In light of the recent court decision that Roche adequately warned of Accutane risks (based on labeling and warning literature issued to physicians), it is timely to remind those in the public health community that the FDA’s most potent weapon in the battle for accurate, timely, “rational” prescribing is clear, approved labeling.
And yet the debate over who should make decisions about safety and efficacy – and on what evidence those choices should be made is still blazing. Today, the FDA has the responsibility to determine approvals and labeling language based on a scientific review of the evidence. Should this authority be ceded to the tort bar?
The dedicated members of our legal profession have always provided, and continue to provide, vital protection against those who would prey on consumers or intentionally try to pass off harmful products. The threat of litigation can be an important disincentive to many predatory behaviors.
The problem is that the current liability system doesn’t reward lawyers who focus on these real public health concerns. Instead, the most experienced and well-financed law firms know that the biggest payouts regularly go to those who take advantage of the FDA’s best efforts to promote the safe and effective use of medications.
More and more often, these “mass tort” firms specialize in taking a new product-warning label or withdrawal decision by the FDA and viewing it as a signal to go forward with all guns blazing. Their bullets, unfortunately but not unpredictably, hit multiple innocent targets.
Have a look at this new paper from the Journal of Commercial Biotechnology – and weigh in on this important issue. Maybe when our elected officials understand that it’s the health of their constituents versus the pocketbooks of lawyers, our public servants will finally get serious on tort reform.