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After years of debate, the Food and Drug Administration has withdrawn a rule that would have allowed generic drug makers to unilaterally update their product labeling when they learn of new information.

In explaining its reasons, the agency worried the rule could create “unintended consequences” by confusing patients and doctors if some generic companies did not revise labeling on a timely basis, or if generic and brand labels appeared different. FDA officials also pointed to concerns expressed by generic makers that they would have to raise prices to cover added costs for complying with the rule.


“This is a very careful balancing act,” FDA Commissioner Scott Gottlieb said in a media call. “The rule would have imposed some costs and burdens…. There would have been potential drawbacks and downsides. It’s one of the reasons we may look toward Congress and broader efforts to get additional resources to do the things we currently can’t do.” He noted, however, the agency plans a new program to update labels on certain generic cancer drugs.

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  • let’s be clear – this isn’t about ALLOWING generics manufacturers to update the labels of the drugs they sell, they’re complaining because the regulation would COMPEL them to.
    Making the original company responsible when the brand has lost patent protection and so they’ve lost essentially all profit on that product seems unfair at best and frankly irrational. Once generics companies are making all the $ on a drug (and let’s be clear, on many of these generics they’re making tens of millions per year), they should bear responsibility, in concert with the FDA, to adjust labels as new data (usually safety) becomes known. The generic company’s complaint is essentially that this is a cost that cuts into their profits. Patient safety and prescriber confusion arguments are obfuscation, pure and simple.

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