Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Republican Maneuver May Clear the Way for Califf Approval for Top FDA Job

Republican Maneuver May Clear the Way for Califf Approval for Top FDA Job | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a move designed to circumvent opposition to Califf, who was nominated in September, Senate Majority Leader Mitch McConnell has scheduled a procedural vote for Monday afternoon. If Califf wins the support of at least 60 senators in that vote, he would move on to a final confirmation vote — likely Tuesday — and his Senate opponents would lose their leverage to stop him.


The move will likely vanquish the remaining senators — led by Democrats Bernie Sanders of Vermont, Edward Markey of Massachusetts, and Joe Manchin of West Virginia — who disapprove of Califf because of his close ties to industry and what they consider a poor FDA response to the opioid epidemic.

 

Califf joined the FDA as a deputy commissioner in February 2015 after many years working at Duke University.


Pharma Guy's insight:

When Califf assumes the position of FDA Commish, will he be like to back a plan by his former Duke colleagues and implement their plan to open the off-label drug promotion floodgates? For more on that, read "Duke Chimes in on Off-Label Drug Promotion"; http://bit.ly/dukeofflabel 

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Another Senator Vows to Block Califf Nomination for #FDA Commish

Another Senator Vows to Block Califf Nomination for #FDA Commish | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Yet another senator throws a shoe at Robert Califf, the shoo-in candidate for FDA Commissioner.


Sen. Edward Markey (D-Mass.) says he's blocking the nomination of Dr. Robert Califf to be commissioner of the Food and Drug Administration until the agency makes reforms to its approval process for opioid painkillers.


Markey said Monday he put a hold on Califf, whose nomination cleared the Senate Health Committee earlier this month and was headed to the floor for a vote.


Markey is upset with the FDA’s decision last year to approve the use of OxyContin to treat children as young as 11 years old. He called on the agency to commit to holding advisory committees before approving such painkillers in the future.


“While people in every community across the country are dying every day from opioid overdoses, the FDA continues to operate as if safety just means the right dose when it should include all the dangers of these painkillers,” he said in a statement.


“Expert after expert has warned about the real world dangers of abuse of and dependence on these new supercharged opioid painkillers, but the FDA has willfully blinded itself to the warning signs.

Pharma Guy's insight:

Read:

  • "FDA Officials - Including Commish Nominee Califf - Colluded with Device Industry to Draft "Cures" Legislation"; http://sco.lt/7feuEz 
  • "Bernie Sanders to Robert Califf: 'You're Not the One'."; http://sco.lt/5yQxqT 
  • "NYT Has Questions for President Obama’s Nominee to lead the F.D.A."; http://sco.lt/9LrfNp 
  • "Califf Removes His Name as Author of Scientific Paper Critical of FDA"; http://sco.lt/8dwRer 


Public Citizen said: "It should be unimaginable that the most senior Food and Drug Administration (FDA) officials would collude with the lead medical device trade association to write legislation to weaken the agency’s regulatory oversight and approval standards for medical devices. But that is exactly what appears to have happened. The result is contained within the House-passed 21st Century Cures Act – more accurately known as the False Cures Act – which would eviscerate the already far-too-weak safety rules for medical devices."; http://bit.ly/1lUzR4I

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Senate Committee Clears Califf But Bernie Sanders May Throw Shoe

Senate Committee Clears Califf But Bernie Sanders May Throw Shoe | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Two senators, including presidential candidate Bernie Sanders, threatened to hold up his nomination.


The Senate Health, Education, Labor and Pensions Committee on Tuesday voted unanimously in favor of Dr. Robert Califf to become commissioner of the FDA. Two senators have threatened to block the former Duke cardiologist's nomination, however. 


Sen. Lisa Murkowski (R-Ala.) said she would hold up a vote on the Senate floor, the next and final step in Califf's nomination, until the FDA addresses her concerns about the labeling of genetically modified salmon. 


Sen. Bernie Sanders(I-Vt.), too, opposes the nomination and is considering a hold—he has cited Califf's ties to the pharmaceutical industry, particularly his work as a consultant for drugmakers. Sanders was not present at the committee hearing. Open Payments data show that Califf received over $29,000 in consulting fees, food and travel from drugmakers in 2014.

Pharma Guy's insight:

Read:

  • "FDA Officials - Including Commish Nominee Califf - Colluded with Device Industry to Draft "Cures" Legislation"; http://sco.lt/7feuEz 
  • "Bernie Sanders to Robert Califf: 'You're Not the One'."; http://sco.lt/5yQxqT 
  • "NYT Has Questions for President Obama’s Nominee to lead the F.D.A."; http://sco.lt/9LrfNp 
  • "Califf Removes His Name as Author of Scientific Paper Critical of FDA"; http://sco.lt/8dwRer 


Public Citizen said: "It should be unimaginable that the most senior Food and Drug Administration (FDA) officials would collude with the lead medical device trade association to write legislation to weaken the agency’s regulatory oversight and approval standards for medical devices. But that is exactly what appears to have happened. The result is contained within the House-passed 21st Century Cures Act – more accurately known as the False Cures Act – which would eviscerate the already far-too-weak safety rules for medical devices."; http://bit.ly/1lUzR4I

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Califf a "Shoe-in" to be Approved for FDA Commish

Califf a "Shoe-in" to be Approved for FDA Commish | Pharmaguy's Insights Into Drug Industry News | Scoop.it
He has been trying to satisfy Democratic concerns that he's too close to pharmaceutical companies.


He has had to spend time addressing concerns from Democratic committee members — especially Senator Bernie Sanders of Vermont, the presidential candidate, and Senator Elizabeth Warren of Massachusetts. They’ve grilled Califf on his close ties to pharmaceutical companies and the impact of their funding on research he oversaw at Duke. Sanders, who has been out on the campaign trail, isn’t expected to show up for the vote.


In written responses to follow-up questions from Warren, Califf said he and his Duke Center did not permit its pharmaceutical industry funders to influence the outcome of the studies — although he acknowledged their input into the design.


Read:

  • "FDA Officials - Including Commish Nominee Califf - Colluded with Device Industry to Draft "Cures" Legislation"; http://sco.lt/7feuEz 
  • "Bernie Sanders to Robert Califf: 'You're Not the One'."; http://sco.lt/5yQxqT 
  • "NYT Has Questions for President Obama’s Nominee to lead the F.D.A."; http://sco.lt/9LrfNp 
  • "Califf Removes His Name as Author of Scientific Paper Critical of FDA"; http://sco.lt/8dwRer 


Public Citizen said: "It should be unimaginable that the most senior Food and Drug Administration (FDA) officials would collude with the lead medical device trade association to write legislation to weaken the agency’s regulatory oversight and approval standards for medical devices. But that is exactly what appears to have happened. The result is contained within the House-passed 21st Century Cures Act – more accurately known as the False Cures Act – which would eviscerate the already far-too-weak safety rules for medical devices."; http://bit.ly/1lUzR4I

 

Pharma Guy's insight:

Remember when FDA Commissioner Andrew von Eschenbach was announced that he planned to resign as FDA commish in 2009? A disgruntled FDA staffer rose abruptly from his seat about 12 feet away, reared his right arm and fired a shoe at the commissioner’s head while shouting: “This is a gift from the entire FDA staff; this is the farewell kiss, you dog!”; http://bit.ly/1E74Dv 

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Califf Is Not the Person to Lead FDA, Says Bernie Sanders

Califf Is Not the Person to Lead FDA, Says Bernie Sanders | Pharmaguy's Insights Into Drug Industry News | Scoop.it

“At a time when millions of Americans cannot afford to purchase the prescription drugs they need, we need a new leader at the FDA who is prepared to stand up to the pharmaceutical companies and work to substantially lower drug prices. Unfortunately, I have come to the conclusion that Dr. Califf is not that person,” Sanders said after speaking with the nominee. Califf’s confirmation will come before the Senate health committee, which Sanders sits on.

Pharma Guy's insight:

Califf says his salary is contractually underwritten in part by several large pharmaceutical companies, including Merck, Bristol-Myers Squibb, Eli Lilly and Novartis. He also receives as much as $100,000 a year in consulting fees from some of those companies, and from others, according to his 2014 conflict of interest disclosure [pdf]. In an interview with TIME, Califf estimates that less than half of his annual income comes from research money provided by the pharmaceutical industry, though he says he is not certain because he doesn’t tend to distinguish between industry and government research funding. http://bit.ly/1L3DUno 

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Dr. Robert Califf - Despite "Thicket of Conflicts" - Nominated to Be Head of FDA

Dr. Robert Califf - Despite "Thicket of Conflicts" - Nominated to Be Head of FDA | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Dr. Robert Califf, a current deputy commissioner, spent decades at Duke University and is not expected to face serious opposition in his Senate confirmation.


The post requires Senate confirmation, but Dr. Califf, who has had a distinguished academic career, much of it at Duke, is not expected to face serious opposition.


“He is the consensus choice of an academic-industry nexus that is increasingly centered at Duke,” said Daniel Carpenter, a Harvard University political scientist who studies the F.D.A. He said the pharmaceutical industry had farmed out a significant amount of research and clinical trials to Duke. This is common practice in the drug world, but Professor Carpenter said it could have shaped Dr. Califf’s approach. “Many will worry that he has little public health experience,” Professor Carpenter said.



Pharma Guy's insight:

Califf was hand-chosen by Hamburg as the FDA Deputy Commissioner for Medical Products and Tobacco, which several FDA and industry insiders took as a signal that he would be Hamburg's even- tual successor despite “a thicket of conflicts of interest,” according to some.


Here’s what investigative health reporter Martha Rosenberg had to say about Califf’s conflicts in a CounterPunch article:


“A disclosure statement on the website of Duke Clinical Research Institute says ‘Robert M. Califf, MD, reports receiving research grant support from Novartis Pharmaceuticals, Johnson & Johnson/Scios, Lilly, Merck, and Schering Plough, and consulting fees from Annenberg, Aterovax, Bayer/Ortho McNeil, BMS, Boehringer Ingelheim, GSK, WebMd/theheart.org, Johnson and Johnson/Scios, Kowa Research Institute, McKinsey & Company, Medtronic, Merck, Novartis Pharmaceuticals, Sanofi Aventis, and Schering Plough, and has an equity position with NITROX, LLC.’


“In disclosure information for a 2013 article in Circulation, Dr. Califf’s also lists financial links to Gambro, Regeneron, Gilead, AstraZeneca, Roche, others companies and equity positions in four medical companies. The medical website Medscape discloses that Dr. Califf “served as a director, officer, partner, employee, advisor, consultant or trustee for Genentech” as well as for Medscape LLC/theheart.org. Portola Pharmaceuticals says Dr. Califf served on the Board of Directors until he was appointed FDA Deputy Commissioner for Medical Products and T obacco.”


Dr. Califf was a contender for Dr. Hamburg’s job in 2008 and the Pharma Marketing News reader poll showed he was a favorite among voters who were supportive of the drug industry. Read more about that in this Pharma Marketing News article: http://bit.ly/pmn140202p 

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Should This Person, Half of Whose Salary is Paid by Big Pharma, Be a Candidate to Lead FDA?

Should This Person, Half of Whose Salary is Paid by Big Pharma, Be a Candidate to Lead FDA? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Last May, Duke University’s Vice Chancellor for clinical research, Dr. Robert Califf, told an audience of executives that the American system for developing drugs and medical devices was in crisis. Using slides [pdf] developed by Duke’s business school, he said the system was too slow and too expensive, and required disruption and transformation. Towards the end of his talk, he put up a slide that identified a key barrier to change: regulation.


Such views are not uncommon in industry, academic research and on Capitol Hill, but they are noteworthy coming from Califf because he could soon be America’s top regulator overseeing the safety and efficacy of the country’s drugs and medical devices. Califf is already set to become deputy commissioner at the Food and Drug Administration (FDA) next month. Now sources familiar with the process tell TIME he is on President Barack Obama’s short list to run the agency following this month’s announcement that its long-serving commissioner, Margaret Hamburg, will step down in March.


The White House declined to comment on pending personnel decisions, but word that Califf is in contention for the top spot at the FDA comes at a key moment. The agency faces potentially dramatic changes this year as Congress prepares to rewrite many of the rules for how drugs and medical devices are reviewed and tested for safety and efficacy. Califf is widely respected in the public and private sectors, but his candidacy is seen by some as a threat to the independence and authority of the FDA, thanks to his views on the need to accelerate change and his deep financial and intellectual ties to the pharmaceutical and medical device industries.

Califf says his salary is contractually underwritten in part by several large pharmaceutical companies, including Merck, Bristol-Myers Squibb, Eli Lilly and Novartis. He also receives as much as $100,000 a year in consulting fees from some of those companies, and from others, according to his 2014 conflict of interest disclosure [pdf]. In an interview with TIME, Califf estimates that less than half of his annual income comes from research money provided by the pharmaceutical industry, though he says he is not certain because he doesn’t tend to distinguish between industry and government research funding. He says he is divesting his holdings in two privately-held pharmaceutical companies he helped get off the ground.

Pharma Guy's insight:


In a new survey, Pharma Marketing News asks your opinion about who should be the next FDA commissioner. The survey has been seeded with the candidates mentioned in this article. You can choose one of these or enter your own choice.



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Hand-chosen by Hamburg, Robert Califf, M.D. May Be Next FDA Commish: His Many Ties to #Pharma

Hand-chosen by Hamburg, Robert Califf, M.D. May Be Next FDA Commish: His Many Ties to #Pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it
FDA Commissioner Hamburg Appointed WHO Deputy?


Many had high hopes for the FDA when Margaret Hamburg was confirmed as Commissioner in 2009 because of her public health background. But she swiftly moved to loosen conflict of interest rules governing those who can serve on FDA expert advisory panels, claiming it was too hard to find experts without Pharma financial links.


Her move followed a Philadelphia Inquirer reporter’s revelations that child psychiatrist Jorge Armenteros, a paid consultant to AstraZeneca, was on an FDA committee voting on–any guesses?–the AstraZeneca drug Seroquel.


Last month, more questions about embedded conflicts of interest at the FDA were raised when Commissioner Hamburg appointed Robert Califf, M.D., chancellor of clinical and translational research at Duke University, as the next FDA Deputy Commissioner for Medical Products and Tobacco despite a thicket of conflicts of interest. It was one of her last official acts before announcing her resignation last week.

A disclosure statement on the website of Duke Clinical Research Institute says “Robert M. Califf, MD, reports receiving research grant support from Novartis Pharmaceuticals, Johnson & Johnson/Scios, Lilly, Merck, and Schering Plough, and consulting fees from Annenberg, Aterovax, Bayer/Ortho McNeil, BMS, Boehringer Ingelheim, GSK, WebMd/theheart.org, Johnson and ohnson/Scios, Kowa Research Institute, McKinsey & Company, Medtronic, Merck, Novartis Pharmaceuticals, Sanofi Aventis, and Schering Plough, and has an equity position with NITROX, LLC.”


In disclosure information for a 2013 article in CirculationDr. Califf’s also lists financial links to Gambro, Regeneron, Gilead, AstraZeneca, Roche, others companies and equity positions in four medical companies. The medical website Medscape discloses that Dr. Califf “served as a director, officer, partner, employee, advisor, consultant or trustee for Genentech” as well as for Medscape LLC/theheart.org. Portola Pharmaceuticals says Dr. Califf served on the Board of Directors until he was appointed FDA Deputy Commissioner for Medical Products and Tobacco.


Appearing on PBS with Susan Dentzer after Vioxx was withdrawn because of its links to thousands of heart attacks and stroke, Dr. Califf said, “Merck played by the rules from everything that I’ve seen.” He also said, “many of us consult with the pharmaceutical industry, which I think is a very good thing. They need ideas and then the decision about what they do is really up to the person who is funding the study.”


This is not the first time Dr. Califf’s extreme Pharma links have not blocked him from consideration for a top government post. He was up for Dr. Hamburg’s job itself, reported Reuters along with three others (see chart). At the time, some medical voices asked how someone who helps drug companies market their products could possibly be considered as thenation’s chief watchdog over unsafe medications.

Pharma Guy's insight:


Hamburg became FDA commissioner on May 18, 2009. She wasn't on anybody's radar when I surveyed Pharma Marketing News readers about who the next FDA Commissioner would be back in the fall of 2008!


Robert Califf, however, was at the time one of the contenders for the job. As seen in the chart above, Califf was favored by the drug industry .


I'm doing the survey again: Who Will Be the Next FDA Commissioner?


  • Robert Califf, M.D. (Professor of Cardiology at the Duke University School of Medicine)
  • Steve Nissen, M.D. (chairman of cardiovascular medicine at the Cleveland Clinic)
  • Stephen Ostroff, M.D. (Chief Scientist at FDA & designated acting commissioner)
  • Janet Woodcock, M.D. (anet Woodcock, M.D., Director, Center for Drug Evaluation and Research)
  • Susan F. Wood (Director, Jacobs Institute of Women’s Health)
  • None of the above
You tell me: Take the Survey Now
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Curated by Pharma Guy
Pharmaguy™ (@pharmaguy) is a "constructive critic" of the pharmaceutical industry. He is not shy about giving his opinion, which is respected by many insiders who share some of his views but who are unable to voice them on their own. See pharmaguy.com