First, Pharma companies should not promote products for uses that are not approved by the FDA.  If a company is found guilty of “off-label” promotion, in addition to any corporate fines (which should equal total product revenues during the time of illegal promotion) , responsible individuals should be held legally accountable and convicted, with personal fines, disgorgement of incentive compensation during the time of illegal activities, and even incarceration if warranted.  No corporate settlements.  It is very likely that criminally charged front line employees directed or even trained to promote for off-label uses may be more than willing to offer up and provide evidence against culpable higher level executives who encouraged or approved of the promotion.  I’m pretty sure this would increase executive management oversight to ensure compliance.

To remove the financial incentives for “off-label” promotion, government programs (Centers for Medicare and Medicaid Services and states) should not reimburse for unapproved uses of prescription drugs.  If the patient wants to pay for the unapproved use of a prescription drug that a physicians has prescribed, that should be their choice.  At the same time, that choice carries the liability that if something should go wrong; the only legal recourse for the patient should be to hold the prescribing physician and perhaps their healthcare provider accountable.  Because “off-label“ use is an informed decision, neither the patient nor the physician (or healthcare provider system) could sue the pharmaceutical company for any negative consequences resulting from the unapproved use.  Physicians who prescribe for unapproved uses but post a diagnosis that aligns with approved uses just so the patient can get it reimbursed would face fraud charges and be held personally liable.  Similarly, there would be no need for federal or state litigation against pharmaceutical companies for False Claims that inappropriately causing taxpayers to fund unapproved uses.

If physicians and patients have made a choice to use a product “off-label” and private payers (insurance companies, employers, or PBMs) choose to pay for the unapproved use then they should assume the same liabilities as stated above.  They are making an informed decision and the payer is agreeing with that choice by reimbursing for the unapproved use.  The patient could sue the prescribing physician, healthcare system, and perhaps the payer, but they would have no legal recourse against the pharmaceutical company should a harmful event occur from the unapproved use.

But what about all the “medically established” unapproved uses in treating things like cancer?  The same rules and legal liabilities should apply.  Physicians have the choice to prescribe, patients have the choice to take, and payers have the choice to reimburse for the unapproved use if they want to assume the liabilities with the inability to sue the pharmaceutical company.  If the medical experts, patient advocacy groups, or government programs and insurance companies feel a prescription drug should be approved and reimbursable for a particular use, they should petition the FDA and submit their clinical proof of efficacy and safety to obtain an FDA approved label claim for the product.

While preserving physician, patient, and payer choice these recommendations remove a major financial incentive (reimbursement) for pharmaceutical companies and increase the legal consequences for individuals who inappropriately promote for off-label uses of prescription drugs.  More importantly, it appropriately shifts product liability for unapproved uses to healthcare providers and payers.   www.PharmaReform.com

The conference is the premiere healthcare conference in the industry and has become “old home week” for industry executives to reconnect, schmooze, and initiate discussions for potential deals.  Getting an invitation is near impossible if you are not among the presenting companies or on the JP Morgan A-list.  I am neither, so I spent last week listening to all the webcasts that are available for the Pharma and biotech company presentations.

Perhaps the single most stunning, yet less obvious (non- investor perspective) “take away” for me was how rapidly Big Pharma is moving away from Primary Care.  With almost 75% of prescriptions now being filled with generic drugs, the trend may not be that surprising.  What is surprising is that the pace of proactive strategic abandonment of Primary Care is far more dramatic than what I believe most people in the industry would want to admit or even realize.

This trend really got my attention when companies with traditional Primary Care portfolios blatantly stated or clearly outlined that they have strategically refocused their pipelines and commercialization efforts to target specialty markets.  With very few exceptions, company presentations were absent references to products or commercial strategies targeting the Primary Care market.  Oncology, neurology, psychiatry, rheumatology, and dermatology seem to be the focus of attention unless you had a Hepatitis C compound in your pipeline.

Again, the interest in specialty products is not surprising.  They command higher prices, yielding higher margins with less onerous managed market intervention into prescribing practices.   From a commercial perspective, specialists represent a smaller, more easily targeted and sales force friendly customer base.   Specialty market physicians and their patients also seek out and are more receptive to disease and treatment information making promotional education a viable and efficient tactic.

The implications of this trend away from Primary Care are clear.  Fewer sales reps needed for calling on Primary Care.  Less need for expensive Primary Care sales and marketing support activities such as purchasing mass market prescription data, coordinating the complexities of territory management and sales reporting, and dealing with sales force related employee relations issues.  It also means fewer industry sponsored educational programs for Primary Care.  Fewer Primary Care clinical trials.   And,  fewer new Primary Care products means Primary Care physicians and their patients will have to be satisfied and content with the treatment options currently available to them.

The real message here is that while Primary Care has been at the foundation of Big Pharma growth and financial success in the past and there may well be exceptions in the future, the importance and interest of Primary Care to Big Pharma is diminishing quickly.  If your expertise or responsibilities include pharmaceutical sales and marketing to the Primary Care market, I believe your days are numbered and you probably have fewer days than you might think.  Specialty products and markets are where the action is and where the industry is headed and it is moving fast.   mike@pharmareform.com

Product liability litigation against pharmaceutical companies often feature how the pharmaceutical company insufficiently or inaccurately informed physicians  (often highlighting what the sales representative said or didn’t say and the brochure used) about the appropriate use of products (right patients, right dose) or communicated misleading understatements or outright omissions of the risks associated with prescribing those drugs.  Companies who can demonstrate they did everything they could to accurately and comprehensively inform the prescribing physician, especially about the risks involved in the plaintiff claims, are generally afforded some degree of legal protection under what is called the “learned intermediary” doctrine.

An increasing number of healthcare systems, hospitals, and academic medical centers are banning pharmaceutical sales representatives from their institutions.  Some group practices and even individual physicians are also placing restrictions on pharmaceutical representatives.  The intent is often to control the influence of sales representatives on physician prescribing but also to preclude representatives from distracting physicians and consuming practice time with interactions that are perceived to have little or no value.

Whatever the reason for limiting sales rep access to physicians, I am wondering how pharmaceutical companies could possibly be expected to fulfill and demonstrate their “duty to warn” responsibilities when institutions and physicians have decided to ignore and outright refuse one of the historically most effective means of communicating product information.  Will the package insert information now be the basis for appropriately “informing” the medical community and satisfy the “learned intermediary” doctrine?

Again, I am not a lawyer but I wonder what the courts and patients are going to say when a pharmaceutical company facing a “failure to warn” product liability charge demonstrates that their package insert clearly delineates the appropriate use and potential risks and they did everything they could to get the information to the physician but they were banned or denied access.  What are physicians going to tell their suing patients when the pharmaceutical company representatives testify that they tried repeatedly to get time with the treating physicians  to discuss the risks and benefits of the drug but were prohibited by policy and rejected at the office or hospital.

If healthcare systems and physicians make the decision not to include pharmaceutical company representatives in their drug education process are they also assuming more liability when pharmaceutical companies defend themselves by demonstrating that healthcare systems and physicians “chose” not to be informed or educated by the company?   They may in fact feel this is no big deal, they’ll just do their own educating.  But if physicians and healthcare systems assume this responsibility and take the deep pockets of the pharmaceutical company  “off the table” , are they really ready to assume the financial consequences or will patients seeking compensation and their lawyers be less quick to file these product liability suits?

mike@pharmareform.com

Ok.  I’m not an attorney but the recent U.S. District Court ruling (Kuzinski, et al. v. Schering Corporation, Civil No. 3:07cv233 (JBA), August 5, 2011) would seem to suggest that all pharmaceutical representatives will have to be classified “non-exempt” hourly employees and be eligible for overtime pay.

By the courts’ strict interpretation of the FLSA (Fair Labor Standards Act) definition, pharmaceutical representatives do not actually make sales. Basically, they do not “consummate sales or obtain contracts or orders” or “binding commitments for purchase” from the physicians they call on and therefore do not qualify for the “outside sales exemption.”  This is hard to argue when a Department of Labor FLSA literal definition for prescription drug “sales” would only occur at the pharmacy or within the supply chain (e.g., wholesalers, chain pharmacies, buying groups, and hospitals) through negotiation, contract, and transaction activities that do not directly involve pharmaceutical representatives.  Despite arguments about the regulatory requirements dictating the role of physicians in the prescription drug sales process, without a lenient interpretation (consideration for regulatory and prescription drug market limitations) of the FLSA definition, it is unlikely that pharmaceutical representatives could ever qualify under the “outside sales exemption.”

The court’s interpretation of “administrative exemption” as it pertains to pharmaceutical representatives, however, is even more disconcerting.  It seems that if you do any training, supply any company developed sales materials or territory management assistance, or provide any management oversight, the courts will determine that “the primary duties” of pharmaceutical representatives do not include the “exercise of discretion and independent judgment with respect to matters of significance.”  This would suggest that the only way to qualify for the “administrative exemption” is to make sure pharmaceutical representatives have complete autonomy (totally independent of any corporate input), do their own training and planning, do whatever they want in the territories that they define as theirs (on their own with no physician or account data supplied by the company), decide and say what they want about the products they choose to promote, and are not managed or supervised in any way.

While this may sound absurd, this is not meant as a sarcastic commentary and certainly is not meant as legal advice but rather a practical observation of how the courts seem to be interpreting the FLSA definitions for “outside sales” and the “administrative exemption” as they pertain to pharmaceutical representatives.  As a result, if the courts continue to rule on these grounds,  I believe pharmaceutical companies will have little choice but to classify pharmaceutical representatives as “non-exempt” hourly employees and will be forced to implement some of the types of tactics discussed in an earlier post.  mike@pharmareform.com

•  Your work day is expected to be 8 hours per day Monday through Friday between 7am and 6pm.  You must not work more than 8 hours per day or more than 40 hours per week without prior written approval from your District Manager.

• Working weekends (Saturday or Sunday) or holidays is prohibited unless you have prior written approval from your District Manager for a particular weekend or holiday requiring your presence for work related activities.

• You are expected to “clock in” using your iPad when you leave your home for work and “clock out” when you have completed your 8 hour work day.  You must plan to complete your 8 hour work day with arrival back at your home.  You can chose to complete your 8 hour work day in your territory but that will be your choice and you will be on personal time after the point you “clock out.”   Use of the company car from that point to the return to your home must be recorded as personal miles .

• If you receive emergency customer calls (you are not to make customer calls except in response to their call) outside your work day hours, you are to record those (caller name, time of call, purpose of call) in your weekly activity report and include the time in your time log.  You will have to adjust your subsequent work time so as not to exceed the 40 hours per week maximum.

• Failure to “clock in and out” may result in loss of pay for that period of time.  Repeatedly “forgetting to clock in or out” may result in disciplinary action including the possibility of termination.

• You may take personal time during the work day as long as you put in your 8 hours between the hours of 7am and 6pm.  You must clock out and back in for all personal time taken during the work day.  Other than clocking out and back in, you do not have to provide any information regarding personal time activities.

• If you plan to take more than 2 hours of personal time during work day hours (7am to 6pm) on any one day you must get prior approval for a vacation day.

• You will be gps tracked to verify time and location for all work related time during your work day.  This will also be used to verify mileage for business versus personal use of the company car.

• You are required to clock out and back in for your mandatory 15 minute breaks, once in the morning and once in the afternoon.  You can not skip breaks or combine break times. You are not to do work related activities during your breaks.

• You must clock out and back in for your mandatory 1 hour lunch break during which you are not to do work related activities.  You can not skip your lunch break and your lunch break must be taken daily between 10am and 1pm.   If you do a work related food activity with physicians or office staff during lunch time, this can not be your lunch break.

• Nobody, not even your District or Region Manager or the VP of Sales, can require you or request that you do work related activities when you are clocked out, including for breaks and lunches.

• Because all work related travel time counts against your 8 hours per day and 40 hours per week, all territories will be reevaluated and realigned where necessary to minimize travel requirements.

• Where possible, all company required meetings will now be by teleconference or video conference to avoid travel.

• You will not be expected or allowed to travel outside your territory to attend any medical or scientific meetings or conferences, if it means you will exceed your 8 hours per day of work.

• District meetings will be kept to a minimum and centrally located to minimize travel for all attendees.  District meetings will be structured to an 8 hour work day with the mandatory “non-business-related” breaks and lunch for which you must “clock out and back in”.  You will be required to take your lunch break and can not do any work related activities during your District meeting lunch break.   So as to not encourage work related activity during District meeting lunch breaks, you will be expected to determine where you would like to have your lunch and pay for your own lunch.  There will be no District meetings requiring overnight stays.

• Any travel outside your territory, except for District Meetings, will require prior written approval from your District Manager.  If travel time requires you to take more than 8 hours per day to attend and return home from a District meeting, you must have prior written approval from your District manager with the anticipated “Overtime” required to make the meeting.

• Only company provided training programs will be considered “work related” required training for which work day time will be allotted.   Any additional training, reading, or research you choose to do with regards to your job or career development will be your choice and done on your personal time.  These “extra” activities will not be required and are therefore “on your own personal time.”

• You will be allotted 2 hours of “work time” every week to take care of any company required administrative tasks (e.g., expense reports, weekly activity reports, or planning) or training. You must be clocked in during this time.

• Your biweekly pay will be automatically calculated from your time sheets captured from your “clock in and clock out” data.

• Any exceptions to these work rules must be identified upfront with the anticipated number of “work hours” involved, any anticipated overtime hours identified, and must have prior written approval from your District Manager.

• Failure to comply with any of these new work rules will result in disciplinary action including the potential for termination.

I am not espousing these rules and I have probably missed a few.  I’m not an attorney but I tried to look at what pharmaceutical companies might have to do to avoid further Fair Labor Act liabilities by establishing work day expectations and accurately tracking and recording work hours for pharmaceutical representatives who are considered “non-exempt” hourly employees.

Of course, the company will have the choice to just pay the overtime when they want to make the exceptions for business reasons.  But, to manage overtime pay and not have it be abused or extended beyond financial feasibility and to avoid litigation, these types of work rules will almost certainly be required.  One could also argue that these work rules are necessary to protect the “non-exempt” pharmaceutical representative from being taken advantage of by management.

While I’m sure some reps may be applauding the overtime pay rulings, I see this as an unfortunate situation, fostering a distrustful work environment with a demoralizing outcome for “professional pharmaceutical representatives.”  How disappointing that it has come to this.    mike@pharmareform.com

A recent featured article in Health Benefit News highlights the success WellPoint has experienced in a pilot program to enlist and pay pharmacists for more attentive “medication therapy management.”  They were able to demonstrate increases in adherence which not surprisingly translated to better control of disease symptoms for hypertension,  hyperlipidemia, and diabetes mellitus.   While pharmacy costs went up they also “saw a great reduction in hospitalizations.”  Overall, in the one year study, they saw cost neutral results, but concluded “it’s going to take more than a one-year time frame to see dramatic changes in cost.”

The healthcare market (with pressure from government, payers and insurers) is getting more aggressive about delivering better clinical outcomes as one way to help increase quality and lower the cost of care.  So whether it is through Accountable Care Organizations, Integrated Healthcare Systems, or just enhancing outcomes from solo or group practice settings, I believe pharmacists will play an increasingly important role in medication therapy management, especially adherence-enhancing programs.   Pharmaceutical marketers who view the retail or hospital pharmacist as merely a dispenser of medications and cursory counseling will be putting their products at risk of competitive erosion and never meeting their full commercial potential in the evolving new healthcare market.

So what’s a pharmaceutical marketer to do?

Well, how many pharmaceutical marketers have assessed (not just mentally speculated) how their product might perform in this type of a trial or study?  How many have commissioned similar types of studies?  How many marketers have partnered with healthcare provider systems to determine the adherence value (clinical outcome differences) between adherent and non-adherent patients and what the value proposition could be?  How many marketers have actually met with pharmacists about their evolving role? How many have started to work with pharmacists on developing educational programs and materials for their products?  How many have pharmacist training programs for their patient education programs?  More importantly, how many pharmacists are considered high priority calls for your sales representatives?

I think I just heard somebody say…”of course we are doing all this.”

Great.  Now, are you doing it as  just another marketing tactic?

I might suggest that if you are doing it to genuinely help patients, pharmacists, and healthcare provider systems achieve their goals, you will find a much more receptive audience, ready to embrace your efforts and make meaningful contributions to your product success without feeling compromised.      mike@pharmareform.com

1. Who is Killing the Pharmaceutical Sales Position?

2. What does your CEO think about Pharmaceutical Sales Representatives?

3. Lasting District Sales Manager Advice for his Pharmaceutical Sales Representative

4. Healthcare Market considerations for Eliminating Pharmaceutical Sales Representatives

5. Professional Pharmaceutical Representative Compensation

Thank you.  mike@pharmreform.com

Here are some of the nuggets of wisdom I found helpful that might be of interest regardless of where you are in your career.  You’ll notice these apply more universally to business than just to the sales position I was in at the time.  They may seem simple and obvious but like many things in life, holding true to their full intent and purpose is much harder than the words might suggest, especially over the course of a career.

Show up: Put in a full day, everyday.  Not just when you feel like it or want to,  but especially when you don’t feel like it or don’t want to.  Most people don’t.

Follow up: check regularly and return phone calls immediately. You don’t know the customer’s sense of urgency, it could be an emergency.  When you promise to do something, send something, or check back … do it… no excuses.

Make one more call: At the end of the day when you are ready to go home, make one more sales call.  This extra effort accumulates into an additional month of sales calls every year.  You never know when that one extra call is going to make a difference for your customer, a patient, or for your incentive compensation.

You get one shot at trust: If your customers quit trusting you, they quit buying from you.  They catch you once in a lie, misrepresentation, or faking an answer, they have no reason to believe you after that.

Be ready for your next job before you get it: This meant that I would have to find the time, energy, and commitment to stretching my development to include subjects and skills beyond my current position. In other words, take responsibility for my own education and career development.  

As busy as we were the days he rode with me, I always found it interesting that he found quiet time to have a cup of coffee to have these discussions.  He made it a point to make sure I was able to listen, commit my complete attention, and engage in the discussion.  This was never during drive time in the car when it might have been convenient and perceived as a good use of time but he knew I would have too many distractions to absorb the salient points he was making.

I feel fortunate to have the opportunity to pass these along to you.  Hopefully they will be useful in the pursuit of your career aspirations.  Perhaps some of you will share some of the more useful pieces of insight, advice, or coaching that you received in your career.

mike@pharmareform.com

“Having been in Pharma most of my professional career, I appreciate the author’s perspective and fact-referenced historical account of pivotal events.  Even though I don’t agree with some of the conclusions, they could stimulate some great conversations.”

Pam Marinko, Pharmaceutical Representative Magazine, December 2010

mike@pharmareform.com

It has to be very tempting for pharmaceutical executives to just:

• Eliminate the traditional sales rep positions entirely

• Hire contract sales (or MSLs) for product launches

• Find non-traditional ways to get product information to key customers

• Increase investment in medical and scientific communications activities

• Provide each customer with a personal customer service rep (phone/internet contact)

• Pay customer service reps hourly with bonus based on customer satisfaction ratings

So why should pharmaceutical companies continuing to deploy sales representatives in the face of such an expensive and daunting selling environment?

Not to be disrespectful but if you peel back all the activity based stuff that pharmaceutical sales representatives do or have done (sample delivery, lunch and learns, distribution of product brochures, etc.) it really boils down to keeping physicians informed about the company’s products, creating and maintaining a positive brand image, and understanding what individual physicians think about the products and how they fit into their practice.

Marketing has tools and tactics to accomplish many of these same objectives for the mass market.  None of them however, is as effective as sales representatives can be when it comes to intervention with individual physicians.  Making sure individual physicians are aware of products, stay current with their appropriate use and correcting misinformation or misperceptions require personal interactions and feedback.

Unfortunately, if you justify the sales representative role as a way “to drive sales” you may have discovered the reason pharmaceutical sales representatives are less welcome in a lot of offices today and why, when you do get in, you don’t get much time.  When you focus on “driving sales” you have a different call.  Your mindset and presentations change and the dynamics of the interaction change as well.    mike@pharmareform.com

• Many of your products are losing patent protection

• Pipeline is slow to replace older, off-patent products

• Market changes and regulatory constraints are negatively impacting sales

• Traditional advertising and promotion are becoming less effective in driving revenue

• Sales force operating costs are a major expense (becoming harder to justify)

• Your company faces prosecution for allegations of illegal sales and marketing activities

• Customers perceive little or no value from sales visits

• Your sales people don’t get sufficient time to make sales presentations to key customers

• Sales people are suing you because they now claim to be hourly employees

• Industry gossip boards are filled with complaints and discontent from your sales people

What do you think you would do?     mike@pharmareform

I should have made a point that pharmaceutical sales representatives should not be expected to deliver the exact same script verbatim to the same physicians more than once. I don’t believe there is any way to make the exact same scripted presentations not sound disingenuous.

If your company feels that compliance with a Corporate Integrity Agreement mandates tightly scripted sales presentations, then those responsible for drafting those scripts must do a much better job of crafting them as prescribed in the previous blog.

Companies and commercial management that feel scripted presentations will be more impactful than letting reps “wing it”  must also do a much better job of crafting the presentations, making them much more rep and physician-friendly as prescribed in the previous blog.

Perhaps I got this from my first District Manager ( one of the best I ever met in the industry)  but I am a firm believer that for product presentations there is always “a best way to say it.”  Getting a scripted presentation right is really hard work and requires an iterative process to get it right.

I also know that when I am shopping to make an important purchase I prefer a sales person who is well prepared with a carefully crafted, well thought out, information packed, and smooth flowing logical presentation (including answers to my questions and objections) than somebody who just “wings it.”  You may nail it occasionally by “winging it”, but I believe you will be more consistent in delivering important information and come across as more professional with a well scripted, prepared presentation.   Again, I also believe the more you practice delivering the presentation the less it will sound robotic and monotonous.

My impression from the feedback is that the scripted presentations pharmaceutical sales representatives are being asked to deliver do not meet the quality of presentations I have referred to in these posts and no amount of practice will make them better.   That being the case,  I would probably hate them as well.   mike@pharmareform.com

I’m guessing most representatives see scripted presentations as demeaning, belittling of their competence, and unprofessional.

Let’s think about this.  Do stage performers such as for Broadway shows or comedians, feel this way?  Do musicians (think of your favorite singer or band) feel this way?  Do great orators and professional speakers feel this way?  Do even the best of news anchors feel this way?  When the president or another politician delivers a speech, do they feel this way?

Hardly.   So why do pharmaceutical sales representatives feel this way?

I believe there are several reasons why pharmaceutical sales representatives hate scripted sales presentations.  Here are just a few:

• The scripts are poorly written and not honed to perfection through an iterative process using real sales representatives with real customer feedback
• The scripts don’t accommodate different practice settings, physician personalities, patient types, or treatment alternatives
• The scripts are not conversational, sound scripted, and often intentionally avoid opportunities for customer engagement (lack interaction)
• The scripts are more focused on delivering message than they are about how they affect (“land on”) the customer (think emotionally and intellectually)
• The scripts (including answers to questions) are not practiced (rehearsed) to perfection with incorporation of natural voice modulations and corresponding supportive intonations
• The scripts don’t anticipate the questions that are likely to be asked (or reps don’t practice the answers) so it looks like the rep only knows the product message script.

Yes, there are legitimate reasons why pharmaceutical sales representatives don’t like and even despise scripted sales presentations.  In the context of the above issues, scripted sales presentations can seem demeaning, belittling of a person’s competence, and come across as unprofessional.  That doesn’t mean they have to be.

I believe it is actually unprofessional to think you are so good at sales that you feel you can “wing it” without a scripted, well rehearsed presentation on sales calls.

Like many sales professionals in other industries, professional pharmaceutical representatives should embrace and arm themselves with carefully crafted, engaging, information packed, rehearsed to perfection presentations.  And, answers to customer questions they have encouraged should just become a natural part of their well prepared presentations.

It is hard work to get the scripts right in the first place and then it takes more hard work and practice (to perfection, not just random impromptu “role plays” with your District Manger) to deliver impactful scripted sales presentations professionally.  mike@pharmareform.com

The comprehensive care expectations for Accountable Care Organizations are beyond the capabilities of most solo physician practices or even small groups.  Also, hospitals will need to expand their roles to include better coordinated post hospitalization care to ensure patients continue their recovery without relapse and re-hospitalization.   This integration of care approach is causing some private practice physicians to consider joining larger group practices and encouraging hospitals to reach out to employ and align with the best physicians in their geographic coverage areas.

So how will this affect pharmaceutical sales?

The first implication of Accountable Care Organizations is most likely going to be a further reduction in sales representative access to primary care physicians as they join larger, busier group practices or hospitals.  Representative access to these physicians is  likely to be governed by even more selective product recommendations and administrative policies developed by the Accountable Care Organization.  The impact on physician time with patients and the potential for sales reps to influence expensive branded product use will also affect access decisions.  If representatives can demonstrate value by favorably impacting quality of care or cost reductions, they will find physician access less challenging.

Adoption of best practices and formalizing treatment guidelines will mean physicians will  be less autonomous in their prescribing practices. They will also have a financial vested interest in prescribing cost effective treatments, complying with formularies, and following recommended treatment guidelines established by the Accountable Care Organization. This will make it more difficult for pharmaceutical representatives to directly influence prescribing of products not supported by ACOs.

Electronic health records (a prerequisite for Accountable Care Organizations) will make the real world impact of drugs on provider quality of care and costs more readily available for evaluation.  Electronic medical records and e-prescribing will also allow for managing and monitoring compliance with treatment guidelines. These assessments and compliance monitoring will leave less opportunity for random use of expensive branded products with marginal clinical benefit.  Deviations from treatment guidelines will require justification and could result in reprimand or potentially expose physicians to financial penalties if repeated non-compliance results in increased costs without clinical benefit.

Companies with products that can demonstrate improvements in clinical outcomes (better than alternative treatment options) or reductions in overall healthcare costs will find a much more receptive institutional audience than they might have in the past.  Companies armed with compelling data will be able to influence the inclusion of their products on formularies and in treatment guidelines.  This is especially true for value-priced preventive medicines, vaccines, and companion diagnostics.

Sales representatives with new products or products that are not favorably received by the ACOs in their territories will be faced with the challenge of gaining acceptance.  Unlike having to convince (selling) individual physicians to prescribe your product, formulary and treatment guideline recommendations will be determined by healthcare provider teams with therapeutic and cost benefit expertise.  More importantly, electronic health records will provide these teams with easy to analyze comparative clinical outcomes and cost data from their own organizations, making it even more difficult for companies (and representatives) without comparable data to make their case.  Collective expertise, real world data, and financial incentives for delivering good clinical outcomes at low cost will make for a hostile environment for companies and representatives who are not equally armed with expertise and real world therapeutic and cost benefit data.

On the other hand, if the Accountable Care Organizations feel a product can help them achieve their quality of care and cost savings goals, representatives may be enlisted to assist the ACO achieve its goals.  Representatives could be encouraged to help educate physicians and other healthcare providers about the appropriate use of their product (within treatment guidelines).  They might even be called on to assist with implementing adherence and compliance programs to make sure patients take their medications as directed.  It might even get to a point where products are placed in treatment guidelines contingent on delivering the expected clinical outcomes and cost benefits.  This would require representatives to understand the metrics for assessing their product performance and staying current with how their products are performing (clinical outcomes and cost savings) within that ACO.

Regardless of how the ACOs are structured or how they decide to operate, it will mean a completely different work environment for pharmaceutical sales representatives.

mike@pharmareform.com

I believe it is because it takes experience and a much higher level of coaching skills and management expertise to leverage the value and satisfy the performance expectations of a professional representative.

You may have heard the term “high maintenance rep.”  Well, they can exist on both ends of the performance spectrum but it is probably used most often to describe professional representatives.   The reason is that professional representatives will push sales managers, sales training, and marketing to their limits of technical and scientific competence, coaching skills expertise, and management capabilities.  When the skills and expertise of the professional representative exceed the management competence of the sales manager, it becomes personally threatening to the manager and makes their job much more difficult and sometimes even impossible.

Professional representatives are so good at what they do and they have such an instinctive sense for what is going on in their market that they are often the ones that ‘complain” about the crappy marketing materials and boring marketing messages they are being asked to use.  When they point out that they really don’t have the data to support the claims or the efficacy implications of the marketing materials they get labeled as trouble makers.  Professional representatives also expect insightful post call coaching for improvement not just critique of what they did wrong.   And, despite being less driven by numbers, when they point out that their sales forecast makes no sense as it applies to their territory, professional representatives are frustrated by the lack of rationale for their increase, especially in the context of other conspicuously low territory growth rates.

Experienced, skilled sales managers with expertise treasure and nurture professional representatives.  They lean on them for help. They tap their technical and scientific expertise for the benefit of the district or region.   Experienced and skilled sales managers know how to inspire and help professional representatives achieve their seemingly impossible expectations for excellence.  They have the exceptional coaching skills necessary to identify the nuances of interpersonal and presentation skills that can make the difference between an impactful discussion and merely delivering another marketing message.  It takes a confident (not arrogant) manager to hear what is really being said in the “complaints” of the professional representative.  You have to be a much better, more experienced sales manager to appreciate and effectively manage a highly skilled professional representative.

If you lack experience, sales management skills, coaching expertise, and technical competence, you will hate managing a professional representative.

mike@pharmareform.com

In fact, I predict that sales organizations will be most resistant to this change as most pharmaceutical sales representatives and managers are too grounded in the traditional sales mentality.  Many sales people are just going to see this as a take-away and will want nothing to do with the job.  It will also be hard for managers to get their arms around how to manage sales (“drive sales”) and evaluate performance without sales quotas and other activity based numbers.   They will complain about the inability to fairly and consistently assess performance if they don’t have hard numbers.  They ignore the fact that today’s prescription data and sales volumes are not accurate and are filled with national, regional, district, and territory caveats.   They also like to think that today’s sales goals and territory alignments are fairly distributed and accurately reflect potential.  And when was the last time we correlated the number of territory activities to sales results?

In the end, none of this matters because incentive compensation is not a performance driver for professional representatives the way it is for traditional sales representatives.  Incentive pay is not a scorecard like it is for traditional sales reps.  In fact if the lack of incentive pay is the reason for a representative to quit, you really didn’t lose a professional representative, you lost a sales representative and this is fine because they wouldn’t be happy or satisfied trying to make it work.  This is the hardest concept to get comfortable with if you have a traditional sales and sales incentive mentality.

Professional representatives want to be paid for their expertise, their stature in their medical community, and recognized for their personal performance excellence.  They prove their expertise and the effectiveness of that expertise by the business health of their territory in terms of how their products are perceived, formulary and reimbursement status, their access to key decision makers, and the professional respect those decision makers have of them personally.   They appreciate that actual sales of their product depends on a number of factors, some they can influence while for others it would be inappropriate to influence (e.g., encouraging the use of their product for patients who are not good candidates or where there is a better product available).  Sales and prescriptions are merely surrogate markers for a lot of things going on, not just their performance.

So how do you compensate the professional representative?  You pay them relatively high base salaries (compared to traditional sales representatives) consistent with their expertise and ability to create or maintain a healthy market environment for your products.   How many people can you hire with that level of expertise and ability to keep a territory healthy?  If you think you can find a lot of these people, you don’t have much for expectations and you are probably not looking beyond physician prescribing.  Are the people you are talking about able to hold their own in a scientific discussion with the Medical Director of an insurance company or pharmacy benefits manager that is considering how your product should be used in their patient population?  Can your representative cite the scientific literature to support their claims and recommendations for appropriate use? Is your professional representative so knowledgeable and good at their job that the insurance company Medical Director wants to hire them?

As for incentive pay, you might as well save it or better yet, invest it in your professional representative’s development.  You’d be better off spending the $20,000 per year on training, development, or sending them to more scientific meetings not to stand in an exhibit but to go to sessions and interact with their professional and academic colleagues.  If you still feel compelled to provide incentive pay, test them regularly on their expertise and give cash awards for testing performance.

You have to remember, professional representatives don’t do things because there is an additional pay opportunity associated with it.  They inherently want to do it because they see it as their responsibility. Their job is a big part of who they are and they take pride in themselves and the work they do. They view their compensation as a reflection of the level of expertise they have and the value they bring to the company when they apply that expertise.  They get more job satisfaction out of applying their expertise than any incentive pay could possibly achieve.   In fact, they’d rather have a pay raise as recognition of their advanced expertise than an incentive to drive sales.

The industry’s strong sales mentality will make it difficult to embrace the professional representative concept and even more challenging to formulate sales compensation plans that are not tied to sales and prescription volume.  You have to start someplace so perhaps this at  least has got you thinking about it philosophically.

mike@pharmareform.com

So what keeps representatives from having more engaging, more informative, and more credible discussions with physicians?  One of the most frequent reasons, or excuses, I hear about is the regulatory constraints placed on representatives.  Regulatory restrictions get in the way of being more effective as a sales representative when opportunities for product use exceed the label claims or where representatives could drive more sales by implying or even making comparative claims they can’t support with label claims or “substantial evidence.”

To ensure regulatory compliance, many companies, especially those with Department of Justice Corporate Integrity Agreements, now require representatives to stick to verbatim scripted presentations that mostly do not resonate well with physicians.  This “regurgitation of the company message” is an immediate turnoff for physicians, lacks credibility, and makes for awkward representative – physician interactions.

Now, keep in mind the premise of our discussion here. You are a professional representative and your mindset and focus is on making sure patients in your territory are getting the best treatment possible.  You are not just “driving sales” by doing and saying whatever it takes to get physicians to prescribe your product as much as possible.   Professional representatives don’t need to be reminded of fair balance or to stick to label claims and approved literature, they just do.  The challenge for them is whether or not they have the claims and sufficient regulatory compliant data and literature to meet the information needs of their customers.

Some sales representatives might suggest that they have all they need in terms of claims and published data and regulatory is just getting in the way.  If that is the case, then why would there be a regulatory compliance issue?  Why is regulatory review such a big deal?  Why would companies and representatives feel a need to promote off-label to make their sales? Why would companies feel compelled to script boring marketing messages to ensure sales representative compliance? More importantly, why is the market still clamoring for more comparative trials and better data to help them identify best treatment options for patients?

In this competitive market and knowing that products we now have were developed with a “get it to market “ mentality and indication – driven clinical trials to satisfy regulatory requirements for safety and efficacy, I’m going to suggest you do not have the claims or data you need.  How many of your products have two well controlled comparative efficacy trials to support claims of differentiation that you can use in sales presentations?  Can you claim superiority?  If not, how can you discuss why your product is better than another for a particular patient type? Can you do this and be compliant with regulatory requirements or are you expected to just cleverly implying a difference?

Here is the problem.   Even today, research gets the indications and it is up to marketing and sales to differentiate the product in the market.  When a physician or managed plan decision-maker asks why they should use your product rather than a competitive product, how do you answer?  Blatant claims of superiority or implied differentiation are the only way to convince them why your product should be used over another product.

What’s interesting is that when research and management talk about products to investors or in company presentations, especially before launch, they talk about and always answer questions about how the product is better than anything else out there, often using historical data from competitive products compared to their just released clinical data.  They highlight all the wonderful features and benefits that your product has over the competition, even quote data that imply superiority.

But, when marketing and sales wants to take those same messages to the market they have this regulatory issue.  While the research and management statements may be true,  they don’t necessarily come with the label claims or “substantial evidence” to support those same claims in advertising and promotion.  Yet, revenue forecasts are driven off those claims and expectations for differentiation.   And besides, who ever launched a product that wasn’t considered by their research team and management to be better than anything out there?

Pharmaceutical companies can no longer expect, pharmaceutical representatives to fill the label claim and “substantial evidence” data void for products.  The disconnect between product differentiation assumptions used for revenue forecasts and the regulatory constrained messaging puts the representative in an unfair position of having to deliver sales expectations beyond that which would be or ever could be achievable given a compliant presentation.

To be effective, even professional representatives need regulatory compliant information, comprehensive label claims, and more importantly, “substantial evidence” documented in peer-reviewed published literature.  This is the responsibility of management and the research team.  It is then marketing’s responsibility to develop forecasts that are aligned with the label claims and regulatory compliant information available for presentations and discussions by representatives.   mike@pharmareform.com

So here goes.

When it comes to skills and expertise each of the following representative profiles has its strengths and these strengths may or may not be a good fit for a particular industry or job function.  Here is how I see the two profiles:

Traditional Pharmaceutical Sales Representative:

• Strong interpersonal and social skills help build rapport and establish relationships
• Exceptional selling skills and persuasive techniques
• Tactically oriented, relying on sales materials, promotional programs, and samples
• Customers are seen as prospects and a source of sales revenue
• Selling is seen as a competition (if I get more prescriptions I win, you lose…even if my product isn’t as good as yours)
• Sales numbers are a scorecard for incentive compensation
• Work Objective:  “get the doctor to prescribe your product as much as possible”

Future Professional Representative:

Has many of the skills of the sales representative including interpersonal, social, and selling skills but…

• They have a patient-oriented focus around meeting or exceeding customer and market expectations (want the best product for the patient)
• Rely heavily on technical and scientific expertise as their base of confidence  to establish rapport and build credibility and trust
• Sales numbers and incentive pay are not performance motivators
• Work Objective:   “make sure patients  get the right product and customers realize the maximum benefit from your products”

The biggest differences between these two profiles for selling pharmaceuticals are the level of expertise and the mindset about their jobs.  The professional representative goes well beyond the company training and resources to understand the science around their products and diseases.     They pride themselves in staying current and knowing more about their products, the diseases being treated, and competitive products than anybody in their territories, including the physicians.  They base their knowledge, presentations, and conclusions on data from the literature which they can quote objectively and accurately.  They do this because they see this not just as their job but their responsibility.

The professional representative has a different motivational mindset.  They are motivated more by personal performance excellence and expertise than sales numbers and incentive pay.   The reason they like and do their job goes well beyond making the sale.   In fact you might even think the sale is a collateral benefit of their work.   This is a very hard attribute and concept to describe because it is inherent in the thinking of a professional representative.  This is one of those “you know it when you see it” type things.  Their drive and motivation may not even make sense to the hard core traditional sales representative and certainly isn’t compatible with most traditional pharmaceutical sales management thinking or expectations.

There is nothing wrong with being a traditional sales person.  This profile drove sales in the pharmaceutical industry for decades.  And, there are industries , especially retail and consumer products, that require a sales mentality to succeed.  And, you can be a professional sales person, mastering the skills and acquiring the expertise related to sales of the products you are selling.  But if your mindset is still that you  are motivated by making the sale and the only reason for your interaction with a customer is to generate a sale, you are a sales person.

The healthcare market has changed however, and one of the changes that the pharmaceutical industry must accommodate is the declining effectiveness and diminishing tolerance for the traditional sales representative role and profile.  Declining physician access was perhaps the first indication of this market change.  State legislation to restrict sales representative activities followed and intensified regulatory scrutiny has now made for a much more challenging environment for pharmaceutical sales representatives.  As a result, I believe that a professional profile as described here and in  a previous post is the only hope for pharmaceutical companies to have a local “in the field” presence in the evolving new healthcare market.

I can hear it now….but the regulatory and legal constraints won’t allow for this profile.  I’ll address that in the next post.  Stay tuned.  mike@pharmareform.com

Professionals have an inherent need to know as much as they possibly can about their profession and the work they are doing.  This includes learning about differing points of view and why people might hold them.  This includes different ways of doing things,  even though they may not agree with the method.  Professionals strive to keep themselves up to date and ahead of their colleagues and anybody else for that matter.  They go well beyond what the average person will do to stay current or to do their jobs better.   And, while they know they can command higher compensation than non-professionals doing similar work in the same field, compensation is not a motivator for true professionals.

Professionals maintain their expertise and keep it current because it is a big part of who they are and they know that being a true professional with genuine expertise is rare.  They  continuously look  for ways to improve and enhance their expertise, often evaluating and employing new technology quickly if they think it might help them.  And while the internet makes it easier for them, books, including electronic versions, still provide information, insights, and unique author perspectives that can not be found on the internet.

Are you a professional or are you just doing a job?  It really is a personal choice and being a professional may not be for you.  It is also not a right or wrong choice, good or bad choice type thing.   It is also not about doing your best but more about being the best.  It takes commitment, dedication, skill, expertise, and an internal, self motivating drive to be the best at what you do.

So, if you consider yourself a professional, what’s on your bookshelf?  What have you read lately?

mike@pharmareform.com

This organizational transformation will require that commercial management step up their game and the level of their own professionalism.  Expertise in traditional marketing and sales tactics is not going to help much in this evolving new healthcare market. There are no slick technology quick fixes or gimmicky tactics that will substitute for meeting product and data needs of the market.  It is critical that marketing and sales management understand and accept that tactics that worked in the past and the bad behaviors that drove revenues in the past, are no longer going to be tolerated and will not work in the evolving new healthcare market.  It means marketing and sales management must reformulate their strategies and acquire new skills and expertise that are better aligned with the needs and expectations of the evolving new healthcare market.  This includes being able to effectively deploy a  sophisticated team of professional representatives and arm them with products and support resources that address the evolving healthcare market needs and expectations.

Unfortunately, most executives and the people running commercial teams today are grounded in a traditional mentality about pharmaceutical marketing and sales.  This is where I predict most organizational transformations will fall short and stall out.  Those who can make the changes and should be championing the changes will feel threatened by a move away from their own expertise, experience base, and comfort zone.

Here is something to think about.  Let’s assume the company decides to embrace the organizational changes we have discussed and it is ready to embrace the new professional representative profile. Where do you find marketing and sales management with the new skills, expertise, and mindset needed to formulate and implement the new commercial strategy?  For example, will sales managers understand and appreciate the differences between sales reps and professional representatives?  Will marketing managers understand that they need to spend more time comprehending the complexities of the evolving decision-maker processes and nuances of customer expectations (not just market research) rather than worrying about the copy and graphics for their next TV commercial?

Again, don’t underestimate the need for executives and commercial management to really understanding the market at the customer level and having the right mindset about how to approach this new commercial model.  Some sales representatives and some commercial management may be close to the desired profile and mindset needed for these changes but they also need corporate executives who can create an environment in which these individuals can champion these changes and flourish.   Unfortunately, there are probably more who don’t get it, won’t get it, and will probably fight it, if not actively, passively by doing nothing.

mike@pharmareform.com