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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A Deeper Look at FDA's 2015 Enforcement of Drug Promotions

As mentioned in a previous 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").

Of the 9 letters OPDP sent to drug companies regarding violations, 2 were serious "Warning Letters" and 7 were "Untitled Letters." The following chart shows the Warning vs. Untitled letter trend from 2010 through 2015.

One Warning Letter went to Duchesnay for the promotion of Diclegis via Instagram. FDA cited 2 violations: (1) Omission of Risk Information (see "OMG. Kim Kardashian Shills for Pharma! No Worry - No Side Effects!") and (2) Omission of Material Fact (the post failed to provide material information regarding DICLEGIS’ full approved indication, including important limitations of use). The other Warning Letter went to a Valeant subsidiary for the promotion of Tussicaps. FDA cited 3 violations: (1) Omission of Risk Information, (2) Inadequate Communication of Indication, and (3) Unsubstantiated Claims.

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2015 Was Another Good Year for Orphan Drugs & Pharma Marketers

UPDATED 4 Jan 2016: FDA approved 45 new drugs in 2015, four more than in 2014 and the highest number since 1996. Twenty-one (21) of those (47%) were "orphan" drugs (find FDA data here). This compares to 17 orphan drugs approved in 2014 or 41% of the total (see CDER New Drug Review: 2015 Update and "2014 Was a Good Year for FDA & Pharma").

Click on image for an enlarged view.

That's good news for the pharma industry, which often submits drugs to the FDA as orphan drugs but once approved the drugs are "used broadly off-label with the lucrative orphan drug protections and exclusivity benefits," according to the authors of a study recently published in the American Journal of Clinical Oncology (read "#Pharma Welfare: 'Orphan' Blockbuster Drugs on Rise - Including Crestor!").

Pharma marketers also have good news regarding FDA marketing enforcement actions in 2015.

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2014 Was Another Record Year for FDA: Fewest Number of Untitled/Warning Letters Ever!

In 2014, the FDA approved 41 new drugs -- the most since 1996 (see here). That's quite a "record" even if 37% of the approvals were made in December alone.

But FDA wasn't as anxious to set any advertising enforcement records in 2014. The Agency sent out only a meager 9 Untitled Letters and 1 Warning Letter last year (see chart on left).

Could the reason for this be that pharmaceutical marketers are getting better at complying with FDA regulations?

Or is the FDA afraid of being sued by the pharmaceutical industry in the wake of the 2012 Caronia decision in the U.S. Second Circuit that found off-label promotion was protected by free speech?

Or perhaps FDA depends more and more on "user fees" paid by the drug industry and does not want to "bite the hand that feeds it"?

I think the latter is the most likely explanation. Read on to learn why.

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