FDA trying to ease Califf's pain
On Thursday, FDA released new policies on opioids in an unsuccessful effort to wipe away opposition in the U.S. Senate to Robert Califf's confirmation as FDA commissioner. Califf, who is deputy commissioner for medical products and tobacco, is the only FDA official quoted in a press release announcing the agency's policy (see BioCentury, Feb. 1). Sens. Edward Markey (D-Mass.) and Joe Manchin (D-W.Va.) said the new policies are welcome, but fall short of meeting their conditions for dropping holds they have placed on a Senate vote to confirm Califf.
According to a fact sheet, FDA will "fundamentally re-examine the risk-benefit paradigm for opioids and ensure that the agency considers the wider public health effects." It is seeking advice from the Science Board in March, and has already asked the National Academy of Medicine to provide recommendations on "how to take into account our evolving understanding of the risks of opioids, not only to the patient but also the risks of misuse by other persons who obtain them." ...