How FDA Plans to Use Drug Amount 

Reporting Data

Matthew Rosenberg, MSPPM

Economist

Office of Strategic Programs

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act

September 8, 2022
www.fda.gov 2

Overview

• FDA’s vision for the use of drug amount reporting

data

• How drug amount reporting data will enhance the

Agency’s understanding of drug supply chains

• How FDA plans to use drug amount reporting data

to support efforts on supply chain issues and drug

shortages
www.fda.gov 3

FDA’s Vision For Using Drug Amount 

Reporting Data
www.fda.gov 4

FDA Plans to Use Drug Amount Reporting Data to 

Enhance Understanding of Drug Supply Chain Issues

Drug Amount Reports

(Across Establishments and Products)

Other FDA Operational and Regulatory Data

Drug Registration

and Listing

Regulatory

Submissions/Forms

External Data 

(e.g., Sales)

Enhanced Understanding of Drug Supply Chain Issues and 

Drug Shortages
www.fda.gov 5

How These Data Enhance 

Understanding of Drug Supply Chains
www.fda.gov 6

A Hypothetical Drug Supply Chain

Product

1

Product

2

Estab A

(API)

Estab C 

(FDF)

Estab B 

(API)

Estab D 

(FDF)
www.fda.gov 7

FDA Insights Prior to Drug Amount Reporting

Estab A

(API)

Estab C 

(FDF)

Estab B 

(API)

Estab D 

(FDF)

Market Share: 30%

History of CGMP Issues Market Share: 70%

Product

1

Product

2
www.fda.gov 8

Drug Amount Reporting Will Help FDA Understand 

Dependence on Specific Establishments

Estab A

(API)

Estab C 

(FDF)

Estab B 

(API)

Estab D 

(FDF)

Product 1 by C: 100%

Product 2 by C: 90%

Product 2 by D: 10%

API by A: 40%

API by B: 60%

API by A to C: 100%

API by B to C: ???

API by B to D: ???

Market Share: 30%

Market Share: 70%

Product

1

Product

2

History of CGMP Issues
www.fda.gov 9

How Drug Amount Reporting Data 

Support FDA Efforts
www.fda.gov 10

Three Main FDA Efforts Supported By 

Drug Amount Reporting

Analyzing the globalization of the U.S. drug supply chain

(e.g., location of manufacturing)

Enhancing the assessment of each establishment’s patient 

exposure in the site selection model 

Evaluating immediate and long-term supply chain 

vulnerabilities to help respond to and potentially predict

supply chain issues (e.g., drug shortages)
www.fda.gov 11

Drug Amount Reporting Will Help FDA Move 

Beyond Analyzing Establishment Location 

52% of Finished Dosage Form (FDF) 

Establishments Outside of the U.S.

73% of Active Pharmaceutical Ingredient

(API) Establishments Outside of the U.S.

Drug Amount Data: Which products, and how much of their volume, are manufactured

outside of the U.S.?

Source: 100-Day Reviews Under Executive Order 14017, June 2021, Pages 215-216

https://www.whitehouse.gov/wp-content/uploads/2021/06/100-day-supply-chain-review-report.pdf
www.fda.gov 12

Drug Amount Reporting Will Help Enhance 

FDA’s Risk-Based Inspection Prioritization 

High-Risk Injectable

Medium-Risk Injectable

Low-Risk Oral

Products at Hypothetical

Establishment

Hypothetical Drug 

Amount Report

Higher Patient Exposure to

Low-Risk Oral Products

Lower Patient Exposure to

High-Risk Injectable Products
www.fda.gov 13

Drug Amount Reporting Will Help FDA Respond

to Potential Drug Shortages in Emergencies

https://journals.sagepub.com/doi/abs/10.1177/0092861512448569?journalCode=dijb

https://www.nytimes.com/2017/10/04/health/puerto-rico-hurricane-maria-pharmaceutical-manufacturers.html

https://www.fiercepharma.com/manufacturing/fda-anticipates-drug-and-device-disruptions-as-china-outbreak-plays-out
www.fda.gov 14

Is There a Potential Drug Shortage if 

Establishment D Ceases Production?

Estab A

(API)

Estab C 

(FDF)

Estab B 

(API)

Estab D 

(FDF)

Product 1 by C: 100%

Product 2 by C: 90%

Product 2 by D: 10%

Market Share: 30%

Market Share: 70%

Product

1

Product

2
www.fda.gov 15

Is There a Potential Drug Shortage if 

Establishment D Ceases Production?

Estab A

(API)

Estab C 

(FDF)

Estab B 

(API)

Estab D 

(FDF)

Product 1 by C: 100%

Product 2 by C: 90%

Product 2 by D: 10%

Market Share: 30%

Market Share: 70%

Product

1

Product

2

7% (10% of 70%) of the

Market Will Be Affected
www.fda.gov 16

What if Establishment C Ceases 

Production?

Estab A

(API)

Estab C 

(FDF)

Estab B 

(API)

Estab D 

(FDF)

Product 1 by C: 100%

Product 2 by C: 90%

Product 2 by D: 10%

Market Share: 30%

Market Share: 70%

Product

1

Product

2
www.fda.gov 17

What if Establishment C Ceases 

Production?

Estab A

(API)

Estab C 

(FDF)

Estab B 

(API)

Estab D 

(FDF)

Product 1 by C: 100%

Product 2 by C: 90%

Product 2 by D: 10%

Market Share: 30%

Market Share: 70%

Product

1

Product

2

30% (100% of 30%) of the

Market Will Be Affected

Up to 63% More (90% of

70%) May Be Affected

(If D Can’t Ramp Up)
www.fda.gov 18

Drug Amount Reporting Could Help FDA 

Measure Supply Chain Vulnerabilities

Source: Tillman et al. A System Reliability Approach for Assessing the Vulnerability of United

States Pharmaceutical Supply Chains. 2020 ESREL Conference Proceedings.

https://www.rpsonline.com.sg/proceedings/esrel2020/html/4832.xml

FDA is exploring systems engineering approaches for incorporating drug 

amount reporting data into quantitative measures of supply chain vulnerability
www.fda.gov 19

Which Could Potentially Help FDA 

Predict Future Supply Chain Issues
www.fda.gov 20

Supply Chain Issues Can Have Substantial 

Public Health Impacts 

Norepinephrine Shortage Per FDA Website1: 

Feb 2011 – Feb 2012

2017 JAMA Study2: During the Shortage...

Deaths increased by 3.7 percentage points

Patients switched to alternatives like phenylephrine

Nationally Projected Losses3: $13.7 Billion

1Sources: FDA Website

2Vail et al. Association Between US Norepinephrine Shortage and Mortality Among Patients With Septic Shock. JAMA. 2017.

3We project to all US septic shock admissions using Rhee et al. 2017 and Table 82 of Health, United States 2016. We assume a value of mortality risk reduction of $10 

million.
www.fda.gov 21

Summary
www.fda.gov 22

Summary

• FDA plans to combine drug amount reporting data with 

other information to enhance its understanding of drug 

supply chain issues and drug shortages

• Drug amount reporting data will help FDA evaluate the 

dependence of drug supply chains on each establishment

• Several FDA efforts will benefit from drug amount reporting 

data, including risk-based inspection prioritization and 

response to supply chain issues (including drug shortages)