FDA Expanding Role of Office of Criminal Investigations
Over the last year or two, the Food and Drug Administration's (FDA) Office of Criminal Investigations (OCI) has grown to play a crucial role in protecting the public health from fraudulent or counterfeit drugs, devices, cosmetics and other FDA regulated products. Increasingly, OCI has also played a large role in several recent high-profile settlements involving off-label marketing or deceptive promotional practices.
Several recent posts on the FDAVoice blog, written by OCI's director, John Roth, explain the work OCI has done in the past and what the future holds.
OCI consists of numerous federal agents, who have t...
Source: Policy and Medicine - June 20, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
Tecfidera's Price
Let us take up the case of Tecfidera, the new Biogen/Idec drug for multiple sclerosis, known to us chemists as dimethyl fumarate. It joins the (not very long) list of industrial chemicals (the kind that can be purchased in railroad-car sizes) that are also approved pharmaceuticals for human use. The MS area has seen this before, interestingly.
A year's supply of Tecfidera will set you (or your insurance company) back $54,900. That's a bit higher than many analysts were anticipating, but that means "a bit higher over $50,000". The ceiling is about $60,000, which is what Novartis's Gilenya (fingolomod) goes for, and Biogen ...
Source: In the Pipeline - April 2, 2013 Category: Chemists Tags: Drug Prices Source Type: blogs
JAMIA: Reduction in medication errors in hospitals due to adoption of computerized provider order entry systems
This study appears reasonable for inclusion in a meta-analysis, although ideally there might have been accounting for possible influence of non-intervention (computer)-related pre-post interval changes. The transition to CPOE, training, increased awareness, etc. can influence results, especially short term. Included study #7 (footnote 16):Error reduction in pediatric chemotherapy: computerized order entry and failure modes and effects analysis. Arch Pediatr Adolesc Med 2006;160:495–8.Before-and-after study from 2001 to 2004. After CPOE deployment, daily chemotherapy orders were less likely to have improper dos...
Source: Health Care Renewal - March 3, 2013 Category: Health Medicine and Bioethics Commentators Tags: Mark D Spranca AMIA Melanie R Wasserman medication error Lauren EW Olsho David C Radley healthcare IT risks Sarah J Shoemaker Bethany Bradshaw JAMIA healthcare IT benefits CPOE Source Type: blogs
