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Califf’s nomination for Food and Drug Administration Commissioner is approved by a Senate committee

Some Democrats expressed reservations about Dr. Robert Califf’s commitment to combating the opioid epidemic in his confirmation hearing before a divided Senate committee on Thursday. The nomination of Dr. Robert Califf to be commissioner of the Food and Drug Administration was advanced to a full Senate vote on Thursday.

Doctor Califf’s candidacy was approved by the Senate Committee on Health, Education, Labor, and Pensions with the support of four Republican senators, including North Carolina Senator Richard Burr, who voted in favour of the nominee. According to Senator Burr, the top Republican on the committee, the commissioner’s post is one of the “most critical public health positions in the federal government” and that the agency has been operating without a Senate-confirmed head for almost a year. In his appeal, Dr. Califf’s “unparalleled expertise” and desire to encourage innovation in the medical industry were cited, and he asked other Republicans to do the same. Members of the G.O.P. committee who voted against him did so mostly because of their worries regarding abortion policy.

Doctor Califf’s confirmation to the position has been called into question by Senator Bernie Sanders of Vermont, an independent, and Senators Maggie Hassan of New Hampshire and Edward Markey of Massachusetts, all Democrats, who have indicated that they would vote no. Dr. Califf’s path through the “revolving door” from the Food and Drug Administration to private sector has been challenged by Senator Sanders, who hails from a New England state that has been badly affected by opioids.

The Democratic senator from West Virginia, who represents a state that has been especially hard hit by overdose fatalities, has criticised Dr. Califf’s record on the opioid crisis without indicating how his party would vote on the issue of prescription opioids. A request for comment from his office did not get an instant response.

Doctor Califf spent more than three decades as the director of clinical trials at Duke University Medical Center in North Carolina, where he received his medical degree. Most recently, he served as vice president of clinical policy and strategy at Verily, the life sciences division of Alphabet, the parent company of Google, until his departure. The importance of existing data, particularly that included in patients’ electronic medical records, was underlined throughout the hearing in order to assist answer challenging issues concerning the evidence for medications and devices.

Politicians from both parties questioned him on how he would handle laws governing abortion-inducing medicines, which had been eased during the epidemic after years of stringent regulations. Two days after the hearing, the Food and Drug Administration (F.D.A.) announced that it would permanently lift restrictions, allowing patients to terminate a pregnancy in the first 10 weeks after a telemedicine visit with medications taken at home. Dr. Janet Woodcock, the interim commissioner, made the announcement.

Dr. Califf was previously approved by the Senate by a vote of 89 to 4 to serve as Commissioner of the Food and Drug Administration during the last year of the Obama administration. If he is re-elected, he will confront difficult choices on tobacco control as he attempts to strike a balance between e-cigarettes as a tool to assist certain smokers in quitting and the creation of a new generation of users. Given the ongoing controversy surrounding the FDA’s approval of the controversial Alzheimer’s medicine Aduhelm, the agency’s approval of rapid drug approvals will be scrutinised much more closely.

Following Senator Sanders’s criticism of Dr. Califf’s ties to pharmaceutical companies, which include consulting fees and stock ownership worth up to $8 million, the nominee told a Senate committee in mid-December that he would adhere to the ethics rules set by the Food and Drug Administration and its parent agency, the Department of Health and Human Services, and that he would follow the law.

Senator Markey of Massachusetts, who was not a member of the committee that voted on Thursday, released a statement in which he cited shortcomings in opioid policy and said that he would vote against Dr. Califf’s nomination. Specifically, he said that the Food and Drug Administration “repeatedly rubber-stamped new prescription opioids” and “moved too slowly to remove them off the market or set limits on their labelling.”

During a meeting with Dr. Califf late last year, Senator Markey expressed dissatisfaction with the outcome, adding that the doctor “did not commit to the decisive and comprehensive action required” to control opioids.

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