Pharma Execs Indicted for Off-Label Promotion

While Word on Health has repeatedly written about the fines being levied against pharmaceutical companies, we were somewhat surprised to learn from the Philadelphia Inquirer of the indictments of four high-level medical device executives for off-label marketing practices.

Although, we’d heard threats that industry executives might have charges brought against them, many people thought these were nothing more than empty words.

These indictments therefore mark a bold step in the enforcement of off-label marketing practices in the US and will undoubtedly serve as a warning to others.

In these landmark cases, Federal prosecutors in Philadelphia indicted two company Presidents, a Vice President and a Director of Clinical Regulation at Synthes, a Pennsylvania-based orthopedic medical device company.

The company has already been fined $23.7 million for the off-label promotion of its Bone Cement but prosecutors are also seeking jail time for those they believe responsible and accountable for the illegal behavior. They point to at least three incident-related patient deaths resulting from off-label promotion and use of the product.

“We are concerned that the providers that engage in health care fraud may consider civil penalties the cost of doing business. As long as the profit from fraud outweighs those costs, abusive corporate behavior is likely to continue,” said Lewis Morris of the HHS Office of Inspector General (OIG) regarding the case.

While we all wonder if using pharma executives as a deterrent against “what not to do” will become the norm or whether this was simply a “one off”, it’s clear that there are now very real and very personal consequences to off-label promotion.

For people in the pharmaceutical industry maybe this news should serve as a “heads up” that it’s not enough to just talk about compliance, you really have to practice it at every level of the organization.

What’s your reaction to this development?  Let us know.

Love and Other Problems

The new movie Love And Other Drugs, starring Anne Hathaway and Jake Gyllenhaal tells the tale of a pharma salesman who meets the love of his life at a doctor’s office.  The highly-paid hero is portrayed as a vain, flirtatious pushy rep who will stop at nothing to get doctors to write more scripts for his drug.   Armed with gifts, flowers and free lunches, he pitches his marketing message from office-to-office.

Clearly neither he nor the producers ever heard of the PhRMA code, OIG or the myriad of other pharmaceutical compliance governance.

And while it succeeds as a feel-good, romantic comedy, SRxA’s Word on Health suspects that it did little to help the reputation of the much maligned pharmaceutical industry.

A further nail in the coffin has just been delivered by Vanity Fair. In the January edition of the magazine, investigative reporters Donald Barlett and James Steele have penned a scathing attack on pharmaceutical companies in an article entitled Deadly Medicine.  In it, they dub the industry a “lethal profit machine.”

Unlike the movie, it’s not pretty.

They conclude: “In 2009, according to the Institute for Safe Medication Practices, 19,551 people died in the United States as a direct result of the prescription drugs they took. That’s just the reported number. It’s decidedly low, because it is estimated that only about 10 percent of such deaths are reported. Conservatively, then, the annual American death toll from prescription drugs considered “safe” can be put at around 200,000. That is three times the number of people who die every year from diabetes, four times the number who die from kidney disease. Overall, deaths from F.D.A.-approved prescription drugs dwarf the number of people who die from street drugs such as cocaine and heroin. They dwarf the number who die every year in automobile accidents. And with more and more of its activities moving overseas, the industry’s behavior will become more impenetrable, and more dangerous, than ever.”

For pharmaceutical companies, that’s one tough pill to swallow!

So…How can we change the perception that the industry is despicable and dangerous?

And…how can pharmaceutical companies regain trust and provide real value in their conversations with physicians and patients?

First, all sides of the debate need to acknowledge a few simple facts:

• Healthcare is a business – from the largest global pharma company to the smallest single doctor family practice.
• The pharmaceutical industry is not alone in wanting to sell its products and generate profits.  That’s what all businesses do
• Billions of dollars of these profits are reinvested in new drug development
• On average only 1:50 new drugs make it to market
• The average time to develop a new drug is 10 years and the cost around 1 billion dollars
• Human beings influence and are influenced by numerous factors / people everyday – it is called life.
• In order to control costs and treat patients effectively, everyone must work together.

Second, the relationship between the pharmaceutical industry and its critics needs to change. The current confrontational environment is a lose-lose situation. Pharmaceutical companies need to be perceived as bringing value to the healthcare equation and genuinely understanding what doctors and patients need.

Thirdly, and with apologies to Jake and 20^th Century Fox, the industry needs to kill the stereotype of the “goody” toting pharma rep and reinvent the role as one of collaborator, consultant, and educator.

SRxA can help companies manage these relationships and inject real value back into the mix.  To find out more, please contact us.

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.