Quit Blaming Drug Companies for Healthcare Market Prescribing and Reimbursement Decisions

Pharmaceutical industry marketing and sales are often blamed for promoting  “off label” prescribing and have been highlighted in prescription drug fraud and product liability cases.

If the healthcare market, industry critics, regulatory agencies, and patients are looking for a way to control and reduce the influence of pharmaceutical company advertising and promotion on prescription drug choice, they should step up and take responsibility for the decisions they are making.  Don’t blame the drug companies for prescribing and reimbursement choices being made by the healthcare market.

Nobody is forcing physicians to prescribe these drugs.  Nobody is forcing insurance companies or the government to reimburse prescriptions written for “off-label” uses.  Nobody is forcing patients to take drugs for unapproved uses or to take drugs that might result in side effects or adverse reactions.  These are all conscious choices.

Information about the appropriate use of prescription drugs and the known potential risks associated with taking these drugs is readily available in the prescribing information (FDA approved label claims or package insert) for each drug.

One would think that prescribing decisions would be based on careful evaluation and assessment by the healthcare market, physicians, and patients and not driven by the influences of pharmaceutical company marketing and sales activities.  How irresponsible is it for physicians, government agencies, or insurance companies to accuse drug company advertising and promotion for determining their prescribing practices or reimbursement policy rationale?  It is also not credible to suggest the government (including state agencies) and insurance companies are being duped by drug companies and are blindly reimbursing for drugs prescribed for “off-label” uses.

So how should this be working?  (I am not trying to be a lawyer here, just proposing how it should be working)

  • When a physician and a patient decide to use a product, it should be implicitly acknowledged that they are aware of and understand the information in the product prescribing information (FDA approved label claims and safety information).  If the patient does not understand the information in the product label or the implications of the wording in the product label, it is the physician’s responsibility to help them understand the potential risks and benefits.
  • The patient has a choice to take the drug or not based on the information they receive from the physician (and they can read the product prescribing information themselves, if they want to).  By deciding to take the drug, patients acknowledge they are aware of the potential for side effects and adverse reactions and accept these risks (shouldn’t be able to come back and sue the pharmaceutical company for something that is in the package insert).  They have made an informed choice to accept the risks.
  • Pharmacists, before dispensing a prescription, should make sure patients understand how to take their medications and the potential side effects, adverse reactions, and food or drug interactions.  Dispensing pharmacists should be accountable for making sure patients understand the risks.
  • Physicians should prescribe products only for the FDA approved label claim indications.  Physicians who prescribe and patients who decide to take a drug for an “off-label” indication or use should assume the product liability for how the patient responds to the drug (lack of efficacy or any resulting side effects and adverse reactions). They have made a conscious informed decision and choice to prescribe the product for a use for which the manufacturer has not obtained sufficient evidence of safety or efficacy (FDA approval).
  • Government programs (e.g., CMS), private insurance companies, healthcare provider plans (including state government programs), and pharmacy benefits managers should reimburse only for FDA approved label claim indications.  By providing reimbursement for “off-label” uses, I believe they are complicit in the promotion of “off-label” use of prescription drugs.  The lack of reimbursement makes the promotion of products for “off-label” uses much less attractive for drug companies.
  • Insurers (private or public) who provide reimbursement for off-label uses of a product should assume all product liability for its “off-label” use, including lack of efficacy or any resulting side effects or adverse reactions. (can’t come back and sue the pharmaceutical company)
  • Insurers (private or public) who agree to reimburse for “off-label” use of a product should not be able to sue for false claims or fraud related to that “off-label” use.  The insurer knows the physician has made a conscious decision to prescribe the product for an “off-label” use, the patient has been informed of this decision and how it was reached (discussion with the physician), and the reimbursing insurer has the prescribing information against which to evaluate their decision.  By providing reimbursement, the insurer acknowledges agreement with these decisions and should accept the potential liabilities.

If the healthcare market, insurers, physicians, and patients don’t want to be influenced by drug company advertising and promotion, they can simply take responsibility for the drug treatment choices and reimbursement decisions they make.  The ready availability of FDA approved prescribing information leaves little excuse to be unduly or inappropriately influenced by drug company marketing and sales activities.  In fact, isn’t it embarrassing to admit that prescribing and reimbursement decisions are based more on pharmaceutical company marketing and sales than medical information and clinical judgment.

So quit blaming drug companies for prescribing choices and reimbursement decisions.  mike@pharmareform.com

When is a High Sense of Urgency a Liability for Pharmaceutical Companies?

We are definitely living in a “Just Do It” global economy that rewards action and speed of execution.   This sense of urgency is reinforced by our instant access to new information on the internet and capabilities such as high speed trading on Wall Street.  Service providers and advertisers reinforce this need for speed and create universal expectations with offerings to get it done faster, quicker, and in less time.  In fact, we can’t seem to get things done fast enough, all in the name of taking advantage of a fleeting opportunities and staying competitive.

Almost nothing of importance in the pharmaceutical industry happens fast yet an incessant sense of urgency almost seems to be a badge of honor and is often applauded by Wall Street.  There seem to be a pervasive need to get things done quickly at pharmaceutical companies to create a competitive advantage (first to market) and potentially increase the commercial opportunity (more time left on the patent to market the product).

But, is having this sense of urgency always a good thing? Let’s take a look at four areas where an indiscriminately managed sense of urgency can lead to inferior, if not disastrous, results for a pharmaceutical company.  A reckless sense of urgency in research, manufacturing, commercialization, and employee development all carry significant potential liabilities.

Looking for quick hits in discovery research, rushing products through clinical development and even quickly killing product candidates early in development can all lead to disappointing results, even for products that might have otherwise done really well.  Missed therapeutic applications, overlooked safety issues, and product failures in late stage clinical trials can be symptomatic of making urgency and speed a priority in research.

Manufacturing operation with a heightened sense of urgency may be able to get up and running quickly or increase production output but run the risk of operational errors, increased waste, and fostering damaging quality issues.

Similarly, when commercial plans and tactics are deployed without due processes in an effort to get it done or to make a change quickly, marketers run the risk of medical-legal compliance liabilities, market miscommunication, misdirection of the sales force, and potentially slow adoption or even instigate rejection of the product by the market.

Also, when individuals who have accelerated promotions to higher levels of corporate responsibilities before they are truly ready, they are probably not thinking about the potential liabilities of premature advancement. Unfortunately, the realities of their inexperience can quickly catch up with them,  resulting in mistakes and poor decisions that have increasingly greater and longer lasting impacts on the company and the people who report to them.

I’m not suggesting the pharmaceutical industry and executives abandon this sense of urgency but rather to apply it discriminately and manage it carefully.  Not everything should have the same heightened sense of urgency and those that do require a commensurate high level of attention to detail with a disciplined, realistic assessment of expectations and potential liabilities.  Somebody needs to be asking; “Are these timelines necessary and realistic?  Why? And For what end result? “  With these timelines; “What are we missing here?” and “How do we mitigate the risks?”   mike@pharmareform.com

Pharmaceutical Representative Magazine Publishes Review of Pharmaplasia™

Pam Marinko, cofounder of the Atlanta Medical and Pharmaceutical Representative Association and a member of Pharmaceutical Representative ‘s advisory board gives Pharmaplasia™ 4 of 5 stars in her review in the December 2010 issue of Pharmaceutical Representative Magazine.

“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

Deploying Pharmaceutical Sales Representatives to Drive Product Sales

So what would you do in the previously described post? If you wanted to continue the sales representative role, could you justify the expense and the return on investment? What would your justification be?

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

Pharmaceutical Sales Representative Reality Check

As owner of a pharmaceutical company faced the following scenario, what would you do?

  • 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

How to Affect Change with the help of Pharmaplasia™

I really appreciate all of you PharmaReform readers who have purchased Pharmaplasia™.  Thank you.

I’m sure many of you realize how hard and seemingly impossible it is at times to affect the magnitude of change we have been talking about for over a year now at Pharma Reform and as described in Pharmaplasia™.  This is especially true in large organizations where the changes have dramatic financial implications for the company, puts careers and the livelihood of so many people at risk, and that are clouded by uncertainty at every step of the transformation.  Yet a more prosperous pharmaceutical industry for the future will require dramatic change.   Some people won’t want to change while others will just complain that things must change but they’ll feel helpless in being able to affect the change.

As a reader of Pharma Reform you have probably even thought, “this is all well and good Mike but… how do I get my management and corporate executives to start thinking differently about these issues and the need to formulate plans that make sense for the evolving new healthcare market?”

For those still contemplating the purchase of Pharmaplasia™, I am certain that as readers of Pharma Reform you would relate to the suggestions and recommendations proposed in Pharmaplasia™ but more importantly, you’ll be well informed and inspired with confidence to begin making your case for change where you feel you can have an impact.  But, how do you do that without sounding like a “whiner” or feeling like the “lone soldier?”

OK.  Here is a self serving but low risk strategy to help you at least get your management to start thinking about what this evolving new healthcare market really means to your company and what they can be doing about it.  If you have already bought a copy of Pharmaplasia™ and read it, this is going to be easy.  If you haven’t bought and read Pharmaplasia™, that’s the first step. Buy a copy and read it.  Wait…I’m not done yet.  Hang on.  This is not just about selling more books, although that would be nice.

If you agree that your company could benefit by at least exploring some of the suggestions and  recommendations in Pharmaplasia™ or  from just talking about the issues, pass the book on to your manager (or somebody else who you feel could help make a difference) with the simple recommendation that Pharmaplasia™ presents some interesting perspectives that are worth reading about.  That’s a pretty benign, low risk commentary and referral.  Then follow up to see what they thought about it and see if they think it’s worth discussing further or doing something about.

If nothing else, Pharmaplasia™ gives you a great opportunity to instigate thinking about the future (rather than day to day activities) and have a non-judgmental discussion around specific issues that might pertain to your company, to better understand your management’s thinking and to explore their strategic rationale.  If you can get the book back from them, you can then pass it along to another person who could help make a difference.

OK.  If you keep passing it around like this I might not sell as many books but that’s not the point.  Neither is agreeing with everything in the book.  The point is to stimulate thinking about your company in the context of the evolving new healthcare market and encourage discussion (not complaining).  Perhaps you will identify some areas where you can take easy first steps to make a change for the better or perhaps even get to the point where it makes sense to “Invite Mike to Speak.”

So. You can remain frustrated, complain all you want, and see what happens or you can make this small effort to contribute to change and maybe you’ll be surprised by the initial impact you can have, even in a large organization.

mike@pharmareform.com