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
Call to Order: Amanda Pedersen, Panel Chair
FDA Introductory Remarks: Janet Woodcock, M.D.
Overview of Hearing Procedures: Amanda Pedersen, Panel Chair
- Mitchell E. Daniels, Jr., North American, Pharmaceutical Operations, Eli Lilly & Co.
- Stephen Stefano, Health Management Division,, Glaxo Wellcome, Inc.
- Bryan R. Luce, Ph.D., Panel on Cost-Effectiveness in Health and Medicine and MEDTAP International, Arlington, Virginia
- Alan L. Hillman, M.D., M.B.A., Task Force on Principles for Economic Analysis of Health Care Technology, and Leonard Davis Institute of Health Economics, University of Pennsylvania
- Jonathan Lax, The Marketing Audit, Philadelphia, Pennsylvania
- Elizabeth Moench, MediciGroup, Inc., King of Prussia, Pennsylvania
- Allan Zimmerman, Academy of Managed Care Pharmacy, Alexandria, Virginia
- William A. Zellmer, American Society of Health System Pharmacists, Bethesda, Maryland
- Calvin Knowlton, M.Div., Ph.D., American Pharmaceutical Association, Washington, D.C.
- Juliet J. Goodfriend, Strategic Marketing Corporation, Bala Cynwyd, Pennsylvania
Day 2: Contains Panel 3, Panel 4, Panel 5, Panel 6, and Closing Remarks
DR. PEDERSEN: Good afternoon. I am Amanda Pedersen, FDA's Chief Mediator and Ombudsman. I will be chairing this hearing on "Pharmaceutical Marketing and Information Exchange in the Managed Care Environment". This is a public hearing which was announced in the Federal Register on August 14, 1995, and will be conducted under Part 15 of FDA's regulations.
The purpose of this hearing is to solicit information and views concerning the potential impact of changing organizational structures and information dissemination channels in the managed care setting on the agency's responsibilities to regulate drug marketing and promotion.
The agency is particularly interested in exploring the issues surrounding new modes and techniques of drug information dissemination and the formation of alliances between manufacturers and prescription benefit management companies.
At this point, I would like the members of the FDA Panel to introduce themselves starting this time to my left with Dr. Woodcock.
DR. WOODCOCK: Janet Woodcock. I am Director of the Drug Evaluation and Research Center at FDA.
DR. BERNSTEIN: I am Ilisa Bernstein, Senior Science
Policy Advisor in the Office of the Commissioner.
DR. TEMPLE: Good afternoon. I am Bob Temple. I am Associate Director for Medical Policy in CDER.
MR. DREZIN: Good afternoon. I am Norman Drezin. I am Acting Deputy Director of the Division of Drug Marketing, Advertising and Communications.
MS. BAYLOR-HENRY: Good afternoon. I am Minnie Baylor-Henry, Acting Director, CDER, Drug Advertising.
MS. BURKE: I am Laurie Burke, Senior Regulatory Research Officer, DDMAC, CDER.
MR. TART: I am Byron Tart. I am the Director of the Promotion, Advertising and Policy Staff in the Center for Devices and Radiological Health.
DR. MORRIS: I am Lou Morris, Chief of the Marketing and Communications Branch in DDMAC in CDER.
MS. STIFANO: Good afternoon. I am Toni Stifano, Senior Regulatory Review Officer, Center for Biologics, Advertising and Promotional Labeling Staff.
MR. BRASLOW: Good afternoon. I am Larry Braslow, Director of the Economics Staff, the Office of Planning and Evaluation.
DR. PEDERSEN: I would also like to note that tomorrow we will be joined by three additional panelists: Mary Pendergast, the Deputy Commissioner; Ann Wion, Deputy Chief Counsel; and Diane Thompson, the Associate Commissioner for Legislative Affairs.
At this point, Dr. Woodcock will make some opening remarks.
DR. WOODCOCK: Thank you, Amanda.
The reasons that sparked us having this hearing and listening to various inputs on the questions that are going to be facing us today and tomorrow is that we have observed a remarkable evolution and change in the way health care is being delivered in the United States and we recognize that this is something that is in evolution and in flux and that additional changes are to be expected.
In particular, the ways in which health care is delivered affect drug marketing and promotion activities and have changed them from their traditional forms. The physician-patient relationship and the physician as the gate keeper and provider and prescriber of medications, this whole structure is being changed in a variety of different ways. FDA must understand this changing environment and adapt our regulatory principles to assure that our goals of protecting and promoting the public health are met.
The medical marketplace itself is really vastly different than it was 30 or 15 or even two years ago. The medical products that we regulate are being purchased by third parties. Medical product communication is often directed toward managed care organizations and managed care decision makers and then, subsequently, toward physicians.
Direct comparative information on effectiveness, safety, and cost effectiveness is a kind of information that is being sought by these managed care organizations in order to make formulary decisions on drugs and other medical products.
FDA's responsibility to promote the public health includes the concern that decisions about these medical products are based on truthful and non-misleading information, but also that all available truthful and non-misleading information can flow to the people who have to make the decisions.
Now, another related change that we've recently observed is the expansion of business by the traditional marketers of prescription drug products to include the distribution channels for these pharmaceuticals. FDA needs to be concerned that these changing organizational structures can have implications on manufacturers' responsibilities to maintain accuracy, reliability, and balance in the information they disseminate.
What we need to have people help us address at this hearing is how, if at all, should FDA respond to these changes in the health care delivery system and the changes in marketing strategies that are being spawned by these changes.
On an informal basis, FDA has held a series of discussions with pharmaceutical companies and with managed care organizations to gather information concerning the evolving pharmaceutical marketplace. These discussions have served to heighten our level of concern for the marketing issues that these changing health care paradigms raise.
The hearing we are conducting today and tomorrow is our first formal step in developing policies to assure that health care decision makers have access to the information they need to make the best possible decisions and that the public health is protected at the same time by assuring that false or misleading promotional information does not become the basis for medical decision making. I think the importance of this balance cannot be overestimated.
Thus, we ask for your help in these deliberations. We are anxious to hear the testimony. As you are prompted during these hearings, we hope you will seriously consider a written submission that will either emphasize or clarify the issues that are raised here. The hearing docket will be open until the end of the calendar year and we would welcome any submissions. Thank you very much.
MS. PEDERSEN: Thank you, Dr. Woodcock.
Let me now say a brief word about the procedures that we will be following this afternoon, which, for those of you who were participating in the direct-to-consumer advertising hearing that we held yesterday and this morning, will sound very familiar.
First, all of you should have an agenda listing the Panel members as well as the speakers and the time allotments.
Second, members of the Panel will hear from the speakers and be able to ask them questions, but we will not permit speakers to be questioned from the floor. If members of the audience have questions, however, please use the form attached to the agenda or just a simple piece of paper and pass them up to the FDA representatives that will be up and down the aisles and we will try and ask as many questions as we have time for. If we don't have time to get to them, they will be placed in the administrative record so that they can be taken into account and commented on as this process continues.
As Dr. Woodcock indicated, we will be encouraging people to file comments after this hearing is concluded tomorrow afternoon and we will be keeping the record open until December 29. Transcripts of the hearing will be available in about two weeks. If you want to order a transcript, you can speak to Gloria Ortega at the back desk or call the Advisors and Consultants staff at the Center for Drugs and they will be able to help you.
As indicated on the agenda, we will be hearing from six panels on this subject, two this afternoon, two tomorrow morning, and two tomorrow afternoon. All members of the panel should come to the table at the same time and speak in the order indicated on the agenda. We will hold our questions until all speakers have had an opportunity to present.
Each speaker should introduce him or herself and make the requested financial disclosures that are listed on the form, and those are taped to the tables there for your convenience. For consistency, we are also asking that each of the speakers address each of the points there in the same order so that the record will be clear.
We have a very full schedule this afternoon and we will be making every effort to keep to that. To help us do that, we are using an electronic timing system and I will not start the timer, which each speaker has 15 minutes, and I will not start the timer until you have made your financial disclosures. The timing will be green for ten minutes, yellow for five minutes, and then it will turn to red, at which point the speaker needs to conclude his or her remarks. For the speakers who are sharing presentations, we also can set it for seven-and-a-half and seven-and-a-half, if you will just let me know which you would like to do.
With that brief introduction, let's now go to the first panel. Our first speaker will be Mitchell Daniels.