Are Women’s Health Concerns Prioritized at the NIH and the FDA?

1. Are Women’s Health Concerns Prioritized at the NIH and the FDA? Nicole C. Quon, Ph.D. Assistant Professor Indiana University

2. Scientific Agencies • Scientific agencies use scientists and scientific evidence to make science policy • Likely to seek bureaucratic autonomy • May respond to external pressure under certain conditions

3. Women’s Health Movement • Relied on frames of gender inequity • Concerns about medical research • Increasing attention to women’s health • Participation of women in clinical trials • Research funding for women’s health issues, especially breast cancer

4. Mobilizing Resources • Scientific agencies may consider the demands of resource-rich groups

5. Raising Awareness • Scientific agencies may respond to signals of issue importance • Political/social influence vs. scientific influence

6. Reducing Monitoring Costs • Administrative procedures • Introduce decision makers who share the same values

7. Gender Politics • Issues related to gender may become more salient under certain conditions

8. Disease Burden • Agency missions reflect public health goals • Rate for women or men could influence priority setting

9. NIH Dependent Measures • Related to decisions in the NIH grants program • Grants for “women or female” studies • Extramural program (n=556) • Intramural program (n=418) • Grants for studies on 23 diseases on the women’s health agenda • Extramural program (n=749) • Intramural program (n=660) • Collected from the CRISP database of funded grants from 1972 to 2004 • Keyword searches of grant titles and abstracts

10. NIH Independent Variables • Mobilization of resources • Raising awareness • Reducing monitoring costs • Gender politics • Disease burden • Other variables • Female medical school faculty, year trend, presidential dummies

11. NIH Model Specification • Count data • Data was overdispersed • Data was a panel design • 32 years • 23 institutes or 23 diseases • Random effects negative binomial models • Offset to account for varying institute sizes • Lagged independent variables

12. NIH Extramural Priorities Models * p<0.10, ** p<0.05, *** p<0.01

13. NIH Extramural Priorities Models * p<0.10, ** p<0.05, *** p<0.01

14. NIH Extramural Priorities Models * p<0.10, ** p<0.05, *** p<0.01

15. NIH Intramural Priorities Models • Fewer influences seem to matter compared to extramural program decisions • Studies on women or females • Gender politics: negative gender gap • Studies on 23 disease priorities • Mobilizing resources: other disease-specific groups • Raising awareness: congressional oversight on specific diseases • Disease burden: death rate for men

16. FDA Dependent Measures • Related to decisions for new drug approval • Assignment of “priority” review • Speed of new drug review in months • Approval dates from 1970 to 2004 • Focused on drugs approved for diseases on the women’s health agenda (n=131)

17. FDA Independent Measures • Mobilizing of resources • Interest groups • Raising awareness • Congressional oversight, media coverage, scientific articles • Disease burden • Other variables • FDA workload, previous firm success, PDUFA

18. FDA Model Specification • Logistic regression to examine assignment of priority review • Proportional hazards regression to examine the speed of drug review

19. FDA Priorities Models * p<0.10, ** p<0.05, *** p<0.01

20. FDA Priorities Models * p<0.10, ** p<0.05, *** p<0.01

21. Summary of Main Results • The FDA was responsive to the women’s health movement • But not in priority setting for new drug approval • Female leadership (scientific and political) are associated with increased priority setting at the NIH • Congressional oversight and some signals from health advocates are also important

22. Study Limitations • NIH dependent measures collected using keywords • Data on grant applications unavailable • Women’s health advocacy measure is crude • Few drugs for diseases on the women’s health agenda

23. Policy Implications • Scientific agencies are not insulated from gender politics • Influence depends on the type of decision and agency culture • Some pathways of influence seem more effective • Collaborations between interest groups and Congress • Increasing the role of women leaders

25. Pathways of External Influence • “External signals” theory • Josckow, Olson • Mobilizing resources • Raising awareness • “Political control” theory • Weingast and Moran, McNollGast, McCubbins and Schwartz • Reducing monitoring costs • Political salience

26. Agency Mandates and Culture • Research scientific agencies • NIH intramural grants program • Distributive scientific agencies • NIH extramural grants program • Regulatory scientific agencies • FDA Center for Drug Evaluation and Research

27. NIH Independent Variable Lags • Agencies respond to most recently available information • 1 year lag: Congressional oversight, media, and scientific journal coverage • 2 year lag: interest groups • 3 year lag: disease burden

28. Grants for Women's Health Agenda Diseases Percent of Total NIH Grants Year

29. Studies on Women or Females (%) 1972-1974 1 % 1-5 % 5-10 % >10%

30. Studies on Women or Females (%) 1972-1974 1982-1984 1 % 1-5 % 5-10 % >10% 1992-1994 2002-2004

31. NIH Results Summary • Priority setting in the NIH extramural and intramural programs for women’s health is not insulated from politics • All four pathways of external influence seem to matter • Extramural decisions are associated with more external influences

32. Priority Review of New Drugs

33. Mean Drug Review Times (in months)

34. FDA Independent Measures I

35. FDA Independent Measures II

36. Directions for Future Research • Examine impact of women’s and women’s health movement on other scientific agencies • Study whether other disease groups that do not have historical gender inequities have influenced scientific agencies decisions