are women’s health concerns prioritized at the nih and the fda?

Are Women’s Health Are Women’s Health Concerns Prioritized at the Concerns Prioritized at the

NIH and the FDA?NIH and the FDA?

Nicole C. Quon, Ph.D.Nicole C. Quon, Ph.D.Assistant ProfessorAssistant ProfessorIndiana UniversityIndiana University

Scientific AgenciesScientific Agencies

Scientific agencies use scientists and Scientific agencies use scientists and scientific evidence to make science policyscientific evidence to make science policy

Likely to seek bureaucratic autonomyLikely to seek bureaucratic autonomy

May respond to external pressure under May respond to external pressure under certain conditionscertain conditions

Women’s Health MovementWomen’s Health Movement

Relied on frames of gender inequityRelied on frames of gender inequity

Concerns about medical researchConcerns about medical research– Increasing attention to women’s healthIncreasing attention to women’s health– Participation of women in clinical trialsParticipation of women in clinical trials– Research funding for women’s health issues, Research funding for women’s health issues,

especially breast cancerespecially breast cancer

Mobilizing ResourcesMobilizing Resources

MeanMean RangeRange

General women’s health groupsGeneral women’s health groups 7.57.5 2 – 142 – 14

Disease-specific women’s health groupsDisease-specific women’s health groups 1.11.1 0 – 90 – 9

Other disease-specific groupsOther disease-specific groups 5.05.0 0 – 560 – 56

National Women’s Health Network budget ($1000)National Women’s Health Network budget ($1000) 401.8401.8 0 – 7430 – 743

Scientific agencies may consider the Scientific agencies may consider the demands of resource-rich groupsdemands of resource-rich groups

Raising AwarenessRaising Awareness

MeanMean RangeRange

Congressional oversight index Congressional oversight index (alpha=0.62)(alpha=0.62) 17.817.8 0 – 420 – 42

Media coverage index Media coverage index (alpha=0.91)(alpha=0.91) 21.421.4 0-2770-277

Scientific journal articlesScientific journal articles 331.1331.1 0 – 34670 – 3467

Scientific agencies may respond to signals of issue Scientific agencies may respond to signals of issue importanceimportance

Political/social influence vs. scientific influencePolitical/social influence vs. scientific influence

Reducing Monitoring CostsReducing Monitoring Costs

MeanMean RangeRange

Women in senior NIH positionsWomen in senior NIH positions 3.63.6 0 – 90 – 9

Women in NIH study sections (% change)Women in NIH study sections (% change) 0.80.8 -1.8 – 5.2-1.8 – 5.2

Administrative proceduresAdministrative procedures– Introduce decision makers who share the Introduce decision makers who share the

same valuessame values

Gender PoliticsGender Politics

MeanMean RangeRange

Women in Congressional committees (%)Women in Congressional committees (%) 6.56.5 1.0 – 16.71.0 – 16.7

Positive gender gap in Presidential election (%)Positive gender gap in Presidential election (%) 1.71.7 0 – 110 – 11

Negative gender gap in Presidential election (%)Negative gender gap in Presidential election (%) -4.9-4.9 -10 – 0-10 – 0

Partisanship in CongressPartisanship in Congress 1.11.1 0.9 – 1.40.9 – 1.4

Issues related to gender may become Issues related to gender may become more salient under certain conditionsmore salient under certain conditions

Disease BurdenDisease Burden

MeanMean RangeRange

Hospital admission rate for womenHospital admission rate for women 1427.81427.8 1153 – 19601153 – 1960

Overall death rate for menOverall death rate for men 94.594.5 85 – 10985 – 109

Prevalence rate for womenPrevalence rate for women 982.0982.0 0 – 76600 – 7660

Disease-specific death rate for menDisease-specific death rate for men 3.03.0 0 – 420 – 42

Agency missions reflect public health goalsAgency missions reflect public health goals Rate for women or men could influence priority settingRate for women or men could influence priority setting

NIH Dependent MeasuresNIH Dependent Measures Related to decisions in the NIH grants programRelated to decisions in the NIH grants program

– Grants for “women or female” studies Grants for “women or female” studies Extramural program (n=556)Extramural program (n=556) Intramural program (n=418)Intramural program (n=418)

– Grants for studies on 23 diseases on the women’s Grants for studies on 23 diseases on the women’s health agenda health agenda

Extramural program (n=749)Extramural program (n=749) Intramural program (n=660)Intramural program (n=660)

Collected from the CRISP database of funded Collected from the CRISP database of funded grants from 1972 to 2004grants from 1972 to 2004

Keyword searches of grant titles and abstractsKeyword searches of grant titles and abstracts

NIH Independent VariablesNIH Independent Variables

Mobilization of resourcesMobilization of resources Raising awarenessRaising awareness Reducing monitoring costsReducing monitoring costs Gender politicsGender politics Disease burdenDisease burden Other variablesOther variables

– Female medical school faculty, year trend, Female medical school faculty, year trend, presidential dummiespresidential dummies

NIH Model SpecificationNIH Model Specification Count dataCount data

– Data was overdispersedData was overdispersed– Data was a panel designData was a panel design

32 years 32 years 23 institutes or 23 diseases23 institutes or 23 diseases

Random effects negative binomial modelsRandom effects negative binomial models

Offset to account for varying institute sizesOffset to account for varying institute sizes

Lagged independent variablesLagged independent variables

NIH Extramural Priorities ModelsNIH Extramural Priorities ModelsStudies onStudies on

Women or FemalesWomen or Females

Studies onStudies on

23 Disease Priorities23 Disease Priorities

Coeff.Coeff. S.E.S.E. Coeff.Coeff. S.E.S.E.


General women’s health groupsGeneral women’s health groups -0.0013-0.0013 0.01080.0108 -0.0811-0.0811 ** 0.04700.0470

Disease-specific women’s health groupsDisease-specific women’s health groups ---- -0.1457-0.1457 ****** 0.02130.0213

Other disease-specific groupsOther disease-specific groups ---- 0.04710.0471 ****** 0.00410.0041

National Women’s Health Network budgetNational Women’s Health Network budget 0.00030.0003 0.00030.0003 -0.0003-0.0003 0.00030.0003


Congressional oversightCongressional oversight

On women’s healthOn women’s health 0.00170.0017 0.00180.0018 0.00750.0075 ****** 0.00180.0018

On specific diseaseOn specific disease 0.01320.0132 **** 0.00600.0060

Media coverageMedia coverage -0.0003-0.0003 0.00030.0003 0.00400.0040 ****** 0.00080.0008

Scientific journal articlesScientific journal articles -0.0002-0.0002 0.00020.0002 -0.0003-0.0003 ****** 0.00010.0001

* p<0.10, ** p<0.05, *** p<0.01






Reducing Monitoring CostsReducing Monitoring Costs

Women in senior NIH positionsWomen in senior NIH positions 0.03190.0319 ** 0.01680.0168 0.02700.0270 0.01740.0174

Women in NIH study sectionsWomen in NIH study sections 0.00630.0063 0.01720.0172 -0.0163-0.0163 0.01170.0117

Political SaliencePolitical Salience

Women in Congressional committeesWomen in Congressional committees 0.02150.0215 0.02240.0224 0.03890.0389 **** 0.01890.0189

Positive gender gap in Presidential electionPositive gender gap in Presidential election 0.02520.0252 ** 0.01500.0150 0.03250.0325 ****** 0.00960.0096

Negative gender gap in Presidential electionNegative gender gap in Presidential election 0.00200.0020 0.01500.0150 -0.0159-0.0159 ** 0.00930.0093

Partisanship in CongressPartisanship in Congress -0.0449-0.0449 0.25350.2535 0.21020.2102 0.18230.1823

* p<0.10, ** p<0.05, *** p<0.01







Hospital admission rate for womenHospital admission rate for women -0.0001-0.0001 0.00010.0001

Hospital admission rate for menHospital admission rate for men 0.00030.0003 0.00020.0002

Overall death rate for womenOverall death rate for women 0.01850.0185 0.02460.0246

Overall death rate for menOverall death rate for men -0.0501-0.0501 0.03580.0358

Prevalence rate for womenPrevalence rate for women 0.00010.0001 ****** 0.00000.0000

Prevalence rate for menPrevalence rate for men -0.0001-0.0001 0.00010.0001

Disease-specific death rate for womenDisease-specific death rate for women -0.1570-0.1570 ****** 0.01510.0151

Disease-specific death rate for menDisease-specific death rate for men 0.14970.1497 ****** 0.01260.0126

* p<0.10, ** p<0.05, *** p<0.01

NIH Intramural Priorities ModelsNIH Intramural Priorities Models Fewer influences seem to matter compared Fewer influences seem to matter compared

to extramural program decisionsto extramural program decisions

Studies on women or femalesStudies on women or females– Gender politics: negative gender gapGender politics: negative gender gap

Studies on 23 disease prioritiesStudies on 23 disease priorities– Mobilizing resources: other disease-specific Mobilizing resources: other disease-specific

groupsgroups– Raising awareness: congressional oversight on Raising awareness: congressional oversight on

specific diseasesspecific diseases– Disease burden: death rate for menDisease burden: death rate for men

FDA Dependent MeasuresFDA Dependent Measures

Related to decisions for new drug approvalRelated to decisions for new drug approval– Assignment of “priority” reviewAssignment of “priority” review– Speed of new drug review in monthsSpeed of new drug review in months

Approval dates from 1970 to 2004Approval dates from 1970 to 2004

Focused on drugs approved for diseases Focused on drugs approved for diseases on the women’s health agenda (n=131)on the women’s health agenda (n=131)

FDA Independent MeasuresFDA Independent Measures

Mobilizing of resourcesMobilizing of resources– Interest groupsInterest groups

Raising awarenessRaising awareness– Congressional oversight, media coverage, Congressional oversight, media coverage,

scientific articlesscientific articles Disease burdenDisease burden Other variablesOther variables

– FDA workload, previous firm success, FDA workload, previous firm success, PDUFAPDUFA

FDA Model SpecificationFDA Model Specification

Logistic regression to examine assignment Logistic regression to examine assignment of priority reviewof priority review

Proportional hazards regression to Proportional hazards regression to examine the speed of drug reviewexamine the speed of drug review

FDA Priorities ModelsFDA Priorities Models

Priority ReviewPriority Review Drug Review TimesDrug Review Times



Disease-specific women’s health groupsDisease-specific women’s health groups 0.19630.1963 0.20490.2049 -0.0817-0.0817 0.07340.0734

Other disease-specific groupsOther disease-specific groups 0.01910.0191 0.09280.0928 0.02590.0259 0.01780.0178


Congressional oversight on specific diseasesCongressional oversight on specific diseases -0.7353-0.7353 0.64610.6461 0.02130.0213 0.09060.0906

Media coverageMedia coverage 0.09690.0969 0.53120.5312 -0.0325-0.0325 0.17930.1793

Scientific journal articlesScientific journal articles 0.10760.1076 0.06570.0657 0.02290.0229 ****** 0.00810.0081

* p<0.10, ** p<0.05, *** p<0.01

FDA Priorities ModelsFDA Priorities ModelsPriority ReviewPriority Review Drug Review TimesDrug Review Times



Prevalence rate for womenPrevalence rate for women -0.0007-0.0007 0.00100.0010 0.00020.0002 0.00030.0003

Prevalence rate for menPrevalence rate for men -0.0039-0.0039 0.00370.0037 0.00000.0000 0.00020.0002

Disease-specific death rate for womenDisease-specific death rate for women -0.5468-0.5468 1.21301.2130 0.13100.1310 0.12590.1259

Disease-specific death rate for menDisease-specific death rate for men -2.4601-2.4601 ** 1.44441.4444 -0.1057-0.1057 0.11280.1128

Priority ratingPriority rating ---- ---- 1.40611.4061 ****** 0.35560.3556

Other VariablesOther Variables

FDA workloadFDA workload -0.0270-0.0270 2.00562.0056 -0.5728-0.5728 0.62310.6231

Previous firm successPrevious firm success 0.27180.2718 0.77080.7708 0.31450.3145 0.34010.3401

PDUFA trendPDUFA trend -0.0208-0.0208 0.11900.1190 0.08710.0871 0.04560.0456

* p<0.10, ** p<0.05, *** p<0.01

Summary of Main ResultsSummary of Main Results

The FDA was responsive to the women’s The FDA was responsive to the women’s health movementhealth movement

But not in priority setting for new drug But not in priority setting for new drug approvalapproval

Female leadership (scientific and political) Female leadership (scientific and political) are associated with increased priority are associated with increased priority setting at the NIHsetting at the NIH

Congressional oversight and some signals Congressional oversight and some signals from health advocates are also importantfrom health advocates are also important

Study LimitationsStudy Limitations

NIH dependent measures collected using NIH dependent measures collected using keywordskeywords

Data on grant applications unavailableData on grant applications unavailable Women’s health advocacy measure is Women’s health advocacy measure is

crudecrude Few drugs for diseases on the women’s Few drugs for diseases on the women’s

health agendahealth agenda

Policy ImplicationsPolicy Implications

Scientific agencies are not insulated from gender Scientific agencies are not insulated from gender politicspolitics

Influence depends on the type of decision and Influence depends on the type of decision and agency cultureagency culture

Some pathways of influence seem more Some pathways of influence seem more effectiveeffective– Collaborations between interest groups and CongressCollaborations between interest groups and Congress– Increasing the role of women leadersIncreasing the role of women leaders

Pathways of External InfluencePathways of External Influence

““External signals” theory External signals” theory – Josckow, OlsonJosckow, Olson– Mobilizing resourcesMobilizing resources– Raising awarenessRaising awareness

““Political control” theory Political control” theory – Weingast and Moran, McNollGast, McCubbins and Weingast and Moran, McNollGast, McCubbins and

SchwartzSchwartz– Reducing monitoring costsReducing monitoring costs

Political saliencePolitical salience

Agency Mandates and CultureAgency Mandates and Culture

Research scientific agenciesResearch scientific agencies– NIH intramural grants programNIH intramural grants program

Distributive scientific agenciesDistributive scientific agencies– NIH extramural grants programNIH extramural grants program

Regulatory scientific agenciesRegulatory scientific agencies– FDA Center for Drug Evaluation and FDA Center for Drug Evaluation and

ResearchResearch

NIH Independent Variable LagsNIH Independent Variable Lags

Agencies respond to most recently Agencies respond to most recently available informationavailable information

1 year lag: Congressional oversight, 1 year lag: Congressional oversight, media, and scientific journal coveragemedia, and scientific journal coverage

2 year lag: interest groups2 year lag: interest groups

3 year lag: disease burden3 year lag: disease burden

Grants for Women's Health Grants for Women's Health Agenda DiseasesAgenda Diseases

Per

cen

t of

Tot

al N

IH G

rant

s

Year

Studies on Women or Females Studies on Women or Females (%)(%)

1972-1974

1 %

1-5 %

5-10 %

>10%

Studies on Women or Females Studies on Women or Females (%)(%)

1972-1974 1982-1984

1992-1994 2002-2004

1 %

1-5 %

5-10 %

>10%

NIH Results SummaryNIH Results Summary

Priority setting in the NIH extramural and Priority setting in the NIH extramural and intramural programs for women’s health is intramural programs for women’s health is not insulated from politicsnot insulated from politics

All four pathways of external influence All four pathways of external influence seem to matterseem to matter

Extramural decisions are associated with Extramural decisions are associated with more external influencesmore external influences

Priority Review of New DrugsPriority Review of New Drugs

30%

34%

0%

10%

20%

30%

40%

All drugs (n=653) Women's health drugs (n=131)

Mean Drug Review Times Mean Drug Review Times (in months)(in months)

23.6 24.2

0

10

20

30

All drugs (n=653) Women's health drugs (n=131)

FDA Independent Measures IFDA Independent Measures I

MeanMean RangeRange


Disease-specific women’s health groupsDisease-specific women’s health groups 1.41.4 0 – 100 – 10

Other disease-specific groupsOther disease-specific groups 7.67.6 0 – 460 – 46


Congressional oversight indexCongressional oversight index 2.12.1 0 – 160 – 16

Media coverage indexMedia coverage index 136.88136.88 0 – 9230 – 923

Scientific journal articlesScientific journal articles 3004.43004.4 0 – 120970 – 12097

FDA Independent Measures IIFDA Independent Measures II

MeanMean RangeRange

Disease burden per 10,000 populationDisease burden per 10,000 population

Prevalence rate for womenPrevalence rate for women 606.6606.6 0 – 44980 – 4498

Prevalence rate for menPrevalence rate for men 403.1403.1 0 – 55900 – 5590

Death rate for womenDeath rate for women 4.44.4 0 – 300 – 30

Death rate for menDeath rate for men 5.55.5 0 – 400 – 40

Other VariablesOther Variables

FDA workloadFDA workload 1.11.1 0.7-1.80.7-1.8

% of firms with previous success% of firms with previous success 73%73%

Directions for Future ResearchDirections for Future Research

Examine impact of women’s and women’s Examine impact of women’s and women’s health movement on other scientific health movement on other scientific agenciesagencies

Study whether other disease groups that Study whether other disease groups that do not have historical gender inequities do not have historical gender inequities have influenced scientific agencies have influenced scientific agencies decisionsdecisions

are women’s health concerns prioritized at the nih and the fda?

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