All health agencies that fall under the Department of Health and Human Services umbrella can no longer issue their own regulatory actions related to foods, medicines, medical devices and vaccines, according to a memo from HHS Secretary Alex Azar obtained by The New York Times.
In a stunning declaration of authority, Alex M. Azar II, the secretary of health and human services, this week barred the nation’s health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines. Going forward, Mr. Azar wrote in a Sept. 15 memorandum obtained by The New York Times, such power “is reserved to the Secretary.” The bulletin was sent to heads of operating and staff divisions within H.H.S. (Kaplan, 9/19)
Former FDA commissioner Scott Gottlieb said Health and Human Services Secretary Alex Azar’s move to bar agencies under his authority from signing their own rules is a “major distraction” that creates “an implication, or at least a specter” that the FDA’s independence is being eroded or influenced.“The timing of this is really poor right now, because it’s going to distract the agency and frankly creates headlines that could leave the perception that the agency is being bullied,” Gottlieb said on CBS on Sunday. (Shields and Yang, 9/19)
Dr. Scott Gottlieb, the former head of the Food and Drug Administration (FDA), criticized a new policy by the Department of Health and Human Services (HHS) giving only the secretary the authority to sign off on new rules, saying the timing “makes no sense” and risks creating the perception that the agency he helmed is being bullied. “I think that this is the wrong move at the wrong time,” Gottlieb said Sunday on “Face the Nation. “At a time that they should be reaffirming the independence and the integrity of these agency, to do this now just makes no sense.” (Quinn and Tillett, 9/20)
HHS on Friday finalized rulemaking that aims to increase living organ donations by providing more financial support to donors. The policies have widespread support from stakeholders, and HHS didn’t make many changes from the initial versions. Under the proposals, living donors would be reimbursed for the expenses they take on while they’re hospitalized and recovering, such as lost wages or childcare. (Cohrs, 9/18)