Robert Califf testifies through the Senate Well being, Schooling, Labor and Pensions Committee listening to on the nomination to be commissioner of the Meals and Drug Administration on Tuesday, Dec. 14, 2021.
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The Senate narrowly confirmed Dr. Robert Califf as Meals and Drug Administration commissioner on Tuesday, over objections to his pharmaceutical business ties and considerations he wouldn’t act aggressively sufficient to stem the opioid epidemic.
The White Home relied on six Republicans to maneuver Califf throughout the end line after 5 Democrats voted in opposition to President Joe Biden’s nominee. The ultimate vote was 50-46 for Califf.
“Dr. Califf is a supremely certified nominee with bipartisan help,” stated Sen. Richard Burr, the rating Republican on the Senate well being committee, earlier than Tuesday’s vote.
Califf is a distinguished heart specialist with in depth medical analysis expertise who served as FDA commissioner throughout President Barack Obama’s closing yr in workplace. Biden has stated Califf will carry a gentle hand to the FDA because the drug regulator faces pressing selections on Covid vaccines, therapeutics and testing to combat the pandemic.
Califf’s affirmation comes greater than a yr after Biden took workplace. Dr. Janet Woodcock, a three-decade company veteran, served as appearing commissioner final yr whereas the FDA steadily lowered the eligibility age for Pfizer’s vaccine, licensed booster pictures and permitted two main antiviral medicine to deal with Covid sufferers.
Although the White Home reportedly thought of Woodcock for the everlasting function, she confronted opposition on Capitol Hill. Woodcock led the FDA’s Middle for Drug Analysis and Analysis when prescription opioids, together with OxyContin, have been permitted within the Nineteen Nineties.
In a December letter to the Senate well being committee, six former FDA chiefs stated the year-long absence of a confirmed commissioner had sophisticated the drug regulator’s capacity to satisfy its mandate. They endorsed Califf as somebody with the expertise to instantly play an efficient management function in a time of disaster.
“Confirming Dr. Califf is vital not just for transferring past the Covid-19 emergency, but in addition to assist meet FDA’s many different main regulatory obligations the place Senate confirmed management is crucial for the nation’s wellbeing,” wrote Drs. Scott Gottlieb, Stephen Hahn and 4 different former commissioners.
Nonetheless, Califf’s nomination was not with out controversy, with opposition coming from a number of members of Biden’s personal get together.
Sen. Bernie Sanders, I-Vt., has criticized Califf for proudly owning thousands and thousands of {dollars} in pharmaceutical inventory, accusing him of collaborating in a revolving door between business and the FDA.
Califf is as a senior advisor for Google Well being and Verily, the life science arm of Alphabet. He obtained a wage of $2.7 million and as much as $5 million in inventory at Verily, in keeping with an ethics disclosure type. Califf serves on the board of administrators at Centessa Prescription drugs and the biopharmaceutical firm Cytokinetics. He has as much as $5 million in unvested inventory choices at Centessa and owns a whole lot of 1000’s of {dollars} in Cytokinetics inventory. Califf additionally has inventory in Amgen, Gilead Sciences and Bristol-Meyers Squibb.
Califf has stated he’ll resign from Verily, Centessa and Cytokinetics upon affirmation and divest his pharmaceutical inventory holdings inside 90 days.
Sens. Joe Manchin, D-W.Va., and Maggie Hassan, D-N.H., opposed Califf’s nomination over his earlier management of the the FDA through the opioid disaster. Overdose deaths from all opioids elevated 12% to greater than 47,000 throughout Califf’s tenure as commissioner from 2016 to 2017, whereas fatalities particularly from prescription opioids remained excessive with greater than 17,000 individuals succumbing to overdoses, in keeping with the Facilities for Illness Management and Prevention.
Manchin final week known as on Biden to withdraw Califf’s nomination, arguing that he had “failed to deal with this disaster in any significant means” and wouldn’t carry the change wanted on the FDA to deal with opioids, which have hit West Virginia notably laborious.
“We want new, devoted management that understands the gravity of the drug epidemic and can combat again in opposition to the greed of the pharmaceutical business,” Manchin wrote with Sen. Mike Braun, R-Ind., in an op-ed printed in USA Right now. In an announcement final month, Hassan stated “it doesn’t seem that issues can be completely different” below Califf’s management.
Whereas serving as FDA deputy commissioner for medical merchandise, Califf introduced a overview of the drug regulator’s opioid coverage. Nonetheless, Manchin criticized Califf for the FDA approval of three new opioid medicine throughout his tenure because the company’s commissioner.
Throughout his nomination listening to, Califf acknowledged FDA’s failure when it permitted OxyContin in 1995 with out long-term research or an evaluation of the drug’s addictiveness. He stated the FDA ought to aggressively take a look at relabeling opioids to warn they don’t seem to be supposed for long-term use.
“I feel we have to be taught from all that is occurred over the past a number of a long time with us and reassess the place we’re immediately,” Califf stated. “As a result of no matter we have executed up till now, it is not sufficient. It should take all fingers on deck and particularly, the FDA must redouble its efforts on prescriber training.”
A report variety of Individuals, greater than 68,000, died of opioid overdoses in 2020, in keeping with the CDC information. Greater than 500,000 Individuals have died of opioid overdoses since 1999, in keeping with the info.
Lawmakers additionally pressed Califf about his stance on the FDA’s fast-track approval course of for medicine which have potential to assist sufferers with severe circumstances who’ve few different remedy choices. Woodcock confronted backlash over the accelerated approval of Biogen’s Alzheimer’s drug, aduhelm, in June after a report revealed that firm executives met with FDA officers outdoors official channels. The appearing commissioner requested an inspector normal investigation into the approval of Biogen’s Alzheimer’s drug.
Sen. Ron Wyden, D-Ore., instructed Califf in a letter earlier this month that some corporations have taken benefit of the fast-track course of whereas the FDA has shied away from wielding its authority to punish those that abuse the method. Califf, in his response letter, stated he’ll work with Congress to shut gaps in accountability.
Throughout his nomination listening to, Califf stated the American individuals need earlier entry to medicine that may probably deal with life-threatening sicknesses. Nonetheless, he acknowledged the fast-track course of inherently comes with uncertainty, and the FDA must do higher at monitoring the efficiency of medication which are permitted early.
“We received to have a greater system to guage these merchandise as they’re used in the marketplace,” Califf instructed the Senate well being committee in December.
