Tag: FDA

The FDA has rejected the drug/device combination designed to monitor patient adherence with Abilify from Otsuka Pharmaceutical and Proteus Digital Health. Just last week...

Dr. Nardo, on his 1boringoldman blog, recaps his letter to the FDA concerning his findings after reviewing the research data on the new antidepressant...

Takeda and Lundbeck had prepared to advertise that their latest antidepressant Brintellix (Vortioxetine) could give patients a cognitive boost and help them think and...

The Food and Drug Administration (FDA) is attempting to reclassify the electroconvulsive therapy (ECT) device for use in treating severe depression (MDE) or bipolar “disorder” (BPD). The device is currently a class III device and the proposal is to make it a class II device.

Gepirone, a new depression drug by Fabre-Kramer Pharmaceuticals, did not meet the FDAs efficacy standards. The new drug application for gepirone has now received...

Two companies have committed to FDA review for video games that they claim can be used to treat “ADHD,” but many scientists remain skeptical. “At the annual meeting of the American Academy of Child & Adolescent Psychiatry on Wednesday, Akili Interactive Labs presented data from a pilot study of its video game, Project: EVO, that showed some positive results in children with attention-deficit hyperactivity disorder (ADHD).”

Despite concerns about the drug’s necessity, effectiveness, and side-effects, Flibanserin (Addyi) has come to market as the first drug designed to increase sexual desire in women

Bernie Sanders joins numerous public health groups and opposes Robert Califf's nomination to lead the FDA over industry ties.

With the explosion of genetic testing and the emerging field of pharmacogenetics, patients can now take a DNA test and receive psychiatric drug recommendations customized to fit their genetic makeup. In an editorial for the latest issue of the Journal of Nervous and Mental Disease, Columbia University Psychiatrist Robert Klitzman warns that clinicians need to be aware of the limitations of these genetic tests being marketed to them.

The October edition of the Journal of World Psychiatry, the 3rd ranked journal of Psychiatry, will publish a reanalysis of antidepressant efficacy versus placebo in major depression. When the researchers, Arif Khan and Walter Brown, analyzed the data from the FDA archives for antidepressants approved between 1985 and 1997, “it was evident that the conventional wisdom of 70% response with antidepressants was at best an overestimate.” In fact, “the magnitude of symptom reduction was about 40% with antidepressants,” compared to “about 30% with placebo.”

In Saturday’s New York Times, Sabrina Tavernise describes the close industry ties of Dr. Robert Califf, a cardiologist and researcher recently tapped by the Obama administration to head the FDA. In a conflict of interest statement published last year, Califf “declared financial support from more than 20 companies,” leading some public health advocates to “question whether his background could tilt him in the direction of an industry he would be in charge of supervising.” Tavernise points to a presentation Califf gave on “Disrupting Clinical Research: Transforming a System” in 2014 where he singled out regulation as a barrier to research and innovation. “I think it illuminates his thinking,” Daniel Carpenter, a Harvard professor who studies the FDA, said of the slide. “In a sense, he’s the ultimate industry insider.”

On Tuesday, the Obama administration nominated Dr. Robert Califf to be the new commissioner of the Food and Drug Administration (FDA). In a statement, director of the Public Citizen’s Health Research Group, Dr. Michael Carome called on the Senate to reject the nomination. He contends that Califf “racked up a long history of extensive financial ties to multiple drug and medical device companies, including Amgen, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck Sharp & Dohme and Sanofi-Aventis, to name a few.”

Huffington Post and journalist Steve Brill have combined to launch a 15 part series about how Johnson & Johnson illegally violated FDA restrictions by pushing the antipsychotic drug, Risperdal, for use with adolescents and the elderly. The series, entitled “America’s Most Admired Lawbreaker,” launched yesterday and will include mixed media, videos, podcasts, source documents, as well as 15 written chapters. Click more for a synopsis of part 1.

Last Thursday, the FDA agreed to review a “digital pill,” combining a sensor with the antipsychotic Abilify, in order to track patients’ compliance with drug treatment. Patients taking the tracker pill would also wear a patch, which would receive information and relay it to a mobile device, according to a brief report by BioPharmaDIVE.

In the September issue of The Journal of the American Medical Association (JAMA) three FDA advisory committee members describe the convergence of factors that made the committee’s recommendation to approve flibanserin especially challenging and politically charged.

Writing for Forbes, Matthew Herper documents the FDA’s increasing drug approval rates. “In 2008, BioMedTracker says the FDA approved 20 new molecular entities (NMEs) and rejected 20, for an approval rate of 50%.” So far this year, he writes, “the FDA approval rate is more like 96%.”

We spend a lot of time writing about knowledge dissemination in mental health, and over time, have increasingly recognized the important role of science...