–Shifting the burden of proof from preapproval to postapproval. The new FDA commissioner Scott Gottlieb is quietly and persistently revamping the FDA to make it easier for drug and device companies to get their products on the market. The news, which is being welcomed by industry, also almost certainly means that more people will be…
Barely Half of Postmarket Studies Completed After 5 Years
September 20, 2017 by Leave a Comment
–FDA fails to enforce requirements. Pharmaceutical and device companies are often taking advantage of a lenient (or, some would say, negligent) FDA to shirk their obligation to perform timely post-approval studies, a new Perspective published in the New England Journal of Medicine shows. The topic has gained increasing visibility and importance as the FDA has…
Cardiac Stem Cell Therapies May Get Boost From New FDA
September 14, 2017 by 1 Comment
–The FDA may not require companies to prove that stem cell therapies are safe and effective prior to approval. Cardiac stem cell therapy could gain FDA approval far earlier than most people expect, despite the fact that these therapies have consistently failed to produce any convincing evidence of safety and efficacy. Under the old FDA…
No One Knows What’s Actually In Red Yeast Rice Supplements
June 23, 2017 by 1 Comment
–Despite tighter FDA rules red yeast supplements may not contain the active ingredient– or far too much of it. A new study offers fresh evidence that it is impossible for consumers (or their doctors) to know what they are getting when they buy dietary supplements. Dietary supplements have long been, at best, loosely regulated in…
New Stroke Prevention Device May Not Prevent Strokes
June 7, 2017 by Leave a Comment
–There’s no hard evidence the Sentinel Cerebral Protection System reduces stroke in TAVR. Here’s how to get a second generation medical product or add-on product approved: show that the original device isn’t nearly as safe and effective as believed back in, you know, the dark ages before the new product showed up. Until now proponents…
Abbott Pulls Troubled Absorb Stent From European Market
April 6, 2017 by Leave a Comment
(Updated) Abbott Laboratories has sent a letter to European physicians informing them that the Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS “will only be available for use in clinical registry setting at select sites/institutions.” The company’s action comes in response to an avalanche of bad news for the controversial device. Last fall 3-year results from…
Scott Gottlieb’s Sham Ideology Rejects Clinical Trials
March 14, 2017 by 3 Comments
Donald Trump has nominated Scott Gottlieb to be the next FDA Commissioner. To his credit, Gottlieb is not certifiably crazy like several of the other candidates who were reported to be under consideration for the job. But he is is a deeply conservative ideologue who is determined to reduce the government’s role in healthcare. On two occasions in…
For Scott Gottlieb, Business Trumps Health
March 14, 2017 by Leave a Comment
Donald Trump has nominated Scott Gottlieb to be the next FDA Commissioner. To his credit, Gottlieb is not certifiably crazy like several of the other candidates who were reported to be under consideration for the job. But he is is a deeply conservative ideologue who is determined to reduce the government’s role in healthcare. On two occasions in…
The GiveAway Act
December 6, 2016 by Leave a Comment
The 21st Century Cures Act should be called the 21st Century GiveAway Act. The Act may not even deliver on its main attraction– the funding of new research– but will instantly definitely give a regulatory boost to a host of special interests, including drug and device makers. As Michael Hiltzik writes in the LA Times,…
Cardiac Devices Could Become a Big Problem For Califf And The FDA
November 7, 2016 by 1 Comment
–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…
The Impact Of ABSORB II: Down The Slippery Slope
November 2, 2016 by 2 Comments
When it was approved earlier this year in July the Absorb (Abbott) bioresorbable stent provoked a fair amount of discussion about the “slippery slope of noninferiority.” Although the stent met the FDA criteria for approval, the available trial results went in the wrong direction and there was a particularly concerning warning sign of a higher…
Novel Cholesterol Drugs Move Forward In Clinical Trials
October 18, 2016 by 1 Comment
–New information about upcoming cholesterol drugs from the Medicines Company and Esperion Recently the makers of two novel cholesterol-lowering drugs in development provided important updates on their progress. On Tuesday, the Medicines Company announced positive top-line results for a trial of its unusual PCSK9 synthesis inhibitor scheduled to be presented in November. Last week Esperion…
FDA Reaffirms Safety And Efficacy Of Rivaroxaban
October 11, 2016 by Leave a Comment
–FDA says no changes needed to the rivaroxaban label. Following a year of controversy and uncertainty relating to the anticoagulant drug rivaroxaban (Xarelto, Johnson & Johnson), the FDA has reaffirmed the drug’s safety and efficacy. Rivaroxaban is approved for stroke reduction in patients with atrial fibrillation. The indication is based on results of the ROCKET-AF…
Experts Weigh In On The Decline In Cardiovascular Drug Development
August 30, 2016 by 1 Comment
–CV disease is the top killer but pharma is pulling back on developing new drugs. Although cardiovascular disease is the number one cause of death in the world fewer cardiovascular drugs are under development now than in the past, according to a study published in JACC: Basic to Translational Science. Thomas Hwang and colleagues at…
FDA Delays Approval Of First Agent To Reverse Effect Of New Anticoagulants
August 17, 2016 by Leave a Comment
Portola Pharmaceuticals announced late on Wednesday evening that it had received a complete response letter (CRL) from the FDA regarding its Biologics License Application (BLA) for AndexXa (andexanet alfa). Approval for the drug had been widely expected earlier in the day, which was the drug’s PDUFA date. The drug had been on an accelerated…
Alere Withdraws Anticoagulation Monitoring System At Heart Of ROCKET AF Controversy
July 13, 2016 by Leave a Comment
–FDA says the manufacturer has not demonstrated that it has fixed the problem. The Alere INRatio® and INRatio®2 PT/INR Monitoring System are being pulled from the market. Alere, the manufacturer of the devices, which are used by people taking warfarin to monitor their INR, said that the action follows a “collaborative process” with the FDA. The…
Empagliflozin May Be Poised To Gain CV Indication
June 24, 2016 by Leave a Comment
–FDA reviewers have raised no major questions ahead of Tuesday’s advisory panel meeting. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will likely lend its support to an important new expanded indication for empagliflozin (Jardiance, Boehringer Ingelheim). The new indication is to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death,…
FDA Proposes Voluntary Sodium Cuts by Food Industry
June 1, 2016 by Leave a Comment
–AMA, AHA, ACC, etc voice support, but not everyone agrees. After decades of discussion and inaction, the FDA today took a first concrete step toward reducing sodium levels in the general population: It issued draft guidance for voluntary sodium reduction targets for the food industry. The FDA said that the new recommendations come from “leading…
FDA Ends Niacin and Fenofibric Acid Combinations With Statins
April 17, 2016 by 4 Comments
–“In the absence of benefits, there remain only harms.” The FDA is putting an end to the combined use of statins with two once-popular lipid drugs, niacin and fenofibric acid. On Monday the FDA will announce in the Federal Register that it is withdrawing its approval for indications for coadministration of these drugs with statins…
Orexigen Terminates Another Cardiovascular Outcomes Trial
April 13, 2016 by Leave a Comment
Updated–In a further sign of the chaos surrounding its weight loss drug Contrave, Orexigen has again terminated an FDA-mandated cardiovascular outcomes trial with the drug. Following a year of controversy (see below) Orexigen last month assumed sole control of Contrave (the combination of naltrexone and bupropion) from its former partner, Takeda. The company has now terminated enrollment…
FDA Expands Metformin Label
April 10, 2016 by Leave a Comment
— The diabetes drug can now be used in more patients with reduced kidney function The FDA on Friday greatly expanded the indication for the type 2 diabetes drug metformin. Until now use of metformin in patients with reduced kidney function had not been recommended. The new label states that metformin “can be used safely…
FDA Adds Heart Failure Warning To Saxagliptin and Alogliptin Labels
April 6, 2016 by Leave a Comment
The FDA said on Tuesday that it was adding new warning to the labels of diabetes drugs containing the saxagliptin and alogliptin. The FDA said the drugs “may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.” The announcement comes two years after an FDA panel recommended that…
The Door Opens Wider For Drug Companies To Make Off-Label Claims
March 9, 2016 by Leave a Comment
The FDA has finally reached a settlement in its long dispute with Amarin Corporation, manufacturer of the prescription fish oil product Vascepa. Last year a US judge ruled against the FDA. The settlement brings an end to the litigation and will permit Amarin to promote off-label usage of Vascepa as long as its statements are…
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 Turns Down Expanded Indication For Zetia And Vytorin
February 16, 2016 by Leave a Comment
The FDA has turned down Merck’s application to expand the indication for its cholesterol-lowering drug ezetimibe (Zetia and Vytorin, Merck). This means there’s still no end in sight for this drug’s very long and very winding road. Ezetimibe is now indicated to reduce LDL cholesterol in people with hyperlipidemia. The proposed new indication was for…
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