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2 C DEPARTMENT OF HEALTH AND HUMAN SERVICES

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Silver Spring MD 20993

CERTIFIED MAIL-RETURN RECEIPT REQUESTED

Hospira, Inc. December 5, 2019
Attention: Erin Wierzbicki

Senior Associate, Pfizer Global Regulatory Affairs

275 North Field Drive

Bldg. H1

Lake Forest, IL 60045

Dear Madam:

This letter is being sent under Section 506C(f) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) for the reasons set forth below.

Section 506C of the FD&C Act requires a manufacturer of a drug product that is “life-supporting, life-
sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition” to
notify the Food and Drug Administration (FDA or the Agency) of: (1) a permanent discontinuance in
the manufacture of the drug; or (2) an interruption of the manufacture of the drug that is likely to lead to
a meaningful disruption! in the supply of that drug in the United States; and (3) the reasons for such
discontinuance or interruption of manufacturing (FD&C Act § 506C(a)). The notification must be
submitted at least 6 months prior to the date of the discontinuance or interruption of manufacturing, or
as soon as practicable (FD&C Act § 506C(b)). Compliance with this notification requirement is
essential to facilitating the mitigation or prevention of a shortage or potential shortage, and ultimately
may ensure availability of critical drugs for patients.

Ifa person fails to submit this required notification within the required timeframe, FDA must issue a
letter to that person informing the person of the failure to comply with the FD&C Act (FD&C Act §
506C(f)).

Vincristine sulfate injection is a product that is “life-supporting, life-sustaining, or intended for use in
the prevention or treatment of a debilitating disease or condition.” This product is indicated for acute
leukemia and has also been shown to be useful in combination with other oncolytic agents in Hodgkin’s
disease, non—Hodgkin’s malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms’ tumor,
It is our understanding that sometime before October 2019 there was an interruption in the manufacture
of vincristine sulfate injection. This interruption was likely to lead to a meaningful disruption in the
supply of this drug product in the United States. The Agency learned of the disruption from outside
stakeholders on October 3, 2019, and contacted Pfizer on that date and were told by Pfizer that
vincristine sulfate injection was in shortage. Pfizer provided information to post on the FDA website on

' The statute defines “meaningful disruption” to mean “a change in production that is reasonably likely to lead to a reduction
in the supply of a drug by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders
or meet expected demand for its product,” and “does not include interruptions in manufacturing due to matters such as
routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations ina
short period of time.” (FD&C Act § 506C(h)(3)).


October 15, 2019 and the information was posted on October 16, 2019. Our records indicate that Pfizer
did not notify FDA of the interruption in supply of this product. Accordingly, we are issuing you this
letter to notify you of your noncompliance with the FD&C Act.

No later than thirty calendar days after the issuance of this letter, you must submit to the Agency a
written response setting forth the basis for noncompliance with Section 506C and providing the required
notification, including the reasons for the interruption in manufacturing that led to a disruption in the
supply of vincristine sulfate injection in October 2019 (FD&C Act § 506C(f)(2)).

No later than forty-five calendar days after the issuance of this letter, FDA will make this letter and your
response to the letter available to the public on FDA’s Drug Shortage website, unless the Agency
determines that this letter was issued in error, or, after review of your response, determines that there
was a reasonable basis for noncompliance (FD&C Act § 506C(f)(3)). In posting the letter and your
response on the Drug Shortage website, FDA would protect confidential commercial information and
trade secrets, if any, as required by applicable law.

If you have further questions, please contact the Drug Shortage Staff at (240) 402-7770.
Please submit all communications regarding this drug product to the following address:

Drug Shortage Staff

Food and Drug Administration
WO 22, Room 6204

10903 New Hampshire Avenue
Silver Spring, MD 20993

Sincerely,
Wwe)

CAPT Valerie Jensen

Associate Director

Drug Shortage Staff

Center for Drug Evaluation and Research