use one of those as opposed to full-text search.
What I usually tell people is try three or four different searches and see what kind of results you get. Don't stick to one. Kind of slide back and forth and whichever one is more comfortable for you. I usually end up using two of all those that I use. I use one that is more of a full-context search and one that is a littl focussed on subject matter.
If you get too much information, you have to learn a little bit about how to search. Say you want to do a search on Black Forest cake. I want to find out ab Black Forest cake. If I just type in the term, in a lot of search engines, it is go do a search for "black" or "forest" or "cake". I will get a hundred thousand hits. lot of them are going to not be about things I want.
So if I put that term in quotes, it is going to look for only "Black Forest cake". So anything that doesn't match that is going to be dropped out. So all of a sudden now I've only got 300 hits. That's a lot more reasonable and that's stuff I really care about. So using quotes, using longer strings to define things, using a advanced search to limit your results, can be a lot more helpful to get you the information you really want.
There are a couple other kinds of search engines out there besides just looking for text. There is a site that just gives you E-mail addresses. Say you wa find out about some friend yours who you know works in California at some company. You can type in his name and it will give you--if he's registered, and a lot of peop have--his E-mail address so then you can just send him a note saying, "Hi, how are y doing?"
There is also another site that lists companies. It gets them from phone books in areas. I don't know if it is underwritten by AT&T or what. But you ca a company; it doesn't have to be on the Web. I one time was trying to get hold of m accountant and I didn't have his business card and I couldn't find his number. I lo in this and I found his address up on Connecticut Avenue and I called him. So it comes in very handy. So it's a search engine but it's a specialized search engine.
Everyone has a different name for them. What they really are is you're saving that information so you can come back to it later. I have a list here of bookmarks. These are places that I've decided I want to go to again. I've tried to organize them in some kind of form. Sometimes it doesn't always work real well. As you can see, there are quite a few of them here. So, try to organize them so they m sense to you and you can change the names. Whatever name somebody gave it, you're not stuck with that. Change the name to something that makes sense to you.
Set your preferences up to suit your needs. Pick a default homepage so when you start the program--as I said, in Netscape, you start it up, it's going to g Netscape's homepage. That's the way they set it. You can change it. You can put anything you want. If you think you're going to start at a search engine, type in t URL for that search engine as your start place.
Find a font size and style that suits you. I have made this font large today to make sure it displays better. This isn't the size I would use if I was sit my home machine. It's too big. I'm going to make it smaller.
An important thing that I think everybody should do is set up your E-mail account information. If you go to a lot of Websites, there are little E-mail that say if you have a comment about this or you want more information or something click here. You can send an E-mail message from within your browser. But it is onl going to work if you've gone into your browser and set up, this is my E-mail address this is where my E-mail account is; a couple of things like that, so that it knows h route your mail and who you are.
I do this little graphic because I want to give people an idea of how the whole thing works. You start on the right there. You have your own personal computer sitting on your desktop. You're running a browser, Netscape Navigator. You type in a URL and hit the button. Your computer connects out to--the cloud is t Internet. I don't know why but someone just decided the cloud is the Internet. Eve time you see a thing on the Internet, it's always a cloud.
So it goes into the cloud. It goes and finds the server that you address. The server is, for the sake of this, www.fda.gov; right? You've just typed in "http://www", that whole thing. In FDA's site, they have a computer that's called "www". It's got a whole bunch of html files in the directories on that machine.
You make a connection through your browser directly to that computer, directly to that page you look for. The server processes the information, sends it to your browser. Most people think it's a one-shot deal, it just sends all the information at once. It sends all the text first and then it keeps going back to ge graphics. Graphics take a lot longer to load. So you'll see the picture start to c and then you'll see the graphics fill in. Those are all separate connections, compl distinct from each other.
It makes the connection; it sends information; it quits. Another connection; sends the information; quits. So it will just keep making connections a connections and connections. When it completely finishes loading the page, boom: there's no connection whatsoever between you and that computer. It's an instantaneo connection. That information is sent back to your browser. Your browser is what interprets the information. It looks at all these goofy little codes and figures ou should be bold, this should be big, this needs a picture here, and displays it for y If you click on another hyperlink on that page to look at, like, the next page of that server, it's going to do the whole thing all over again. As I said, it total instantaneous connection. There is nothing that stays open.
That's pretty much all I wanted to say. I just put together a listing of terms that I talked about. I think I covered everything. This is just definitions they all mean.
I guess that's it. Does anybody have any questions?
MR. SCHULTZ: Thank you very much.