ROBERT CALIFF

Opioids FDA Promises FILE - U.S. Food and Drug Administration Commissioner Dr. Robert Califf speaks at a news conference at the Hubert H. Humphrey Building in Washington, Thursday, May 5, 2016. Califf says a comprehensive review of the opioid painkillers that triggered the nation's ongoing drug overdose epidemic is in the works. But he faces skepticism about the long-promised review from lawmakers, experts and advocates after years of delay. In response to questions about the recommendations, the FDA provided a list of actions it has taken on opioids, some which predated the report. It's been nearly 10 years since the agency required makers of long-acting opioids to conduct a dozen studies of their drugs' risks and effectiveness.

The head of the Food and Drug Administration says a comprehensive review of the opioid painkillers that triggered the nation's ongoing overdose epidemic is in the works.

The latest data shows nearly one-third of powdered formula products are still out of stock nationwide.

The FDA's tobacco center, which regulates traditional cigarettes and vaping products, is facing challenges navigating policy and enforcement issues.

FDA Commissioner FILE - U.S. Food and Drug Administration Commissioner Robert Califf testifies during a Senate Committee on Health, Education, Labor and Pensions hearing on the nationwide baby formula shortage on Capitol Hill in Washington on May 26, 2022. The announcement comes as FDA Commissioner Robert Califf attempts to push past several controversies that have dominated his second stint running the agency, including the delayed response to contamination problems at the country’s largest infant formula plant. “Fundamental questions about the structure, function, funding and leadership need to be addressed” in the agency's food program, Califf said in a statement. A cardiologist and widely respected researcher, Califf planned to focus his time at FDA on fighting medical misinformation and streamlining the agency’s data systems. But those efforts have been eclipsed by newer controversies, including political outrage over the formula shortage, which has forced the U.S. to airlift millions of containers of formula from Europe.

The head of the Food and Drug Administration is asking for a review of the agency’s food and tobacco programs.

The U.S. is getting another COVID-19 vaccine choice.

>> Read more trending newsHRA Pharma, based in Paris, will announce Monday that it has asked the FDA to authorize the pill that is now available by prescription. A second company, Cadence Health, is also expected to formally request permission to sell its birth control pill over the counter. Levonorgestrel, known by its generic name “Plan B,” an emergency contraceptive pill, was approved for over-the-counter sales in 2011. A federal judge overruled Sebelius’s decision and allowed the pill to be sold over the counter. The anti-abortion group Students for Life of America oppose contraceptive pills the group calls abortifacients.

Juul An electronic cigarette from Juul Labs is seen on on Feb. 25, 2020, in Pembroke Pines, Fla. Juul has asked a federal court, Friday, June 24, 2022, to block a government order to stop selling its electronic cigarettes. Federal health officials on Thursday, June 23, ordered Juul to pull its electronic cigarettes from the U.S. market, the latest blow to the embattled company widely blamed for sparking a national surge in teen vaping. (Brynn Anderson/AP Photo, File)A federal appeals court on Friday issued a temporary stay of a ban announced one day earlier by regulators, which would prohibit the sale of Juul electronic cigarettes nationwide, court records show. >> Read more trending newsIn an order filed in court, the U.S. Court of Appeals for the D.C. The FDA order required that Juul Labs Inc. stop selling and distributing its products in the U.S.

Before shots can be administered to kids as young as 6 months old, the CDC's vaccine advisers are scheduled to vote on updated recommendations this Saturday.

Less than two weeks after restarting formula production at its Michigan facility, Abbott has again had to halt manufacturing there amid flooding.

Abbott announced that it has put a halt on production at its Michigan plant following severe thunderstorms and heavy rains in the region Monday that resulted in power outages and flood damage.

U.S. regulators have historically inspected baby formula plants at least once a year, but they did not inspect any of the three biggest manufacturers in 2020.

Abbott says it's restarted production at the Michigan factory that's tied to the ongoing baby formula shortage.

FDA Commissioner Dr. Robert Califf said it will take about two months for shelves to be full with formula again.

Commissioner Robert Califf admitted the agency's reaction was "too slow," while a formula maker exec apologized to parents.

Sluggish response and questionable decisions by the Food and Drug Administration exacerbated the nation's infant formula shortage, officials say.

Baby Formula Congress Food and Drug Administration Commissioner Robert Califf testifies via video during a House Commerce Oversight and Investigations subcommittee hybrid hearing on the nationwide baby formula shortage on Wednesday, May 25, 2022, in Washington. The shortage mostly stems from Abbott’s Michigan plant, which the FDA shut down in February due to contamination issues. The FDA's response was: “Too slow and there were decisions that were suboptimal along the way,” Califf told lawmakers. Several lawmakers raised longstanding concerns that the FDA’s food program — which oversees most U.S. foods except meat, poultry and eggs — is underfunded and needs restructuring. When Rep. Nanette Diaz-Barragan, D-Calif., asked who is in charge of food safety, Califf and food center director Susan Mayne gave extended answers, describing different roles and responsibilities.

Abbott Nutrition and U.K.-based Kendal Nutricare plan to ship more than 2 million cans of formula.

Abbott Nutrition and U.K.-based Kendal Nutricare plan to ship more than 2 million cans of formula.

Baby Formula Congress Food and Drug Administration Commissioner Robert Califf testifies via video during a House Commerce Oversight and Investigations subcommittee hybrid hearing on the nationwide baby formula shortage on Wednesday, May 25, 2022, in Washington. The shortage mostly stems from Abbott's Michigan plant, which the FDA shut down in February due to contamination issues. FDA staff began honing in on Abbott's plant last fall while tracking several bacterial infections in infants who had consumed formula from the facility. As a result, the FDA didn't begin its inspection until Jan. 31. Califf also faced questions about why his agency didn't anticipate the shortage, given that Abbott's plant supplies roughly one-sixth of the U.S. formula supply.

The FDA and President Joe Biden face mounting political pressure to explain why they didn't intervene earlier to try and address the supply problems.

The FDA and President Joe Biden face mounting political pressure to explain why they didn't intervene earlier to try and address the supply problems.

ADDITION Baby Formula Shortage Michelle Saenz of Santee, Calif. buys baby formula at a grocery story across the border, Tuesday, May 24, 2022, in Tijuana, Mexico. As the baby formula shortage continues in the United States, some parents are opting to cross the border into Mexico, where the shelves are still stocked with options to feed their babies. FDA staff began honing in on Abbott's plant last fall while tracking several bacterial infections in infants who had consumed formula from the facility. As a result, the FDA didn't begin its inspection until Jan. 31. FDA regulators did not contact the U.S. Department of Agriculture about impacts to the formula supply until Feb. 11.

Members of Congress began a House subcommittee hearing Tuesday by accusing north suburban-based Abbott Laboratories of negligence

FDA Commissioner Robert Califf will answer questions from House lawmakers about what's caused the formula shortage.

ADDITION Baby Formula Shortage Michelle Saenz of Santee, Calif. buys baby formula at a grocery story across the border, Tuesday, May 24, 2022, in Tijuana, Mexico. FDA staff began honing in on Abbott's plant last fall while tracking several bacterial infections in infants who had consumed formula from the facility. As a result, the FDA didn't begin its inspection until Jan. 31. The FDA has also faced questions over delays in reviewing an October whistleblower complaint alleging numerous safety violations at Abbott’s plant, including employees falsifying records. FDA regulators did not contact the U.S. Department of Agriculture about impacts to the formula supply until Feb. 11.

The House Oversight and Investigations subcommittee hearing will begin at 11 a.m.

ADDITION Baby Formula Shortage Michelle Saenz of Santee, Calif. buys baby formula at a grocery story across the border, Tuesday, May 24, 2022, in Tijuana, Mexico. As the baby formula shortage continues in the United States, some parents are opting to cross the border into Mexico, where the shelves are still stocked with options to feed their babies. Members of an Energy and Commerce subcommittee will also hear from three infant formula manufacturers, including a top Abbott executive. FDA staff began honing in on problems at Abbott's plant after tracking four bacterial infections in infants who had consumed formula from the facility. The FDA has also faced questions about its timeline for reviewing an October whistleblower complaint alleging numerous safety violations at Abbott’s plant, including employees falsifying records and failing to test formula.

The head of the Food and Drug Administration testified about a series of setbacks that led to a months-long delay in inspecting the plant at the center of a nationwide baby formula shortage.

But Abbott has said that, after production resumes, it could take about two months before new formula begins arriving in stores. The company's factory has been closed due to contamination problems.

Doctors: Don’t make baby formula at home The American Academy of Pediatrics said DIY formulas lack the “critical components babies need.” (NCD)The head of the Food and Drug Administration said parents who have been met with empty shelves when they are seeking baby formula for their children “should begin to see improvement” shortly. >>Related: House panel to examine baby formula shortage; when will it be available? He also said that Abbott Nutrition’s plant in Sturgis, Michigan, should resume production by next week the following week at the latest. Previous coverage:• Baby formula shortage: Biden announces steps to help lessen supply chain issues• Baby formula maker Abbott reaches agreement to restart largest production plant• Why is there a baby formula shortage; what can parents do? • Baby formula shortage: What parents need to know• Baby formula shortage: FDA approves plan to release some Abbott-produced formula• Baby formula shortage worsens, nearly 30% of popular brands sold out• Recall alert: More Similac baby formula added to recall list• American Academy of Pediatrics offer new guidance for parents who can’t get formula• FDA closes investigation into contaminated powdered infant formula produced by Abbott Nutrition©2022 Cox Media Group

The FDA closed the plant in February — after four infants who drank formula produced there contracted bacterial infections, two of whom died.

Baby Formula Shortage FILE - Infant formula is stacked on a table during a baby formula drive to help with the shortage May 14, 2022, in Houston. FDA Commissioner Dr. Robert Califf faced a bipartisan grilling from House lawmakers over the baby formula issue that has angered American parents and become a political liability for President Joe Biden. The problems are largely tied to Abbott Nutrition's Michigan formula plant, the largest in the U.S., which has been closed since February due to contamination problems. The FDA announced a preliminary agreement with Abbott earlier this week to restart production, pending safety upgrades and certifications. The baby formula shortage is the first major crisis for Califf since returning to the FDA in February.

Republicans argued that the plan didn't force federal agencies to look for formula that could be redirected to U.S. homes immediately.

Baby Formula Shortage FILE - Infant formula is stacked on a table during a baby formula drive to help with the shortage May 14, 2022, in Houston. President Joe Biden has invoked the Defense Production Act to speed production of infant formula and has authorized flights to import supply from overseas. The company shut its Michigan plant in February after FDA inspectors began investigating four bacterial infections in infants who had consumed formula from the plant. The baby formula shortage is the first major crisis for Califf since returning to the FDA in February. On Wednesday evening, House Democrats passed a $28 million spending bill that would boost FDA funding to inspect domestic and international formula producers.

Baby Formula Shortage FILE - Infant formula is stacked on a table during a baby formula drive to help with the shortage May 14, 2022, in Houston. Behind the shortage are several distinct issues, including supply disruptions caused by the coronavirus pandemic and the recent shutdown of the largest U.S. formula factory. The company shut its Michigan plant in February after FDA inspectors began investigating four bacterial infections in infants who had consumed formula from the plant. The baby formula shortage is the first major crisis for Califf since returning to the FDA in February. While the baby formula shortage is certain to take center stage, Thursday's hearing was originally scheduled to review the FDA's budget request for next year.

The Food and Drug Administration's commissioner says a shuttered baby formula factory could be up and running by next week.

Baby Formula Factory Explainer FILE - An Abbott Laboratories manufacturing plant is shown in Sturgis, Mich., on Sept. 23, 2010. But it's not certain the bacteria came from the plant; strains found at the plant didn't match the two available samples from the babies. But former FDA officials say the agency is supposed to consider potential shortages that result from shutting down plants. The FDA is doing that now under a new policy that eases imports of baby formula from foreign manufacturers. The company continues to produce baby formula at its other plants in the U.S. and overseas.

The Food and Drug Administration on Tuesday authorized a Pfizer booster dose for children ages 5 through 11 years old at least five months after they complete their two-dose primary series. Dr. Peter Marks, head of the FDA division responsible for vaccines, said data increasingly shows that the protection provided by two shots wanes off over time. The FDA determined that a third shot can help boost protection for children in this age group and the benefits outweigh the risks, Marks said. The FDA did not convene its committee of independent experts to discuss the data before authorizing the booster dose. New hospital admissions of people with Covid have also increased 8% over the past week, according to the CDC.

Abbott, one of the largest formula-makers in the U.S., has reached an agreement with the government to bring a closed factory back on line. And the FDA is easing some restrictions on imported formula.

President Joe Biden's administration has announced new steps to ease the national shortage of baby formula, including allowing more imports from overseas.

States have been asked to increase accessibility of baby formula for recipients of the low-income program. And the Food and Drug Administration is looking at ways to make it easier to import formula.

Menthol Cigarettes FILE - Menthol cigarettes and other tobacco products are displayed at a store in San Francisco on May 17, 2018. The U.S. government is set to release its long-awaited plan to ban menthol cigarettes and flavored cigars. (AP Photo/Jeff Chiu, File) (Jeff Chiu)WASHINGTON — (AP) — The U.S. government on Thursday released its long-awaited plan to ban menthol cigarettes and flavored cigars, citing the toll on Black smokers and young people. The Food and Drug Administration said eliminating menthol cigarettes could prevent between 300,000 and 650,000 smoking deaths over 40 years. Industry documents released via litigation show companies viewed menthol cigarettes as a good “starter product” because they were more palatable to teens.

Menthol Cigarettes FILE - Menthol cigarettes and other tobacco products are displayed at a store in San Francisco on May 17, 2018. The U.S. government is set to release its long-awaited plan to ban menthol cigarettes and flavored cigars. (AP Photo/Jeff Chiu, File) (Jeff Chiu)WASHINGTON — (AP) — The U.S. government on Thursday will lay out its long-awaited plan to ban menthol cigarettes and flavored cigars, which have taken a disproportionate toll on Black smokers and other minorities. The agency has been under legal pressure to issue a decision after anti-smoking and civil rights groups sued the FDA for “unreasonably” delaying action on earlier requests to ban menthol. Industry documents released via litigation show companies viewed menthol cigarettes as a good “starter product” because they were more palatable to teens.

The U.S. government has released its long-awaited plan to ban menthol cigarettes and flavored cigars.

Once President Joe Biden nominated Dr. Robert Califf to head the agency, it took the Senate three months to confirm him. The political battles over Califf’s nomination highlight the difficulties that Biden faces in filling key positions throughout his administration. The White House says the Biden administration has nominated 569 people, of whom 302 have been confirmed and 247 are waiting to go through the confirmation process. In Biden’s first year, the Senate confirmed 41% of his nominations, according to the Partnership for Public Service. “People have been nominated who are too controversial to be nominated, or the White House knows they’re going to be held up,” she said.

Vacant high-ranking positions across the executive branch could be taking a toll on the Biden administration.

The razor-thin vote underscores the increasing political polarization around the health care issues FDA oversees and contrasts with Califf's overwhelming support just six years ago. White House press secretary Jen Psaki said the administration is “thrilled” that the Senate confirmed Califf on a bipartisan basis. The White House long assumed enough Republicans would support Califf to easily overcome any Democratic defections, given his strong support from pharmaceutical companies and patient groups. But anti-abortion advocates recently launched a campaign to sink his Senate vote, outraged by a recent FDA decision that eased access to abortion pills. Dr. Janet Woodcock, the FDA’s longtime drug center director, had been serving as acting commissioner since last January.

The Senate voted on Tuesday to confirm Dr. Robert Califf to head the agency on a 50-46 vote. The agency has been without a permanent leader for the last 13 months.

The razor-thin vote underscores the increasing political polarization around the health care issues FDA oversees and contrasts with Califf's overwhelming support just six years ago. The Senate previously confirmed him to the job by a vote of 89-4. The White House long assumed enough Republicans would support Califf to easily overcome any Democratic defections, given his strong support from pharmaceutical companies and patient groups. But anti-abortion advocates recently launched a campaign to sink his Senate vote, outraged by a recent FDA decision that eased access to abortion pills. The FDA is also crafting new regulations to ban menthol cigarettes, a long-sought goal for many Democratic lawmakers and public health advocates.

Califf already served as FDA commissioner under the Obama administration.

Robert Califf testifies during the Senate Health, Education, Labor and Pensions Committee hearing on the nomination to be commissioner of the Food and Drug Administration on Tuesday, Dec. 14, 2021. The Senate narrowly confirmed Dr. Robert Califf as Food and Drug Administration commissioner on Tuesday, over objections to his pharmaceutical industry ties and concerns he would not act aggressively enough to stem the opioid epidemic. "Dr. Califf is a supremely qualified nominee with bipartisan support," said Sen. Richard Burr, the ranking Republican on the Senate health committee, before Tuesday's vote. Califf is a prominent cardiologist with extensive clinical research experience who served as FDA commissioner during President Barack Obama's final year in office. Biden has said Califf will bring a steady hand to the FDA as the drug regulator faces urgent decisions on Covid vaccines, therapeutics and testing to fight the pandemic.

The Senate has narrowly confirmed President Joe Biden’s pick to lead the Food and Drug Administration, filling a position that had been open for more than a year.

No vote has been set on Califf's nomination as Senate Democrats, the White House and other administration officials make a full-court press to lock up the votes needed to pass the 50-50 chamber. “If he can’t get confirmed it bodes poorly for almost anyone else who could be nominated,” said Dr. Stephen Ostroff, who twice served as acting FDA commissioner. The Biden administration remains “incredibly confident” that Califf will be confirmed, according to a White House official who spoke on condition of anonymity to discuss the effort. Health and Human Services Secretary Xavier Becerra and top White House aides are also lobbying senators on his behalf. The White House long assumed enough Republicans would support Califf to easily overcome any Democratic defections, given his strong support from the pharmaceutical lobby.

President Joe Biden’s pick to lead the powerful Food and Drug Administration has stalled in the narrowly divided Senate.

FDA Commissioner Senate Robert Califf testifies before a Senate Committee on Health, Education, Labor and Pension hearing on the nomination to be commissioner of Food and Drug Administration on Capitol Hill in Washington, Tuesday, Dec. 14, 2021. A cardiologist with strong connections to the pharmaceutical industry and academic research centers, Califf insisted that public service is his motivation for returning to the FDA. New Hampshire Democratic Sen. Maggie Hassan pressed Califf on the need to change FDA prescribing information for opioids, to better reflect the risk of addiction. Califf's first stint as FDA commissioner came after more than 35 years at Duke University, where he founded a contract research organization that conducts studies for many of the world’s largest drugmakers. Under Califf in 2016, the FDA added bolstered warnings to prescription opioids and began publicly scrutinizing all new opioid drug applications.

FDA Commissioner Senate Robert Califf testifies before a Senate Committee on Health, Education, Labor and Pension hearing on the nomination to be commissioner of Food and Drug Administration on Capitol Hill in Washington, Tuesday, Dec. 14, 2021. (AP Photo/Manuel Balce Ceneta) (Manuel Balce Ceneta)WASHINGTON — (AP) — President Joe Biden’s pick to lead the Food and Drug Administration parried questions on crises ranging from the COVID-19 pandemic to the opioid epidemic, during a collegial Senate hearing Tuesday that seemed to bode well for his confirmation. Last month, the FDA ultimately signed off on boosters for all adults as COVID-19 cases surged again. Califf's first stint as FDA commissioner came after more than 35 years at Duke University, where he founded a contract research organization that conducts studies for many of the world’s largest drugmakers. Under Califf in 2016, the FDA added bolstered warnings to prescription opioids and began publicly scrutinizing all new opioid drug applications.

President Joe Biden’s pick to lead the Food and Drug Administration deftly parried questions on crises ranging from the COVID pandemic to the opioid epidemic.

Dr. Califf served as FDA commissioner for the last 11 months of President Barack Obama's second presidential term.

Dr. Califf served as FDA commissioner for the last 11 months of President Barack Obama's second presidential term.

Biden FDA Commissioner FILE - Food and Drug Administration (FDA) Commissioner Dr. Robert Califf speaks at a news conference in Washington, May 5, 2016. President Joe Biden is nominating Califf to again lead the regulatory agency. A cardiologist and clinical trial specialist, Califf, 70, served as FDA commissioner for the last 11 months of President Barack Obama's second term. He would be the first FDA commissioner since the 1940s to return for a second stint leading the agency. Califf arrived at the FDA in 2015 determined to modernize how the agency reviewed drug and device study data.

Califf, a cardiologist, was briefly the agency's commissioner under the Obama administration beginning in 2016.

A cardiologist and clinical trial specialist, Califf served as FDA commissioner for the last 11 months of President Barack Obama's second term. He would be the first FDA commissioner since the 1940s to return for a second stint leading the agency. “He will have broad support from FDA stakeholders.”The FDA regulates the vaccines, drugs and tests used to combat COVID-19. The White House faced a legal deadline of mid-November to a nominate a permanent commissioner or name another acting commissioner. Califf arrived at the FDA in 2015 determined to modernize how the agency reviewed drug and device study data.

President Joe Biden is nominating former Food and Drug Administration Commissioner Dr. Robert Califf to again lead the powerful regulatory agency.