DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
FAX: (410) 779-5707

September 7, 2006

ADVERSE DETERMINATION LETTER

BY FACSIMILE &
CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. John F. McGuire
Executive Vice President
Biomedical Services
American National Red Cross
2025 E Street, N.W.
Washington, D.C.  20006

RE:  United States v. American National Red Cross, Civil Action No. 903-0949 (JGP)

Dear Mr. McGuire:

Paragraph X of the Amended Consent Decree of Permanent Injunction (Decree) entered on April 15, 2003 permits the Food and Drug Administration (FDA) to assess a penalty for “each unit of unsuitable blood or blood component that [the American Red Cross (ARC)] distributes after entry of [the Decree] for which FDA determines that the release was preventable by ARC….”  Paragraph X.A.2. of the Decree provides that “[i]f FDA determines that use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote, FDA may assess a penalty of up to $5,000 for each such unit of blood or each such blood component.  Notwithstanding the foregoing, FDA shall not assess ARC under this subparagraph (X.A.2) for the improper release of more than 100 units in any one event.”

FDA has recently completed a review of its database and files to identify classified¹ recalls conducted by ARC.  We identified 165 events in which ARC reported to FDA that it retrieved unsuitable blood components that were distributed during the period of April 15, 2003 through April 15, 2005 (this does not include any classified ARC-conducted recalls previously identified in the May 15, 2005 adverse determination letter).  FDA determined that these events were preventable by ARC, that they meet the health hazard criteria of paragraph X.A.2. of the Decree, and that no penalty exception listed in Paragraph X.B. of the Decree applies.  These events involved 12,233 unsuitable blood components.  

Seven of the events involved more than 100 unsuitable blood components but were limited for penalty purposes to 100 units as provided by Paragraph X.A.2. of the Decree.  The total number of unsuitable blood components for which FDA assessed a penalty under Paragraph X.A.2. of the Decree is 1083. 

The unsuitable blood components are listed by event in the attachment to this letter.  The events are identified by ARC-assigned biological product deviation numbers and FDA-assigned recall numbers and are arranged by ARC regions.  The attached list does not include all events that occurred during the specified time period; it includes only those events classified by FDA as of May 1, 2006.  After FDA review, additional penalties may be assessed for events that occurred during the aforementioned time period but are not listed in the attachment.

Paragraph X.A.2. of the Decree sets forth three factors FDA must consider when determining whether to assess a penalty and the amount of a penalty:  “(1) the potential effect of the event on the public health, e.g., the number and seriousness of exposures; (2) ARC’s trends with respect to the same or similar events involving the release of unsuitable products; and (3) the degree to which ARC contributed to the improper release of the blood or blood components.”  FDA has considered these factors and has assessed penalties accordingly for each unsuitable blood component (see attached list).  The total penalty is $4,224,000.   

As provided in the Decree, if ARC agrees with this adverse determination, it must, within 20 days of receipt of this letter, notify FDA of its intent to come into compliance with the Decree, submit a plan to do so, and pay the penalty no later than thirty days (30) thereafter.  If ARC disagrees with FDA’s adverse determination, it shall respond in writing within 20 days of receipt of this letter, explaining the reason(s) for disagreeing with FDA’s determination.  The response must be submitted to me at the Food and Drug Administration, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215, with a copy to Jesse Goodman, M.D., M.P.H., Director, Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N, Rockville, Maryland 20852.

Sincerely yours,

[Handwritten Signature]

Evelyn Bonnin
Director, Baltimore District

ATTACHMENT

cc: Mr. John F. McGuire
Interim President and CEO
American National Red Cross
2025 E Street, N.W.
Washington, D.C.  20006

C. William Cherry
Senior Vice President for Quality
and Regulatory Affairs
American National Red Cross
2025 E Street, N.W.
Washington, D.C.   20006

Mary Elcano
General Counsel
American National Red Cross
2025 E Street, N.W.
Washington, D.C.  20006

Bonnie McElveen-Hunter
Chairman, Board of Governors
American National Red Cross
2025 E Street, N.W.
Washington, D.C.  20006

[1] Recall classifications are numerical designations assigned by FDA to indicate the relative degree of health hazard presented by the recalled product. 21 C.F.R. § 7.3(m).

AMERICAN RED CROSS

CLASS II RECALLS FOR THE PERIOD 4/15/03 THROUGH 4/15/05 (EXCLUDING THOSE
PREVIOUSLY ADDRESSED IN THE MAY 15, 2005 PARAGRAPH X ADVERSE DETERMINATION LETTER)

The following regions have no recall information included in this report:

Alabama Region, FDA Registration 1073001
Central Plans, Wichita, KS, FDA Registration 1973042
Gulf Coast, Mobile, AL, FDA Registration 1073005
Midwest, Omaha, NE, FDA Registration 1973037
Northern California, Oakland, CA, FDA Registration 2971430
Puerto Rico, Rio Piedras, PR, FDA Registration 2675945
Tennessee Valley, Nashville, TN, FDA Registration 1073006