Those that teach us about innovation and future trends talk about paying attention to those things that seem very odd at first but then seem to linger. A few weeks ago, the NY Times ran an extensive piece followed by this editorial that centered on two similar very sad patient situations. Both patients took the same drug and had similar serious adverse events. The only difference was one took the brand name drug and one took the generic. The woman who took the brand drug successfully sued the manufacturer and received a significant settlement. The woman who took the generic lost her case because, due to last year’s Supreme Court decision, the generic companies were viewed as not liable.
The Supreme Court in Pliva v. Mensing ruled that generic companies could not be sued based on not having adequate warnings in their package inserts as they were not allowed to change the label as per the Waxman-Hatch legislation that is so important to the generic world. This argument makes some sense and most of the debate has now turned to changing policy and whether we should allow the generic companies to control what is in their own package inserts.
To further add to this public interest story, last week Senator Leahy (D-VT) introduced a bill that would allow the generic companies to update their inserts. A similar bill will also be introduced in the House. Note in the article that Public Citizen is strongly in favor of the law and the generic companies are against it. Obviously, not much is getting through Congress these days, and it would be a good bet that Leahy’s bill will not move forward, but it is definitely worth noting.
What does all of this mean to the branded pharmaceutical marketers? First, please don’t start an ad campaign saying to use brand drugs so that if something goes wrong you can sue us. I am sure there are more than a few consumers who are thinking this after reading the articles, but that is not a path we should go down. Perhaps, if nothing else, it is time to start considering generic companies as true competitors and begin demanding regulations that are fair and equitable to all parts of the industry.
What would happen if generics were forced or allowed to update their label? The obvious result would be the need to hire massive numbers of people to monitor, analyze, work with FDA and defend legal cases. This would drive up their costs and increase the cost of their products and probably drive marginal companies out of the market. Would every company have their own insert based on their own data? If 50 companies produced phenobarbital would there be 50 unique inserts? We are talking about a lot of potential chaos here. By at least pushing forward the discussion it becomes more and more obvious how little generic companies are required to do compared to the branded part of the business and perhaps some change is needed.
The bigger trend that may be worth watching is now that generics have over 80% of the prescriptions in our country, they may be asked to take on greater responsibility for the products they sell. As one of the commentators suggested, if the generic company knows there is a problem with the drug and can’t change the warnings, perhaps they should not market the drug. If they can’t change the package insert, are there other things they should be doing to help ensure patient safety? Perhaps, the days when generics just get a “free ride” may be coming to an end.
All of this is going on at the same time as we are awaiting Pfizer’s first quarter results, where it is hoped they will discuss the success they have had with their Lipitor post-LOE strategy. The world will see how their tactics have impacted the generic world during their most profitable first six month period.
Maybe it is time for a “Waxman-Hatch 2012″ (with new names) discussion to really examine how best the generics and brand parts of the industry should work together to both insure lower costs and drive innovation. Let’s keep watching.