On Tuesday, a Senate panel questioned Robert Califf, the nominee for commissioner of the Food and Drug Administration, on pressing issues like the coronaviruses epidemic, the opioid crisis, his financial ties to the pharmaceutical industry and possible changes in the rules for medications used for abortion.
The ranking members of the panel expressed their confidence in Dr. Califf, signalling that his confirmation to the commissioner's post for a second time might receive bipartisan support by the full Senate. The Senate confirmed Dr. Califf as F.D.A. commissioner in the last year of the Obama administration.
Dr. Califf would take over the agency that has been led by Dr. Janet Woodcock for nearly a year. It is unlikely that he would be confirmed before the year 2022, as the United States prepares for a third Pandemic year and anticipates vaccines for children younger than 5 and new Covid-19 treatments.
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There are many vaccines that have been tested in humans.
The New York Times has an interactive tracker for the coronaviruses vaccine.
The agency came under scrutiny for caving in to political pressure during the Pandemic. There were a lot of decisions that allowed questionable treatments and other products to flood the market. The cost and scarcity of rapid tests would be one of the things Dr. Califf would inherit. At the hearing, Dr. Califf said emergency readiness and response would be his first priority, but he gave few details.
The Senate Committee on Health, Education, Labor and Pensions expressed satisfaction with the agency's response to the swine flu. The next commissioner could not take their foot off the gas according to the panel's ranking Republican member.
Six former agency commissioners signed a letter of support for Dr. Califf, according to Senator Patty Murray.
The Senate hearing grew emotional when some members talked about the toll of the epidemic. 100,000 deaths were recorded in the 12 months that ended in April. The agency has been criticized for its handling of the powerful painkillers.
Senator Joe Manchin of West Virginia, whose state has felt the drug crisis acutely, announced on Tuesday that he would oppose Dr. Califf's confirmation. Senator Manchin voted against Dr. Califf because he was concerned that he wouldn't do enough to curb the epidemic.
Senator Manchin said in a statement that the F.D.A. has failed to keep Americans safe. How many more Americans have to die before we see a culture change? The F.D.A., an institution with such a direct impact on the American people, needs a change in leadership.
Richard Blumenthal, a Democrat from Connecticut, said he hadgrave reservations about Dr. Califf's nomination. Five years ago, he voted against him.
As the death toll soared for years, the agency failed to change their policies. She called for changes to the labeling of the drugs. Senator Ben Ray Lujn, a Democrat from New Mexico, expressed outrage about the approval of the medication Zohydro, which was authorized over the objection of an agency advisory committee.
Senator Lujn said something needs to change. I hope you can be that person.
Dr. Califf promised to undertake a comprehensive review of the agency's policies if he were confirmed. He said he would look into changing the labeling of the drugs. He said he would take a very aggressive approach if he was confirmed.
The hearing ended without a vote. A full vote in the Senate is not yet set, but the panel will take one at a later date. Dr. Califf was commissioner for nearly a year before Donald J. Trump was sworn into office.
As the agency considers how to proceed with new vaping products and whether to allow Juul to stay on the market, Dr. Califf's experience as deputy commissioner for medical products and tobacco may help guide him. The F.D.A. decided to allow the sale of an electronic cigarette in the United States because of the benefits of helping people quit smoking. The appointment of a new leader of the agency's tobacco unit would be a key decision, as Dr. Califf described the level of youth vaping as an "alarming rate."
The agency has a role in approving and ensuring the safety of many products, including prescription and over-the-counter drugs, medical devices, food and tobacco products. 20 cents of every dollar is spent on goods.
The F.D.A. is expected to make a decision on the first of two drugs used to end a pregnant womans life in the first 10 weeks of her life. The abortion drug had been restricted by the F.D.A., which required it to be delivered to patients in person.
In April, the F.D.A. lifted the requirement for in-person visits for the duration of the Pandemic, writing in a letter to doctors that a review of medical literature showed few adverse events from the treatment and noted the risk of Covid-19 transmission during office visits The letter signed by Dr. Woodcock made it easier for patients to get the pills. The Biden administration was concerned that the Republicans would strengthen their opposition to Dr. Califf.
Dr. Califf told the Senate panel that the staff would look at the latest data and make the best decision. I know the staff well and I have confidence in them.
Dr. Califf emphasized the importance of generating and relying on thorough data and using it to advance therapies that work and abandon those that fail. He said that his contributions to cardiology drug and device development helped millions of Americans. He said that it was important to produce high-quality evidence to sort the effective and ineffective treatments.
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Pfizer has a pill. Pfizer announced that a study showed that its oral Covid treatment helps stave off severe disease even from the Omicron variant. If the treatment was given within three days of the start of symptoms, it reduced the risk of hospitalization and death by 89 percent.
The US has around 800,000 deaths. The United States is on the verge of killing more people than any other country from the virus. Most of the people who have died in the US have been 65 or older. One in 100 older Americans have died from the disease.
U.S. mandates. New York State has a vaccine requirement for health care workers which the Supreme Court refused to block. New York has a new mask mandate, and California decided to restore it.
The revolving door nature of the agency made Dr. Califf's career an example of how officials can leave and take lucrative jobs in the industry. Since leaving his post as F.D.A. commissioner, Dr. Califf has moved from academic leadership at Duke University to executive and consulting roles with pharmaceutical and biotech companies.
Nine out of the last 10 F.D.A. commissioners went on to work for or serve on the boards of directors in the pharmaceutical industry, according to Senator Bernie Sanders.
"Unfortunately, Dr. Califf, you are not the exception to that rule, Senator," he said, asking how the American people can feel comfortable that they are going to stand up to this powerful special interest."
Dr. Califf agreed to comply with the agency's ethics pledge.
After the hearing, Senator Sanders said he was against Dr. Califf's nomination.
In May of last year, Dr. Califf joined Verily, the life sciences arm of Google, and he earned between $1 million and $5 million in stock from his role as head of clinical policy and strategy. He said in a government ethics filing that he would step down from the position.
Supporters of Dr. Califf say that working in the industry provides critical knowledge and insight into life-saving technology. He nodded to his experience in technocrat medicine, which required better data to guide decision making.
He said that all F.D.A. actions must focus on protecting consumers and patients. Safety matters.
He retired from Duke University in November of last year, according to his income disclosure. If confirmed, he would step down from his role as an adjunct professor.
Dr. Califf said that he would not make decisions related to companies where he served as a compensated board director. He was given more than $1 million in unvested stock options and some of them will be accelerated so he can cash them out. The company is working on therapies for a number of conditions. He made at least $850,000 from stock options in the company.
If confirmed, he pledged to sell his stock in Bristol-Myers Squibb and Gilead Sciences if he owned more than $250,000 in stock. There are two approved treatments for Covid and an approved antiviral treatment from Gilead.
Pam Belluck was involved in reporting.
