When doing strategic planning and looking at various scenarios it is critical that you consider what type of early signs or signals could indicate that a change might happen. This way you will be able to maneuver your plans toward an emerging scenario faster than your competition. Maybe I am being overly optimistic, but last week’s New York Times report might be one of the first signs that something positive may be coming for our industry. An appellate court in New York overruled the conviction of a sales representative for “off label” discussions. They ruled that the representative’s “freedom of speech” rights were more important than the FDA regulations. Experts feel that the government will re-appeal and eventually the case could be heard by the Supreme Court.
Last week I wrote about some of the changes that must be made to allow our industry to survive. One of the changes needed involves the huge billion dollar settlements paid by the industry for “illegal” marketing practices. Let me start by saying I clearly recognize the need for marketing regulations and the absolute need for true claims to be backed up by data. I am not advocating a return to the times of the wild west when men went from town to town with their magic elixir making all kinds of wild claims. No, I am just advocating for a little common sense and a little fairness. These settlements have severely impacted medical education, the proper positioning of new drugs and have had an impact on drug pricing as well. Some change is needed.
The first concern that needs to be addressed is the unfairness of the system. What does the government or a whistleblower really have to lose when bringing a case against the company? I would argue very little when compared to the lottery type payouts if they win. A whistleblower is protected and the government is working with other people’s money (ours!). The companies may want to put up a legitimate fight, even using the freedom of speech argument, but if they lose they could lose even higher amounts of money than they have in reserve, lose their ability to do business with the government and suffer an incredible blow to their image. In reality, the companies have very little room to try their case. They are doomed from the start.
The second concern has to do with the severity of the fines. Does the penalty really match the offense? Doctors use products “off label” all the time because it is the best thing for them to do for their patients. Managed care organizations have protocols and step edits that do not always follow the official labels but that seems alright as well. But if the drug rep or company talks about this they are immediately placed in huge jeopardy. The fines that need to be paid indicate that all the use of the product was wrong even though informed healthcare providers actually made the prescribing decision. To me it is like a person getting a speeding violation and the town fines them enough to totally rebuild the highway because the highway was only built for a certain speed limit. It just seems a little excessive. Reform is needed.
Perhaps the biggest casualty to all of this is the non-CME medical education that is the backbone of the industry and perhaps even medical practice. Leading medical experts are forced to present material straight from the package insert with little ability to interpret or guide the audience based on their clinical experience. Everyone knows the limitations of clinical trials and even the drug approval process. Medical education, when used correctly, can help physicians fully understand where to best use a product based on the real world experience of these experts. They can help other doctors interpret the label. Today this has stopped happening and this may be one major reason new drugs, that could benefit patients and improve care, are not being used. It just seems overly restrictive.
Perhaps this really is a freedom of speech issue. I hope it does go up to the Supreme Court and I hope their wisdom allows for some change. Right now the industry is cowering in a corner on this issue and we just need some legitimate discussion on the best way to move forward. There needs to be a balance between freedom of speech and the regulations. There needs to be fairness in the legal process. There needs to be a recognition that innovation is driven by imagination and when the restrictions are so tight on the experts this process is impossible. Could the appellate court in New York be on the cutting edge of something? Let’s hope so.