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…
Live Blog: The FDA Advisory Panel On IMPROVE-IT
December 14, 2015 by 1 Comment
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…
Report Finds Problems With FDA Mandated Postapproval Device Studies
November 16, 2015 by Leave a Comment
As a condition of approval FDA often requires manufacturers of medical devices to perform postapproval studies. Now a General Accounting Office (GAO) audit [PDF] finds that, among other problems, many studies remain unfinished for a great many years. In addition, digging on its own into the FDA database of postapproval studies, The Gray Sheet, a device industry newsletter, focused…
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…
Amarin Begins Legal Off-Label Promotion Of Vascepa
September 10, 2015 by 4 Comments
Barely a month after a big victory in a federal court over the FDA, Amarin Pharma has started off-label promotion of Vascepa, its much-disputed prescription fish-oil product, Medical Marketing & Media reports. Vascepa was first approved by the FDA in 2012 as as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG > 500mg/dL),…
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…
FDA Approves Repatha, Amgen’s PCSK9 Inhibitor
August 27, 2015 by Leave a Comment
Late on Thursday Amgen announced that the FDA had approved its highly anticipated and much debated PCSK9 inhibitor, Repatha (evolocumab). The drug will be the second PCSK9 inhibitor on the market, following the approval last month of Sanofi’s and Regeneron’s Praluent (alirocumab). In a press release the FDA said Repatha “is approved for use in addition to diet…
FDA Approval Of Second PCSK9 Inhibitor Expected Soon
August 24, 2015 by 1 Comment
The FDA has until Thursday, August 27 to make its decision about Repatha (evolocumab), Amgen’s much anticipated cholesterol lowering PCSK9 inhibitor. The drug is widely expected to gain approval. Last month the FDA approved Praluent (alirocumab), Sanofi’s and Regeneron’s similar drug. Beyond approval the major questions that should be answered this week concern the drug’s label…
The Amarin Decision: Free Speech Or Truthiness?
August 11, 2015 by 7 Comments
Amarin, which makes the prescription fish oil product Vascepa, won a big victory last Friday in its ongoing battle against the FDA. The bottom line: a federal judge ruled that the FDA can’t restrict Amarin’s first amendment right to disseminate off-label information about Vascepa providing it is neither false nor misleading. (You can read a detailed description…
Novartis Heart Failure Drug Gains Speedy FDA Approval
July 7, 2015 by Leave a Comment
Entresto, Novartis’s novel heart failure (HF) drug, gained FDA approval earlier today. The approval arrived 6 weeks ahead of the drug’s action date. Formerly known as LCZ 696, the drug had already received a fast track designation and an expedited review under the FDA’s priority review program.Novartis said the wholesale acquisition cost of Entresto will be $12.50 per day, less discounts….
Steven Nissen, Conflicts Of Interest, And The New Cholesterol Drugs
June 12, 2015 by 6 Comments
(Updated) Does Steve Nissen, an outspoken critic of inappropriate industry influence in medicine, have his own conflict of interest problem? This week Nissen, the chief of cardiology at the Cleveland Clinic, was widely quoted in news reports about the FDA advisory panels evaluating two new highly promising cholesterol drugs from Amgen and Sanofi/Regeneron. Nissen was broadly supportive of the drugs….
Novartis’ Summer Blockbuster LCZ696 Gains A Name, Skips An Advisory Panel
May 22, 2015 by Leave a Comment
Entresto. That’s the brand name Novartis has chosen for LCZ696, its new heart failure drug that is expected to be a blockbuster. The name won’t be final until official confirmation, which comes with FDA approval. But Novartis will introduce the name for the first time this weekend in presentations at the European Society of Cardiology Heart Failure meeting in Seville, Spain. FDA approval of Entresto is expected…
Diet Drug Study Crashes And Burns In The Wake Of Leaked Results
May 12, 2015 by Leave a Comment
The ill-fated Light trial, which was supposed to examine the cardiovascular outcomes of the weight loss drug Contrave, a combination of naltrexone and bupropion marketed by Orexigen and Takeda, came to a spectacular halt today. The action was probably inevitable given the extreme controversy generated earlier this year when it became known that Orexigen had widely disseminated results from an early…
Secret Letter To Doctors Shows That The Amarin Lawsuit Is About Marketing, Not Free Speech
May 8, 2015 by Leave a Comment
A confidential letter sent by top Amarin executives to doctors clearly demonstrates that the primary motive for the lawsuit the company filed yesterday against the FDA has far more to do with marketing than free speech. Amarin said it is suing the FDA to gain the right to disseminate information about Vascepa that would support use…
Cardiovascular Outcomes With Merck’s Januvia: No Better Or Worse Than Conventional Care
April 27, 2015 by Leave a Comment
Late Monday afternoon Merck released the top line results of TECOS, the cardiovascular outcomes trial with its blockbuster diabetes drug Januvia (sitagliptin). The company said that the trial “achieved its primary endpoint of non-inferiority for the composite cardiovascular (CV) endpoint.” Merck announced only one additional detail: “Among secondary endpoints,” they reported, “there was no increase in hospitalization for…
Diabetes Drugs Get Neither Restrictions Nor Endorsements From FDA Committee
April 14, 2015 by Leave a Comment
Two diabetes drugs survived a meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Tuesday. Rejecting recommendations from critics that the drugs should either be withdrawn or get new restrictions on use, the committee voted against any harsh measures, recommending only that information from two neutral clinical trials with the drugs be added to the drugs’ labels….
FDA Grants Premarket Approval To AbioMed Heart Pump
March 24, 2015 by Leave a Comment
The FDA said today that it had approved Abiomed’s Impella 2.5 System. According to the company it is is the first hemodynamic support device to gain FDA premarket approval for use during high risk PCI procedures. The miniature blood pump is designed for temporary use in patients with severe symptomatic coronary artery disease and diminished (but stable) heart…
Orexigen ‘Crying All The Way To The Bank’ After ‘Egregiously Unethical’ Actions
March 5, 2015 by Leave a Comment
On Tuesday morning the members of the Data Monitoring Committee of Orexigen’s Light study began a planned meeting in a hotel in Chicago. They had no way of knowing that in a few hours their routine duties would be completely interrupted by the news that data from the trial– which they thought was known only to…
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