Genetics and Molecular Medicine
Genetics is the study of how biological traits and characteristics are transmitted through generations and families. Molecular medicine examines how illness and disease occurs or can be prevented at the cellular or molecular level. Both fields are experiencing exciting new developments in research and in practical applications, as well as confronting important legal, ethical and policy issues about their use.
The AMA is committed to providing extensive and up-to-date news and information about these new fields of medicine and law, whether discussing genetic testing and genetic discrimination, investigating gene patenting, or explaining the Human Genome Project.
Below are important announcements and personalized medicine topics.
AMA submits comments on FDA proposal to regulate laboratory developed testing services and procedures
On Feb. 2, 2015, the AMA submitted comments to the FDA expressing concern that the agency's proposal to impose new regulatory requirements for laboratory developed testing services and procedures would hinder medical innovation and result in reduced patient access to essential care. Laboratory developed testing services and procedures are a critical part of the practice of medicine and represent the majority of the advanced laboratory tests used in patient care. In order to ensure physicians can continue to provide patients with the best care possible and to innovate and improve upon that care, the AMA urged the FDA to withdraw it proposal, collaborate with other federal entities to modernize existing laboratory oversight processes, conduct a comprehensive environmental scan to identify key concerns, and streamline and reform its regulation of manufacturers of commercial diagnostic testing kits.
AMA and others ask the FDA for notice and comment rulemaking for LDT regulatory framework
On Nov. 18, 2014, the AMA and approximately 50 other groups representing a broad range of stakeholders in genomic medicine asked the FDA to withdraw its proposed guidance “Framework for Regulatory Oversight of Laboratory Developed Tests” and instead proceed using notice and comment rulemaking. Laboratory developed testing (LDT) services are a vital area of medical practice impacting the majority of patients across the country, and wholesale change in oversight and regulation should be done with full consideration of the clinical realities of health care delivery. Notice and comment rulemaking will increase the likelihood that the agency will be able to achieve regulatory goals without jeopardizing the current delivery of testing services to patients and the continued advancement in testing and patient care. View the letter to the FDA.
Guiding Principles on Personalized Medicine
The AMA, in collaboration wth several medical specialty societies, has developed legislative principles on personalized medicine that guide its advocacy efforts. These principles are rooted in the belief that physicians are integral to the scientific inquiry and innovation processes that drive personalized medicine, and that they must have the discretion to utilize the genetic tools that are most appropriate for patient care. Since regulation of genetic tests is integral to physician practice and patient care, the principle addressing oversight of laboratory-developed tests has been further elaborated upon.
Education and research
Listing of several educational programs and initiatives in the fields of genetics and molecular medicine.
Describes the importance of a family medical history and provides resources on how to collect information and generate a simple pedigree.
Current topics in genetics and medicine
Background information on the areas of applied genetics that have the potential to affect medicine most profoundly.
Genetics and policy issues
There is a vast body of evolving policy to guide physicians and researchers through the maze of ethical, legal and social issues surrounding genetics and molecular medicine. Highlights of some of the most pressing policy topics are described here. Topics include the stem cell research, genetic testing, genetic discrimination, gene patenting, and use of human participants in scientific research.