Why Is FDA Issuing Fewer Marketing Violation Letters?

As mentioned in a previous Pharma Marketing Blog post, the FDA's Office of Prescription Drug Promotion (OPDP) issued the fewest ever enforcement letters regarding non-biologic Rx drug promotions in 2015 (read "2015 Was Another Good Year for Orphan Drugs & Pharma Marketers").

Mark Senak - who works for the public relations firm Fleishman-Hillard and who writes EyeOnFDA blog - suggested a couple of theories as to why OPDP is issuing fewer warning letters these days:

Senak noted that these days "letters largely involved companies that are lesser known and are likely to have fewer products on the market," which implies that they have less experience complying with FDA regulations whereas larger pharma companies are becoming better at complying with FDA regulations. A Pharmalot blog post also suggested that "smaller drug makers [are] bigger risk takers when it comes to promotions" (see here).

It is interesting that the pharma companies that received serious WARNING LETTERS as opposed to less serious UNTITLED LETTERS in 2015 were two small Canadian companies. One of these companies was Duchesnay  which received a warning letter for the promotion of Diclegis via Instagram. It should be noted that an American agency was responsible for dreaming up the violative Instagram post. This agency claims to have a deep understanding of FDA regulations especially when it comes to social media. For more on that, read "How Kim Kardashian Got Hired to Shill for Diclegis".

Senak has another, more interesting theory. But I can trump that with a totally different theory based on the tried and true investigative journalistic axiom; i.e., "Follow the Money."

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