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said CDER is revising some of its current draft guidance and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
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