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# Attorneys Predict Enforcement Changes After Pacira Settlement
- URL: https://www.fdaweb.com/attorneys-predict-enforcement-changes-after-pacira-settlement/
- Published: 2016-01-05T12:00:00.000Z
- Updated: 2026-09-15T02:25:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134346

The new year should see more changes in FDA’s enforcement of off-label promotion, according to a Latham & Watkins [client alert](https://ca.linexsystems.com/contents/transit/815851395?ref=fdaweb.com) that examines the recent FDA and Pacira Pharmaceuticals settlement ([see earlier story](http://fdaweb.com/login.php?sa=v&aid=D5134219&searchWords=pacira&cate=S&stid=%241%24JD2.eT5.%243lb.ryefFAzSVkvjMIOU1.&ref=fdaweb.com)). “FDA’s concessions regarding the lawfulness of Pacira’s promotion of specific uses within a broad indication may offer some insight into how FDA will balance First Amendment requirements with the agency’s enforcement mandate under the FDCA going forward,” the law firm says. Latham & Watkins represented Pacira in challenging FDA’s actions, along with litigation counsel from Ropes & Gray and Lowenstein Sandler.

Last month, FDA conceded to Pacira Pharmaceuticals, [settling](http://media.corporate-ir.net/media%5Ffiles/IROL/22/220759/The%5FStipulation%5Fand%5FSettlement%5FAgreement.pdf?ref=fdaweb.com) a First Amendment challenge by the company over alleged off-label promotion involving Exparel. In October, the agency began making concessions and quietly removed ([see earlier story](http://www.fdaweb.com/login.php?sa=v&aid=D5133693&searchWords=pacira&cate=S&stid=%241%248T%2F.vo3.%24jT2rSoFuli3QA31UjX%2FbJ%2F)) from its Web site a 2014 Warning Letter to Pacira on off-label promotion, which became the center of the company’s [lawsuit](http://www.fdaweb.com/download.php?file=15266087-0--30956.pdf) seeking First Amendment protection when such speech is truthful and non-misleading about lawful uses of Exparel. The lawsuit came on the heels of a recent New York federal court [decision](http://fdaweb.com/login.php?sa=v&aid=D5132940&searchWords=amarin&cate=S&stid=%241%24Tm5.g51.%24.G%2F0hmnmbTZK6N0uFp80H.&ref=fdaweb.com) supporting Amarin’s right to engage in truthful and non-misleading speech about its Vascepa, including off-label promotion.

The client alert notes that already CDER’s 2016 priorities include as a “front burner priority” the need to “re-evaluate FDA’s regulation of drug advertising and promotion in light of current jurisprudence around the 1st Amendment.” It also offers the following key lessons for industry:

1. **FDA Is Accountable for Its Construction of Authorizing Statutes**  
“FDA can only act within the bounds that Congress authorizes through statute. While courts will defer to the agency’s construction of an ambiguous statutory authorization, they can — and will — strike down agency action that exceeds statutory authority. This concept underlies every action FDA takes, and (as here) targeting FDA’s statutory authority can serve as an effective way to challenge unlawful FDA actions.”
2. **Warning Letters Are Not Unassailable**  
“The immediate impact of receiving an FDA Warning Letter (including potential impacts on share value, shareholder litigation and publicity), combined with the ambiguity surrounding the avenues available to Warning Letter recipients to bring legal challenges, tend to incentivize quick concession to FDA’s Warning Letter assertions. While concession may be in a company’s best interest in some instances, the Pacira settlement is a reminder that Warning Letters can be successfully challenged with a sound regulatory strategy and perseverance. Warning Letter recipients should carefully consider responses, and clearly and unequivocally state objections to FDA’s positions, even if the recipient ultimately decides in the interest of resolution to implement FDA’s requested changes. Though FDA’s complete rescission of the Pacira Warning Letter is historic — we are aware of only two other cases of FDA rescinding Warning Letters in the agency’s history — the strength of the administrative record can be a critical factor in determining the ultimate outcome. Accordingly, Warning Letter recipients should carefully consider what arguments to assert in their Warning Letter correspondence, with an eye toward creating the best possible record. Moreover, if the recipient legitimately disagrees with FDA’s allegations of violation, it may be beneficial as part of the overall strategy to push aggressively to meet directly with the agency before the agency moves forward with additional enforcement activities using a faulty violation theory.”