A Senate panel on Tuesday intensely questioned Dr. Robert Califf, the nominee for commissioner of the Food and Drug Administration, on pressing issues like the coronavirus pandemic, the opioid crisis, his financial ties to the pharmaceutical industry and possible changes in the rules for medications used for abortion.Ranking members of the panel expressed solid confidence in Dr. Califf, 70, signaling that his confirmation to the commissioner’s post for a second time might receive bipartisan support by the full Senate. Dr. Califf is familiar to most members of the Senate: He had been F.D.A. commissioner in the last year of the Obama administration, confirmed by the Senate by a vote of 89-to-4.If confirmed this time around, Dr. Califf would assume command of an agency that has been led on an interim basis by Dr. Janet Woodcock for nearly a year. It is unlikely that he would be confirmed before 2022, as the United States heads into its third pandemic year and anticipates vaccines for children younger than 5 and new Covid-19 treatments.
Coronavirus Vaccine Tracker
A look at all the vaccines that have reached trials in humans.During the Trump administration, the agency came under scrutiny for caving in to political pressure as the pandemic unfolded. A flurry of decisions that allowed questionable treatments and other products to flood the market stirred concerns. Dr. Califf would also inherit frustrations over the cost and scarcity of rapid tests, the challenges posed by a mutating coronavirus and a demoralized staff. At the hearing, Dr. Califf said emergency preparedness and response would be his first priority, but he offered few specifics.Members of the Senate Committee on Health, Education, Labor and Pensions expressed satisfaction with the agency’s pandemic response so far. Senator Richard Burr of North Carolina, the panel’s ranking Republican member, said the next commissioner could “not take their foot off the gas.”Senator Patty Murray, a Washington Democrat who led the hearing, said she received 13 letters of support for Dr. Califf from 90 signatories, including six former agency commissioners.The Senate hearing grew emotional when some members delved into the devastating toll wrought by the opioid epidemic. Fatalities are at a historic peak, with 100,000 deaths through the 12 months that ended in April. Critics in Congress are bitter over the agency’s handling of the potent painkillers.Even before the hearing, Senator Joe Manchin, a West Virginia Democrat whose state has felt the drug crisis acutely, announced on Tuesday that he would oppose Dr. Califf’s confirmation, noting that opioid deaths have only mounted since Dr. Califf’s previous term as commissioner. In 2016, Senator Manchin delayed and voted against Dr. Califf, citing the same concerns that Dr. Califf would do little to curb the opioid epidemic.“It is abundantly clear the F.D.A. has failed to keep Americans safe,” Senator Manchin said in a statement on Tuesday. “How many more Americans have to die before we see a culture change at the F.D.A.? If there was ever a time for a change in leadership at the F.D.A., an institution with such direct impact on the American people, it is now.”Another senator, Richard Blumenthal, a Democrat from Connecticut, said he had “grave reservations” about Dr. Califf’s nomination. He had voted against him five years ago, too.At the hearing, Senator Maggie Hassan, a New Hampshire Democrat, criticized the agency for failing to change opioid policies as the death toll soared for years. She called for an overhaul of opioid medication labeling. Senator Ben Ray Luján, a Democrat from New Mexico, expressed outrage about the 2013 approval of the medication Zohydro, which was authorized over the objection of an agency advisory committee.“Something’s got to change,” Senator Luján said. “And I’m hoping, doctor, that you can be that person.”The senators’ concerns drew a pledge from Dr. Califf that he would undertake a “comprehensive review” of the agency’s opioid policies if he were confirmed. He said he would look at options for addressing the crisis, including a change to the labeling of opioid medications. “If I’m confirmed, I’m going to take a very aggressive approach on this,” he said.The Coronavirus Pandemic: Latest Updates
Updated Dec. 14, 2021, 5:30 p.m. ETBroadcaster Dave Ramsey fired an employee for taking Covid precautions, a lawsuit says.Amtrak temporarily drops its vaccine mandate, avoiding cuts to service.The U.S. health secretary hints that more federal funds may be needed to fight an Omicron surge.The hearing concludedBy: Christina Jewett
Title: Senators Question Califf, the F.D.A. Nominee, on Opioid Crisis and Pandemic Response
Sourced From: www.nytimes.com/2021/12/14/health/fda-commissioner-califf-senate.html
Published Date: Tue, 14 Dec 2021 23:07:04 +0000
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