Generic drug makers argue against new FDA safety label rule - Torts Blog - Alberto Bernabe

Back in August I reported on an opinion piece in the New England Journal of Medicine urging that the FDA allow generic drug makers to make the same kind of safety labeling changes as the patent holders have.  Alberto Bernabe reports on the continuing debate.  - GWC

Torts Blog: Generic drug makers argue against new FDA safety label rule:

by Prof. Alberto Bernabe



You would think that manufacturers interested in making sure their products are safe would welcome the new rule.  However, because the current system works to immunize generics manufacturers, a change that would work to make the products safer would also open the door to possible liability.  Thus, as you would expect from those who are more interested in profit than safety, the manufacturers hired a consulting firm  to conduct a cost-beneift analysis of the consequences of the new rule.  And, not surprisingly, the analysis concludes that the change is not good for consumers.  You can read the report here.  Then, go herefor a report by Center for Justice & Democracy (called "America’s Unaccountable Generic Drug Industry; How Legal Immunity Could Be Making You Sick") which explains how deficient the current system is. You can read a short comment on it here.  and form your own opinion. 

For more on this issue go here.



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