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Transcript of Pharmaceutical Marketing and Information Exchange in Managed Care Environments - Day 2 Introduction

Department of Health and Human Services
Public Health Services
Food and Drug Administration
FDA Public Hearing

Friday, October 20, 1995

8:35 a.m.

Quality Hotel
3727 Colesville Road
Silver Spring, Maryland



Amanda Pedersen, J.D., M.P.H., Panel Chair

Panel Members

  • Ilisa Bernstein, Pharm.D., J.D.
  • Minnie Baylor-Henry, R.Ph., J.D.
  • Larry BraslowLaurie BurkeD.
  • Bruce Burlington, M.D.
  • Norm Drezin, Esq.
  • Louis A. Morris, Ph.D.
  • Bill Purvis
  • Toni Stifano
  • Byron L. Tart, Jr.
  • Robert Temple, M.D.
  • Diane Thompson
  • Ann Wion
  • Janet Woodcock, M.D.



Call to Order: Dr. Pedersen

Overview of Hearing Procedures: Ms. Pedersen


  • Richard Jay, Pharm.D.
  • James R. Lang
  • Elizabeth Dichter
  • Per Lofberg and Russell Teagarden


  • Peter J. Neumann, Sc.D.
  • John E. Calfee, Ph.D.
  • David R. Henderson, Ph.D.
  • Dale A. Bultemeier, Ph.D.


  • Bruce N. Kuhlik
  • Diane Zipursky
  • Jeffrey N. Gibbs
  • Richard A. Samp
  • Harry A. Sweeney, Jr.


  • Victor Dorodny, M.D., M.P.H.
  • Edward L. Lennard, Pharm.D
  • Questions for Speakers
  • Public Comment

Closing Remarks



MS. PEDERSEN: If you would all please take your seats, we would like to get started.
I am Amanda Pedersen, FDA's chief mediator and ombudsman, and I will be chairing this hearing again today. This is the second day of a hearing being held under Part 15 of FDA's regulations on pharmaceutical marketing and information exchanged in the managed care environment.
For those of you who were not here yesterday, and because there have been some changes, I would like to have the panel reintroduce itself, starting with Dr. Woodcock to my left.
DR. WOODCOCK: I am Janet Woodcock. I am director of the Drug Center at FDA.
DR. BERNSTEIN: Good morning. I am Ilisa Bernstein, senior science policy advisor in the Office of the Commissioner.
MR. DREZIN: Good morning. I am Norman Drezin, and I am the acting deputy director of the Division of Drug Marketing, Advertising and Communications.
MS. BAYLOR-HENRY: Good morning. I am Minnie Baylor Henry, acting director, CDER/Drug Advertising.
MS. BURKE: I am Laurie Burke, a senior regulatory research officer, DDMAC/CDER.
MR. TART: Good morning. I am Byron Tart. I am the director of the Promotion and Advertising Policy Staff in the Center for Devices and Radiological Health.
MS. WION: Good morning. I am Ann Wion, deputy chief counsel for program review in the Office of the Chief Counsel.
DR. MORRIS: Lou Morris, chief of the Marketing Practices and Communications Branch in DDMAC and Center for Drugs.
MR. PURVIS: Good morning. I am Bill Purvis, director of the Advertising and Promotional Labeling Staff in CBER.
MR. BRASLOW: Good morning. I am Larry Braslow, director of the Economic Staff in the Office of Planning and Evaluation.


MS. PEDERSEN: Thank you.
Let me also just very briefly review the procedures that we will be using. I wanted specifically to mention that although members of the audience cannot directly pose questions, there is a question form attached to the agenda, or you can just use a blank piece of paper and write your questions down, hand them to the FDA representatives who will be walking up and down the aisles, and we will try and pose as many of those questions to the panel as we can. If we are not able to get to them all, they will be placed in the administrative record for further comment and consideration.
Second, anyone who has not signed up to be a speaker but who would like to make a presentation should contact Lee Zwanziger, if you could, standing over there against the wall. There will be a public comment section at the end of the day today, and we will try and allot time to as many speakers who choose to make a brief presentation at the end.
On the agenda, as it is indicated, we will be hearing from four panels, two this morning and two this afternoon. As the first panel has already done, we would like all members of the panel to come up at the same time, and then they will speak in the order indicated on the agenda. We will hold all of our questions until all speakers have presented. Each speaker should introduce him or herself and then make the requested financial disclosures that are listed on the form that are taped to the table for you.
We are giving each speaker 15 minutes. The green light on the timer system will be on for 10, the yellow light on for 5, and then the red light will come on when time has expired.



DR. WOODCOCK: Thank you, Amanda.
To summarize the last day and a half of meetings, I think we have heard a wide range of opinions and input on the issues that we set forward to hear about, and I think this has been successful in providing the FDA staff with information on these very important issues.
Despite the disparity of opinions, I think there is a consensus on a number of things. Number one, the medical care delivery world is changing and is going to continue to change and is not going to go back to the world that we are used to so long with the provider and the patient, that the relationship between physicians, pharmacists, providers and purveyors of medical products is continuing to evolve. We are in the midst, it sounds to me. There is a consensus of continuing change, and the configurations we see and are discussing today are probably not going to be the configurations one year or five years hence.
It also seems clear and agreed upon there is a great hunger for cost-effectiveness data everywhere and comparative data. But there doesn't seem to be a consensus on how valid the existing data might be or how valuable.
There were a number of clearly contentious issues. We talked about the regulation of information provided by manufacturers to managed care. Pharmacoeconomic information was a major subject. All other information was also brought up as far as the regulation of all types of information provided by manufacturers, and then some speakers even said why stop at managed care. I think this is one major issue that we got a fair amount of input on.
The second issue is the relationship of manufacturers, managed care, marketing and information dissemination by managed care as a result of this relationship. We heard a lot about the fact that although there are vertically integrated pharmaceutical manufacturers plus various drug delivery groups, there is a desire for a level playing field and these distinctions which seem clear-cut perhaps as far as ownership, or actually when you look at the relationships, are not that clear-cut.
So you might have a managed care organization that was quite independent or a pharmacy benefit manager that seems quite independent, we have a lot of contractual relationships that, once you looked under the surface. And there was a request that whatever interventions FDA would be considering, whether we consider across-the-spectrum of these different arrangements.
There was also a lot of talk about independence, transparency and things we have just been discussing in these arrangements and in their impact on physicians and on the ultimate consumer, the patient.
The next steps for us after we conclude this, the docket, as you have heard, will stay open until the end of December. We really would like to encourage those who wish to comment on these proceedings or have further information or further opinions in this area to contribute to the docket.
Internally, FDA will be convening some work groups to work on these sets of issues that we have been discussing as comments come in to the docket. We will not comment publicly or make any further public indications until after the docket is closed. But hopefully soon after that we can indicate what direction we will be taking on this important set of issues.
I would like to thank all the people who have testified and assisted us in this area of regulation.
DR. PEDERSEN: I would like to second that and also to say that all of the questions and comments submitted from the floor that did not get directly addressed will also be made part of the docket, and we do encourage any additional submissions up through December 29, 1995.
Thank you very much. This completes the public hearing portion of this docket.
[Whereupon, at 4:00 p.m., the hearing was adjourned.]