Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Center for Biologics Evaluation and|
1401 Rockville Pike
Rockville, MD 20852-1448
April 10, 2012
VIA FACSIMILE AND UPS
Sr. Director Compliance & Government Policy
Octapharma USA, Inc.
121 River Street, Suite 1201
Hoboken, NJ 07030
Re: BLA#: 125062
Octagam® [Immune Globulin Intravenous (Human) 5%]
Dear Mr. Ammons:
The Advertising and Promotional Labeling Branch (APLB) in the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has reviewed your journal advertisements, printed in the BDI Pharma Product Catalog and BioSupply Trends Quarterly, which were prepared in December 2011 for your product Octagam® [Immune Globulin Intravenous (Human) 5%].
Your promotional material is false and misleading because it omits risk information. Therefore, your material misbrands Octagam under Sections 502(n) and 201(n) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §352(n) and §321(n), and FDA implementing regulations, 21 CFR §202.1(e). In addition, Octapharma failed to submit promotional materials to CBER at the time of initial dissemination, in violation of 21 CFR §601.12(f)(4).
Moreover, we are concerned by your continued violative promotion of your products. Octapharma was cited for similar violations (including failure to reveal material facts and failure to submit promotional materials to the FDA) in a Warning Letter on August 31, 2005. Furthermore, in a teleconference on October 13, 2009, we reminded you that promotional materials must be submitted on FDA Form 2253 at time of first use.
The FDA-approved prescribing information (PI) for Octagam has a boxed warning for its potential to cause acute renal dysfunction and renal failure:
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may be associated with Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Octagam 5% liquid does not contain sucrose. Administer IGIV products at the minimum concentration available and the minimum infusion rate practicable.
The PI also includes detailed risk information including contraindications, warnings and precautions, and adverse reactions.
Omission of Risk Information
Promotional materials shall present a true statement of information in brief summary relating to side effects, contraindications, and effectiveness (21 CFR §202.1(e)(1)). The journal advertisements described above fail to provide any information pertaining to the potential risk of acute renal dysfunction and renal failure with the use of Octagam. Furthermore, they fail to contain any important safety information, including the boxed warning, contraindications, warning and precautions, and adverse reactions.
Please note that reminder advertising is not permitted for Octagam because the product labeling contains a boxed warning relating to serious adverse reactions associated with the use of the product (21 CFR §202.1(e)(2)(i)).
Failure to Submit Post-Marketing Reports at the Time of Dissemination
Octapharma failed to submit promotional material to FDA at the time of initial dissemination of such material, in violation of 21 CFR §601.12(f)(4). We have no record of submission of the referenced materials, which were printed in the BDI Pharma Product Catalog and BioSupply Trends Quarterly.
Conclusion and Requested Actions
For the reasons discussed above, your promotional material misbrands Octagam under sections 502(n) and 201(n) of the Act, 21 U.S.C. §352(n) and §321(n), and FDA implementing regulations, 21 CFR §202.1(e). You also have failed to submit promotional material to FDA at the time of initial dissemination, in violation of 21 CFR §601.12(f)(4).
We request that you immediately cease the dissemination of violative promotional materials described above and the same or similar materials for Octagam. 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 Octagam 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.
Additionally, since we have cited you previously for similar violations, we request a response in writing, indicating what policies and procedures you intend to adopt to ensure that your prescription drug promotional activities comply with the Act and its implementing regulations, and an explanation of why/how you expect these policies and procedures to succeed. 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 BLA 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 Octagam comply with each applicable requirement of the Act and FDA implementing regulations.
Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.
Mary A. Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research