FDA’S New Pharmacovigilance

FDA’s New Generic Drug Labeling Rule

The FDA is proposing an about-face on a controversial issue: to allow (or require? [1]) generic drug companies to alter the label on drugs, whereas they are currently  required to keep the identical label as used by the brand-name company (See earlier post here and here.) While it clearly makes sense to alert the public to newly found side-effects, this change, if adopted, will open generic companies to lawsuits to which they’d been immune (as determined by a 2011 Supreme Court decision).  Whether or not the rule passes, the FDA is ready with a training session for you!  The following is from the notice I received by e-mail:

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.This event will be broken into two parts:

  1. 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. 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.
  1. 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, and 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.

Register today for the webinar that helps you do just that — 90 minutes spent with two of the industry’s most respected attorneys.

Price: Webinar PLUS Audio CD and Transcript: $547 Webinar Only: $347

Three Easy Ways to Register
Please mention priority code 13D06 when registering.

  1. Enroll online.
  2. Call toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600. Use your American Express, Visa or MasterCard.
  3. Mail your check to: FDAnews, 300 N. Washington St., Suite 200 Falls Church, VA 22046-3431.

On Monday, Dec. 9, Mr. Kracov and Mr. Pariser will 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

[1] Allow or require? If there’s to be lawsuits, then it would seem to be the latter. So will generics lose much of their discount?



Categories: Announcement, PhilStatLaw, science communication

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4 thoughts on “FDA’S New Pharmacovigilance

  1. So what happens if different generic companies produce different labels for the same drug? I spoze the FDA will have to require harmonious labels, but as I’ve been learning from reading Senn, generic versions of a drug are not all the same, so maybe different labels are warranted? Maybe its best for the brand company to issue the drug together with generic companies (as they sometimes do), but then (given all the difficulty in statistically showing “equivalence”, and I know there are even different kinds) why have generics at all? Maybe the branded drug company can sell at a reduced price after so many years…?

    • lawdude

      There’s been no cost benefit analysis here. Generic manufacturers have always been required to report adverse events. The changed rule will mandate much more than that. For the first time generic manufacturers will need to carry out medical and statistical analysis to ascertain if there exist grounds for a label revision: The amount the FDA estimates in increased costs to these companies is an immensely lowball figure. This is all about avoiding preemption of civil lawsuits.

      • Lawdude: I didn’t know generics were required to inform, but I guess the threat of lawsuit is needed. What I find comical is the writing in the notices the FDA sends out nearly daily about webinars and regulatory “bootcamps”, with non-subtle hints that if your company doesn’t sign up in sufficient numbers, the FDA might not be very happy with you.

  2. Litigator

    More money for plaintiffs’ lawyers, and higher priced drugs for everyone else. I am sure it is constitutional as a tax to help support the litigation industry (a/k/a plaintiffs’ bar).

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