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# FDA Off-Label Power ‘Diminishing’: Attorneys
- URL: https://www.fdaweb.com/fda-off-label-power-diminishing-attorneys/
- Published: 2016-01-04T12:00:00.000Z
- Updated: 2026-09-15T02:24:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134288

> Attorneys **Erin Bosman**, **Julie Park**,and **Brittany Scheinok** (Morrison & Foerster) say that FDA’s settlement with Pacira Pharmaceuticals over the company’s off-label promotion of Exparel “represents the latest marker of FDA’s diminishing power to regulate off-label promotion.” Writing in an online blog [post](http://www.lexology.com/library/detail.aspx?g=78ff1d69-cc5b-4173-aeee-a255c60cfb99&utm%5Fsource=Lexology+Daily+Newsfeed&utm%5Fmedium=HTML+email+-+Body+-+General+section&utm%5Fcampaign=Lexology+subscriber+daily+feed&utm%5Fcontent=Lexology+Daily+Newsfeed+2015-12-21&utm%5Fterm=), the three say that while the settlement agreement may be another sign of the agency’s waning power to regulate off-label promotion, several factors may limit the resolution’s implications.  
>  
> They note that FDA is attempting to limit the implications of the settlement agreement by saying that it is “specific to the parties involved in this matter.” They also say that the settlement may be attributable to the existing broad language in Exparel’s label. For instance, they write, the label stated that Exparel was indicated for administration into the surgical site to produce postsurgical analgesia. “FDA may not have agreed to settle with Pacira if Exparel’s label did not already include this broad language of indication, which arguably included indications of use beyond those specifically tested in the clinical trials,” the attorneys say.  
>  
> Meanwhile, attorneys **Meredith Manning**, **Heidi Gertner**, and **Nancy Parsons** (Hogan Lovells) say in an online blog [post](http://www.lexology.com/library/detail.aspx?g=443bb691-f3a5-4d91-9f26-e1f399ab2de2&utm%5Fsource=Lexology+Daily+Newsfeed&utm%5Fmedium=HTML+email+-+Body+-+General+section&utm%5Fcampaign=Lexology+subscriber+daily+feed&utm%5Fcontent=Lexology+Daily+Newsfeed+2015-12-21&utm%5Fterm=) that the legal significance of the settlement is noteworthy. They point out that a Warning Letter issued to Pacira followed closely on the heels of two Justice Department settlements in which the government took a position that the scope of drug labeling must be interpreted narrowly. “The Exparel settlement could limit the Department of Justice’s ability to make such allegations going forward,” they write. “Additionally, this is the first time, to our knowledge, that CDER has withdrawn a Warning Letter. Going forward, we expect FDA to be more careful in approving broadly worded indication statements, which could affect the agency’s class labeling policies. At the same time, we do not think that the settlement necessarily opens the door for sub-population or disease subtype claims for products with broad indication statements. It does, however, provide an opportunity for companies in these situations to advance a clear medical argument to support broader extrapolation (e.g., taking into account the drug, its mechanism of action, the characteristics of the population, disease subtypes), especially where they have a favorable regulatory history on point.”