• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Fenwal, a Fresenius-Kaby Company 6/1/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Center for Biologics Evaluation and
Research
1401 Rockville Pike
Rockville, MD 20852-1448 

 

June 1, 2012
 
WARNING LETTER
 
VIA FACSIMILE AND UPS
 
Robert Baker
Manager Regulatory Affairs
Fenwal, Inc.
Three Coporate Dive, Suite 300
Lake Zurich, IL 60047
 
Re:   BN080041
        InterSol® (Platelet Additive Solution)
 
 
Dear Mr. Baker:
 
The Advertising and Promotional Labeling Branch (APLB) of the Office of Compliance and Biologics Quality in the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER), in consultation with CBER’s Division of Hematology, has reviewed the InterSol Solution Platelet Research Update Slides (2610), InterSol Bellyband (2619) and the InterSol Brochure (2605), submitted by Fenwal under cover of Form FDA-2253 for InterSol® (Platelet Additive Solution).
 
These promotional materials are false and misleading because they present unsubstantiated claims, broaden the indication of InterSol, and omit risk information. Therefore, your material misbrands InterSol under Sections 502(a) and 201(n) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §352(a) and §321(n), and FDA implementing regulations, Cf. 21 CFR §202.1(e)(1) and (e)(6)(i).
 
Background
 
According to the FDA-approved prescribing information (PI), InterSol is an isotonic solution designed to replace a portion of the plasma used in the storage of AMICUS™-derived leukoreduced apheresis platelets under standard blood banking conditions. There is no direct therapeutic effect to be expected from the formulation. The solution should never be infused into a patient.
 
The Warnings and Precautions section of the PI states:
 
  • InterSol solution is NOT FOR DIRECT INTRAVENOUS INFUSION.
  • Do not use if particulate matter is present or if the solution is cloudy.
  • Do not use if the container is damaged, leaking or if there is any visible sign of deterioration.
  • Do not vent.
  • Do not reuse. Discard unused or partially used InterSol solution.
  • Protect from sharp objects.
  • Verify that the InterSol solution has been securely attached to the PAS Connector line to avoid disconnection and leaks.
 
Unsubstantiated Claims/Broadening of Indication
 
Promotional materials are misleading if they suggest that a product is more effective or useful in a broader range of conditions or patients, or is safer, has fewer, less incidence of, or less serious adverse reactions or contraindications, than has been demonstrated by substantial evidence or substantial clinical experience.
 
The InterSol Solution Platelet Research Update Slides (2610), InterSol Brochure (2605), and the InterSol Bellyband present the following claims:
 
  • “InterSol Solution Reduces Transfusion Reactions…”
  • “Lower titers of anti-A and B were seen with InterSol Platelets…”
  • “...platelets stored in the InterSol platelet additive solution (PAS) resulted in fewer allergic transfusion reactions than platelets stored in 100% plasma.”
 
The above claims misleadingly broaden the indication and present unsubstantiated claims  by suggesting that the use of platelets stored in InterSol will render a reduction in transfusion reactions and lower titers of anti-A and B. These statements cite American Association of Blood Banks (AABB) 2011 abstracts Cohn et al. SP232; Becker et al. S84-040A. FDA is not aware of substantial evidence or substantial clinical experience demonstrating these findings for InterSol.  The unsubstantiated claims and indication-broadening result in your product being misbranded with the meaning of section 502(a) of the Act. See section 201(n) of the Act, 21 U.S.C. 321(n), Cf. 21 CFR §202.1(e)(6)(i). 
 
Omission of Risk Information
 
The slides and brochure described above fail to provide any risk information pertaining to the use of InterSol including the warning, precautions and the risk due to direct infusion. The omission of risk information results in your product being misbranded with the meaning of section 502(a) of the Act. See sections 201(n) and 502(f)(2) of the Act, 21 U.S.C. 321(n), 352(f)(2). Cf. 21 CFR §202.1(e)(1).
 
Conclusion and Requested Actions
 
For the reasons discussed above, your promotional materials misbrand InterSol under sections 502(a), 502(f)(2) and 201(n) of the Act, 21 U.S.C. §352(a), §352(f)(2), and §321(n), and FDA implementing regulations, Cf. 21 CFR §202.1(e)(1) and (e)(6)(i).
 
We request that you immediately cease the dissemination of the violative promotional materials described above and other similar materials for InterSol. Please submit a written response to this letter within ten (10) business days of receipt of this letter, stating whether you intend to comply with this request, listing all promotional materials in use for InterSol that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials. Because the violations described above are serious, we further request that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials.
 
Please direct your response to me at the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, HFM-600, 1401 Rockville Pike, Rockville, Maryland 20852-1448. In all future correspondence regarding this matter, please refer to the NDA number. We remind you that only written communications are considered official responses. If you choose to revise your promotional materials, we are willing to assist you with your revised materials by commenting on your revisions before you use them in promotion.
 
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for InterSol comply with each applicable requirement of the Act and FDA’s implementing regulations.
 
Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.
 
Sincerely,
/S/
Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research