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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Who Will Be "Miss Viagra" 2015?

Wowie zowie! Is that a roll of dimes quarters in your pocket or are you just excited to see those sexy women of every ethnic persuasion (except latina?) in Viagra ads? If there were a "Miss Viagra" beauty contest, which one would you crown Miss Viagra 2015? (I included the woman who appeared in the first ad that aired in 2014.)

Which contestant should wear the crown for "Miss Viagra" 2015?

No. 1   No. 2   No. 3   No. 4

BTW, Actress, model and former Miss Hawaii Kelly Hu is featured in one of the new Viagra ads. She’s #4 in the lineup shown above.

My Favorite Drug Ad Celebrities

Drug Advertising Celebrities

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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SEO Made Simple 2016

Many people are wondering if SEO, search engine optimization, still matters.  As someone who's been focused on SEO for a long time, I can definitely say it's essential for success. However, the process of optimizing your website and the process for doing so has radically changed.

Back in the day you could trick search engines into believing that your website had more authority than your competitors. Authority is essentially Google's way of assessing a point value to indicate site popularity. Google has become much more sophisticated and trying to put one over on them is a waste of time.

One of the most fundamental changes in search engine optimization is local optimization. Thanks to the proliferation of mobile devices, most searches using search engines have some type of local intent. This type of search query has changed the Google algorithm and ranking factors. Even if you are a national business, you must think locally and optimize for local search.

The second area that have evolved over the last few years is content.  As I talk about in SEO Made Simple (audio version), content is the driving force behind site authority and valuation.  The more engaging content you produce, the more users will stay on your site, interact with, and share your web pages. This had a dramatic and lasting impact on search engine results.

When people ask me for my optimization advice, I always point to the two items above, local optimization and content creation. When these two factors are at the heart of your optimization strategy, you can influence search engine rankings.

What about those old SEO tactics?

If you're still getting emails from India promotion number one Google rankings, there's probably a bunch of outdated tactics behind it. The best case scenario is that you don't get penalized when these companies start posting links to your website all across the internet. The worst case scenario is that Google catches on (and they will), banning your site.

I've found that websites who have received a Google penalty rarely, if ever, fully recover.  Is it worth the risk?  No, definitely not.  My recommendation is always to learn SEO best practices and either implement them on your own or simply hire a reputable firm to implement specific tactics like blogging, digital assets, etc. under your supervision.

To be successful with search engine optimization, you need to take a fresh approach. Focus on how to build quality information online that others want to interact with. When you do, you'll naturally attract links to your website or blog and improved organic rankings will follow.

Pharmaguy's 2016 New Year's Resolutions for the Pharma Industry

2015 is coming to an end, thankfully. It's not been an especially good year considering that the media and politicians have found a face for evil pharma and rising drug prices: Martin Shkreli!

Shkreli's recent arrest will only heighten pharma's bad press as some people wonder why more pharma CEOs have not been arrested.

Be that as it may, let's look ahead to 2016 and what I recommend as New Year’s Resolutions for the drug industry and especially pharmaceutical marketers. If you're interested in how well my 2015 resolutions fared, go here.

My #1 personal New Year's Resolution is the same every year:

Stop telling the pharmaceutical industry what to do all the time. Unfortunately, I have never kept that resolution. So, here's my recommended list of 2016 resolutions for pharma...

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