FDA Nominee Faces Steep Climb to Senate Approval

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White House abortion-hating Republican senator nominee Dr. He is facing pressure from leading lawmakers over his choice to lead the Food and Drug Administration, with Robert Califf urging him to reject him and key Democrats cutting their support over opioid policies and industry ties.

Dr. About six years after Califf was taken overwhelming bipartisan support To lead the agency in the final year of the Obama administration, lawmakers and their aides are struggling to lock in the votes they need to clear an evenly divided Senate, with Vice President Kamala Harris serving as the tiebreaker vote.

Few candidates for FDA have faced such opposition from both sides of the aisle, and the agency has lacked a permanent commissioner for more than a year. A number of important issues are on the agenda of the agency: Control of drugs, tests and devices related to Covid-19; the pandemic-induced decline in inspections of drug and device manufacturers; and the popularity of flavored e-cigarette products among youth.

Management officials Dr. He’s trying to garner support for Califf and says he continues to have the support of President Biden and senior health officials. Senate Democratic leaders also continue to support him publicly. However, no date has been set for the confirmation vote before the full Senate. At least five Democrats publicly oppose his candidacy, so Dr. Califf needs at least five Republicans to support him.

“We are confident that Dr. Califf will be confirmed with bipartisan support, and confirming FDA leadership in the midst of a pandemic is critical,” said White House spokesman Chris Meagher. Dr. Califf declined interview requests pending his nomination.

This week, some senators, Dr. He wasn’t sure he could survive the splits over Califf’s candidacy. “I’m not sure it will come to the vote, and that’s when I will make the final decision,” said Senator Roy Blunt, Republican from Missouri. “I love him as a person, I think he can do the job and let’s see what else unfolds between now and the vote.”

Expectations could be higher for a quick vote complex in the absence New Mexico Democratic Senator Ben Ray Luján is recovering from a stroke. A senior aide to Mr. Luján’s said Wednesday that he is in the hospital and will be back in four to six weeks unless there are any complications. Mr. Luján, at the committee stage, Dr. He voted in favor of Califf.

Senators III from West Virginia, an important centrist. Obama administration.

“From a healthcare perspective, from the FDA point of view, we need aggressive leadership ready to take on the greed of the pharmaceutical industry,” Sanders said. “Unfortunately, I don’t think Dr. Califf is that person.”

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

The second-ranked Senate Republican, Senator John Thune of South Dakota, said on Wednesday, Dr. She said Califf’s experience and competence bodes well for her prospects for many in her party, but concerns about her role in abortion decisions drive others away.

“It’s hard for me to say where our members will be at this point,” said Mr. Thune, “but I know there are differing opinions.”

Two Democrats—Mr. Sanders of New Hampshire and Senator Maggie Hassan facing a tough re-election in an opioid-hit state—repeated the election and are said to be against the nomination of more Democrats. In 2016, Dr. The three Democrats who voted against Califf’s initial confirmation for the office, Mr Manchin and Senators Ed Markey of Massachusetts and Richard Blumenthal of Connecticut, remain in office.

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

“I still believe strongly that a new era and leadership is needed that will separate the FDA from the pharmaceutical industry in a very clear and important way,” said Mr. Blumenthal. He added that he had ongoing concerns after meeting with Califf. . On Wednesday, he made a point to reiterate his opposition.

Dr. Califf is making their Senate tour, with an estimated 45 members among the most scheduled for any Biden nominee. His aides privately stated that they believed they could gather the necessary support for his appointment. “I think Dr. Califf will be the next FDA commissioner,” Mr. Burr predicted this week.

Despite the concerns of Mr. Manchin and other Democrats, Dr. Califf was elected. for the position in November. Manchin, whose condition was devastated by the opioid epidemic, summarized a large number of changes He wants to see it in the FDA for opioid prescribers, including mandatory training similar to that required for addiction drug prescribers.

The Senator’s concerns about the crisis hampered negotiations over Mr Biden’s $2.2 trillion domestic policy bill, as Mr Manchin rejected plans to extend the child tax credit over concerns that monthly payments to families with children were being used to purchase opioids.

“I strongly objected to his candidacy, which is an insult to those affected by the drug epidemic,” said Mr Manchin. from twitter On the panel’s voting day, he added: “The time has come for the FDA to have leaders willing to step forward to protect Americans from the drug epidemic that continues to devastate our nation. Dr. Califf is not that leader.”

This week, Dr. Several senators who pressed Califf for their support said they had yet to make a decision.

West Virginia Republican Senator Shelley Moore Capito said he was still undecided: “I know there are some issues that have arisen, but he’s been to West Virginia — he’s seen some of the issues we’ve had firsthand. That’s important to me.”

FDA commissioner role is subject to Senate approval since 1988Unlike the director of the Centers for Disease Control and Prevention, who is appointed by the Presidency. While the candidate tends to be subject to sharp questioning, observers say the decision has never been so wrapped up in national politics that has nothing to do with the candidate’s qualifications.

Without an approved leader, interim commissioner Dr. Janet Woodcock may serve while the nomination is pending. According to Charles Young, spokesperson for the State Accountability Office, Dr. If Califf’s nomination is rejected, he can run the agency for another 210 days.

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

As head of clinical policy and strategy there, he has earned $2.7 million in revenue and between $1 million and $5 million in stock, according to his statement. ethical statement. He has also held lucrative leadership roles in pharmaceutical and biotech companies that develop drugs for patients with hemophilia and muscle dysfunction. In an effort to garner further support, she pledged to Massachusetts Democratic Senator Elizabeth Warren that she would adhere to additional restrictions to separate any management decision from her previous work.

“The FDA nominee has agreed to go beyond the current legal requirement to stop participating in the revolving door after government service and insulate herself from her interactions with former employers,” Ms Warren said. Said. “I will support him as he is willing to make a public commitment to stop the revolving door.”

Dr. Some critics of Califf cite his record with the FDA, where he was deputy commissioner for medicinal products and tobacco beginning in 2015 and agency commissioner approved by the Senate in 2016 and 2017.

Anti-abortion group Susan B. Anthony List, Republican senators Dr. He leads a coalition that forces him to vote against Califf. This The group was criticized changes in drug abortion policies, became less restrictive In 2016, Dr. With Califf leading the agency. “He was a no-record candidate in 2016; now she’s a candidate with a life-destroying past,” the group wrote.

The group also includes Dr. He objects to Califf for his answers to questions during the interview. December 14 committee hearing about the agency’s imminent decision on the medical abortion drug mifepristone. Dr. Califf said he trusted the agency to make the right decision with the evidence available.

Two days later, the FDA announced that it will Permanently allow telehealth providers to prescribe home abortion remedies.

All Republicans included Tommy Tuberville of Alabama, Mike Braun of Indiana, and Roger Marshall of Kansas, who were part of the committee on abortion-related issues, with Dr. They voted against Califf, staff members confirmed.

The advocacy group also print Romney, one of four Republicans to vote on the Senate Committee on Health, Education, Work and Pensions in favor Dr. Califf, on January 13.

Concerned by some lawmakers about opioid policy, Dr. It is also based on Califf’s short-term commission in 2016. Three months into his term, the Centers for Disease Control and Prevention has released new guidelines. and a burning comment Condemning the often deadly risks of opioid drugs among the “unproven and temporary benefits.”

Dr. Andrew Kolodny, instead of following the policy changes, Dr. He said Califf commissioned another study. criticizing the FDA Opioid policies advising Mr Manchin, Mr Markey and Ms Hassan.

Dr. Brandeis University Medical Director of the Opioid Policy Research Collaboration. Kolodny, Dr. If Califf is approved, “there’s a chance we can do something and maybe we’ll finally get somewhere,” he said. “But I couldn’t hold my breath. Because I think at the end of the day he’s an industry man.”

The CDC reported that nearly 100,000 Americans died from an overdose in 2020, although most of the deaths were related to illicit fentanyl.

Sheryl Gay Stolberg contributing reporting.



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