FDA Public Hearing
Wednesday, October 18, 1995
3727 Colesville Road
Silver Spring, Maryland
Amanda Pedersen, J.D., M.P.H., Panel Chair
- Ilisa Bernstein, Pharm.D., J.D.
- Minnie Baylor-Henry, R.Ph., J.D.
- Norm Drezin, Esq.
- Louis A. Morris, Ph.D.
- Nancy M. Ostrove, Ph.D.
- Bill Purvis
- William Schultz, Esq.
- Stephen Sundlof, D.V.M., Ph.D.
- Robert Temple, M.D.
- Byron L. Tart, Jr.
- Janet Woodcock, M.D.
- Andrew S. Krulwich
- Richard A. Samp
- Nancy Buc
- Valerie Robertson, Ph.D.
- Jon Schommer, Ph.D.
- Julie Magno Zito, Ph.D.
- Paul H. Rubin, Ph.D.
- John E. Calfee, Ph.D.
- Mary Jane Sheffet, Ph.D.
- Donald Sullivan, R.Ph., M.S.
- John F. Kamp
- Thomas P. Lom
- Daniel L. Jaffe
- Jeffry Perlman
- Matthew R. Seymour
- Peter R. Seaver
- Nancy Sander
- Linda Golodner
- Eugene P. Schonfeld, Ph.D.
Day 2: Contains Panel 8, Panel 9, Panel 10, and Public Comment
CALL TO ORDER
MS. PEDERSEN: Good morning. I am Amanda Pedersen. I am FDA's Chief Mediator and Ombudsman. I will be chairing this hearing today. This is a Public Hearing which was announced in August, on August 16, 1995, and it will be held under Part 15 of FDA's regulations.
The purpose of the hearing is to solicit information and views from interested persons, including health-care professionals, scientists, professional associations, manufacturers, marketers and consumers, on the issues and concerns relating to the promotion of prescription drug products directly to consumers through print, broadcast, or other types of media.
FDA is particularly interested in exploring whether and how the agency's current regulatory approach should be modified.
At this point, I would like to ask the members of the FDA Panel who are up here with me to introduce themselves. I would like to start to my right with Dr. Sundlof.
DR. SUNDLOF: Thank you. I am Steve Sundlof, and I am the Director for the Center for Veterinary Medicine.
MR. PURVIS: Good morning. My name is Bill Purvis. I am the Director of the Advertising and Promotional Labeling Staff in CBER.
DR. MORRIS: Good morning. Lou Morris, Chief of the Marketing Practices and Communications Branch in the Center for Drugs.
MR. TART: Good morning. I am Byron Tart. I am the Director of the Promotion and Advertising Staff in the Center for Devices and Radiological Health.
DR. OSTROVE: Good morning. I am Nancy Ostrove. I am with the Marketing Practices and Communications Branch.
MS. BAYLOR-HENRY: Good morning. I am Minnie Baylor-Henry. I am the Acting Director of the Division of Drug Marketing, Advertising and Communications, CDER.
MR. DREZIN: Good morning. I am Norman Drezin. I am the Acting Deputy Director of the Division of Drug Marketing, Advertising and Communications.
DR. TEMPLE: Good morning. I am Bob Temple. For today, I am Associate Director for Medical Policy to which DDMAC reports.
MR. SCHULTZ: I am Bill Schultz. I am, today and tomorrow, Deputy Commissioner for Policy.
DR. WOODCOCK: Janet Woodcock, Head of the Drug Center at FDA.
DR. PEDERSEN: Thank you. We will now have some opening remarks from Mr. Schultz.
MR. SCHULTZ: I will try and be very brief so we can get to the hearing. It is very appropriate that we have this hearing because the issue of what the appropriate rules are for advertising of prescription drugs to consumers has been one that in the agency has been around for at least 15 years. Prior to that time, prior to 1980, there was effectively no advertising of prescription drugs to consumers except for price advertising, I think principally because prior to that time there was no interest in doing that sort of advertising on the part of the companies.
But since 1980, the agency has patched together a policy of using voluntary moratoriums and regulations that are really more designed to deal with advertising to physicians than to deal with the issue of advertising to consumers. And so I think this is the time--maybe the time is long past--when we should step back from those regulations and those policies and ask the question of what is the appropriate role for the Food and Drug Administration in this area.
There are several considerations that I think we ought to keep in mind as we go through the hearing and several questions that we need to think about. Let me just mention some of those.
One is it seems to me that whatever policy is developed needs to be consistent with First Amendment values. I am not saying there is a First Amendment issue here, but there are certainly First Amendment values at stake. This is a country where I think there is a presumption that is in favor of the free flow of information, and anybody who is trying to stop that or any agency that is trying to stop that has a burden to carry to explain why and what the interests are.
Secondly, we need to take into account new technologies. Part of what is increasing the interest of this is obviously TV, but we have the Internet and all sorts of other new technologies that I think we can look forward to in the future. We need to figure out how this policy fits into the use of those technologies.
Third, we have to obviously look at the question of what elements in our current regulations make sense for advertising to consumers. What is the appropriate role for fair balance for disclosure of risks? And as I indicated before, it is not necessarily true that the answer is the same for physicians as it is for consumers.
Fourth, historically we have allowed, effectively, very little direct advertising of prescription drugs to consumers, and we need to take into account the effect of that history on a possible change in policy which allows more. If we were to really open the floodgates here, we need to think about how consumers will receive that information and what sort of impact that will have.
Fifth, we also today are in a country where patients typically learn very little about prescription drugs. They rely almost exclusively on their doctors and physicians to make the decisions and often don't participate in making risk/benefit decisions or in the process of identifying potential adverse reactions. And I think the issue is will this kind of advertising help consumers be more involved in these kinds of decisions.
And, finally, the purpose of advertising is to persuade consumers to use products that they need, but it often has the effect of persuading them to use products that they don't need. Many would argue that the advertising of over-the-country drugs has been extremely successful in that respect, and I think the question is: Are prescription drugs sufficiently different from other products to identify special treatment? And if so, or if not, what kinds of safeguards are appropriate?
That concludes my statement. I look forward to the hearing.
MS. PEDERSEN: Thank you very much, Mr. Schultz.
Let me then now say a quick word about the procedures that we will be following today, and then we will get started with our first panel.
First, for anyone who did not get it, there is an agenda available outside that lists the panel members, the speakers, and the time allotments.
Second, as we specified in the Federal Register, members of the panel will hear from speakers and be able to ask them questions, but we will not be permitting speakers to be questioned from the floor. However, if members of the audience have questions that they would like asked, please fill out the form that you will find attached to the agenda and hand it to the FDA representatives who will be walking around the room. Within applicable time constraints, we will try and pose as many of those questions as we can, and any questions that we are not able to get to will be made part of the administrative record so that people can see them and file responses if they would like to.
As we also announced in the Federal Register, the administrative record will remain open in this matter until December 29, 1995. This will permit additional comments, responses to questions, and additional information for the agency to consider.
Transcripts of this hearing will be available in about two weeks. If you would like to order one, you should see Gloria Ortega who is the hearing clerk, or you can call the advisors and consultants staff at CDER to order one.
Finally, anyone who has not signed up to be a speaker but who would like to make a presentation should contact Lee Zwanziger, who is over against the wall. We will try to accommodate any of these last-minute requests if we have the time to do it. And if we can't, obviously there remains plenty of time to file written comments to the record.
As indicated on the agenda, we are going to have ten panels of speakers who will be making presentations. We are going to try and do four this morning, three this afternoon, and three tomorrow morning. All members of the panel should come up to the table to my left and speak in the order specified on the agenda. We will hold all questions from the FDA panel until all of the speakers have made their presentations.
For the record, each speaker should introduce him- or herself and make the requested disclosures that are on the handout. And for consistency, we are asking each of the speakers to go through the five disclosures specified on the handout.
Finally, we do have a pretty full schedule today, and we are going to try and keep to it. I think all the speakers have been advised we will be using an electric timing system which will give each of the speakers 15 minutes. For 10 minutes there will be a green light; for 5 minutes there will be a yellow light; and then when time has expired, the red light will come on, and after 15 seconds it will start flashing. I have the beeper turned in the off position, and hopefully it will remain that way. But we are trying to both keep to the schedule and be fair in time allocation.