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Senate confirms Biden FDA pick Califf, despite objections to drug industry ties


Robert Califf was present at the Senate Health, Education, Labor and Pensions Committee hearing regarding the nomination for the Food and Drug Administration commissioner on Tuesday, December 14, 2021.

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On Tuesday, the Senate approved Dr. Robert Califf 50/46 to be Food and Drug Administration Commissioner. This was over concerns about his pharmaceutical industry connections and concern that he wouldn’t take action to stop the epidemic of opioids.

Califf is an internationally recognized cardiologist who has extensive experience with clinical research. He was the FDA commissioner in President Barack Obama’s last year. The President Joe Biden stated that Califf will be an FDA commissioner, providing a steady hand as the regulator deals with urgent decisions about Covid vaccines, therapies and testing in order to combat the pandemic.

The confirmation of Califf comes nearly a year since Biden was elected. Janet Woodcock (a former three-decades agency veteran) served as acting Commissioner last year. Pfizer gradually decreased the eligibility age to get the vaccine. FDA authorized booster shots. They also approved major antiviral medicines for Covid patients.

Woodcock was reportedly offered the position, but she encountered resistance from Capitol Hill. Woodcock headed the FDA’s Center for Drug Evaluation and Research in the 1990s when OxyContin and other prescription opioids were approved.

In December, six ex-FDA chiefs stated that the lack of a confirm commissioner for over a year had hindered drug regulators’ ability to carry out their mandate. Califf is a person with the skills and experience needed to be able to act as a leader in times of crisis, they said.

Drs. Scott Gottlieb, Stephen Hahn, and four other ex-commissioners.

The nomination of Califf wasn’t without controversy. Biden had to face opposition from several members. Senator Bernie Sanders (I-Vt.) has criticised Califf’s ownership of millions in pharmaceutical stock and accused him of being part of a loop between the FDA and industry.

Califf works as a senior adviser for Google Health and Verily. Verily is Google’s life-science arm. Alphabet. An ethics disclosure form revealed that he received up to $5 million stock and a salary worth $2.7million. Califf sits on the board. Centessa PharmaceuticalsThe biopharmaceutical and pharmaceutical company Cytokinetics. Centessa offers him up to $5 million worth of unvested stock options. He also has hundreds of thousands in Cytokinetics stock. Califf has stock in Amgen, Gilead Sciences Bristol-Meyers Squibb.

Califf said that he would resign from Verily and Centessa upon confirmation, and will divest all of his pharmaceutical stock within the next 90 days.

Sens. Senators. The number of opioid-related overdose deaths rose by 12%, to more than 47,000 in the time that Califf was commissioner. However, fatalities due to prescription opioids were high. More than 17,000 people died from opioid-related overdoses. according to the Centers for Disease Control and Prevention.

Biden was asked by Manchin to pull Califf’s nominating letter last week. Manchin argued that Biden had failed to “resolve this crisis in any meaningful fashion” and could not make the FDA change necessary to deal with opioids. West Virginia has been particularly affected.

In an editorial published in USA Today, Manchin co-authored with Senator Mike Braun, R.I. “We require new, committed leadership that understands and will fight against the greedy pharmaceutical industry.” Hassan stated that “it does not seem that things would change” under Califf’s leadership in a statement published last month.

Califf, who was FDA deputy commissioner medical products announced that he would be reviewing the opioid regulation. Manchin however criticized Califf over the FDA’s approval of three additional opioid drugs by him as commissioner.

Califf admitted that FDA failed to properly assess the addictiveness of OxyContin when it was approved in 1995. Califf suggested that FDA consider aggressively rebranding opioids, to indicate they were not for long-term usage.

Califf explained that “I feel we have to take all the lessons from these past decades together and evaluate where we stand today.” “Because no matter what we have accomplished up to now, it is not sufficient. It will take everyone on the deck, and in particular the FDA should redouble their efforts to educate prescribers.

According to CDC data, a record 68,000 Americans died from opioid overdoses during 2020. The data shows that more than 500,000 Americans were killed by opioid overdoses between 1999 and 2020.

Califf was also asked by lawmakers about his position on FDA’s expedited approval of drugs with the potential to treat serious illnesses. Woodcock was criticized for the June accelerated approval by Biogen of aduhelm (an Alzheimer’s drug) after an investigation revealed that executives from the company met with FDA officials without official permission. Acting commissioner demanded an investigation by the inspector general into Biogen’s approval for its Alzheimer’s drug.

In a letter to Califf earlier this month, Sen. Ron Wyden (D-Ore.) stated that certain companies took advantage of the expedited process, while the FDA shied away form exercising its power to sanction those who misuse the system. Califf responded to the letter by saying that he was willing to work with Congress on closing any gaps in accountability.

Califf stated that the American people desire faster access to life-threatening drugs during his nomination hearing. He acknowledged that the FDA must do better in tracking performance for drugs approved earlier than the expedited process.

Califf stated to the Senate Health Committee in December that “we got to have better systems to evaluate these products when they’re on the market.”