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1


GOVERNMENT

OF

THE UNITED STATES OF AMERICA


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FOOD AND DRUG ADMINISTRATION


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PUBLIC HEARING


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ELECTRONIC SUBMISSION OF REGULATORY INFORMATION AND CREATING AN ELECTRONIC PLATFORM FOR ENHANCED INFORMATION MANAGEMENT


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Monday

December 18, 2006


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9:00 a.m.


PANELISTS PRESENT:


JANET WOODCOCK Deputy Commissioner

RANDALL LUTTER Panelist

RANDY LEVIN Panelist

ARMANDO OLIVA Panelist

KEVIN FAIN Panelist

LANA SKIRBOLL Panelist

KEN BUETOW Panelist

BARBARA MITTLEMAN Panelist

CLARK NARDINELLI Panelist


The transcript constitutes the minutes from the public hearing held on December 18, 2006.


A-G-E-N-D-A


Presentations to the Panel


S. Albert Edwards

TAP Pharmaceutical Products 10


Thomas W. Littlejohn

Piedmont Medical Group 34


Ron Celeste, ThinSpring 55


Tom Klaff, Surety 97


Nancy Smerkanich

Octagon Research Solutions 113


Mark Scheineson, Alston & Bird, LLP 138


Debra Bremer, Pfizer 150


Diana McKenzie, Amgen 157


Sue Dubman, Theravance 161


Bob Beck, Fox Chase Cancer Center 167


Diane Paul, CRIX . . . . . . . . . . . 173


Dan Ruggles, Liaison Technologies . . . 178


Mark Adams, Booz Allen Hamilton . . . . 183


Ed Tripp, Abbott Laboratories . . . . . 211


Bill Rosen, Pfizer . . . . . . . . . . 225


John Rapoza, JRRapoza Associates . . . 253


Ari Kaliannan

Newtech Global Solutions . . . . . . . 255


Mark Rutkiewicz, AGA Medical. . . . . . 263


Presentations to the Panel (cont.)


Jason Rock, Global Submit . . . . . . . 287


Laurie Rose, SAS . . . . . . . . . . . 307


Harry Fisher, Northrop Grumman . . . . 328


Robert Cothran, Northrop Grumman . . . 335


Terence Zagar, Northrop Grumman . . . . 347


Public Comments


Bob Bard, Aastrom Biosciences . . . . . 363


Michael Brennan, Centocor . . . . . . . 367


Bill Kubeck, Steeple Laboratories . . . 368


Antoinette Azevedo

e-Submissions Solutions . . . . . . . . 372


Madeline Palla

Animal Health Institute . . . . . . . . 375


Stephanie Vatleit

Animal Drug Alliance . . . . . . . . . 376

P-R-O-C-E-E-D-I-N-G-S

9:44 a.m.

DR. WOODCOCK: Good morning, I'm Janet Woodcock. I'm Deputy Commissioner for Operations at the Food and Drug Administration and I'll be serving as the presiding officer at this hearing. On behalf of the Commissioner of Food and Drugs, Andrew von Eschenbach, I'd like to welcome you to this public hearing on electronic submission of regulatory information and also on creating an electronic platform for enhanced information management.

With me today on the panel that will be listening to the presentations are: Dr. Ken Buetow who is Associate Director for Bioinformatics and Information Technology at the National Cancer Institute; Mr. Kevin Fain who is Associate Chief Counsel, Food and Drug Administration; Dr. Randy Levin, Director for Health and Regulatory Data Standards at Food and Drug Administration; Dr. Randy Lutter, Associate Commissioner for Policy and Planning at FDA; Dr. Armando Oliva, Deputy Director for Bioinformatics in the Office of Critical Path Programs at FDA; and Dr. Lana Skirboll, Director of Policy and Planning at NIH. And it's no accident that NIH and FDA are together on this panel. We have a great deal of both agencies' interest in these various topics.

So first let me describe briefly the issues we're going to be talking about today and then I'll review the format for this hearing. FDA and NIH is interested in hearing about issues concerning the feasibility and effect of an all-electronic submission environment as well as issues related to the electronic regulatory information exchange platform. Over the last decade FDA has been moving toward transforming all regulatory submissions from paper to electronic means. For example, we've issued regulations related to voluntary electronic submissions of regulatory information which many of you are familiar with. We've also issued numerous guidance documents to assist in the submission of these various regulatory documents in electronic format. We've also collaborated with manufacturers, with standard development organizations, with healthcare information suppliers and other government agencies to develop data standards and build databases for sharing certain clinical trial information. NIH has also in the last five years been extremely interested in sharing clinical trial information on behalf of its investigators and the research it pursues.

To help us answer our questions related to these two issues, we published in the Federal Register on November 21, 2006, an invitation to interested organizations and individuals to participate in making presentations at today's meeting specifically addressing the questions that were listed in the notice. These questions were divided into the two topics. The first set of questions addressed the transition from paper submissions to electronic submissions, related costs, interested in time spent and how to implement this transition. Now we recognize there are a broad range of FDA-regulated products and that they're on a spectrum of experiencing electronic submissions right now. Some product areas such as pharmaceuticals, there's a great deal of electronic submission. In other areas, much less to no electronic submission and few associated standards. And therefore, we recognize that whatever we do we're going to have to take a step-wise approach to implementation depending on the particular area on where we're starting and that will probably influence how long it would take to get there.

Now the second set of questions relate to the concept and feasibility of an electronic platform that would facilitate the exchange of clinical research information and regulatory product information and the role of the public-private partnership in the creation of such a platform. Our experience to date has shown that, although we may have the standards in certain areas for electronic submission, we don't perhaps quite have the network.

Fourteen people signed up today to help answer those questions and we'll hear from those folks first. When that is done and if time permits we'll open the floor to anyone else who may wish to address those questions. If you're a scheduled speaker, we request you stay within the allotted time and I will make sure you do.

Before we go on, let me stress this is a listening exercise for FDA and the NIH. We really want to hear what you have to say on these issues. We are having this meeting transcribed, we hope, and the members of this panel and their staff will pay careful attention to what is said today as we decide our future course. And I expect that you can look forward to prompt action from us on these matters. The direction will depend in part upon the input we receive today. The docket will continue to stay open until February 16, 2007 to receive additional comments.

Now there are several housekeeping items I'd like to address. Number one, please restrict yourselves to this room, the hallways, the stairs if you like and the lavatories, and do not move otherwise about the building because it's an FDA facility and there are other people working. At lunch we have only an hour. There is across Fisher's Lane a cafeteria-style public restaurant that you can go to and there are some other restaurants down. You go out this door and go to your left. So but we have talked to the folks across the way and told them they may expect a larger group today, so hopefully they will be ready and so we can all reconvene promptly at the time for the afternoon. So we have a very busy day and I'd like to begin with our first speaker.

Okay, our first speaker is Dr. S. Albert Edwards, who is the Director of Regulatory Affairs at TAP Pharmaceutical Products, Inc. He will speak for 30 minutes. Dr. Edwards.

DR. EDWARDS: Okay, thank you very much. I'm here today in my current role as the Director of Regulatory Affairs and Operations. If I were speaking to you 20-some years ago, and I'm not going to divulge the exact number of years, I could say I'm Al Edwards and I'm here talking to you from the FDA. So I've kind of sat on both sides of things and I would say to you initially I wish in my lifetime early on I had access to electronic submissions to have done my job. The greatest enemy I guess that I faced at FDA in my time was the fact that I would get to that very, very last volume in the NDA and then I'd have to go into the documents room and I'd have to try and find it. Documents rooms then got closed and secured which was a good idea at FDA at the time, but then it put all the documents in the control of the document clerk and if you wanted your volume soon, you had to come up with an incentive plan. And my incentive plan was to always turn in my volume request with a suitable incentive, okay? I'll talk more about more formal incentives later, but those kind of things were needed.

Back to present day. I want to share with you eight observations that I have about electronic submissions. Those span about the 10 years of experience that I've had and this next slide will show you what TAP's experience has been completing about 700 ECTD submissions to date. We did a complete conversion in September of `05. That conversion included all original INDs, supplements and amendments. The conversion also included all original INDs and amendments. And the last thing we did was convert all of our existing applications. So we are a 100 percent ECTD shop.

FDA is our customer. I can reinforce that because I sat on the other side of the fence many years ago. I'm not going to take time to read this entire slide, and Dr. Woodcock, when I get to my allotted time I know you're going to cut me off. So everybody has my handout. Overall it has taken TAP some time to put the ECTD process in place. I want to emphasize that that's process and technology on our side of the fence. I suspect it will be on FDA's as well. We have some improvements along the way and that is we intend to control content and meta-data from authoring through submissions to archival. We believe that the electronic tool sets are currently available for others to manage information and complete ECTD submissions, as well.

Let me take you on my travels through these general observations. A couple of footnotes along the way. Number one, I recently learned in an important meeting that adult audiences really won't listen to you unless you give them about five why's for everything you tell them. So you will see "why" pop up on the screen here very often. That's to convince you or at least open your mind to my points. Some of my points will be, `Oh yes, Al, we already know that. Please go on.' Some of them will be rather controversial and so that's kind of the span of where we're going today.

Number one. We, meaning FDA and industry, should be a partnership, must work closely together and listen attentively to each other's concerns. Why? Computers are fussy beasts and the information must not be changed when it's moved from one electronic environment to another. Two, second why, again my former life as a reviewer. Reviewers depend on this information. It's their day-to-day feeding and care that happens, to perform their job functions. Also, the industry depends on this information submitted to support and maintain healthcare product approvals. Why again? If electronic systems cannot talk to each other successfully and share unchanged information, the process can be compromised. I'm not saying it's compromised every time, I'm saying it can be.

Observation number two. We must carefully select and closely supervise any third party that may handle electronic systems and any information stored, either by FDA or by us in industry. This is contract organizations that produce, transmit and otherwise interface, touch e-submission information. Why? The lifecycle of a healthcare product, the development, marketing of a prescription drug for instance, and I know there are other products at issue here, is a long-term process that could last decades. In contrast to that why, the lifecycle of electronic systems and software is much shorter than a healthcare product lifecycle. Only third parties with extensive appreciation for and commitment to managing the disconnect between this long lifecycle that we have for our healthcare products and the short cycle for systems and software should be considered suitable candidates for handling e-submission information. For the good of patients that we serve we need to be in this for the long haul, folks. It's not just something you can do on Sunday afternoon. Forget about it.

Again, still on observation two, why? Disconnects resulting in information migration and retrofits are costly endeavors. Migration and data retrofits may be likely outcomes when inexperienced, low-bid, third party contractors are used. Why? This is not only a dollar cost, it is a time cost. Migration and retrofits take time. Systems are down. Delays disadvantage patients or consumers, whether the delays originate in FDA or from us in the industry.

Finally, confidentiality issues may arise due to incidental or inappropriate release of information. I would let you know that most of these releases are not due to the system, they're actually due to humans. And so therefore staff at third party organizations have to be of suitable quality and they must be invested in the security of the information that we entrust to them. Very, very important.

Observation number three. We must jointly learn how to handle and access repetitive e-submission information., Investigator Forms 1572s, and updates more efficiently and find ways to reduce that workload. Now I'm speaking about prescription drugs. That's been my life for the last, well, let's say 20-plus years. Let's not go there. But it's been a long time. And we must find ways to more efficiently handle that information. I would say current industry submission systems are clogged with this information and it easily accounts for 20-50 percent of an average month's submission activities.

The current trained labor force, and I think this was in the Federal Register as well, from e-submissions available within the U.S. is not sufficient today to handle the upward spiral of this workload if we add more to it. Why? I think we must change and we must turn our attention to and use our limited resources to handle more difficult and challenging repetitive submission types. My example here is advertising and promotion submissions. This will require at a minimum the integration of three-dimensional scanning and viewing. We all watch TV every day. We have camera phones. There are other forms of video. I think that you know - one of the folks in my office always asks me, `What you're saying, can it pass the Washington Post test?' And I guess I would challenge all of us, whether we have FDA jobs or NIH jobs, NCI jobs, industry jobs, if we said, we do this number of submissions electronically, but yet we almost have a whole group of submissions over here, advertising and promotion, other things, and we don't do anything for those. We don't enable those in any way. Would that fly? And I'll just leave that kind of as an open question.
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