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FDA’s new proposed rule allowing generic manufacturers — for the first time — to use the CBE-0 process to unilaterally change labels represents a paradigm shift in managing warnings, product liability and pharmacovigilance.
The biggest concern for generics firms? A potential surge in liability suits, similar to those filed against brand firms, from patients claiming harm by the manufacturer’s failure to add necessary warnings to product labels. Strong safety warnings on generics, moreover, could heighten public concerns about generics being “different” or “inferior” to brand products.
The proposed rule would also have an impact on the regulatory risks and burdens on both brand and generic companies. To date, the framing of the label has largely been a matter of interaction between the brand company and FDA. Under this proposal, however, branded companies will need to address — and at times rapidly rebut —labeling changes that are initiated by others.
While the rule is directed at generics makers, brand makers have a significant interest in the outcome and application of the rule. As part of the CBE-0 process NDA holders are required to respond to the ANDA holder regarding receipt of their requested change. The proposed rule also allows an NDA holder to submit their own labeling change seeking approval for a related or corresponding labeling change based on the CBE-0 submission.
The CD and transcript set is broken into two parts:
Mr. Kracov and Mr. Pariser walk you step-by-step through:
Meet Your Instructors
Regulatory expert Daniel Kracov, who heads the FDA and healthcare practice at Arnold & Porter will dissect the 54-page rule and explain what the FDA is proposing and how generic firms should proceed with requesting updates to their labels. He’ll also highlight areas within the proposed rule that are unique and potentially confusing and provide advice on how generics and brand manufacturers should proceed. In addition, he’ll provide scenarios regarding when labels could be changed and when they should take the same. He’ll describe the responsibilities of the both the brand and generic manufacturers and the regulatory requirements and risk each face in light of the rule.
Dan Pariser, a recognized expert in product liability law, and a partner in Arnold & Porter LLP's Washington, DC office, will focus on the product liability implications of the new rule. Mr. Pariser will discuss the potential surge in liability cases, how to prepare and defend against these cases. Plus, he will examine how generics firms that fail to develop comprehensible pharmacovigilance programs will be inviting very significant liability.
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