FDA Stepping Up Oversight of Stem Cell Outfits
With the aim to separate true promise from unscrupulous hype, the FDA is increasing its enforcement of stem cell and regenerative therapies. In a statement, Commissioner Scott Gottlieb, MD, noted that the agency, “must advance an efficient and least burdensome framework as a way to help new products remain compliant with the law through a regulatory structure that does not become a barrier to beneficial new innovation.” In the fall, the FDA will advance a comprehensive policy framework that, according to Dr. Gottlieb, “will more clearly describe the rules of the road for this new field.” Dr. Gottlieb also noted that the policy is based on the agency’s existing authority and will offer responsible product developers a way to more efficiently gain FDA approval for their products through a process that is minimally burdensome and less costly.
Telemedicine: Know Your State Policies
As physicians and medical groups increasingly adopt telemedicine, understanding state laws and policies regarding the application of telemedicine is essential. The American Telemedicine Association provides up-to-date information on legislative and regulatory developments on a state-by-state basis. In addition, the group offers various toolkits for telemedicine best practices, as well as tips for contacting policymakers. Visit americantelemed.org for more information.
Public Policy Resources from the AAN
If you want to get involved in public policy efforts but aren’t sure where to begin, the American Academy of Neurology offers several resources to physicians. Among these are sample letters to policymakers, information about the role of neurologists in the national health care system, workforce and compensation data, and links to pertinent information from groups such as the Kaiser Family Health Foundation. Visit AAN.com/go/advocacy for more information.