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Thursday, May 23, 2024

The nomination of a Food and Drug Administration official faces a difficult road to Senate confirmation

Dr. Robert Califf, the White House’s nomination to run the Food and Drug Administration, is under fire from prominent legislators, with abortion opponents asking Republican senators to reject him and major Democrats withholding support over his opioid policies and links to the pharmaceutical sector.

In the final year of the Obama administration, nearly six years after Dr. Califf received overwhelming bipartisan support for his appointment as head of the agency, lawmakers and aides are scrambling to secure the votes he needs to clear a Senate that is evenly divided, with Vice President Kamala Harris serving as the deciding vote.

Rarely have candidates to the Food and Drug Administration received such fierce resistance from both political parties, and the agency has been operating without a permanent commissioner for more than a year. The agency’s agenda includes a number of significant issues, including the oversight of drugs, tests, and devices related to Covid-19; the decline in inspections of drug and device manufacturers as a result of the pandemic; and the growing popularity of flavoured e-cigarette products among teenagers, among others.

Administration officials have been attempting to mobilise support for Dr. Califf, who they believe continues to enjoy the backing of President Biden and other senior health authorities in the United States. Senate Democratic leaders have likewise maintained their vocal support for him. There has been no announcement of a date for his confirmation vote before the entire Senate. Dr. Califf need the support of at least five Republicans in order to be confirmed, since at least five Democrats have openly opposed his candidacy.

Some senators expressed scepticism this week about Dr. Califf’s ability to weather the divides over his presidential ambition. According to Senator Roy Blunt, a Republican from Missouri, “I am not certain that it will come up for a vote, and I will make a final judgement then.” “I like him as a person, I believe he is capable of doing the job, and we’ll see what else happens between now and the election.”

The absence of Senator Ben Ray Luján, Democrat of New Mexico, who is recuperating from a stroke, may complicate the prospects for a swift vote even more. According to a top adviser to Mr. Luján, he is still in the hospital and will be discharged in four to six weeks unless there are any issues. During the committee stage, Mr. Luján voted in support of Dr. Califf’s nomination.

Dr. Califf passed a vote in the Senate Committee on Health, Education, Labor, and Pensions in January, with the backing of the Republican majority. Senate Majority Leader Richard Burr of North Carolina, ranking member of the committee, Susan Collins of Maine, Lisa Murkowski of Alaska, and Mitt Romney of Utah voted to advance the nominee. Burr was the committee’s leading member at the time.

The second-highest-ranking Republican senator in the Senate, Senator John Thune of South Dakota, said on Wednesday that Dr. Califf’s experience and competence boded well for his prospects with many members of his party, but that concerns about his role in abortion decisions were driving others away from him.

Mr. Markey’s office confirmed that he will vote against Dr. Califf for the second time in a row. Mr. Blumenthal said on Tuesday that if the vote were to take place on the same day, he would do the same as well.

Dr. Califf was appointed to the job in November, against the objections of Mr. Manchin and other Democratic lawmakers. He has outlined a number of changes he would like to see implemented at the Food and Drug Administration, including mandatory opioid prescriber education, which would be similar to the education required of those prescribing addiction medication. Mr. Manchin’s home state of West Virginia has been devastated by the opioid epidemic.

As a result of the senator’s concerns about the crisis, negotiations over President Biden’s landmark $2.2 trillion domestic policy bill have been hampered. For example, Mr. Manchin has rejected plans to extend the child tax credit because he is concerned that the monthly payments to families with children will be used to purchase opioids.

Some of Dr. Califf’s detractors point to his track record at the Food and Drug Administration, where he served as deputy commissioner for medical goods and tobacco beginning in 2015 and as the agency’s commissioner in 2016 and 2017, both of which were approved by the Senate.

Republicans Tommy Tuberville of Alabama, Mike Braun of Indiana, and Roger Marshall of Kansas all voted against Dr. Califf in committee, staff members confirmed. Their opposition to Dr. Califf was based in part on abortion-related problems.

Additionally, the advocacy organisation is putting pressure on Mr. Romney, who was one of four Republicans on the Senate Committee on Health, Education, Labor, and Pensions who voted in support of Dr. Califf on Jan. 13, according to the advocacy group.

Several members of Congress have expressed worry over opioid policy, in part because of Dr. Califf’s short term as commissioner in 2016. CDC released new recommendations and a scathing editorial three months into President Barack Obama’s term, criticising the often-fatal hazards of opioid drugs while also touting their “unproven and temporary advantages.”

Doctor Andrew Kolodny, a critic of the Food and Drug Administration’s opioid policies who has counselled Senator Joe Manchin, Senator Ed Markey, and Senator Maggie Hassan, claimed that instead of making policy adjustments, Dr. Califf commissioned another research.

Jonathan James
Jonathan James
I serve as a Senior Executive Journalist of The National Era
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