Ladies, Gentlemen and AdvaMed,Thank you very much for the invitation to speak here today on The Deleterious Duo of Product Liability and Off-Label Sales Promotion. I am Maureen Shaffer, Vice President of Life Sciences for Prolifiq. Prolifiq is a mobile multimedia fulfillment platform used by sales and marketing in medical device and pharma companies for speed, savings and compliance. I am also the Executive Editor and Publisher of GoodPromotionalPractices.com, the collaborative and cross-functional blogging site for medical devices (medtech) and pharma covering, not surprisingly, promotional best practices in the increasingly litigious environment. Additionally, I spent my first 20 working years in marketing at cardiovascular medical device companies, mostly emerging growth and startups.
It seemed inappropriate to do a talk on off-label without including a disclosure slide. So, here are mine.Prolifiq is an AdvaMed Business Solutions Partner.And, GoodPromotionalPractices.com is sponsored by Prolifiq and Reprints Desk. Reprints Desk is a one-stop shop for all your scientific literature needs.
Now, let’s jump into our topic today.I really liked this Navigant image of the opportunities throughout the product life cycle to mitigate product liability risk. If you would like to take a more comprehensive approach than we have time for today, the cited Navigant article is a great starting point. However, for today, we are going to focus on sales and off-label as it pertains to creating product liability risk. Sara Dyson has done a wonderful job outlining the product liability risks associated with off-label promotion by sales. Now, I am going to outline Good Promotional Practices (GPP) to prevent off-label promotion by your sales force.
More specifically, we are going to cover three items today:How off-label sales promotion is an important focus for you and your companyHow standard compliance recommends are not enoughSeven steps to preventing off-label sales to avoid the deleterious outcomes Sara discussed.Then, hopefully we will have time for a few questions.
Let’s jump in.When we say that sales is all about the numbers, we are usually talking about setting quotas and driving revenue. However, off-label risk in sales is also driven by the numbers. Let’s take a look.
The last number I want you to know is 70%.In a published Harvard review of off-label pharma whistleblower complaints over the last 10 years, 70% of off-label whistleblowers were sales people.complaints involved sales people41 lawsuits, 55 whistleblowers, 18 suitsunsealed whistleblower complaints against pharmaceutical companies filed in US federal fraud cases that contained allegations of off-label marketing (January 1996–October 2010) At the time of the alleged fraud, the whistleblowers worked as pharmaceutical sales representatives (39/55, 71%), sales or accounting managers (11/55, 20%), and unaffiliated physicians (5/55, 9%). T
Boston-based qui tam attorney Robert M. Thomas, Jr., Thomas and AssociatesDabney Friedrich, Commissioner at US Sentencing Commission92% of DOJ court convictions were with companies less than 1000 employees. The operation was implemented through a joint HHS-Justice Department program called the Health Care Fraud and Abuse Control Program (HCFAC), which coordinated federal, state, and local law enforcement fraud-fighting activities. The Affordable Care Act is providing $350 million for HCFAC activities.
This is an excerpt from the indictment of 3 sales managers and the former CEO of Stryker Biotech by the state of MA all stemming from off-label promotion.They are the front lines promoting and educating HCPs Communicating that first-hand knowledge internally to managers and othersLet me ask you a question:How many people in here have product available for sale today or in the next 6 months?For those of you who just raised your hands, how many expect sales or distributors to be their largest department in terms of people?So, in many organizations, and particularly emerging growth companies here today who are selling, sales or your distribution channel is the largest department. There are simply more of them communicating.-DOJ prosecuted 80,000 individuals and 200 companies, the majority for fraud. (per Dabney Friedrich, Commissioner at US Sentencing Commission)-50% of the company prosecutions involved named high-level individuals.-From 2004 to 2010, 37 corporations and 80 individuals were successfully prosecuted under FCPA. (per Arlen Specter, former US Senator and former Chair of the Senate Judiciary Committee)"Fines are not a deterrent to future conduct like jail terms are.“ Arlen Specter, former US Senator and former Chair of the Senate Judiciary CommitteeStryker's biotech division and four former and current executives face charges of wire fraud, conspiracy, device misbranding and false statements related to the marketing of its OP-1orthopedic bone growth biologic/device combination products.In an Oct. 28 1indictment, a federal grand jury in the District of Massachusetts charged Stryker Biotech, its former president Mark Philip, national sales force manager William Heppner and regional sales managers David Ard and Jeffrey Whitaker with five counts of wire fraud and one count of conspiracy.Philip and the company were also charged with making false statements to FDA. Ard, Whitaker and Stryker Biotech were also charged with misbranding.According to the Department of Justice, the company and executives participated in an illegal marketing scheme dating back to 2005 to promote the unapproved use of the firm's OP-1 Implantand OP-1 Puttybone morphogenic protein products combined with its Calstruxbone void filler.The investigators say Stryker Biotech deliberately manipulated surgeons and surgical staff to use a mixture of OP-1 with Calstrux, without disclosing safety risks or explaining that the products were never studied or approved for use together.Acting U.S. Attorney Michael K. Loucks, District of Massachusetts, says in an Oct. 28 statement the firm was allegedly pushing the unapproved mixture because OP-1 products "were at a competitive disadvantage with other legal products."Medtronic's Infusebone growth graft also contains BMP. That product has been a source of interest for the Justice Department as well (2'The Gray Sheet' Dec. 8, 2008).Stryker announced the DOJ investigation in March. This spring, three former Strykersales reps pled guilty to medical device misbranding in a Boston federal court. They admitted to distributing OP-1/Calstrux mixing instructions to surgeons (3'The Gray Sheet' April 20, 2009).Stryker Biotech reps allegedly provided surgeons and surgical staff with various "recipes" on how to combine Calstrux and OP-1, such as mixing them with saline or blood and rolling them into the shape of a "cigar," "brick" or "Vienna sausage."The company and employees stand to face millions in fines plus several decades of jail time, if convicted. For example, for each count of wire fraud, the employees could face up to 20 years in prison, three years supervised released and a fine of at least $250,000.Quote from CEO’s indictment
October 31st, 2008 to February 2010– 15 months.Small company with limited resources and funds competing against the companies with big pockets
To protect both your company and your growing sales force from expensive, distracting and resource-depleting government actions, there are seven standard compliance recommends that have been put forth first in 1994 and officially since 2003 by the OIG.
"Policies are not enough", says Suzanne Rich Folsom, Former Chief Compliance Officer, AIG at DJ GCSBest practices from when I first learned and applied GMPs as a production supervisor in one of my engineering rotations at Cordis.[walk through talking about production]Inspect it outBuild it inBuild in to make it easierFlip this overand be proactive. What good are a chunk of words on a tome of paper if no one is reading?JNJ’s HCC card
Maureen:Finally, I spent 20 years influencing sales to adopt marketing messages and technology. The most important thing you can do is to understand who they are and how they work. Sales tends to be a very verbal and mobile-oriented group. They are focused on efficiency to maximize their commission check both long and short term. And, we want them face to face with the growing group of constituents to whom we sell as we see here in the lower right, not writing impressive tomes or reading copious amounts of written materials, correct?Who here knows any sales person who loves paperwork? Okay, no hands. Sales people hate paper yet we persist in trying to force them to use it. Would we do this with our customers and a medical device? It is time to consider sales as a key target audience for off-label training and compliance. And, take their needs into consideration.If you think you can’t do this, think about apps and how much easier many of them are to use than laptop programs. If you make it easy for sales to comply with off-label, you will probably make it easier for the rest of your company as well.
Before we move on, let’s take a quick look at the definition of compliance. Compliance with rules and regulations is not about following them at any cost. It is about creating behavioral change, or yielding WITHOUT disruption of the primary purpose, in this case, sales.We are not going to and do not want to make sales mini-lawyers or regulatory gurus. We want them to sell. So…
Let’s take a look at seven insights which you can apply to prevent off-label sales promotion.
Is creative a perjorative?
Is creative a perjorative?
THESE CIAS REQUIRE COMPANIES TO CLOSELY TRACK, MANAGE, AND MONITOR THEIR COMMUNICATIONS WITH PROVIDERS IN ORDER TO ENSURE COMPLIANT COMMUNICATIONS. THEY ALSO PROVIDE FOR A PROCESS BY WHICH COMMUNICATIONS AROUND OFF-LABEL SCIENTIFIC INFORMATION, OR JOURNAL ARTICLES, ARE CHANNELLED THROUGH WHAT I CALL A “GATEKEEPER” WHICH IS RESPONSIBLE FOR COMPLIANCE AND IS RESPONSIBLE FOR TRACKING AND MONITORING COMMUNICATIONS. Maureen:GPP. GPP stands for Good Promotional Practices – the best practices for medical device, diagnostic, pharmaceutical and biotech companies to promote and provide information to their customers and patients about their products and the procedures and disease states that surround them. We have all heard the quote, “those who cannot remember the past are condemned to repeat it.” Well, we learned decades ago with GMPs that inspecting out quality at the end of a manufacturing process is less effective than building quality into the process. However, we are currently facing numerous quality control issues with promotional and non-promotional materials, and the DOJ, FDA, SEC and other regulatory bodies are currently using their enforcement efforts to inspect it out. We already know the solution -- we need to build quality into, as part and parcel of, our promotional processes.We already know how important design controls are to apply solid principles of design to medical devices, GMP is to quality output and human factors are to proper and safe usage. Now we need to apply these principles and understanding to the creation and dissemination of promotional and other customer-facing content to protect your company, your sales people and, most critically, to protect physicians and patients.
Tennis ball bounced in or out of bounds – scanning brain. Had a default. Default is the easy decision so when people when have difficult decisions, they default to Prefrontal cortex sends signals to subthalmic nucleus (motivation)When people went to default (doing the same thing you have always done), less firing, less work, subst. minimized signaling from PFC to STNNature or Sciencehttp://www.psychologytoday.com/blog/the-science-willpower/201003/why-habits-are-hard-change-and-printers-hard-buyHave to be motivated first then ready to make the difficult decisionBasal ganglia striatum is engaged when learning new things even looking at dots in a different orderHabit formation is believed to be a way to conserve cognitive resources and make decisions more efficiently, as habits do not require constant evaluation of potential consequences. Driving home from work, for example, quickly becomes a matter of routine, leaving your mind free to daydream without missing a turn. However, some situations require alterations to such routines, such as stopping by the grocery store on the way home, in which case goal-directed attention is necessary for reaching your destination. In a series of behavioral experiments, neuroscientists Rui Costa of the Champalimaud Foundation in Portugal and the National Institutes of Health (NIH) and colleagues determined that rats that had been stressed repeatedly and unpredictably for three weeks were more likely than unstressed animals to continue performing habitual behaviors, even when it no longer made sense to do so. Read more: Stressed brains rely on habit - The Scientist - Magazine of the Life Scienceshttp://www.the-scientist.com/blog/display/55873/#ixzz0oQJehP79
Preventing Off-label Sales Promotion
Maureen Shaffer<br />Vice President, Life Sciences, Prolifiq<br />www.prolifiq.net/lifesciences<br />Executive Editor & Publisher, Good Promotional Practices www.goodpromotionalpractices.com<br />Preventing Off-Label Sales Promotion<br />First presented at AdvaMed EGCC on 05/03/2011<br />
Deleterious Duo: Off-Label Sales Communications and Product Liability<br />As FDA, DOJ and the SEC increase their investigative and enforcement activities, off-label sales communications and activities have resulted in individual criminal prosecutions and have provided a bottoms-up entree into the company records. These illegal activities can create litigation momentum and have a negative impact on your company's defensibility during product liability litigation. To protect both your company and your growing sales force from expensive, distracting and resource-depleting government actions, join us for an enlightening discussion on how to mitigate both front-end off-label activities and back-end product liability exposure.<br />
Disclosures<br />Good Promotional Practices is sponsored by Prolifiq and Reprints Desk<br />Prolifiq is an AdvaMed Business Solutions Partner<br />
Sales: Off-Label HCP Promotion<br />Image courtesy of Navigant: Life Science Product Value Preservation in a Changing Sea of Liability Risk; firstname.lastname@example.org<br />
Agenda<br />Off-Label Sales Promotion<br />It’s All About the Numbers<br />Standard Seven Compliance Recommends<br />Good Starting Point<br />Rethink for Sales Environment<br />Seven Insights to Preventing Off-Label Sales Promotion<br />
Off-label sales promotionall about the numbers<br />
92% DOJ Convictions are Small Cos<br /><ul><li>In pharma, “we are seeing people driving 67 in the middle lane as opposed to 92 in the fast lane.” “That makes our job harder.”
“You still see a fair amount of wild west behavior in some of these smaller companies, particularly in the biotech and medical device sectors, where you are not necessarily going to have a whole compliance team set up that is deeply immersed in these issues.” </li></ul>Rx Compliance Report, “Federal prosecutors report slowdown in the filing of new fraud claims, say less egregious violations cited”, Vol. IX, Issue 9/July 21, 2010. <br />
400x More Individuals; 50% Mgmt<br />Jailing Individuals: What’s Next in Fraud and FCPA<br />
40% Drop in Stock Price Overnight<br />DOJ probe<br />$3.8M & CIA<br />AtriCure stock plunges amid marketing probe. Wall Street Journal, 11/04/2008. <br />
Standard seven compliance recommendsgood starting Point; rethink for sales environment<br />
Standard Seven OIG Recommends<br />Standards and Procedures<br />Oversight<br />Education and Training<br />Auditing and Monitoring<br />Reporting<br />Enforcement and Discipline<br />Response and Prevention<br />www.ussc.gov<br />www.oig.hhs.gov<br />
Seven insights to preventing off-label sales promotion<br />
Hire Integrity and Team Players<br />Hiring is everyone’s job--Google<br />Cross-functional team interviews<br />Respectful of their colleagues’ environments?<br />No sales prevention or regulatory roadblocks<br />Past cross-functional interactions and references?<br />Independent*, clean background and social media checks?<br />1<br />*9 Notable Insights from AMEX<br />
Listen and Respond<br />Only 3% call the hotline<br />Symantec, low #s for Google and MDT<br />But, 75% take the problem to their manager<br />Symantec<br />“50% of fraud whistleblower cases could have been prevented if someone had listened, responded and investigated proactively”<br />Whistleblower Action Network<br />2<br />Dow-Jones Global Compliance Symposium<br />
Off-Label Education: Who<br />Tone at the middle (Intel and AIG)<br />Interwoven throughout organization<br />Video from CEO doesn’t do it<br />Sales managers train their managers who train their managers<br />Living the story<br />Repetition creates memory and belief<br />3<br />
Off-Label Education: Back to Basics<br />Are your oral and written statements:<br />Truthful and non-misleading<br />Fair balance between benefit and risk<br />Communication of material facts<br />If we can only retain seven things at a time, what 7 things do you want your reps to remember about off-label every day?<br />4<br />
Off-Label Education: How<br />Verbal: Role-playing before and after<br />New launches<br />Major scientific meetings<br />New scientific studies<br />Mandate in ride-alongs and document<br />Mobile is Efficient=$: Incorporate learning with quick, regular communications<br />Work with corpcomm or marketing, e.g. weekly texts<br />Reading paper does not equal compliance<br />5<br />Keeping Companies Out of Trouble: Notes from Google’s and UPS’ Compliance Programs<br />
Make On-Message Easier than Off<br />7<br />Latest and greatest materials?<br />Easy to submit request for article?<br />Off-label scientific requests?<br />Real-time compliance questions<br />Keeping Companies Out of Trouble<br />Poll data courtesy of Prolifiq<br />
Excellent Resources<br />Your own sales force or distributors<br />http://wp.me/p12znw-yH<br />Good Promotional Practices<br />www.GoodPromotionalPractices.com<br />AdvaMed MTLI courses<br />www.advamedmtli.org<br />RAPS.org<br />www.raps.org<br />Dow Jones Global Compliance Symposium<br />www.gcs.dowjones.com<br />
Real-Life Ideas for Sales Managers<br />Educate<br />Your reps need to know what uses are approved/cleared and what is off-label. <br />Before your quarterly sales meetings, review current best practices and emerging uses occurring in the field<br />Surgeons will often come back from a society meeting having talked to their colleagues about new uses; be prepared for this. <br />Practice<br />Have your reps role-play these situations at sales meetings so people know how best to address off-label marketing issues. <br />Practice how to handle an unsolicited request--or whatever company-approved process exists for handling these off-label questions--and still provide the education needed for the physician and staff.<br />Participate<br />Make sure that you are spending time in the field with your reps, listening to their presentations and continuously coaching them. <br />Encourage them to call you with any questions about safely and appropriately navigating these off-label questions.<br />http://wp.me/p12znw-yH<br />
The Habitual Mind<br />When something is a habit, the PFC signals the STN at a very low rate<br />Conserves cognitive resources<br />Make decisions more efficiently<br />When doing something different, as simple as looking at dots in a different order, your PFC signals your STN at a very high rate<br />Doing something new or making a difficult decision requires motivation. Without significant motivation, we default to our habits.<br />Prefrontal cortex (PFC) , the “Decider”<br />Controls decision making, including inhibition of reflexive responses<br />Subthalamic nucleus (STN), the “Doer” <br />Controls motivation<br />