Food and Drug Administration 

Safety and Innovation Act 

(FDASIA), Section 907: 

Inclusion of Demographic Subgroups in 

Clinical Trials
Demographic Subgroups 

Individuals of varying sex, age, race, and 

ethnicity 

2 
Outline 

1. Overview of FDA and OMH 

2. Legislative History 

3. Statutory Requirements 

4. 907 Report 

• Methodology 

• Data and Conclusions 

5. 907 Action Plan 

• Development 

• Stakeholder Concerns 

• 3 Priority Areas 

3 
What Does FDA Do? 

• FDA regulates 25% of US commerce 

• Assures the safety, effectiveness and security of 

human and veterinary drugs, vaccines and other 

biological products, medical devices, our food supply, 

cosmetics and radiation-emitting devices 

• Regulates tobacco products 

• Advances Public Health 

– Helps speed innovations that make products more 

effective, safer and more affordable 

– Helps the public get accurate, science-based information 

about these products 

4 
What does FDA not regulate? 

• Regulate medical practice, services, or pricing 

• Advertising (excluding drugs and medical devices), 

alcohol, consumer products (unless radiation 

emitting), illicit drugs, health insurance, meat and 

poultry, pesticides, restaurants, grocery stores, 

water 

• FDA does not conduct clinical trials 

5 
How is FDA Organized? 

Office of 

the Commissioner 

Center for Biologics 

Evaluation and Research 

(CBER) 

Center for Devices 

and Radiological Health 

(CDRH) 

Center for Drug 

Evaluation and Research 

(CDER) 

National Center for 

Toxicological Research 

(NCTR) 

Center for 

Veterinary Medicine 

(CVM) 

Center for Food Safety and 

Applied Nutrition 

(CFSAN) 

Office of 

Regulatory Affairs 

(ORA) 

Center for 

Tobacco Products 

(CTP) 

OMH 

6
FDASIA Section 907 History 

• 2012 Final legislation reauthorizing FDA 

user fees (essential for Agency 

operations) 

 Requirements for an initial public 

report on inclusion data from 

applications 

 Subsequent action plan to address 

deficiencies 

• American Heart Association, WomenHeart, and Society for Women’s 

Health Research lobbied Congress for legislation requiring FDA to 

publicly report data on the inclusion and analysis of women in FDA 

applications 

• Resulting Legislation: Heart for Women’s Act (HEART)

 Sen. Debbie Stabenow (D-MI) and Rep. Lois Capps (D-CA) 

• Provision added to include reporting of a race and ethnicity 

 Sen. Benjamin Cardin (D-MD) 

7 
Section 907 Requirements: A Report

Within one year of enactment: 

• Provide to Congress 

• Post on FDA website 

• Report On: 

 Extent of clinical trial participation 

 Quality of analyses to determine safety and effectiveness for 

demographic subgroups included in applications submitted to FDA 

 Take into account FDA regulations and requirements for protection of 

sponsor confidential commercial information 

8 
Section 907 Requirements: An Action Plan

• Recommendations to improve the completeness and 

quality of data analyses for demographic subgroups 

in: 

• Summaries of product safety and effectiveness data for drugs 

and devices submitted to FDA for marketing approval; and in 

labeling; 

• Recommendations on the inclusion or lack of 

availability of subgroup safety data in labeling; 

• Recommendations to otherwise improve the public 

availability of such data to patients, health care 

providers, and researchers; 

• A determination with respect to each 

recommendation identified in subparagraphs (A) 

through (C) that distinguishes between product types 

referenced in subsection (a)(2)(B) insofar as the 

applicability of each such recommendation to each 

type of product. 

9 

Not later than 1 year after the publication of the 907 report, acting through the 

Commissioner, FDA shall publish an action plan on the website of the Food and 

Drug Administration, and provide such publication to Congress. 
Section 907 Report Methodology 

• Reviewed approved applications from 2011 

 72 Applications 

 5 CBER (FDA Center for Biologics Evaluation and Research) 

applications, Biological Licensing Applications (BLAs) 

 30 CDER (FDA Center for Drug 

Evaluation and Research) applications, 

New Molecular Entities (NMEs) 

 37 CDRH (FDA Center for Devices and 

Radiological Health) applications, 

Premarket Approval Applications 

(PMAs) 

• Pivotal studies included only 

• Pulled demographic data (sex, age, race, 

and ethnicity) as the variables of interest 10
Section 907 Report Findings 

• In general, sponsors are describing the 

demographic profiles of their clinical trial 

participants for sex and age, and the 

majority of applications submitted to 

FDA include subset analyses. 

• FDA shares this information with the 

public in a variety of ways. 

• The statutes, regulations, and policies currently in place 

generally give product sponsors a solid framework for 

providing data in their applications on the inclusion and 

analysis of demographic subgroups. 

11
Section 907 Report Findings Cont’d (2)

Drugs and Biologic Products 

• Participants’ sex was the most consistently reported in the 

medical product applications 

• Patients’ age and sex reflected the 

disease studied 

Devices 

• Patient participation by age and sex 

varied by product type 

12
Section 907 Report Findings Cont’d (3)

• Ethnicity (as defined by the Office of Management and 

Budget as “Hispanic or Latino” and “Not Hispanic or 

Latino”)* not consistently reported in clinical studies across 

*http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm 

medical product types. 

• Inclusion of subgroups did not 

necessarily mean that sufficient 

data was collected for meaningful 

analysis or to detect differences. 

13
Section 907 Action Plan Development 

• Docket for public comment, August 20, 2013 – May 16th 

2014.

• FDA Working Group 

 Office of Minority Health, Lead 

 Office of Policy and Planning 

 Office of External Affairs 

 Office of Chief Counsel 

 Centers (CBER, CDER, and CDRH) 

 Office of Women’s Health

 Office of Health and Constituent Affairs 

• Public meeting, April 1, 2014 

• Stakeholders meetings for additional input 

14
Patient and Health Professional Groups’ Concerns

• The proportion of women, minorities, and the elderly in 

industry-sponsored clinical trials is not consistent with the 

prevalence of the disease in the underlying population 

• Health professionals and patients do not have sufficient 

demographic information to make well-informed treatment 

and diagnostic decisions 

• Achieving racial and ethnic participation, and relevance to 

U.S. subgroups, can be a particular problem when foreign 

data is used 

15
Industry Concerns 

• General lack of awareness about, and limited physical 

access to, clinical trials among some demographic 

subgroups 

• The needs of global development result in clinical trials in 

geographic regions with substantially different racial and 

ethnic representation than the U.S. 

16
Congressional Concerns 

• Publicly reporting progress 

implementing the Action Plan: 

 regular 

 further action needed 

17

April 30, 2014 Letter to FDA led by Senator Stabenow 

• Require representative proportions of women and 

minorities in industry-sponsored clinical trials comparable 

to NIH 

• Specific actions FDA will take, in cooperation with industry: 

 to achieve meaningful subgroup analyses for safety and efficacy 

 clear timelines for enforcement that do not unnecessarily disrupt 

trials 

 making results transparent and publicly available 

17
Section 907 Action Plan

Three overarching priorities: 

•Priority One: Improve the 

completeness and quality of 

demographic subgroup data collection, 

reporting and analysis (Quality) 

•Priority Two: Identify barriers to 

subgroup enrollment in clinical trials and 

employ strategies to encourage greater 

participation (Participation) 

•Priority Three: Make demographic 

subgroup data more available and 

transparent (Transparency) 18
Priority One: Improve the Completeness and 

Quality of Demographic Subgroup Data (Quality) 

1.4. Enhance FDA’s systems for collecting, analyzing, and 

communicating diverse clinical information to optimize safe and 

effective use of medical products in diverse populations over the total 

product life cycle 

1.5. Conduct research on specific areas of public health concern 

related to demographic subgroups 

1.1. Review and develop a work-plan for updating, and/or finalizing, relevant 

guidance on demographic subgroup data, including FDA staff training and outreach 

to external stakeholders, as needed, for implementation 

1.2. Work with sponsors to revise medical product applications to enhance 

information on demographic subgroups in medical product applications 

1.3. Strengthen FDA reviewer training by adding education/training around 

demographic inclusion, analysis, and communication of clinical data 

19
Priority Two: Identify barriers to subgroup enrollment in 

clinical trials and employ strategies to encourage 

greater participation (Participation) 

2.1 Seek further clarity regarding barriers to subgroup participation rates 

2.2 Implement efforts to enhance appropriate use of enrollment criteria in 

clinical trial protocols 

2.3 Increase collaboration with NIH, industry and other 

interested stakeholders to broaden diverse 

participation in clinical research; and 

2.4 Utilize FDA’s communication channels to 

encourage clinical trial participation by demographic 

subgroups 

20
Priority Three: Making demographic subgroup data 

more available and transparent (Transparency) 

3.1 Post demographic composition and analysis by subgroup in pivotal 

clinical studies for FDA-approved medical products 

3.2 Identify potential methods to consistently communicate meaningful 

information on demographic subgroups in medical product labeling 

3.3 Implement communication strategies that are sensitive to the needs 

of underrepresented subpopulations (focus on language access and 

health literacy) 

3.4 Establish an internal FDA steering committee to 

oversee and track implementation of the action plan 

and serve as planning group for an FDA workshop on 

the action plan 

21
Section 907 Action Plan, In Closing 

Advances in science are also playing an increasingly 

important role in deepening our understanding of how 

patients within various subgroups respond to medical 

products. 

• For example, information from areas such as pharmacogenomics

is now being incorporated into product development and regulatory 

review to further address subgroup characteristics and population 

needs, helping to overcome the challenges of the “one-size-fits all” 

model of patient treatment. 

• Ultimately, this is steering us towards the goal of 

tailoring treatments to individuals or subgroups of 

patients through personalized medicine—

including patients in underserved and 

underrepresented populations.” 22
For Additional Information and to 

Comment on the Action Plan 

FDASIA 907updates: http://go.usa.gov/v8YP

Comment on FDAISIA 907 Action Plan: 

http://go.usa.gov/v8gF - Docket Closing October 21st

Via Email: 

FDASIA907@fda.hhs.gov

 

 

 23
Thank You! 

Website: www.fda.gov/minorityhealth

Email Us: OMH@fda.hhs.gov

 Follow us on Twitter @FDAOMH

24