Posted: 16 Sep 2015 06:23 AM PDT
By David C. Gibbons & Anne K. Walsh –
In the wake of what industry is touting as Amarin’s First Amendment victory (read our Amarin posts here and here), Pacira Pharmaceuticals, Inc. (“Pacira” or the “Company”) filed a suit raising similar claims in the same district court as the Amarinmatter. On September 8, 2015, Pacira filed a Complaint in the U.S. District Court for the Southern District of New York seeking to prevent FDA from bringing an enforcement action against the Company for what it claims is truthful and nonmisleading speech concerning its sole product, Exparel. (Pacira subsequently filed a Motion for Preliminary Injunction in the case.) A key issue is whether FDA can limit the scope of a generally approved product to only those specific uses in which the drug has been studied and approved.
Exparel is approved for “single-dose infiltration into the surgical site to produce postsurgical analgesia.” Exparel (bupivacaine liposome injectable suspension) Label, NDA 022496, 2 (Dec. 2014). The indication does not limit the surgical site for which Exparel can be used, even though the clinical studies used to gain approval were conducted in two specific types of surgeries: bunionectomy and hermorrhoidectomy. According to the Complaint, “Pacira initially felt free to provide truthful and non-misleading information to health care providers about Exparel’s use in surgical sites other than bunionectomy and hemorrhoidectomy.” Complaint at 45, Pacira Pharms., Inc. v. FDA, No. 15-7055 (S.D.N.Y. Sept. 8, 2015).
Three years after approval, in September 2014, FDA’s Office of Prescription Drug Promotion (“OPDP”) issued a Warning Letter to Pacira alleging that Exparel was misbranded. FDA, Warning Letter to Pacira Pharmaceuticals, Inc. (Sept. 22, 2014). Specifically, FDA took issue with Exparel’s distribution of materials describing the use of Exparel in laparoscopic cholecystectomy and open colectomy surgeries. Id. at 4. FDA stated that the promotional materials “suggest[ed] an extensive promotional campaign by Pacira to promote the use of Exparel in surgical procedures other than those for which the drug has been shown to be safe and effective.” Id. at 3. According to the Complaint, Pacira did not agree with FDA, but was “compelled to comply with FDA’s demands” because Pacira feared enforcement action. Compl. at 50.
The Instant Lawsuit
In its lawsuit, the Company seeks to resume promoting Exparel as it did before the Warning Letter issued. Compl. at 71-72. Like Amarin, Pacira identifies in its Complaint specific types of information that it desires to disseminate to healthcare providers, such as the use of Exparel in surgical sites other than bunionectomy and hemorrhoidectomy; the different methods by which Exparel can be administered in these other surgical sites; published studies and reports regarding Exparel’s administration into different surgical sites; and experiences that other physicians have had administering Exparel into other surgical sites to produce postsurgical analgesia. Compl. at 52-53.
Pacira first argues that under Caronia and Amarin, the First Amendment protects the dissemination of information concerning uses of Exparel in patients undergoing a specific type of surgery other than bunionectomy or hemorrhoidectomy, “even if it constituted an off-label use.” Id. at 59. Citing the Amarin decision, Pacira argues that FDA has no constitutional basis to prohibit the dissemination of information concerning specific uses of Exparel, even if not FDA-approved, because it is protected commercial speech. Id. at 56.
In the alternative, Pacira argues that the information was not even off-label because the Company held a reasonable and good faith belief that the “broad pain indication” allows the Company to disseminate information on uses consistent with such an indication. Id. at 57. Under this argument, Pacira disputes FDA’s conclusions that the dissemination of information about the use of the product to produce postsurgical analgesia in other types of surgeries is outside the scope of the approved indication. Id. at 57-58.
Pacira also raises familiar challenges under the Administrative Procedure Act (that FDA’s restrictions are arbitrary and capricious) and the Fifth Amendment (due process). Pacira asserts that FDA changed its position on Exparel, noting that FDA reviewers originally sought to limit the approval to bunionectomy or hemorrhoidectomy surgeries, but that the final Exparel’s approved label did not contain that limitation. Id. at 63. Pacira also focuses on FDA’s requirements for pediatric studies under the Pediatric Research Equity Act (“PREA”), arguing that “FDA could only have reached a conclusion that pediatric studies were required for Exparel if it understood the product’s approved indication to encompass all surgical sites generally, and not just those sites associated with bunionectomies and hemorrhoidectomies.” Id.
Predictions
While this case appears to present the same issues as in Amarin, there are unique aspects of this case that, if resolved in Pacira’s favor, could further erode FDA’s authority in this field. But there also are potential weaknesses that highlight the limitations ofAmarin.
For example, unlike Amarin, Pacira could be at risk of a challenge from FDA given the current posture of the matter. Based on the company’s decision to discontinue the targeted promotional activities, FDA closed out the Warning Letter in July 24, 2015. Given that FDA’s close-out letter suggests there is no imminent threat of prosecution against Pacira, the court may find there is no justiciable controversy at issue. Whether the action is mooted, or whether the company lacks standing, or both, is an issue that was not at play in Amarin.
Also, Pacira’s argument that its promotional claims are in fact within the approved general indication for postsurgical analgesia raises an issue beyond the scope of Amarin and with broader implication on medical device companies. Medical device companies frequently face this “general versus specific use” issue because it is not uncommon for a medical device to receive clearance for a general use. Healthcare practitioners, of course, will use the medical device on specific sites, so the question arises whether medical device representatives can talk to these practitioners about the specific uses directly. The risk is that FDA may view the specific use as a new intended use requiring a new 510(k) clearance or even premarket approval. Given the specific claims that Pacira wants to make, medical device companies should be keenly following this litigation to see whether FDA gives any insight on how it views marketing for specific uses.
Also, the scientific strength of the claims is not as strong as that involved in Amarin. Pacira does not have completed pivotal phase 3 data on the specific indications for which it would like to promote, and instead seeks to extrapolate data that is not directly involving its drug product. See Compl. at 44.
If nothing else, Pacira’s lawsuit tells us that Caronia and Amarin have indeed given courage to other potential First Amendment challengers. The key will be to see who has the heart to file in a circuit other than the Second Circuit where good precedent exists. Even a loss could be a win for industry if it creates a circuit split that could result in the issue being decided by the U.S. Supreme Court.
In the wake of what industry is touting as Amarin’s First Amendment victory (read our Amarin posts here and here), Pacira Pharmaceuticals, Inc. (“Pacira” or the “Company”) filed a suit raising similar claims in the same district court as the Amarinmatter. On September 8, 2015, Pacira filed a Complaint in the U.S. District Court for the Southern District of New York seeking to prevent FDA from bringing an enforcement action against the Company for what it claims is truthful and nonmisleading speech concerning its sole product, Exparel. (Pacira subsequently filed a Motion for Preliminary Injunction in the case.) A key issue is whether FDA can limit the scope of a generally approved product to only those specific uses in which the drug has been studied and approved.
Exparel is approved for “single-dose infiltration into the surgical site to produce postsurgical analgesia.” Exparel (bupivacaine liposome injectable suspension) Label, NDA 022496, 2 (Dec. 2014). The indication does not limit the surgical site for which Exparel can be used, even though the clinical studies used to gain approval were conducted in two specific types of surgeries: bunionectomy and hermorrhoidectomy. According to the Complaint, “Pacira initially felt free to provide truthful and non-misleading information to health care providers about Exparel’s use in surgical sites other than bunionectomy and hemorrhoidectomy.” Complaint at 45, Pacira Pharms., Inc. v. FDA, No. 15-7055 (S.D.N.Y. Sept. 8, 2015).
Three years after approval, in September 2014, FDA’s Office of Prescription Drug Promotion (“OPDP”) issued a Warning Letter to Pacira alleging that Exparel was misbranded. FDA, Warning Letter to Pacira Pharmaceuticals, Inc. (Sept. 22, 2014). Specifically, FDA took issue with Exparel’s distribution of materials describing the use of Exparel in laparoscopic cholecystectomy and open colectomy surgeries. Id. at 4. FDA stated that the promotional materials “suggest[ed] an extensive promotional campaign by Pacira to promote the use of Exparel in surgical procedures other than those for which the drug has been shown to be safe and effective.” Id. at 3. According to the Complaint, Pacira did not agree with FDA, but was “compelled to comply with FDA’s demands” because Pacira feared enforcement action. Compl. at 50.
The Instant Lawsuit
In its lawsuit, the Company seeks to resume promoting Exparel as it did before the Warning Letter issued. Compl. at 71-72. Like Amarin, Pacira identifies in its Complaint specific types of information that it desires to disseminate to healthcare providers, such as the use of Exparel in surgical sites other than bunionectomy and hemorrhoidectomy; the different methods by which Exparel can be administered in these other surgical sites; published studies and reports regarding Exparel’s administration into different surgical sites; and experiences that other physicians have had administering Exparel into other surgical sites to produce postsurgical analgesia. Compl. at 52-53.
Pacira first argues that under Caronia and Amarin, the First Amendment protects the dissemination of information concerning uses of Exparel in patients undergoing a specific type of surgery other than bunionectomy or hemorrhoidectomy, “even if it constituted an off-label use.” Id. at 59. Citing the Amarin decision, Pacira argues that FDA has no constitutional basis to prohibit the dissemination of information concerning specific uses of Exparel, even if not FDA-approved, because it is protected commercial speech. Id. at 56.
In the alternative, Pacira argues that the information was not even off-label because the Company held a reasonable and good faith belief that the “broad pain indication” allows the Company to disseminate information on uses consistent with such an indication. Id. at 57. Under this argument, Pacira disputes FDA’s conclusions that the dissemination of information about the use of the product to produce postsurgical analgesia in other types of surgeries is outside the scope of the approved indication. Id. at 57-58.
Pacira also raises familiar challenges under the Administrative Procedure Act (that FDA’s restrictions are arbitrary and capricious) and the Fifth Amendment (due process). Pacira asserts that FDA changed its position on Exparel, noting that FDA reviewers originally sought to limit the approval to bunionectomy or hemorrhoidectomy surgeries, but that the final Exparel’s approved label did not contain that limitation. Id. at 63. Pacira also focuses on FDA’s requirements for pediatric studies under the Pediatric Research Equity Act (“PREA”), arguing that “FDA could only have reached a conclusion that pediatric studies were required for Exparel if it understood the product’s approved indication to encompass all surgical sites generally, and not just those sites associated with bunionectomies and hemorrhoidectomies.” Id.
Predictions
While this case appears to present the same issues as in Amarin, there are unique aspects of this case that, if resolved in Pacira’s favor, could further erode FDA’s authority in this field. But there also are potential weaknesses that highlight the limitations ofAmarin.
For example, unlike Amarin, Pacira could be at risk of a challenge from FDA given the current posture of the matter. Based on the company’s decision to discontinue the targeted promotional activities, FDA closed out the Warning Letter in July 24, 2015. Given that FDA’s close-out letter suggests there is no imminent threat of prosecution against Pacira, the court may find there is no justiciable controversy at issue. Whether the action is mooted, or whether the company lacks standing, or both, is an issue that was not at play in Amarin.
Also, Pacira’s argument that its promotional claims are in fact within the approved general indication for postsurgical analgesia raises an issue beyond the scope of Amarin and with broader implication on medical device companies. Medical device companies frequently face this “general versus specific use” issue because it is not uncommon for a medical device to receive clearance for a general use. Healthcare practitioners, of course, will use the medical device on specific sites, so the question arises whether medical device representatives can talk to these practitioners about the specific uses directly. The risk is that FDA may view the specific use as a new intended use requiring a new 510(k) clearance or even premarket approval. Given the specific claims that Pacira wants to make, medical device companies should be keenly following this litigation to see whether FDA gives any insight on how it views marketing for specific uses.
Also, the scientific strength of the claims is not as strong as that involved in Amarin. Pacira does not have completed pivotal phase 3 data on the specific indications for which it would like to promote, and instead seeks to extrapolate data that is not directly involving its drug product. See Compl. at 44.
If nothing else, Pacira’s lawsuit tells us that Caronia and Amarin have indeed given courage to other potential First Amendment challengers. The key will be to see who has the heart to file in a circuit other than the Second Circuit where good precedent exists. Even a loss could be a win for industry if it creates a circuit split that could result in the issue being decided by the U.S. Supreme Court.
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