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Senate confirms BDA caliph’s choice, despite objections to pharmaceutical industry ties

Robert Calif testified during a hearing in the Senate Health, Education, Labor and Pensions Committee on his nomination as Commissioner of the Office of Food and Drug Administration on Tuesday, December 14, 2021.

Bill Clark CQ-Roll Call, Inc. | Getty Images

On Tuesday, the Senate narrowly confirmed Dr. Robert Caliph as commissioner of the Office of Food and Drug Administration because of objections to his links to the pharmaceutical industry and fears he would not act aggressively enough to stop the opioid epidemic.

The White House was counting on six Republicans to move the Caliph through the finish line after five Democrats voted against the president Joe Bidennominee. The final vote was 50-46 for Caliph.

“Dr. Caliph is a highly qualified candidate with bipartisan support,” said Senator Richard Baer, ​​a senior Republican on the Senate Health Committee, ahead of the vote Tuesday.

Caliph is a renowned cardiologist with extensive clinical research experience who served as FDA Commissioner during his last year as President Barack Obama. Biden said Caliph will be a steady arm of the FDA as the drug regulator faces urgent decisions on Coronavirus covid infection vaccines, therapeutic agents and tests to combat the pandemic.

Caliph’s confirmation came more than a year after Biden took office. Dr. Janet Woodcock, an agency veteran with three decades, last year served as commissioner, and the FDA gradually lowered the age for PfizerThe vaccine allowed revaccination and approved two major antiviral drugs to treat patients with Covid.

Although the White House viewed Woodcock for a permanent role, she faced opposition on Capitol Hill. Woodcock ran the FDA’s Center for Drug Evaluation and Research when prescription opioids, including OxyContin, were approved in the 1990s.

In a December letter to the Senate Health Committee, six former FDA chiefs said the annual absence of an approved commissioner had hampered the drug regulator’s ability to fulfill its mandate. They endorsed Caliph as a man who has the experience to immediately play an effective leadership role during a crisis.

“Dr. Caliph’s reaffirmation is crucial not only to go beyond the Covid-19 emergency, but also to help meet many other major FDA regulatory obligations, where the Senate reaffirmed that leadership is important to the nation’s well-being,” they wrote. ry. Scott Gottlieb, Stephen Hahn and four other former commissioners.

However, the nomination of Caliph was not without controversy, the opposition was several members of Biden’s own party.

Senator Bernie Sanders, I-Vt., Criticized Caliph for possessing millions of dollars in pharmaceutical stocks, accusing him of involvement in a coup between industry and the FDA.

Caliph is a senior advisor at Google Health and Verily, the life sciences department Alphabet. He was earning $ 2.7 million and up to $ 5 million in shares of Verily, according to the ethics disclosure form. Caliph is a member of the board of directors Centessa Pharmaceuticals and a biopharmaceutical company Cytokinetics. He owns up to $ 5 million in uninvested shares of Centessa and owns hundreds of thousands of dollars in shares of Cytokinetics. Caliph also has supplies Amgen, Gilead sciences and Bristol Myers Squib.

Caliph said he would retire from Verily, Centessa and Cytokinetics after confirmation and get rid of his pharmaceutical stocks within 90 days.

Senators Joe Manchin, DW.Va., and Maggie Hassan, DN.H., opposed Caliph’s nomination compared to his previous FDA leadership during the Opioid Crisis. The number of overdose deaths from all opioids increased by 12% to more than 47,000 during Caliph’s tenure as commissioner from 2016 to 2017, while the death rate from prescription opioids remained high: more than 17,000 people overdosed. according to the Centers for Disease Control and Prevention.

Last week, Manchin called on Biden to withdraw Caliph’s candidacy, saying he “failed to resolve the crisis in any significant way” and would not make the changes needed by the FDA to fight opioids, which have hit West Virginia particularly hard.

“We need a new, committed leadership that understands the seriousness of the drug epidemic and will fight the greed of the pharmaceutical industry,” Manchin wrote with Sen. Mike Brown, R-Ind., In an article published in USA Today. . In a statement last month, Hassan said he “does not seem to be any different” under Caliph’s leadership.

As FDA’s deputy commissioner for medical products, Caliph announced a revision of the regulator’s opioid policy on drugs. However, Manchin criticized Caliph for FDA approval of three new opioids during his tenure as agency commissioner.

During the nomination hearings, Caliph acknowledged the FDA’s failure when it approved OxyContin in 1995 without long-term research or evaluation of drug addiction. He said the FDA should look closely at the labeling of opioids to warn that they are not intended for long-term use.

“I think we need to learn from everything that has happened to us over the last few decades and re-evaluate where we are today,” Caliph said. “Because everything we’ve done so far is not enough. It will take all hands on deck, and in particular the FDA must redouble its efforts to train prescribing physicians.”

According to the CDC, in 2020, a record number of Americans died from opioid overdoses, more than 68,000 people. More than 500,000 Americans have reported deaths from opioid overdoses since 1999.

Lawmakers have also pressured Caliph regarding his position on the speedy FDA approval process for drugs that can help patients with serious illnesses in which there are no other treatment options. Woodschnep faced a reaction to the accelerated assertion BiogenAlzheimer’s disease cure in June after a report revealed that company executives had met with FDA officials outside official channels. The Acting Commissioner requested the Inspector General of the investigation in connection with the approval of the drug Biogen for Alzheimer’s disease.

Earlier this month, Oregon Sen. Ron Wyden said in a letter that some companies took advantage of the expedited process, while the FDA shied away from using its powers to punish those who abuse the procedure. Caliph in his reply letter stated that he would work with Congress to close the gaps in accountability.

During the nomination hearings, Caliph said the American people want earlier access to drugs that could potentially treat life-threatening illnesses. However, he acknowledged that the accelerated process is inherently uncertain, and the FDA needs to better monitor the effectiveness of drugs that were approved early.

“We need to have a better system for evaluating these products when they are used in the market,” Caliph told the Senate Health Committee in December.

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Senate confirms BDA caliph’s choice, despite objections to pharmaceutical industry ties

Robert Calif testified during a hearing in the Senate Health, Education, Labor and Pensions Committee on his nomination as Commissioner of the Office of Food and Drug Administration on Tuesday, December 14, 2021.

Bill Clark CQ-Roll Call, Inc. | Getty Images

On Tuesday, the Senate narrowly confirmed Dr. Robert Caliph as commissioner of the Office of Food and Drug Administration because of objections to his links to the pharmaceutical industry and fears he would not act aggressively enough to stop the opioid epidemic.

The White House was counting on six Republicans to move the Caliph through the finish line after five Democrats voted against the president Joe Bidennominee. The final vote was 50-46 for Caliph.

“Dr. Caliph is a highly qualified candidate with bipartisan support,” said Senator Richard Baer, ​​a senior Republican on the Senate Health Committee, ahead of the vote Tuesday.

Caliph is a renowned cardiologist with extensive clinical research experience who served as FDA Commissioner during his last year as President Barack Obama. Biden said Caliph will be a steady arm of the FDA as the drug regulator faces urgent decisions on Coronavirus covid infection vaccines, therapeutic agents and tests to combat the pandemic.

Caliph’s confirmation came more than a year after Biden took office. Dr. Janet Woodcock, an agency veteran with three decades, last year served as commissioner, and the FDA gradually lowered the age for PfizerThe vaccine allowed revaccination and approved two major antiviral drugs to treat patients with Covid.

Although the White House viewed Woodcock for a permanent role, she faced opposition on Capitol Hill. Woodcock ran the FDA’s Center for Drug Evaluation and Research when prescription opioids, including OxyContin, were approved in the 1990s.

In a December letter to the Senate Health Committee, six former FDA chiefs said the annual absence of an approved commissioner had hampered the drug regulator’s ability to fulfill its mandate. They endorsed Caliph as a man who has the experience to immediately play an effective leadership role during a crisis.

“Dr. Caliph’s reaffirmation is crucial not only to go beyond the Covid-19 emergency, but also to help meet many other major FDA regulatory obligations, where the Senate reaffirmed that leadership is important to the nation’s well-being,” they wrote. ry. Scott Gottlieb, Stephen Hahn and four other former commissioners.

However, the nomination of Caliph was not without controversy, the opposition was several members of Biden’s own party.

Senator Bernie Sanders, I-Vt., Criticized Caliph for possessing millions of dollars in pharmaceutical stocks, accusing him of involvement in a coup between industry and the FDA.

Caliph is a senior advisor at Google Health and Verily, the life sciences department Alphabet. He was earning $ 2.7 million and up to $ 5 million in shares of Verily, according to the ethics disclosure form. Caliph is a member of the board of directors Centessa Pharmaceuticals and a biopharmaceutical company Cytokinetics. He owns up to $ 5 million in uninvested shares of Centessa and owns hundreds of thousands of dollars in shares of Cytokinetics. Caliph also has supplies Amgen, Gilead sciences and Bristol Myers Squib.

Caliph said he would retire from Verily, Centessa and Cytokinetics after confirmation and get rid of his pharmaceutical stocks within 90 days.

Senators Joe Manchin, DW.Va., and Maggie Hassan, DN.H., opposed Caliph’s nomination compared to his previous FDA leadership during the Opioid Crisis. The number of overdose deaths from all opioids increased by 12% to more than 47,000 during Caliph’s tenure as commissioner from 2016 to 2017, while the death rate from prescription opioids remained high: more than 17,000 people overdosed. according to the Centers for Disease Control and Prevention.

Last week, Manchin called on Biden to withdraw Caliph’s candidacy, saying he “failed to resolve the crisis in any significant way” and would not make the changes needed by the FDA to fight opioids, which have hit West Virginia particularly hard.

“We need a new, committed leadership that understands the seriousness of the drug epidemic and will fight the greed of the pharmaceutical industry,” Manchin wrote with Sen. Mike Brown, R-Ind., In an article published in USA Today. . In a statement last month, Hassan said he “does not seem to be any different” under Caliph’s leadership.

As FDA’s deputy commissioner for medical products, Caliph announced a revision of the regulator’s opioid policy on drugs. However, Manchin criticized Caliph for FDA approval of three new opioids during his tenure as agency commissioner.

During the nomination hearings, Caliph acknowledged the FDA’s failure when it approved OxyContin in 1995 without long-term research or evaluation of drug addiction. He said the FDA should look closely at the labeling of opioids to warn that they are not intended for long-term use.

“I think we need to learn from everything that has happened to us over the last few decades and re-evaluate where we are today,” Caliph said. “Because everything we’ve done so far is not enough. It will take all hands on deck, and in particular the FDA must redouble its efforts to train prescribing physicians.”

According to the CDC, in 2020, a record number of Americans died from opioid overdoses, more than 68,000 people. More than 500,000 Americans have reported deaths from opioid overdoses since 1999.

Lawmakers have also pressured Caliph regarding his position on the speedy FDA approval process for drugs that can help patients with serious illnesses in which there are no other treatment options. Woodschnep faced a reaction to the accelerated assertion BiogenAlzheimer’s disease cure in June after a report revealed that company executives had met with FDA officials outside official channels. The Acting Commissioner requested the Inspector General of the investigation in connection with the approval of the drug Biogen for Alzheimer’s disease.

Earlier this month, Oregon Sen. Ron Wyden said in a letter that some companies took advantage of the expedited process, while the FDA shied away from using its powers to punish those who abuse the procedure. Caliph in his reply letter stated that he would work with Congress to close the gaps in accountability.

During the nomination hearings, Caliph said the American people want earlier access to drugs that could potentially treat life-threatening illnesses. However, he acknowledged that the accelerated process is inherently uncertain, and the FDA needs to better monitor the effectiveness of drugs that were approved early.

“We need to have a better system for evaluating these products when they are used in the market,” Caliph told the Senate Health Committee in December.

Reported by Source link

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