January 29, 2019

U.S. Pain Management Task Force Releases Draft Report

The U.S. Department of Health and Humans Services (HHS) Pain Management Best Practices Inter-Agency Task Force recently released a draft report identifying gaps or inconsistencies and proposing updates to best practices and recommendations for pain management. The report comes after one year of regular meetings with the task force, which was authorized by section 101 of the Comprehensive Addiction and Recovery Act of 2016 (CARA). The group’s findings are critical for addressing the mounting public awareness of opioids and clinical efforts to reduce the number of opioids prescribed. The draft report released on Dec. 28, 2018, calls for individualized, patient-centered pain alleviation and management to improve the lives of those who experience acute and chronic pain. It contains proposed recommendations in […]
January 29, 2019

FDA Issues Warning Against Unproven Stem Cell Treatments

On December 20, 2018, the Food and Drug Administration (FDA) issued a warning letter to Genetech Inc., citing numerous deviations from current good manufacturing and tissue practices. The compliance issues were discovered during a facility inspection between June 18 and June 22, 2018. The agency also found that the company was engaged in the manufacturing and distribution of umbilical cord blood products, which were not the subject of an approved biologics license application nor an investigational new drug (IND) application—thereby violating the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. The letter followed a recall of all ReGen Series products manufactured by Genetech, Inc. of San Diego, Calif., and distributed by Liveyon of Yorba Linda, Calif. On September 28, […]
January 29, 2019

Federal Government Shutdown Affects Congressional Healthcare Activity and Federal Agencies

On January 25, 2019, the longest federal government shutdown was ended with the passage and signing of a three-week continuing resolution fully funding the federal government through February 15, 2019.  The partial shutdown began on December 22, 2018 and lasted 35 days. Prior to the partial shutdown, Congress had already passed five of its major appropriations bills funding about three-fourths of the federal government, including the Department of Health and Human Services and the Department of Veterans Affairs. As a result, virtually all government health programs such as Medicaid and Medicare were insulated from the effects of the shutdown, but other health care-related areas were impacted by the shutdown. The Food and Drug Administration (FDA) saw approximately 40 percent of […]