The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
FDA looks to patient advocates and public representatives to contribute their perspectives on issues and to evaluate indications for oncology drugs.
Housed in FDA’s the Office of Special Health Issues, the Cancer Liaison Program is a contact point for the cancer community. The staff assists advocates serving on FDA committees, advisory groups, and programs as well as answers questions from the public about therapies for life-threatening diseases.
The Patient Consultant Program incorporates patient advocates into the drug development and review process prior to FDA ruling. Patient Consultants offer views on clinical trial design, trial endpoints, expanded access protocol development, and patient recruitment strategies. Patient consultants may also sit on the Oncologic Drugs Advisory Committee (ODAC) with full voting rights.
Cancer patient representatives serve on advisory committees in the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH). These representatives also have voting privileges in ODAC.
For more information on advocacy opportunities at the FDA, visit the FDA’s Cancer Liaison Program web site.
]]>HHS represents almost a quarter of all federal outlays, and it administers more grant dollars than all other federal agencies combined. HHS’ Medicare program is the nation’s largest health insurer, handling more than 1 billion claims per year. Medicare and Medicaid together provide health care insurance for one in four Americans.
HHS works closely with state and local governments, and many HHS-funded services are provided at the local level by state or county agencies, or through private sector grantees. The Department’s programs are administered by 11 operating divisions, including eight agencies in the U.S. Public Health Service and three human services agencies. In addition to the services they deliver, the HHS programs provide for equitable treatment of beneficiaries nationwide, and they enable the collection of national health and other data.
There are three agencies that deal with oncology and that fall under HHS’ jurisdiction. They are the Centers for Medicare & Medicaid Services, the Food & Drug Administration and the National Insitutes of Health. This and more information about the Department of Health and Human Services can be found on the department’s website at www.hhs.gov.
]]>The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary federal agency for conducting and supporting medical research. Helping to lead the way toward important medical discoveries that improve people’s health and save lives, NIH scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases. NIH is the nation’s medical research agency — making important medical discoveries that improve health and save lives. Its mission is science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability.
Composed of 27 Institutes and Centers, the NIH provides leadership and financial support to researchers in every state and throughout the world. For over a century, the National Institutes of Health has played an important role in improving the health of the nation. The NIH traces its roots to 1887 with the creation of the Laboratory of Hygience at the Marine Hospital in Staten Island, NY.
This information and more can be found on the NIH website at www.nih.gov.
]]>The National Cancer Institute (NCI) is a component of the National Institutes of Health (NIH), one of eight agencies that compose the Public Health Service (PHS) in the Department of Health and Human Services (DHHS). The NCI, established under the National Cancer Institute Act of 1937, is the Federal Government’s principal agency for cancer research and training. The National Cancer Act of 1971 broadened the scope and responsibilities of the NCI and created the National Cancer Program. Over the years, legislative amendments have maintained the NCI authorities and responsibilities and added new information dissemination mandates as well as a requirement to assess the incorporation of state-of-the-art cancer treatments into clinical practice.
The National Cancer Institute coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients. Specifically, the Insitute:
Childhood cancer advocates can participate in the National Cancer Institute (NCI) and the National Institutes of Health (NIH) through programs and advisory groups that incorporate patient and consumer advocates in science and public policy decision making.
The CARRA Program was created to streamline NCI’s placement of patient advocates in its committees and programs. Over 200 advocates with demonstrated involvement in cancer-related activities were chosen to serve the first 3-year term of this program.
The goals of the CARRA program are to ensure opportunities for consumer advocates to work as lay representatives with the NCI to:
Advocates have the opportunity to select their service preferences. They can work on science and communications, as general cancer advocates, as cancer specific advocates, on prevention, quality of life, clinical trials, treatment, or survivorship.
For more information, visit the CARRA web site.
NCI worked in conjunction with the Director’s Consumer Liaison Group to develop this new program.
The Director’s Consumer Liaison Group (DCLG) was created to advise the NCI director. Fifteen patient advocates, many of whom are cancer survivors, serve as liaisons between the office of the NCI director and the cancer advocacy community. The DCLG makes recommendations on scientific issues, programs, and research priorities. The NCI director selects members from a pool of applicants.
For more information, visit the DCLG web site.
The NCAB meets at least 4 times a year and advises, consults with, and makes recommendations to the Secretary of the Department of Health and Human Services (HHS) and the director of NCI. Its focus is policy issues, grants, and cooperative agreements. NCAB also serves as part of a secondary review process for technical and scientific peer review. Members are appointed by the President and, in addition to public representatives, include leaders in public policy, law, health policy, and health and scientific disciplines.
For more information, visit the NCAB web site.
The BSA offers scientific advice on scientific program policy, progress, and the future direction of the NCI’s extramural research programs. It also provides concept review of extramural program initiatives. Members, including patient advocates, are appointed by the NCI director, and meet quarterly, sometimes in conjunction with the NCAB.
For a complete list of NCI’s advisory boards and groups, visit the BSA web site.
COPR was created to provide advice and recommendations to the NIH director on matters related to medical research, NIH policies and programs, and public participation in agency activities. COPR offers a public forum for discussing such key NIH issues as priority setting, clinical trials and managed care, privacy and genetics, and health disparities among various populations.
]]>