–Approvals with no strong evidence of efficacy: What could go wrong? The FDA has a big problem. It likes to approve new drugs and devices. Approvals look good politically and allow the FDA to boast each year about their large number of approvals. But when the FDA approves a drug or device that doesn’t work…
At the FDA Rob Califf Will Champion Clinical Trials
February 25, 2016 by 4 Comments
Everyone wants to know what Rob Califf is going to do at the FDA. His critics say he’s going to hand the car keys over to industry and allow them to drive the agenda. Or, as one reporter tweeted: Hey, is that the sound of the FDA approving things faster? Must be because the Senate…
FDA Announces Sweeping Changes In Approach To Opioid Drugs
February 4, 2016 by Leave a Comment
The FDA announced today that it planned sweeping changes in its approach to opioids drugs. The move comes in response to growing concerns over abuse of prescription opioids in the US and escalating criticism of the FDA’s lackluster response to the problem. Two US Senators have said they would oppose President Obama’s nomination of Robert…
Four Senators Now Oppose Califf Nomination To Head The FDA
January 25, 2016 by Leave a Comment
(Updated on January 26 and January 27) US Senator Edward Markey, a Democrat from Massachusetts, is seeking to block Rob Califf’s nomination to head the FDA, according to a report in the Boston Globe. Markey will use Senate rules to place a hold on the nomination. In September President Obama nominated Califf, a well-known Duke…
ROCKET-AF Investigators Seek To Calm Concerns About Trial Reliability
December 13, 2015 by Leave a Comment
(Updated) In response to disturbing questions about the integrity and reliability of crucial data in the ROCKET AF trial, the executive committee of the trial has released a statement saying that they have “conducted a secondary analysis of the trial findings” and that “the findings from the analysis are consistent with the results from the original trial and do not…
New Questions Raised About ROCKET AF, Pivotal Xarelto Trial Chaired By Califf
November 30, 2015 by 1 Comment
(Updated) Disturbing questions are being raised about the integrity and reliability of crucial data in the ROCKET AF trial. The investigation could have important implications on several fronts. First, the trial serves as the basis for the use of the blockbuster drug rivaroxaban (Xarelto, Johnson & Johnson) for stroke prevention in atrial fibrillation. Second, the…
A Few Observations About Rob Califf’s Picnic With The US Senate
November 17, 2015 by Leave a Comment
I’m no expert on Washington politics but judging from the senate committee hearing today Rob Califf is going to be the next FDA commissioner. With the exception of Bernie Sanders, who had already announced his opposition, the committee members treated Califf with kid gloves. [Click here to read my live blog of the hearing.] Lamar…
Live Blog: Senate Hearing On Rob Califf’s Nomination For FDA Commissioner
November 17, 2015 by 1 Comment
12:00 Hearing adjourned. It sure looks like Rob Califf will be our next FDA commissioner. 11:58 Scott asks about the high rate of heart disease and diabetes in South Carolina. The high cost of trials is preventing cures for these diseases. Califf asks how many hours he has to answer the question. Califf notes we have…
Possible Setback For Califf On Road To FDA
October 7, 2015 by Leave a Comment
Rob Califf may have just run into his first serious roadblock on his path to become the FDA’s next commissioner. According to a report in the Boston Globe, Califf removed his name as a co-author from a series of papers, some of which were critical of current FDA policy. Until now Califf’s nomination has not encountered a…
Why Rob Califf Running The FDA May Be Like Nixon In China
September 17, 2015 by 1 Comment
(Updated)– There’s a widespread belief that only a conservative like Nixon could have opened up US relations with China. Any attempt by a Democrat to do the same would have been political suicide, but for Nixon it was politically feasible, and today it is recognized as one of his very few untarnished genuine achievements. I want to suggest that…
President Obama Nominates Cardiologist Rob Califf To Lead FDA
September 15, 2015 by 1 Comment
The White House announced on Tuesday that it was going to nominate Duke University cardiologist Rob Califf to serve as the next Commissioner of the FDA. The nomination had been widely expected since his appointment in January as the FDA Deputy Commissioner for Medical Products and Tobacco. Before going to the FDA Califf had most…
Califf, Nissen, And Others Agree And Disagree About Regulatory Standards
September 1, 2015 by 1 Comment
Everyone agrees. A panel of US and European cardiologists, regulators, and industry executives agreed broadly that regulatory standards for drugs and devices need to be rigorous enough to prevent harm to patients. And, they also agreed, the standards shouldn’t be so strict that they stifle innovation. The problem, of course, is how to find the right…
Califf To Leave Duke To Become FDA Deputy Commissioner
January 26, 2015 by Leave a Comment
The FDA announced today that Duke University cardiologist Robert Califf will be the next FDA Deputy Commissioner for Medical Products and Tobacco. The agency said that Califf will be responsible for the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco…
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