Department of Health and Human Services
Public Health Services
Food and Drug Administration
FDA Public Hearing
Thursday, October 19, 1995
3727 Colesville Road
Silver Spring, Maryland
Amanda Pedersen, J.D., M.P.H., Panel Chair
FDA Panel Members:
- 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.
- Toni Stifano
- Byron L. Tart, Jr.
- Robert Temple, M.D.
- Janet Woodcock, M.D.
Call to Order: Amanda Pedersen, Panel Chair
Overview: Amanda Pedersen, Panel Chair
- Loren Abdulezer, Evolving Technologies Corporation, New York, New York
- Irving Schwab, Evolving Technologies, Corporation, New York, New York
- Wendy Borow, Medicus Group International, Inc., New York, New York
- Jim Sandino, Medicus Group International, Inc., New York, New York
- Alicia Martinez, Giant Food Pharmacy Support Service, Washington, D.C.
- Cindy Pearson, National Women's Health Network, Washington, D.C.
- Sidney Wolfe, M.D., Public Citizen's Health Research Group, Washington, D.C.
- Juliet J. Goodfriend, Strategic Marketing Corporation, Bala Cynwyd, Pennsylvania
- Leo Brandstatter, Rubin Ehrenthal & Associates, New York, New York
- Arthur Hayes, M.D.
- Joe Davis
- Jean-Pierre Bader, M.D.
CALL TO ORDER
DR. PEDERSEN: Good morning. I am Amanda Pedersen, FDA's Chief Mediator and Ombudsman. This is the second day of a Public Hearing being held under Part 15 of FDA's Regulations to solicit information and views on the promotion of prescription drug products directly to consumers.
At this point, because there have been some changes from yesterday both in terms of the audience and the Panel, I would like to go around and have the Panel introduce ourselves to you starting on my right.
MS. STIFANO: Toni Stifano, Senior Regulatory Review Officer, CBER's Advertising and Promotional Labeling Staff.
DR. MORRIS: Good morning. I am Lou Morris from the Center for Drugs, the Division of Drug Marketing, Advertising and Communications.
MR. TART: Good morning. I am Byron Tart. I am the Director of the Promotion, Advertising and Policy Staff, Center for Devices and Radiological Health.
DR. OSTROVE: Good morning. I am Nancy Ostrove from the Division of Drug Marketing, Advertising and Communications.
MS. BAYLOR-HENRY: Good morning. I am Minnie Baylor-Henry, Acting Director, CDER, DDMAC.
MR. DREZIN: Good morning. I am Norman Drezin, the Acting Deputy Director of the Division of Drug Marketing, Advertising and Communications.
DR. TEMPLE: Good morning. Bob Temple, Associate Director for Medical Policy, CDER.
DR. BERNSTEIN: Good morning. I am Ilisa Bernstein, Senior Science Policy Advisor in the Office of the Commissioner.
DR. WOODCOCK: Janet Woodcock, Director of the Drug Center at FDA.
DR. PEDERSEN: Thank you. For the benefit of those who were not here yesterday, let me say a quick word about procedures and then we will get started. Members of the Panel from FDA will hear from speakers and be able to ask them questions but we are not going to permit questions to be asked from the floor.
However, if members of the audience would like to ask questions, there is a form attached to the agenda or you can simply write them on a piece of paper and submit them to the FDA people who are out walking around. Lee Zwanziger is over there. The questions will be collected.
If we have time, we will pose them to the Panel for response right now. If we don't have time, we will include them for the record so that others can see them and they can be commented on, as the record is held open until December 29, 1995.
Anyone who has not signed up to be a speaker but would like to make a presentation should also see Lee Zwanziger. We do have a little time at the end of this morning and I think there is at least one additional speaker who has asked to be put on the agenda. So you should see Lee Zwanziger as soon as possible if you would like to make a presentation.
Our plan is to hear from three panels of speakers this morning. Each of the speakers on the designated panel should come up to the table and then speak in the order that is indicated on the agenda. We will hold questions until all speakers have presented.
Each speaker should introduce him or herself and make the requested financial disclosures that are both in the handout and taped to the table. For consistency in terms of reading the record, we would ask that each speaker address the five points in the order that they are listed.
Finally, as you will see, we are using an electric timing system to help us keep to schedule. All the speakers have been allotted 15 minutes and I will not start the timer until after the financial disclosure portion has been made. The green light will be on for 10 minutes, the yellow light on for five minutes and then the red light will come on at which point the speaker will need to conclude his or her remarks.
With that, I would like to turn to our first panel this morning. We have Loren Abdulezer and Irving Schwab, Wendy Borow and Jim Sandino, and Alicia Martinez, starting first with Loren Abdulezer and Irving Schwab.
I would like to now ask Dr. Temple to say a few concluding remarks on behalf of the Center for Drugs.
DR. TEMPLE: We all want to thank everyone for taking so much time and effort to come and give us advice on what to do about direct-to-consumer advertising. It seems only fair that we respond by telling you exactly what we're going to do over the next two years, but I thought about that and decided we shouldn't yet.
DR. TEMPLE: Because the comment period is staying open until December 29, and you should know that. Anything you want to add in response to what other people have said, that you want to rebut, comment, elaborate on, please feel free to do so. You have until essentially the end of the year.
We can't, of course, reach conclusions yet, but I would offer a few observations. The brief summary is not popular and had no explicit friends. It seems to be something like a fish floating belly-up and with little going through its gills.
DR. TEMPLE: There was a very wide range of views about whether most direct-to-consumer advertising is communicating real or useful information or is really there as a stimulus to get people into the doctor's office where real, important information would be communicated. I don't think there's a consensus on that.
But really, no speakers took a position that at least some kinds of direct-to-consumer communication would not be useful. How to be sure that it is useful, how to be sure there's balance and so on remains a very critical issue.
Pre-clearance was generally thought clumsy and unnecessary by people connected with advertising and by people emphasizing First Amendment principles. Some, but not all, speakers thought that guidance at some level of detail was needed, and I think there's considerable discussion and consideration needed about that.
There was enormous consciousness of the many new modes of communication that we're going to be sending all these materials out. As I said to Dr. Hayes, I still think at the bottom there is a message that one can look at that uses words and pictures in relatively traditional ways. Now, how they get distributed and what they interact with and how people find them is quite another matter.
I think most discussants assumed or at least didn't challenge the idea that promotion would be within the bounds of the package insert, but it's possible that issue wasn't really flagged for adequate discussion at this meeting and will surely come up in the next Part 15 hearing that is to follow.
So with those observations, obviously, I'm suggesting that we have a lot of thinking to do and considering to do. I want to thank everyone and close the meeting.
Amanda, are there any final--
MS. PEDERSEN: Yes. I wanted to add to Dr. Temple's specification that the hearing record will remain open until December 29, and I think you heard from many members of the panel sort of an interest and an eagerness. If there is data out there that could be submitted to the agency, FDA is a data-driven agency. We are always interested in seeing data, as well as comments that have been provoked by our very interesting and, I think, provocative discussion over the last day and a half.
This does conclude the oral portion of this proceeding, but, obviously, until the record is closed, the proceeding is ongoing on a written basis.
Thank you all very much.
[Whereupon, at 12:00 p.m., the hearing was adjourned.]