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In Part 1 we looked at the old and the proposed new regulation on generic labeling.  Now we will take a look at possible implications.

Comments and Implications

The new regulation will change the landscape for all the stakeholders.

Branded Companies

For branded companies there will be good and bad points.

Generic Companies

To a certain degree, the “free ride” is over.   The generics will lose their “anonymity”.

The Lawyers

More lawsuits! More work and income for both the plaintiff and the defender bars.


The Patients

The Internet & Social Media



 The Drugs Themselves


Firstly, I think FDA should rethink the concept of “equivalence”.  A generic drug is not exactly the same as the branded drug.  I’d separate the equivalence concept in to efficacy/effectiveness and safety.

It’s likely though not always certain that a small molecule generic drug if delivered in the same way, amount, dose etc. will work the same in the patient as the branded drug.  There will be differences presumably based on excipients, fillers, how tightly the tablet was packed, manufactured etc.

Safety, however, may actually differ from the branded product.  There are different vendors supplying different excipients, fillers, packing machines etc.  So I would propose that the different generics may each have slightly different safety profiles and that there is no reason to presume the safety profile will be exactly the same as the branded drug or any other generic.  So why force the labels to coincide?  Let each drug develop it’s own safety profile.  There should be the equivalent of “class labeling” for some safety issues that clearly transcend the different manufacturer and are due to the active moiety or the delivery system (e.g. injections) or whatever. Don’t artificially force parity where it may not exist.

To this end, FDA should simplify what sounds like a very complex and painful process.

So this is an early posting after the draft regulation is published.  I suspect we will see a lot of comments and the final regulation may be somewhat different.  I also suspect the FDA is under a lot of pressure to get this finalized by mid-2014. Stay tuned.

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