FDA ups the Ante on Pharma Ads

bad ad cme courseAs the feds continue to crack down on pharma marketing infractions the FDA has upped its own stake in making sure advertisers play by the rules. The agency has just launched an e-learning course aimed at healthcare providers to teach them how to spot and report misleading or untruthful drug ads, or promotional activities.

The multi-module, multi-media  course, launched in conjunction with MedScape, uses case studies to help HCP’s “become more discerning readers of drug promotional information,” according to Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion.

bad ad course screen shotThe course is part of Bad Ad, a program the agency designed in 2010 to educate doctors about their role in ensuring advertising stays honest. And to incentivize doctors to take the course they are offering Continuing Medical Education (CME) credit for physicians and Continuing Education (CE) credit for other HCPs.

The FDA estimates that there are more than 80,000 unique new pieces of promotional literature produced each year, including journal ads, sales aids and e-detailing pieces.  In addition, there are approximately 80,000 pharmaceutical sales reps working in the field. Assuming each one makes 8-10 calls per day and presents 1-3 products during every call, that adds up to between 166 and 624 million opportunities to breach promotional guidelines.

Over the past decade, drug-makers have agreed to pay close to $14 billion in penance for off-label and safety-related claims. Click on the links below for details of the biggest 11 settlements in recent years:

Back when the FDA was rolling out the Bad Ad program, the agency drew fire from marketing execs for encouraging physicians and other providers to report false advertising  – and for allowing them to do so anonymously. They accused the agency of deputizing doctors rather than hiring the staff necessary to review advertising internally.

Even so, many states have taken their own steps to combat misleading materials through “academic detailing,” where physicians, pharmacists, nurses and other trained medical reps spread info about prescription drugs. The goal is to improve quality of care and reduce healthcare spending. Advocates of academic detailing say that educating prescribers about all treatment options – not just the new, expensive ones – could help them make informed decisions that could, in turn, bring down drug costs.

Bad Ad brochure Pharma sales and marketing folks take note.  Between these federal and state initiatives, the potential for falling foul of the guidance just increased.

And yes, in case you’re wondering I did take, and pass, the course as part of my research for this blog post.

Contact us today, to find out how SRxA can help you with compliant pharma promotion.

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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 20th 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.