Did you know that when you take a generic drug, you essentially forfeit the ability to sue the company making the drug for damages if you experience an adverse event?
Why the different outcomes? A 2011 Supreme Court decision said makers of generics don't have control over what their labels say.
The problem dates back at least to 1984, when the Hatch-Waxman Act "allowed companies to skip the lengthy process required to approve new drugs if they could preove that the generic drug was equivalent to its brand-name counterpart." [FDA approval process was discussed on my 12/13/11 post.]
Decades later, in 2010, the Supreme Court ruled that brand-name companies can be sued for failing to adequately warn patients of risks.
Factors shaping the legal battle over generics include:
- Claims by companies making generics that they would lose the ability to keep prices low if they became responsible for updating labels
- The reluctance of Congress and the FDA to do anything that makes it more difficult for patients to obtain needed medicines
Next: What's a Healthy Survivor to do?