Big Brother may not be watching, but the FDA, it seems is!

Here at SRxA, we all know how much physicians like to put on their marketing hats. In future, it seems, they might have to reach for their safety helmets instead!

According to our fellow bloggers at Good Promotional Practices doctors are starting to be held accountable to the same promotional compliance standards as pharmaceutical companies.

As most of our readers know, when FDA approves a drug it does so for a given use or indication. However, physicians are still free to make their own decisions based on how a device is used based on their best judgment. When a drug, biologic, or medical device is used for some indication other than the one approved by the FDA it is said to be “off-label.”

In this almost perfect dichotomy, it is perfectly legal, in the United States, for a physician to use a drug or device for “off-label” but it is unlawful to market, advertise or otherwise promote the off label use of a device or drug. Furthermore, based on the flurry of DOJ, OIG and FDA activity, such as the massive fines leveled out to Allergan ($600M), GlaxoSmithKline ($750 M), Novartis ($422 M) and Pfizer (2.3 billion) companies must keep the practices of their marketing and sales department in check to ensure compliance.

Until now the “it is unlawful to market, advertise or otherwise promote off label use of a drug” has been aimed at Pharmaceutical companies and third parties acting on their behalf.  Now people are asking “What if the hospital or physician group is doing the marketing themselves, not the company?

We’ve all seen the billboards and free in-flight magazine ads promoting the latest medical treatments from liposuction to joint and hormone replacement.  With physicians are competing harder than ever to bring patients to their doors, what’s to stop them from stepping over the same lines that the companies may have, either willingly or not?

Blogger Sean McCarthy uses the example of the irregular heart rhythm Atrial Fibrillation (AF, AFib).  While there are very few approved drugs or devices to treat atrial fibrillation, upwards of 2.5 million Americans suffer from this debilitating condition.  Not so surprising then, that physicians use an array of off-label drugs and devices to treat this disease. So, now the hospital or physician communicates their ability to help AFib patients by promoting their latest treatment for the disease on a billboard or newspaper article. Isn’t this the same thing as a company promoting off-label use?

State Attorney Generals, the DOJ and FDA must be taking notice. They drive by the same billboards we do and read the same newspapers.  McCarthy says he’s heard rumors of a state Attorney General investigating a doctor about his referral patterns and advertising activities.

Who better than the pharmaceutical industry to take the lead in providing education to physicians  to help them prevent compliance snafus.  After all we’ve been there, done this!

Contact SRxA today to see how we can get you started.

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s