{"id":5735,"date":"2016-10-24T10:41:00","date_gmt":"2016-10-24T10:41:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/meet-me-at-fda-public-hearing-on-off\/"},"modified":"2019-02-21T01:14:51","modified_gmt":"2019-02-21T01:14:51","slug":"meet-me-at-fda-public-hearing-on-off","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/meet-me-at-fda-public-hearing-on-off\/","title":{"rendered":"Meet Me at FDA Public Hearing on Off-Label Promotion on November 9, 2016"},"content":{"rendered":"<p>I will be Speaking at FDA&#8217;s Part 15 hearing on &#8220;Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products&#8221; on 9 November, 2016 (read &#8220;<a href=\"http:\/\/pharma-mkting.com\/blog\/2016\/09\/fda-readies-itself-for-direct-to.html\">FDA May Have No Choice But to Allow Direct-to-Consumer Off-Label Drug Promotion<\/a>&#8220;). <\/p>\n<p>The purpose of this meeting is to obtain &#8220;input on issues&#8221; related to off-label product communications about by pharmaceutical and medical device companies (see <a href=\"http:\/\/pharma-mkting.com\/blog\/2016\/09\/fda-readies-itself-for-direct-to.html\">here<\/a>). I will presenting the preliminary results of my <b><a href=\"http:\/\/svy.mk\/2caeN82\">Direct-to-Consumer Off-Label Promotion Survey<\/a><\/b> in my allotted time of 8 minutes.<\/p>\n<p>Here&#8217;s the list of speakers (updated 31 Oct 2016):<\/p>\n<p>Wednesday, 9 November<br \/>\n<b>Welcome and Administrative Announcements<\/b><br \/>\nLeslie Kux, Associate Commissioner for Policy<br \/>\n<b>Opening Remarks<\/b><br \/>\nDr. Robert Califf, Commissioner<\/p>\n<ul>\n<li>Mr. Michael Labson, Covington &#038; Burling LLP, on behalf of Pharmaceutical Research and Manufacturers of America (PhRMA)<\/li>\n<li>Ms. E. Cartier Esham, Biotechnology Innovation Organization (BIO)<\/li>\n<li>Ms. Khatereh Calleja, Advanced Medical Technology Association (AdvaMed)<\/li>\n<li>Ms. Kellie Combs and Ms. Coleen Klasmeier, Medical Information Working Group (MIWG)<\/li>\n<li>Mr. James Czaban, DLA Piper LLP (US)<\/li>\n<li>Mr. Daniel Biank, DuVal &amp; Associates, P.A.<\/li>\n<li>Ms. Sandra Kalter, Medtronic PLC<\/li>\n<li>Dr. Andrew Koenig, Pfizer Inc.<\/li>\n<li>Ms. Danelle Miller,Roche Diagnostics<\/li>\n<li>Dr. Sandra Milligan, Merck<\/li>\n<li>Mrs. Penny Levin, Teva Pharmaceuticals<\/li>\n<li>Dr. Edith Perez, Genentech<\/li>\n<li>Mr. Frank Wilton, American Association of Tissue Banks (AATB)<\/li>\n<li>Mr. Nicodemo Fiorentino, G&amp;M Health, LLC<\/li>\n<li>Ms. Zoe Dunn, Hale Advisors<\/li>\n<li>Ms. Tracy Rockney, OneSource Regulatory<\/li>\n<li>Dr. Samuel Nussbaum, Anthem, Inc.<\/li>\n<li>Mr. Michael Hoak, Humana<\/li>\n<li>Ms. Jennifer Graff, National Pharmaceutical Council<\/li>\n<li>Dr. Soumi Saha, Academy of Managed Care Pharmacy<\/li>\n<li>Dr. Vikas Saini, The Lown Institute<\/li>\n<li><b>Mr. John Mack<\/b>, Pharma Marketing News<\/li>\n<\/ul>\n<p>\n<a name='more'><\/a><\/p>\n<ul>\n<li>Dr. John Kamp, Coalition for Healthcare Communication<\/li>\n<li>Mr. Gregory Herbers, Washington Legal Foundation<\/li>\n<li>Mr. Ralph Hall, University of Minnesota Law School and Leavitt Partners<\/li>\n<li>Dr. William Welch, American Association of Neurological Surgeons\/Congress of Neurological Surgeons (AANS\/CNS)&nbsp;<\/li>\n<li>Mr. Jeremy Lew, Individual Stakeholder<\/li>\n<li>Ms. Sandra Raymond, Lupus Foundation of America<\/li>\n<li>Mr. Stephen Marmaras, Global Healthy Living Foundation<\/li>\n<li>Mr. Paul Melmeyer, National Organization for Rare Disorders<\/li>\n<li>Dr. Aaron Kesselheim, Brigham and Women&#8217;s Hospital and Harvard Medical School<\/li>\n<li>Dr. Sidney Wolfe, Public Citizen&#8217;s Health Research Group<\/li>\n<li>Dr. Michael Carome, Public Citizen\u2019s Health Research Group<\/li>\n<li>Mr. Robert Weissman, Public Citizen<\/li>\n<li>Dr. Doris Peter, Consumer Reports<\/li>\n<p>\n<b>Day one closing remarks<\/b><br \/>\nLeslie Kux<\/ul>\n<p>\nThursday, 10 November<br \/>\n<b>Opening Remarks<\/b><br \/>\nLeslie Kux<\/p>\n<ul>\n<li>Dr. Joshua M. Sharfstein, Johns Hopkins Bloomberg School of Public Health<\/li>\n<li>Mr. Steve Francesco, Do No Harm Network<\/li>\n<li>Ms. Kim Witczak, Woodymatters<\/li>\n<li>Ms. Robyn Edwards and Ms. Veverly Edwards, Consumers Union Safe Patient Project<\/li>\n<li>Ms. Lisa Gill, Consumer Reports<\/li>\n<li>Dr. Yanling Yu, Washington Advocates for Patient Safety<\/li>\n<li>Dr. Stephanie Fox-Rawlings, Patient, Consumer, and Public Health Coalition<\/li>\n<li>Ms. Dr. Diana Zuckerman, National Center for Health Research<\/li>\n<li>Ms. Melayna Lokosky, Individual Stakeholder<\/li>\n<li>Dr. Margaret McCarthy, Yale Law School<\/li>\n<li>Ms. Jeanie Kim, Yale Law School<\/li>\n<li>Ms. Amy Kapczynski, Yale Law School<\/li>\n<li>Dr. Lisa Schwartz and Dr. Steve Woloshin, The Dartmouth Institute for Health Policy and Clinical Practice<\/li>\n<li>Ms. Joy Eckert, George Washington University<\/li>\n<li>Ms. Kimberly A. Dougherty and Ms. Cara Jones, Janet, Jenner &#038; Suggs LLC<\/li>\n<li>Dr. Adriane Fugh-Berman, Georgetown University Medical Center<\/li>\n<li>Ms. Alycia Hogenmiller, Georgetown University Medical Center<\/li>\n<li>Dr. Rebecca Jones, Individual Stakeholder<\/li>\n<li>Dr. Doyle Stulting, American Society of Cataract and Refractive Surgery (ASCRS)<\/li>\n<li>Mrs. Katherine McGahey and Ms. Lauren Brown, 1 Million 4 Anna Foundation<\/li>\n<li>Mrs. Sarah Christopherson and Ms. Christina Cherel, National Women\u2019s Health Network<\/li>\n<li>Ms. Amy Leitman, NTM Info &amp; Research<\/li>\n<li>Dr. Adelaide Robb, Children\u2019s National<\/li>\n<li>Mr. Andrew Sperling, National Alliance on Mental Illness<\/li>\n<li>TBD, USA Patient Network<\/li>\n<li>Dr. Megan Coder, Pharmaceutical Care Management Association (PCMA)<\/li>\n<li>Mrs. Brigett Whitted, Individual Stakeholder<\/li>\n<li>Mr. Mychal Wilson, Whistleblower Attorney<\/li>\n<p><\/p>\n<li>OPEN PUBLIC COMMENTS: Multiple 3-minute speaker slots will be available on a first-come, first-served basis.<\/li>\n<\/ul>\n<p>\n<b>Closing Remarks<\/b><br \/>\nLeslie Kux<\/p>\n","protected":false},"excerpt":{"rendered":"<p>I will be Speaking at FDA&#8217;s Part 15 hearing on &#8220;Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products&#8221; on 9 November, 2016 (read &#8220;FDA May Have No Choice But to Allow Direct-to-Consumer Off-Label Drug Promotion&#8220;). The purpose of this meeting is to obtain &#8220;input on issues&#8221; related to off-label product communications about [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":13101,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[44,139,182],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Meet Me at FDA Public Hearing on Off-Label Promotion on November 9, 2016 - Pharma Marketing Network<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/meet-me-at-fda-public-hearing-on-off\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Meet Me at FDA Public Hearing on Off-Label Promotion on November 9, 2016 - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"I will be Speaking at FDA&#8217;s Part 15 hearing on &#8220;Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products&#8221; on 9 November, 2016 (read &#8220;FDA May Have No Choice But to Allow Direct-to-Consumer Off-Label Drug Promotion&#8220;). 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