Policy
Policy Resources
- Health and Human Services (HHS)
-
The
Department of Health and Human Services (HHS) is the United States
government's principal agency for protecting the health of all Americans and
providing essential human services, especially for those who are least able
to help themselves.
- http://www.hhs.gov/
- Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS)
-
The charge
of the Secretary's Advisory Committee on Genetics, Health, and Society
(SACGHS) includes:
- Assessing how genetic
technologies are being integrated into health care and public health,
- Studying the clinical, public
health, ethical, economic, legal, and societal implications of genetic and
genomic technologies and applications,
- Identifying opportunities and
gaps in research and data collection analysis efforts,
- Examining the impact of
current patent policy and licensing practices on access to genetic
technologies,
- Analyzing uses of genetic
information in education, employment, insurance, and law,
- Serving as a public forum for
discussion of issues raised by genetic and genomic technologies.
- The SACGHS is chartered to
have up to 17 members from authorities knowledgeable about biomedical
sciences, human genetics, health care delivery, evidence-based practice,
public health, behavioral sciences, social sciences, health services
research, health policy, health disparities, ethics, economics, law, health
care financing, consumer issues, and other relevant fields. The committee
also includes nonvoting ex officio members from 19 federal agencies and
departments.
- Comments on SACGHS Draft
Report "Coverage and Reimbursement of Genetic Tests and Services"
- Food and Drug Administration (FDA)
-
FDA is an
agency within the Department of Health and Human Services and consists of
centers and offices, which are listed in the menu below.
- The 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, products that emit radiation, and tobacco
products.
- 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.
- PMC Comments on Development of
Companion Diagnostics and the April 2005 Food and Drug Administration (ÒFDAÓ)
Drug-Diagnostic Co-Development Concept Paper-December 2009 (PDF)
- Press Release: January 19,
2011-FDA to improve most common review path for medical devices
- Advancing Regulatory Science
for Public Health-A Framework for FDA's Regulatory Science Initiative
- Comprehensive List of Guidance
Documents at the Food and Drug Administration
- PMC Statement in support of
the FDA Guidelines for Submission of Pharmacogenomic Data
- For more information about the
FDA visit the following links:
- Organization Charts
- About the Office of the
Commissioner
- About the Center for Biologics
Evaluation and Research
- About the Center for Devices
and Radiological Health
- About the Center for Drug
Evaluation and Research
- About the Center for Food
Safety and Applied Nutrition
- About the Center for Tobacco
Products
About the Center for
Veterinary Medicine
- About the National Center for
Toxicological Research
- About the Office of Regulatory
Affairs
- FDA Personalized Medicine Guidance
- Centers for Medicare and Medicaid Services (CMS)
-
CMS'
Mission
- To ensure effective,
up-to-date health care coverage and to promote quality care for beneficiaries
- CMS' Vision
- To achieve a transformed and
modernized health care system.
- CMS will accomplish our
mission by continuing to transform and modernize America's health care
system.
-
- CMS' Strategic Action Plan
Objectives
- Skilled, Committed, and
Highly-Motivated Workforce
- Accurate and Predictable
Payments
- High-Value Health Care
- Confident, Informed Consumers
- Collaborative Partnerships
- http://www.cms.gov/
- Fair and Rational Medicare
Payment for Molecular Diagnostic Tests
- Policy Position
- Background
- CLIA and Genetic Testing
- Policy Position
- Policy Background
- Centers for Disease Control and Prevention
-
CDC
request for public input on public health genomics
- The Centers for Disease
Control and Prevention (CDC) issued a Request for Information for comments,
data, and other information helpful to assess the most important steps in
research, policy, and practice for the field of public health genomics in the
next five years.
- Read PMC's comment here.
- Evaluation of Genomic
Applications in Practice and Prevention (EGAPPª)
- In 2004, the Centers for
Disease Control and Prevention launched the EGAPPª initiative to establish
and test a systematic, evidence-based process for evaluating genetic tests
and other applications of genomic technology that are in transition from
research to clinical and public health practice.
- A key EGAPPª goal is to
provide objective, timely, and credible information that is clearly linked to
available scientific evidence. This information will allow health care
providers and payers, consumers, policymakers, and others to distinguish
genetic tests that are safe and useful.
- Read more about the EGAPPª
initiative in the decade report (10 Years of Public Health Genomics at CDC
1997 - 2007)
Join Today
PMC members shape and advance the future of personalized medicine.
» Sign Up Today