FDA’s Punt on Finalizing the Generic Drug Labeling Rule: Experts Debate image

Regulatory Affairs Professionals Society, May 19, 2016
Zachary Brennan, featuring Rachel E. Sachs (Academic Fellow)


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From the article: 

Rachel Sachs, JD, an academic fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, also told Focus: “In my view, it's worth taking a step back and figuring out what we want the rule to accomplish. If what we want to do is compensate patients who are harmed by generic drugs to the same extent as we compensate patients who are harmed by branded drugs, it's not obvious that the best way to do that is to change the labeling rule. Now, it might be the best way for the FDA to do that – labeling is the tool they have. But it might be that a system more like what we've set up in the vaccine context would be appropriate.”

What Sachs is referring to is the federal law that generally protects vaccine makers from lawsuits seeking compensation for injuries or deaths due allegedly to avoidable design problems, though patients can file suit in a special federal vaccine court established under the National Vaccine Injury Compensation Program.

“Basically, we've got a list of injurious side effects we know can result from these vaccines, and if you suffer from one as a result of getting the vaccine, you receive compensation. And so if what we care about is compensation, not just information, we might want a system that pays out precisely when you suffer a side effect we know about – and that's the vaccine system,” Sachs said.

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fda health law policy pharmaceuticals regulation