FDA's New Generic Drug Safety Labeling Rule - Webinar CD/Transcript
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:
- Regulatory expert Daniel Kracov, who heads the FDA and healthcare practice at Arnold & Porter, dissects the 54-page rule and explain what the FDA is proposing and how generic firms should proceed with requesting updates to their labels. He highlights 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 provides scenarios regarding when labels could be changed. He describes 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, focuses on the product liability implications of the new rule. Mr. Pariser discusses the potential surge in liability cases, and how to prepare and defend against these cases. Plus, he examines how generics firms that fail to develop comprehensible pharmacovigilance programs will be inviting very significant liability.
Mr. Kracov and Mr. Pariser walk you step-by-step through:
- Detailed analysis of the 54-page proposed rule, to show how it could impact both generic and brand drug manufacturers
- Understanding new requirements placed on generics firms regarding communications with the FDA and NDA holders
- Example of the process for submission of CBE-0 supplements by ANDA and NDA holder
- Understanding the FDA's mechanism for rejecting CBE-0 supplements
- Why the FDA removed limitations on submissions of CBE-0 supplement changes to the Highlights of Prescribing Information in the physician labeling rule format
- A clear understanding of new product liability issues raised by the rule
- Tools and tactics to protect your firm against product liability lawsuits
- Overview on the types of new pharmacovigilance programs that generics firms will now have to develop to avoid liability risks
- And much more