U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

w ww.fda.gov

CERTIFIED MAIL-RETURN RECEIPT REQUESTED

Bristol Myers Squibb Company February 2, 2022

Attention: Annie Sturgess, Ph.D.

Vice President, Global Regulatory Sciences-CMC

86 Morris Avenue

Summit, NJ 07901

USA

Dear Sir/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, lifesustaining, 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 disruption1 in the supply of that drug in the United States; and (3) the reason(s) for such 

discontinuance or interruption of manufacturing (section 506C(a) of the FD&C Act). 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 thereafter, but in no case later than 5 business days after the permanent 

discontinuance or interruption in manufacturing occurs (section 506C(b) of the FD&C Act; 21 CFR 

314.81(b)(3)(iii)(b)(2)). Compliance with this notification requirement is essential to facilitating the 

mitigation and/or prevention of a shortage or potential shortage, and ultimately may ensure availability of 

critical drugs for patients.

If a 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 (section 506C(f) of the 

FD&C Act). 

Paclitaxel protein-bound particles for injectable suspension (albumin-bound), 100 mg/vial (marketed under 

the tradename Abraxane), 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 has approved indications for: 

1) the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or 

relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline 

unless clinically contraindicated, 2) the first-line treatment of locally advanced or metastatic non-small cell 

lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or 

radiation therapy, and 3) the first-line treatment of patients with metastatic adenocarcinoma of the 

pancreas, in combination with gemcitabine.

1 Section 506C(h)(3) of the FD&C Act 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 in a short period of time.” Section 506C(h)(3).
U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

w ww.fda.gov

It is our understanding that sometime during April 2021, there was an interruption in the manufacture of 

paclitaxel protein-bound particles for injectable suspension (albumin-bound). 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 interruption on June 18, 2021, after FDA contacted Bristol Myers Squibb Company (BMS) 

about the supply of their paclitaxel product. Since that time, BMS communicated their mitigation efforts 

and assurances of continued supply to FDA. However, the Agency learned of insufficient supply from 

outside stakeholders in late September 2021, and paclitaxel protein-bound particles for injectable 

suspension (albumin-bound) was determined to be in shortage soon thereafter, on October 5, 2021. Our 

records indicate that BMS did not notify FDA of the interruption in manufacture of this product prior to 

FDA’s outreach. 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 of the FD&C Act and providing the 

required notification, including the reason(s) for the interruption in manufacturing that led to a disruption in 

the supply of paclitaxel protein-bound particles for injectable suspension (albumin-bound) in April 2021 

(section 506C(f)(2) of the FD&C Act). 

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 (section 506C(f)(3) of the FD&C Act). 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. Please also send 

electronic copies to: drugshortages@fda.hhs.gov.

Drug Shortage Staff

Food and Drug Administration

WO 22, Room 6204

10903 New Hampshire Avenue

Silver Spring, MD 20993

Sincerely,

CAPT Valerie Jensen, R.Ph., USPHS (Ret.)

Associate Director

Drug Shortage Staff

Center for Drug Evaluation and Research