Update Nov Dec 2013 - (Page 35)

FDLI Activities discussed examples of enforcement actions. CDER's top priorities, he listed in no particular order, include policy and guidance development, labeling reviews, core launch reviews, enforcement, and training and communications. Abrams said CDER is revising some of its current draft guidance and working to address promotion over the internet and social media. Abrams also touched on "The Bad Ad Program," which is designed to increase healthcare professionals' awareness about the role they can play in helping FDA ensure that prescription drug advertising and promotion is truthful and not misleading. Abrams noted that, overall, voluntary compliance for promotional materials is on the rise. Lisa Stockbridge spoke next, concentrating primarily on recent CBER compliance actions and voluntary compliance. One of the worst violations that CBER sees, she noted, is companies that include little to no risk information on their promotional materials. However, overall, Stockbridge said that the industry has been better with complying with CBER regulations. She said that many companies CBER works with are very careful and strive to voluntarily comply with regulations. Many even ask for advisory letters when they are unsure. Toni Stifano discussed CDRH's important promotional concerns and areas that make CDRH's job difficult. Important promotional concerns, she said, include any absence of material facts and inclusion of relevant risk information. Stifano mentioned that some aspects that make CDRH's job more challenging include not knowing the name of the marketed device, there are no specific standards for content and format of labeling for medical devices, and it does not always receive final labeling for products reviewed under the 510(k) process. Thomas Moskal rounded out the panel and discussed common violations, what CVM looks for in promotion material, and its objectives moving forward. During its review of promotional materials, Moskal said CVM considers whether there is truthful and not misleading information, as well as adequate safety and use information. Moskal listed CVM's common violations include minimizing risk, omitting risk information, making unsubstantiated claims, and marketing for unapproved uses. Looking ahead, Moskal said that one of CVM's objectives is to ensure appropriate risk communication in promotional materials. A common thread through each presentation was that companies need to be wary of including too little risk information and overstating the uses of a product. FDLI Winners Announced - 2013 H. Thomas Austern Memorial Writing Competition 2013 WINNERS Each year, FDLI sponsors the H. Thomas Austern Memorial Writing Competitions to encourage law students interested in the areas of law that affect food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices and tobacco to submit papers that provide an in-depth analysis of a current legal issue. There are two competitions - one for papers with a maximum of 40 pages, and one for papers between 41 and 100 pages. Several of the winning papers have been recommended for publication in the Food and Drug Law Journal. The 2014 Competition will open in mid-November. Long Papers 1st Place - Regulation by Settlement Agreement: The Use of Corporate Integrity Agreements to Govern Off-Label Marketing - Joseph Borson, Harvard Law School, 2013 Graduate 2nd Place - The FDA's Risk/Benefit Calculus in the Approvals of Qsymia and Belviq: Treating an Obesity Epidemic While Avoiding Another Fen-Phen - Lauren Azebu, Harvard Law School, 2013 Graduate Honorable Mention - Tragedy, Transformation, and Triumph: Comparing the Factors and Forces that Led to the Adoption of the 1860 Adulteration Act in England and the 1906 Pure Food and Drug Act in the United States - Jillian London, Harvard Law School, 2013 Graduate Honorable Mention - Pharmacogenomics: History, Barriers, and Regulatory Solutions - Sarah Blankstein, Harvard Law School, 2013 Graduate Winners Announced Ad.indd 1 FDLI Short Papers 1st Place - Transitioning Transgenic Seed from Patent to Generic: Supplementing Contractual Solutions with Governmental Action - James Allred, University of Virginia School of Law, 2013 Graduate 2nd Place - FDCA Plus: Why United States v. Caronia Should Motivate the FDA to Adopt a Deceptive Advertising Framework - Sharone Assa, University of Wisconsin Law School, 2013 Graduate Honorable Mention - Buckman Extended: Federal Preemption of State Fraud-on-the-FDA Statutes - Christine Gaddis, Seton Hall University School of Law, 2014 Graduate November/December 2013 11/12/13 11:18 AM Update 35

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013

Update Nov Dec 2013 - (Page 1)
Update Nov Dec 2013 - (Page 2)
Update Nov Dec 2013 - (Page 3)
Update Nov Dec 2013 - (Page 4)
Update Nov Dec 2013 - (Page 5)
Update Nov Dec 2013 - (Page 6)
Update Nov Dec 2013 - (Page 7)
Update Nov Dec 2013 - (Page 8)
Update Nov Dec 2013 - (Page 9)
Update Nov Dec 2013 - (Page 10)
Update Nov Dec 2013 - (Page 11)
Update Nov Dec 2013 - (Page 12)
Update Nov Dec 2013 - (Page 13)
Update Nov Dec 2013 - (Page 14)
Update Nov Dec 2013 - (Page 15)
Update Nov Dec 2013 - (Page 16)
Update Nov Dec 2013 - (Page 17)
Update Nov Dec 2013 - (Page 18)
Update Nov Dec 2013 - (Page 19)
Update Nov Dec 2013 - (Page 20)
Update Nov Dec 2013 - (Page 21)
Update Nov Dec 2013 - (Page 22)
Update Nov Dec 2013 - (Page 23)
Update Nov Dec 2013 - (Page 24)
Update Nov Dec 2013 - (Page 25)
Update Nov Dec 2013 - (Page 26)
Update Nov Dec 2013 - (Page 27)
Update Nov Dec 2013 - (Page 28)
Update Nov Dec 2013 - (Page 29)
Update Nov Dec 2013 - (Page 30)
Update Nov Dec 2013 - (Page 31)
Update Nov Dec 2013 - (Page 32)
Update Nov Dec 2013 - (Page 33)
Update Nov Dec 2013 - (Page 34)
Update Nov Dec 2013 - (Page 35)
Update Nov Dec 2013 - (Page 36)
Update Nov Dec 2013 - (Page 37)
Update Nov Dec 2013 - (Page 38)
Update Nov Dec 2013 - (Page 39)
Update Nov Dec 2013 - (Page 40)
Update Nov Dec 2013 - (Page 41)
Update Nov Dec 2013 - (Page 42)
Update Nov Dec 2013 - (Page 43)
Update Nov Dec 2013 - (Page 44)
Update Nov Dec 2013 - (Page 45)
Update Nov Dec 2013 - (Page 46)
Update Nov Dec 2013 - (Page 47)
https://www.nxtbookmedia.com