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FDA Nominee Faces Senate Confirmed Climb

The White House is facing pressure from prominent lawmakers over its choice to lead the Food and Drug Administration, with abortion enemies urging Republican senators to turn down the nomination. Robert Califf, and with key Democrats relinquishing support for his opioid policies and industry ties.

Almost six years after Dr. Califf received overwhelming bipartisan support To lead the agency into the last year of the Obama administration, lawmakers and aides are struggling to secure the votes he needs to clear an equally split Senate where Vice President Kamala Harris serves as the president. who ended the vote.

Few, if any, FDA nominees have met with much opposition from both sides of the aisle, and the agency has been without a standing commissioner for more than a year. The agency’s agenda includes a wide range of important issues: monitoring Covid-19-related drugs, tests and equipment; pandemic-related drop in inspections of drug and device manufacturers; and the popularity of flavored e-cigarette products among adolescents.

Administration officials have been trying to rally support for Dr. Califf and say he continues to have the support of President Biden and top health officials. Democratic leaders in the Senate also continue to support him publicly. But a date has not yet been set for his confirmation vote before the full Senate. At least five Democrats are openly opposing his nomination, so Dr. Califf needs at least five Republicans to support him.

“We are confident that Dr. Califf will be confirmed with bipartisan support, and it is important to confirm leadership at the FDA amid the pandemic,” said Chris Meagher, a White House spokesman. know. Dr. Califf declined interview requests while his nomination was pending.

This week, some senators seemed unlikely that Dr. Califf could survive the divisions over his candidacy. “I’m not sure that’s going to come to a vote, and then I’ll make the final decision,” said Senator Roy Blunt, a Missouri Republican. “I like him as a human being, I think he can do the job and let’s see what else develops between now and the vote.”

The prospect for a snap vote could be even further complicated by the absence Senator Ben Ray Luján, Democrat of New Mexico, who is recovering from a stroke. A senior aide to Mr Luján said on Wednesday that he remained in the hospital and would return in four to six weeks unless there were complications. Mr. Luján voted in favor of Dr. Califf at the committee stage.

Notable Democrats – including Senator Joe Manchin III of West Virginia, a key center, and Bernie Sanders of Vermont, the independent – have publicly stated that they will oppose the candidacy. member for his ties to the pharmaceutical industry and his handling of the opioid crisis during the Obama Administration.

“On the healthcare front, on the FDA side, we need active leadership who are willing to confront the greed of the pharmaceutical industry,” Sanders said. “Unfortunately, I don’t think Dr. Califf is that person.”

Dr Califf cleared a vote on the Senate Committees on Health, Education, Work and Pensions in January with Republican backing. Four senators crossed the aisle to advance to the nomination: Richard Burr of North Carolina, ranking member of the committee; Susan Collins of Maine; Lisa Murkowski of Alaska; and Mitt Romney of Utah.

Senator John Thune of South Dakota, the second-ranked Republican in the Senate, said on Wednesday that Dr. Califf’s experience and competence bodes well for his prospects with many in the party. his own, although concerns about his role in the decision to have an abortion are driving others away.

“It is difficult for me to say at this point where our members will be,” said Mr. Thune, “but I do know that there are mixed views.”

Two Democrats – Mr. Sanders and Sen. Maggie Hassan of New Hampshire, facing a tough re-election in a state hit hard by opioids – oppose the choice and many Democrats. The owner is said to be leaning towards his nomination. All three Democrats who voted against Dr. Califf’s first confirmation of the position in 2016, Manchin and Senators Ed Markey of Massachusetts and Richard Blumenthal of Connecticut, remain in office. .

Mr. Markey’s office confirmed that he would again vote against Dr. Califf. Mr. Blumenthal said on Tuesday that if the vote were held that day, he would do the same.

“I still strongly believe that a new era and leadership is needed that will separate the FDA from the pharmaceutical industry in a very public and significant way,” Blumenthal said, adding that he has lingering concerns. after talking to Dr. Califf. . On Wednesday, he made a point in reiterating his objections.

Dr. Califf made rounds of the Senate, meeting with an estimated 45 members, among the most scheduled for any Biden candidate. Aides indicated that they believed they could muster the support needed for his appointment. This week, Mr. Burr predicted: “I think Dr. Califf will be the next FDA commissioner.”

Despite concerns from Mr. Manchin and other Democrats, Dr. Califf was named for location in November. Manchin, whose state has been ravaged by the opioid epidemic, has outline many changes he wants to see at the FDA, include mandatory education for opioid prescribers similar to the education required for addiction prescribers.

Senators’ concerns about the crisis hampered talks on Mr Biden’s $2.2 trillion domestic policy bill, as Mr Manchin rejected a plan to extend the tax credit. children because of concerns that monthly payments to families with children are used to purchase opioids.

“I strongly oppose his nomination, it is an insult to those who have been affected by the drug epidemic,” Mr Manchin said. on Twitter on the day of the panel vote, added: “It’s time for FDA to have leadership ready to move forward to protect Americans from the drug epidemic that continues to ravage our nation. Dr. Califf is not that leader.”

This week, several senators have emphasized their support for Dr. Califf, saying they have yet to make a decision.

Senator Shelley Moore Capito, Republican of West Virginia, said she has not yet decided: “I know there are some issues that have come up, but he went to West Virginia – he witnessed it with his own eyes. ant some of the problems that we encountered. That’s important to me.”

FDA Commissioner Role Confirmed by Senate since 1988, unlike the director of the Centers for Disease Control and Prevention, who is appointed by a president. Nominees tend to be harshly questioned, but observers say the decision was never made by national politics unrelated to the nominee’s status.

With no confirmed leadership, Dr Janet Woodcock, interim commissioner, can serve while the nomination is pending. If Dr Califf’s nomination is voted down, she could lead the agency for another 210 days, according to Charles Young, a spokesman for the Government Accountability Office.

Dr. Califf has spent most of his career running cardiovascular trials at Duke University’s medical school, where he gained a reputation as an expert in cardiology. In 2017, he joined Verily, the life sciences arm of Alphabet, Google’s parent company.

As head of clinical policy and strategy there, he earned $2.7 million in earnings and $1 million to $5 million in stock, according to the company. moral disclosure. He also holds lucrative leadership roles at pharmaceutical and biotech companies that develop drugs for patients with hemophilia and impaired muscle function. In an effort to boost support, he pledged to Senator Elizabeth Warren, a Democrat of Massachusetts, that he would abide by additional restrictions to separate any administration decisions from the work. his previous.

“The FDA nominee has agreed to go beyond the current legal requirement to opt out of the revolving door after her time in government service and to isolate herself from interactions with other agents,” Warren said. former employer during his time in office. “Because he’s willing to commit publicly to stop the revolving door, I’ll support him.”

Some critics of Dr. Califf cite his track record at the FDA, where he was deputy commissioner for tobacco and health products starting in 2015 and the agency’s commissioner confirmed by the Senate in 2015. 2016 and 2017.

The anti-abortion group Susan B. Anthony List is leading a coalition that is pressuring Republican senators to vote against Dr. Califf. The criticized group changes to drug abortion policy, become less restrictive in 2016 when Dr. Califf led the agency. “In 2016, he was a nominee without a record; Now he’s made a name for himself with his record of disregarding life,” the group wrote.

The group is also protesting Dr. Califf over his answers to the questions in Committee’s December 14 hearing about the agency’s impending decision on the medical abortion drug mifepristone. Dr. Califf said he was confident the agency would make the right decision with the evidence in hand.

Two days later, FDA announced that it will permanently allow telehealth providers to prescribe home abortion pills.

Tommy Tuberville of Alabama, Mike Braun of Indiana and Roger Marshall of Kansas, all Republicans, voted against Dr. Califf on the committee in part because of issues related to abortion, the staff confirm.

The advocacy group also pressing Mr. Romney, one of four Republicans on the Senate Health, Education, Work and Pensions Committees to vote donate Dr. Califf on January 13.

Some lawmakers’ concerns about opioid policy also build on Dr. Califf’s short term as commissioner in 2016. Three months into his tenure, the Centers for Disease Control and Prevention issued guidance new and a stinging comment decries the often fatal risks of opioids in the context of “transient and unproven benefits”.

Instead of tracking policy changes, Dr. Califf did another study, Dr. Andrew Kolodny, a FDA criticism opioid policy has advised Mr. Manchin, Mr. Markey and Ms. Hassan.

If Dr. Califf is confirmed, “there’s a chance he could do something about it and maybe we’ll get somewhere eventually,” said Dr. Kolodny, chief medical officer of the Main Research Collaboration. book Opium at Brandeis University said. “But I won’t hold my breath. Because I think at the end of the day, he’s an industry insider.”

The CDC reported nearly 100,000 Americans died of opioid overdoses in 2020, although many deaths have been linked to illicit fentanyl.

Sheryl Gay Stolberg contribution report.

https://www.nytimes.com/2022/02/03/health/fda-califf-senate.html FDA Nominee Faces Senate Confirmed Climb

Fry Electronics Team

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