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A Snapshot of 2014 OPDP Enforcement Letters

By Julie Tibbets posted 10-Nov-2014 11:57

  

As the end of the year quickly approaches, I thought I would share a quick snapshot of enforcement letters issued by FDA's Office of Prescription Drug Promotion (OPDP) so far this year.  Here are some interesting numbers and statistics to consider:

 - 9 letters, year-to-date (1 warning letter; 8 untitled letters)
 - 1 warning letter (citing a Bad Ad program complaint and noting violations as "extremely concerning from a public health perspective" due to evidence of use promotion beyond FDA approval)
 - 8 untitled letters identified through routine monitoring and surveillance
 - Year-after-year downward trend in letters continues: compare this year with 2010 in which DDMAC issued 52 letters (13 of which were warning letters)
 - 4 of 9 letters this year addressed violative promotion of boxed warning products
 - 8 letters were issued for NDAs, 1 for an ANDA product (no letters have issued for BLAs or INDs this year)
 - 4 letters addressed violative promotion in online media
 - 7 of 9 letters addressed promotion involving a flawed (i.e., minimized) risk presentation or omitting any risk presentation altogether
 - 4 of 9 letters fall into the category of having omitted any risk presentation altogether
 - 6 of 9 letters cited omission of material fact (generally involving the failure to communicate the full FDA-approved indication, including use limitations or other qualifying language)
 - 4 of 9 letters cited flawed substantiation for claims or data presentations (generally leading to unsubstantiated superiority claims or overstatement of efficacy)
 - 3 of 9 letters discussed lack of adequate directions for use due to promotional claims that broadened the patient population or intended/approved use of the product
 - OPDP added patent documents to its running list of substantiation that did not qualify as "substantial evidence"
 - OPDP highlighted the dangers of promotional campaigns that position the innovator as superior to generic market entrants in its Lipofen(R) letter

As OPDP continues its focus on guidance development and finalization, a low number of enforcement letters per year is likely to continue being a trend. 

Julie Tibbets is a partner in the Food, Drug & Device practice at Alston & Bird LLP where she focuses her practice advising manufacturers and marketers of drugs, biologics, and medical devices on marketing, medical affairs, and health care professional related interactions as well as Sunshine Act compliance. This posting is intended to be informational and does not constitute legal advice regarding any specific situation. This material may also be considered attorney advertising under court rules of certain jurisdictions.  Julie can be reached at julie.tibbets@alston.com or at 202.239.3444.

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