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Science & Research

The Office of Women's Health Scientific Research Program Report (2000): Introduction

Full Summary

Letter

Appendix

 

Regulating products that impact the health of women is an integral part of the Food and Drug Administration's (FDA) overall mission to ensure that food is safe and wholesome and those medical products are safe and effective. FDA's Office of Women's Health (OWH) was established in 1994 to provide leadership and policy direction for the agency regarding issues of women's health, to coordinate efforts to establish and advance a women's health agenda for the agency and to serve as the agency's liaison with other agencies, industry and professional associations with regard to the health of women. To help fulfill this mandate and promote women's health throughout the agency, in 1994, OWH established an intramural scientific research program to 1) address gaps in current knowledge, 2) encourage new directions, and 3) set new standards of excellence in women's health. OWH resources are used to stimulate and support quality projects aimed at protecting and improving the agency's policies and decisions on women's health issues. OWH funded projects display rigorous thought, are well focused, can accomplish meaningful results in the allotted time, and have scientific and regulatory merit.

The program has completed its seventh year of funding. It has funded over 90 research projects and spent about 8.5 million dollars on women's health related projects from all parts of the agency. OWH has funded projects over a wide range of traditional women's health topics including contraceptives, estrogens, pregnancy, developmental and reproductive toxicology, gynecological and breast cancer, breast implants, cosmetics. In addition to ensuring the safety and effectiveness of products used primarily or exclusively by women, the agency assures the safety and effectiveness of products used to treat diseases and conditions that affect women differently from men. Thus, in addition to funding projects that address traditional issues in women health, the program has sought out and funded projects in areas that are not traditionally viewed as women's health. For example, OWH has funded projects investigating questions on autoimmune disease, cardiovascular disease, post marketing surveillance, and gender differences in adverse reactions to medical products. OWH has also funded projects aimed at assessing and preventing inequality or inadvertent gender bias in determining the safety and efficacy of products used for both men and women.

OWH monitors the success of the research program by tracking objective measures of success including the completion rate, the number of papers published, and if the project has lead to additional research or other outcomes. To date, the completion rate is 64%. The results of OWH funded research have been published in 40 papers in peer-review journals. An additional 21 papers have been submitted to peer reviewed journals. OWH funded projects have also lead to further research projects. Animal models developed with OWH fund have been used for other research and regulatory projects. Also, OWH monitors the impact of OWH funded projects on regulatory decision-making including guidance documents issued, label changes and standard development.

Competitive Funding Process 2000

The program utilizes a competitive peer review process to select the highest quality projects with an emphasis on projects that significantly contribute to FDA's actions on women's health. Briefly, the process for selecting research projects for funding in FY 2000 is as follows:

  • Determination of priority topics - During August and September, OWH worked with the OWH Research Program Center Coordinators and Center management to identify and prioritize topics of mutual interest for scientific research in FY 2000.
  • Announcement - On October 1 1999, OWH sent to a letter to the Center OWH Research Coordinator announcing the anticipated availability of FY 2000 funds for scientific research and the priority research topics for FY 2000. (Table 1: Priority Research Topics). The announcement requested that 1-2 page concept papers related to priority topic areas be forwarded to OWH through Center management and the OWH Coordinator.
  • Review of concept papers - On October 20, 1999, concept papers were forwarded to OWH from the Center coordinators. OWH received 58 concept papers on a broad range of topics. The wide range of topics reflected the breath of women's health issues before the agency and need to conduct bridging research in a wide number of areas to improve regulatory decision-making.
  • Selection of concept papers - Between October 21 and November 21, 1999, OWH met with the Center OWH Coordinators and managers to rate and rank the concept papers. During internal meetings, OWH decided to aim for a 50-60% funding rate across all Centers. Based on the anticipated budget, OWH selected 22 concept papers for development into full proposals. When requested, representatives from OWH would meet with or speak to or Centers to aid in proposal development. On November 22, OWH informed the Center, OWH Coordinators of the concept papers that were chosen for development in research proposals (Table 2: Concept Papers Selected for Proposal Development).
  • Proposal Development - Between November 22 and January 5, principal investigators (PIs) developed their proposals. When requested, representatives from OWH met with Centers to aid in proposal development. Concurrently, OWH identified internal and external reviewers for each proposal.
  • Proposal Review - On January 5, 2000, twenty-two research proposals, approved by Center management, were submitted to OWH through the Center Coordinators. Internal and external reviewers provided written evaluations of select proposals. Each proposal was reviewed by at least two internal reviewers to ensure that the research was relevant to FDA's regulatory mission. Each proposal was also reviewed by at least two external reviewers to ensure that the research was up to current standards. In addition, OWH staff reviewed all proposals. OWH used the internal/external evaluations for guidance in selecting proposals to be funded.
  • Awarding Grants - In March, 2000, OWH selected 9 research projects for funding based upon the comments of the reviewers and the internal deliberations of OWH staff. OWH provided Principle Investigators (PI) and Center management with announcements of grant awards. Transfer of funds followed OWH's receipt of a signed Letter of Agreement (Table 3: OWH Funded Projects for FY 2000). A brief summary of each of these projects is included in the Abstracts Section.
  • Grantee Orientation - On May 4, representatives from OWH met with this year's OWH grants awardees to congratulate the recipients, review expectations and discuss common research interests.
  • Project Tracking - Project progress is tracked throughout the life of the project. Periodic phone calls from OWH Project Officers to PIs are made to assess progress and/or resolve problems. Two interim written progress reports are required from PIs for every year of funding. OWH Project Officers review these reports and comments are sent to PIs for clarification. Site visits are conducted by OWH on an as needed annual basis. A final report is due 6 months after the completion of the project. Principle investigators are asked to provide OWH with copies of any outcome document (such as manuscripts (draft and final), abstracts, posters, guidance documents, labeling, presentations, etc) which were created as a result of OWH funding. In addition, OWH is now requesting that investigators inform the office of any other projects or initiatives that were undertaken as a result of OWH funding.
  • Project Completion - OWH reviews and approves the final report. Once approved, the investigator is informed the project is closed.

Monitoring of On-Going Research Projects

At six-month intervals throughout the project, PI's are required to submit a progress report to OWH. The progress report summarizes the accomplishments since project initiation or since the last progress report. PI's are required to describe problems encountered as well as the solution or recommendation for solutions that have been implemented. If the project is not proceeding as originally projected, the PI's must supply a revised timeline. In addition, the PI's are requested to submit any completed publications or presentations as well as note any anticipated activities related to the project. OWH reviews the progress reports and sends a response to the PI noting that the progress report is acceptable or requesting additional information.

In November 1999, OWH received 21 progress reports for ongoing projects and 2 final reports. OWH review of these reports noted that several of the projects were presented at scientific meeting and 13 abstracts of these presentations were provided. There were 17 papers published or prepared for publication. Also many of the projects showed evidence that additional work was being conducted based on the initial results of the OWH funding (see Outcomes Section for a more detailed summary).

Other Activities

In keeping with these program goals, OWH staff recently conducted a site visit of the National Center for Toxicological Research (NCTR). The purpose of the site visit was to assess the program's successes from FY 1994 through to the present, to review the progress of ongoing OWH funded research and to discuss the future direction of women's health research at the NCTR. At the end of this site visit, OWH and NCTR agreed to work together to develop a Women's Health Research Initiative at NCTR. This program will identify one or two high priority women's health issues and develop a 5 year research plan. OWH also recognizes that internal research expertise and facilities do not exist to address all the research questions related to women's health. Therefore, OWH will be exploring opportunities for studies to be completed at non-FDA facilities, such as DHHS Centers of Excellence in Women's Health.

OWH provides information about its scientific program to external stakeholders by reporting on activities and outcomes of the program in the quarterly newsletter, The OWH Update, making this information available via the internet, and encouraging the publication and presentation of profit results.

Conclusions

The OWH Scientific Research Program has been a remarkable success. The program has consistently funded research projects aimed at improving the health of women and the results of these projects has been incorporated into agency policies and regulatory decision making. Over the years, OWH staff has found creative ways of leveraging OWH funding including forming collaborations with FDA's product Centers and co-funding projects with the National Institutes of Health. In the future, the Scientific Program will focus its efforts on improving the quality of funded research projects by increasing OWH oversight of on-going projects, and improving the dissemination of project results to internal and external stakeholders.


Table 1: Priority Research Topics

Pre-clinical models

  • Predicting toxicity in regulated medical products, foods (including dietary supplements/botanicals), and cosmetics
  • Animal models of disease (e.g. gynecological cancers, cardiovascular disease, osteoporosis)
  • Biomarkers for studying diseases in women
  • Pharmacokinetic/Pharmacodynamic differences of regulated products by sex and species
  • Mechanisms of toxicity & disease (e.g., skin cancer and phototoxicity, environmental contaminants, mechanism of action of lightening agents, ingredient safety of cosmetics)

Regulated Product use in Pregnancy and Lactation

  • Analysis of data on human use of medical products (drugs, devices, biologics), functional foods/neutraceuticals and dietary supplements during pregnancy/lactation
  • Use of regulated products and impact on the developing fetus
  • Reproductive toxicity of retinol

Clinical Models

  • Regulated product(s) interaction and toxicity
  • Dietary supplements/Botanicals (i.e., clinical evaluation of the safety and efficacy of botanicals)
  • Product performance in pre- and post-menopausal women

Risk assessment/Risk management

  • Allergenicity of regulated products (i.e., seafood, sulfites)
  • Sunscreens (i.e., UV radiation)
  • Cosmetic ingredient safety
  • Labeling comprehension of products used predominantly by women (i.e., botanicals, cosmetics, devices used during labor and delivery)

Marketing surveillance/pharmacovigilence

  • Strengthening the current knowledge base in adverse event reporting
  • Sex differences in toxicity profiles of medical products

Inclusion of women in clinical trials

  • Data analysis of participation of women in clinical trials
  • Analysis of gender differences and special populations
  • Clinical evaluations of alternative medicines

Table 2: Concept Papers Selected for Proposal Development

Center for Biologics Evaluation and Research (CBER)

  • DNA vaccination in pregnancy
  • Gender differences in adverse events following vaccines and biological products

Center for Drug Evaluation and Research (CDER)

  • The acute liver failure active surveillance program
  • Vaginal volume: optimizing vaginal deployment of topical microbicides
  • Women's participation in randomized drug trials for cardiovascular disease
  • Evaluation of the Tg.AC transgenic mouse as a model for predicting photocarcinogenicity
    of pharmaceuticals and cosmaceuticals

Center for Devices and Radiological Health (CDRH)

  • A more consistent and useful method for presenting ultrasound bone sonometer results to practitioners
  • Potential minimally-invasive breast tumor therapy
  • Surveillance of sex-specific utilization, morbidity, and mortality associated with transmyocardial revasularization
  • Relationship of ultrasonic properties to microarchitectual properties of trabecular bone
  • Role of gender specific cell death in angioplasty balloon-induced stenosis of swine coronary arteries

Center for Food Safety and Applied Nutrition (CFSAN)

  • Feeding practices related to food allergy and mother's understanding of food allergy in infants
  • A laboratory investigation of the teratogenic potential of cosmetic treatment products containing retinol and retinyl palmitate
  • Product safety implications of cosmetics labeling claims

Center for Veterinary Medicine (CVM)

  • Use of a unique animal model to study placental and milk transfer of enrofoxacin from the dam to the offspring during the perinatal period
  • Effect of gender on development of arthritis in a swine model system

Office of Regulatory Affairs (ORA)

  • Development of HSV-1 and HSV-2 quality control serum panel
  • Analysis of dioxins/furan levels in tampons

National Center for Toxicological Research (NCTR)

  • Chemical differences and toxicological effects of Dong Quai Root preparations
  • Evaluation of the effects of genistein on the mutagenicity and carcinogenicity of the model mammary carcinogen 7, 12-dimethylbenz(a)anthracene in female transgenic rats
  • Evaluation of the Tk KO mouse as a model for systemic lupus erythematous
  • Measurement of K-ras mutation in endometrial tissue and analysis of tamoxifen-associated changes in K-ras mutant frequency

Table 3: OWH Funded Projects for FY 2000

  • Debra Birnkrant, M.D., Ajaz Hussain, Ph.D., CDER, "Vaginal Volume: Optimizing vaginal deployment of topical microbicides"
  • Ronald Honchel, Ph.D., Frank Sistare, Ph.D., CDER, "Evaluation of the Tg.AC transgenic mouse as a model for predicting the photocarcinogenicity of pharmaceuticals and cosmeceuticals"
  • Ann Farrell, M.D., Lilia Talarico, M.D., CDER, "Women's participation in clinical drug trials for unstable angina and myocardial infarction"
  • Brad Astor, Ph.D., CDRH, "Surveillance of sex-specific utilization, morbidity, and mortality associated with transmyocardial revascularization"
  • Richard Kotz, Ph.D., CDRH, "A study to evaluate the consistency of T-scores among ultrasound bone measurement devices and the usefulness of these devices for monitoring bone status"
  • Jeffrey Yourick, Ph.D., Thomas Collins, Ph.D., CFSAN, "Teratogenic potential of cosmetic products containing Retinol (Vitamin A) and Retinyl Palmitate" - Phase 1
  • Jurgen von Bredow, Ph.D., CVM, "Use of a unique animal model to study placental & milk transfer of ciprofloxicin from the dam to the offspring during the perinatal period"
  • Anane Aidoo, Ph.D., NCTR, "Evaluation of the effects of daidzein and genistein on the genotoxic and carcinogenic activity of the model mammary carcinogen 7,12-dimethylbenz(a)anthracene (DBMA) in ovariectomized transgenic Big Blue rats"
  • Vasily Dobrolovsky, Ph.D., NCTR, "Evaluation of the Tk knockout (TkKO) mouse as a model of systemic lupus erythematosus"

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