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Table 6. PDUFA IV Meetings – Technical Discussions with Regulated Industry Direct-to-Consumer Advertising Sub-Group

Date Time Length	Subjects	Participants
3/30/06 1:00 to 3:00 PM 2 Hours	FDA proposal for additional PDUFA IV funding for FDA to review DTC broadcast advertisements. FDA response to industry's data request pertaining to DTC advertising review.	FDA: Jane Axelrad, CDER Thomas Abrams, CDER Nancy Boocker, CDER Kristin Davis, CDER Melissa Moncavage, CDER Maryann Gallagher, CBER PhRMA/BIO: Tony Rogers, AstraZeneca/PhRMA Preeti Pinto, AstraZeneca/PhRMA Alan Goldhammer, PhRMA Scott Lassman, PhRMA Annetta Beauregard, Eli Lilly/PhRMA Sara Radcliffe, BIO Donna Paterson, Amgen/BIO Andrew Emmett, BIO
4/19/06 1:00 to 3:00 PM 2 Hours	Additional information about FDA's DTC proposal Possibility of separate fee for DTC PhRMA presentation of their Guiding Principles on DTC advertisements.	FDA: Jane Axelrad, CDER Thomas Abrams, CDER Nancy Boocker, CDER Kristin Davis, CDER Melissa Moncavage, CDER Maryann Gallagher, CBER Seth Ray, OCC Emily Thakur, CDER Industry: Tony Rogers, AstraZeneca/PhRMA Preeti Pinto, AstraZeneca/PhRMA Alan Goldhammer, PhRMA Scott Lassman, PhRMA Annetta Beauregard, Eli Lilly/PhRMA Sara Radcliffe, BIO Patrick Brady, Eli Lilly/PhRMA Minnie Baylor-Henry, J&J/PhRMA
4/26/06Teleconference 1:00 to 3:00 PM 2 Hours	FDA's current workload for DTC broadcast review and estimating the number of submissions anticipated if user fees and performance metrics are developed.	FDA: Jane Axelrad, CDER Thomas Abrams, CDER Nancy Boocker, CDER Kristin Davis, CDER Melissa Moncavage, CDER Maryann Gallagher, CBER Bob Sausville, CBER Seth Ray, OCC Emily Thakur, CDER Industry: Tony Rogers, AstraZeneca/PhRMA Preeti Pinto, AstraZeneca/PhRMA Alan Goldhammer, PhRMA Scott Lassman, PhRMA Annetta Beauregard, Eli Lilly/PhRMA Sara Radcliffe, BIO Donna Peterson, Amgen/BIO Minnie Baylor-Henry, J&J/PhRMA Andrew Emmett, BIO
5/19/06Teleconference 9:00 to 11:00 AM 2 Hours	Assumptions for estimating the number of DTC broadcast ad pre-submissions if user fees and performance metrics are adopted. FDA's current review times for broadcast ad pre-submissions.	FDA: Jane Axelrad, CDER Thomas Abrams, CDER Nancy Boocker, CDER Kristin Davis, CDER Melissa Moncavage, CDER Maryann Gallagher, CBER Bob Sausville, CBER Seth Ray, OCC Emily Thakur, CDER Industry: Tony Rogers, AstraZeneca/PhRMA Preeti Pinto, AstraZeneca/PhRMA Scott Lassman, PhRMA Annetta Beauregard, Eli Lilly/PhRMA Sara Radcliffe, BIO Donna Paterson, Amgen/BIO Minnie Baylor-Henry, J&J/PhRMA Andrew Emmett, BIO
5/24/06 1:00 to 3:00 PM 2 Hours	Assumptions for estimating the number of DTC broadcast ad pre-submissions if user fees and performance metrics are adopted. Possibility of a workload adjustor to account for greater than anticipated workload. Possible fee funding for DTC broadcast ad review	FDA: Jane Axelrad, CDER Thomas Abrams, CDER Nancy Boocker, CDER Kristin Davis, CDER Melissa Moncavage, CDER Maryann Gallagher, CBER Seth Ray, OCC Emily Thakur, CDER Industry: Tony Rogers, AstraZeneca/PhRMA Scott Lassman, PhRMA Annetta Beauregard, Eli LillyPhRMA Sara Radcliffe, BIO Minnie Baylor-Henry, J&J/PhRMA Andrew Emmett, BIO Alan Goldhamrner, PhRMA Donna Peterson, Amgen/BIO
6/7/06 1:00 to 3:00 PM 2 Hours	DTC broadcast ad review	FDA Jane Axelrad, CDER Thomas Abrams, CDER Nancy Boocker, CDER Kristin Davis, CDER Maryann Gallagher, CBER Melissa Moncavage, CDER Seth Ray, OCC Bob Sausville, CBER Emily Thakur, CDER Industry: Minnie Baylor-Henry, J&J/PhRMA Andrew Emmett, BIO Alan Goldhammer, PhRMA Scott Lassman, PhRMA Donna Peterson, Amgen/BIO Preeti Pinto, AstraZeneca Sara Radcliffe, BIO Tony Rogers, AstraZeneca/PhRMA
6/21/06 1:00 to 3:00 PM 2 Hours	Discuss DTC TV advertisement review	FDA: Jane Axelrad, CDER Thomas Abrams, CDER Nancy Boocker, CDER Kristin Davis, CDER Melissa Moncavage, CDER Seth Ray, OCC Bob Sausville, CBER Emily Thakur, CDER Industry: Minnie Baylor-Henry, J&J/PhRMA Annetta Beuregard, Lilly Andrew Emmett, BIO Alan Goldhammer, PhRMA Scott Lassman, PhRMA Donna Peterson, Amgen/BIO Preeti Pinto, AstraZeneca Sara Radcliffe, BIO Tony Rogers, AstraZeneca/PhRMA
7/5/06 1:00 to 3:00 PM 2 Hours	Assumptions and calculations to develop cost estimates for DTC broadcast proposal.	FDA: Jane Axelrad, CDER Thomas Abrams, CDER Nancy Boocker, CDER Melissa Moncavage, CDER Bob Sausville, CBER Emily Thakur, CDER Industry: Annetta Beauregard, Lilly Andrew Emmett, BIO Scott Lassman, PhRMA Donna Peterson, Amgen/BIO Preeti Pinto, AstraZeneca Sara Radcliffe, BIO Tony Rogers, AstraZeneca/PhRMA
7/19/06 1:00 to 3:00 PM 2 Hours	Discuss DTC broadcast ad review.	FDA: Jane Axelrad, CDER Thomas Abrams, CDER Malcolm Bertoni, OC Nancy Boocker, CDER Kristin Davis, CDER Melissa Moncavage, CDER Maryann Gallagher, CBER Mark Gray, OC Bob Sausville, CBER Emily Thakur, CDER Industry: Minnie Baylor-Henry, J&J/PhRMA Annetta Beauregard, Lilly Alan Goldhammer, PhRMA Scott Lassman, PhRMA Donna Peterson, Amgen/BIO Preeti Pinto, AstraZeneca Sara Radcliffe, BIO Tony Rogers, AstraZeneca/PhRMA Bill Rosen, Pfizer/PhRMA
8/2/06Teleconference 1:00 to 3:00 PM 2 Hours	Concepts for separate fee to fund DTC broadcast ad review.	FDA: Jane Axelrad, CDER Thomas Abrams, CDER Nancy Boocker, CDER Kristin Davis, CDER Maryann Gallagher, CBER Ele Ibarra-Pratt, CBER Emily Thakur, CDER Industry: Minnie Baylor-Henry, J&J Annetta Beauregard, Lilly Andrew Emmett, Bio Alan Goldhammer, PhRMA Scott Lassman, PhRMA Donna Peterson, Amgen/BIO Preeti Pinto, AstraZeneca Sara Radcliffe, BIO Tony Rogers, AstraZeneca/PhRMA
8/23/06 1:00 to 3:00 PM 2 Hours	Discuss financial structure stability if a separate fee for funding DTC broadcast reviews.	FDA: Jane Axelrad, CDER Thomas Abrams, CDER Nancy Boocker, CDER Kristin Davis, CDER Maryann Gallagher, CBER Bob Sausville, CBER Industry: Patrick Brady, Eli Lilly/PhRMA Minnie Baylor-Henry, J&J/PhRMA Andrew Emmett, BIO Scott Lassman, PhRMA Donna Peterson, Amgen/BIO Preeti Pinto, AstraZeneca Sara Radcliffe, BIO Tony Rogers, AstraZeneca/PhRMA
8/30/06 Teleconference 1:00 to 2:00 PM 1 Hour	Discuss financial structure stability if a separate fee for funding DTC broadcast reviews.	FDA: Jane Axelrad, CDER Thomas Abrams, CDER Nancy Boocker, CDER Kristin Davis, CDER Ele Ibarra-Pratt, CBER Melissa Moncavage, CDER Bob Sausville, CBER Emily Thakur, CDER Industry: Minnie Baylor-Henry, J&J/PhRMA Annetta Beauregard, Lilly Alan Goldhammer, PhRMA Scott Lassman, PhRMA Donna Peterson, Amgen/BIO Preeti Pinto, AstraZeneca/PhRMA Sara Radcliffe, BIO Tony Rogers, AstraZeneca/PhRMA
9/20/06 1:00 to 5:00 PM 4 Hours	Discuss approaches to separate user fee funding of DTC broadcast reviews.	FDA: Jane Axelrad, CDER Thomas Abrams, CDER Kristin Davis, CDER Industry: Andrew Emmett, BIO Scott Lassman, PhRMA Tony Rogers, AstraZeneca/PhRMA
9/21/06 8:00 to 10:30 AM 2.5 Hours	Discuss approaches to separate user fee funding of DTC broadcast reviews.	FDA: Jane Axelrad, CDER Thomas Abrams, CDER Kristin Davis, CDER Industry: Andrew Emmett, BIO Scott Lassman, PhRMA Tony Rogers, AstraZeneca/PhRMA
9/26/06 Teleconference 1:30 to 2:30 PM 1 Hour	Discuss approaches to separate user fee funding of DTC broadcast reviews.	FDA: Kathryn Aikin, CDER Kristin Davis, CDER Melissa Moncavage, CDER Industry: Minnie Baylor-Henry, J&J/PhRMA Annetta Beauregard, Lilly Patrick Brady, Eli Lilly/PhRMA Preeti Pinto, AstraZeneca/PhRMA
9/27/06 1:00 to 3:00 PM 2 Hour	Discuss proposal for separate user fee funding of DTC broadcast reviews.	FDA: Jane Axelrad, CDER Thomas Abrams, CDER Nancy Boocker, CDER Kristin Davis, CDER Melissa Moncavage, CDER Seth Ray, OCC Maryann Gallagher, CBER Industry: Minnie Baylor-Henry, Johnson & Johnson/PhRMA Annetta Beauregard, Eli Lilly Andrew Emmett, BIO Scott Lassman, PhRMA Donna Peterson, Amgen/BIO Preeti Pinto, AstraZeneca
10/6/06 8:30 to 10:30 AM 2 Hours	Discuss possible legislative language	FDA: Jane Axelrad, CDER Thomas Abrams, CDER Kristin Davis, CDER Maryann Gallagher, CBER Eli Ibarra-Pratt, CBER Melissa Moncavage, CDER Seth Ray, OCC Industry: Patrick Brady, Eli Lilly Andrew Emmett, BIO Scott Lassman, PhRMA Tony Rogers, AstraZeneca Preeti Pinto, AstraZeneca
10/11/06 Teleconference 8:30 to 10:30 AM 2 Hours	Discuss possible legislative language	FDA: Jane Axelrad, CDER Thomas Abrams, CDER Nancy Boocker, CDER Kristin Davis, CDER Melissa Moncavage, CDER Maryann Gallagher, CBER Industry: Tony Rogers, AstraZeneca /PhRMA Annetta Beauregard, Eli Lilly/PhRMA Andrew Emmett, BIO Scott Lassman, PhRMA Donna Peterson, Amgen/BIO Patrick Brady, Eli Lilly/PhRMA
10/17/06 2:00 to 5:00 PM 3 Hours	Discuss proposed draft legislative language.	FDA: Jane Axelrad, CDER Thomas Abrams, CDER Nancy Booker, CDER Frank Claunts, OC Kristin Davis, CDER Kevin Fain, OCC Maryann Gallagher, CBER (by T-con) Mike Jones, CDER Marty Louviere, OC Eli Ibarra-Pratt, CBER (by T-con) Melissa Moncavage, CDER Industry: Annetta Beauregard, Eli Lilly (by T-con) Patrick Brady, Eli Lilly (by T-con) Andrew Emmett, BIO Alan Goldhammer, PhRMA (by T-con) Scott Lassman, PhRMA Preeti Pinto, AstraZeneca
10/25/06 9:30 to 11:30 AM 2 Hours	Discuss proposed draft legislative language.	FDA: Jane Axelrad, CDER Thomas Abrams, CDER Nancy Booker, CDER Kristin Davis, CDER Kevin Fain, OCC Maryann Gallagher, CBER (by T-con) Mike Jones, CDER Melissa Moncavage, CDER Robert Sausville, CBER (by T-con) Industry: Minnie Baylor-Henry, Johnson and Johnson (by T-con) Annetta Beauregard, Eli Lilly (by T-con) Andrew Emmett, BIO Scott Lassman, PhRMA Preeti Pinto, AstraZeneca Sara Radcliffe, BIO (by T-con) Tony Rogers, AstraZeneca
11/1/06 2:00 to 4:00 PM 2 Hours	Discuss proposed draft legislative language.	FDA: Jane Axelrad, CDER Tom Abrams, CDER Nancy Boocker, CDER Frank Claunts, OC Kristin Davis, CDER Kevin Fain, OCC Maryann Gallagher, CBER Mike Jones, CDER Marti Louviere, OC Melissa Moncavage, CDER Industry: Minnie Baylor Henry, Johnson and Johnson/ PhRMA Annetta Beauregard, Eli Lilly Patrick Brady, Eli Lilly Andrew Emmett, BIO Scott Lassman, PhRMA Donna Peterson, Amgen/BIO Preeti Pinto, AstraZeneca Tony Rogers, AstraZeneca /PhRMA
11/8/06 Teleconference 1:00 to 3:00 PM 2 Hours	Discuss proposed draft legislative language.	FDA: Jane Axelrad, CDER Tom Abrams, CDER Nancy Boocker, CDER Kristin Davis, CDER Kevin Fain, OCC Maryann Gallagher, CBER Mike Jones, CDER Marti Louviere, OC Melissa Moncavage, CDER Ele Pratt, CBER Industry: Patrick Brady, Eli Lilly Andrew Emmett, BIO Alan Goldhammer, PhRMA Scott Lassman, PhRMA Donna Peterson, Amgen/BIO Tony Rogers, AstraZeneca /PhRMA

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