Expediting Expanded Access
The FDA clarified its expanded access policies in a series of documents including a Q and A that outlines the process of obtaining expanded access, guidance that describes how companies may charge for therapies given under expanded access programs, and a new form to request access to investigational drugs.
FDA Commissioner Robert Califf said the agency hoped to simplify and streamline the process to reduce "procedural burdens on physicians and patients." (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - June 3, 2016 Category: Pharmaceuticals Source Type: blogs
It's the Volume Stupid..and the Rebates
Most media accounts miss the important impact of insurer imposed cost sharing (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - June 2, 2016 Category: Pharmaceuticals Source Type: blogs
Peter Bach Values PBM Profits Over Patient's
Inventing a fiction that enriches companies by taking from patients. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - May 11, 2016 Category: Pharmaceuticals Source Type: blogs
Purple Reign
When it comes to biosimilars, USP and FDA both have important roles to play. It’s a very small sandbox with very large public health implications. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - May 11, 2016 Category: Pharmaceuticals Source Type: blogs
Opioids put LA Times in a World of Hurt
How the mighty have fallen. Once a newspaper of national importance, the Los Angeles Times has become a shadow of its former self. Consider it’s latest Page One investigation into Purdue Pharma. The drug manufacturer's malfeasance? Promoting on-label claims. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - May 6, 2016 Category: Pharmaceuticals Source Type: blogs
ICER Multiple Myeloma Cherry-picking Update: More People Killed
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - April 8, 2016 Category: Pharmaceuticals Source Type: blogs
Amgen's Right, ICER Cherry Picks Who Lives Or Dies
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - April 7, 2016 Category: Pharmaceuticals Source Type: blogs
How PBMs and Insurers Profit By Discriminating Against 4 Percent of Americans
Some think discrimination is progress. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - April 6, 2016 Category: Pharmaceuticals Source Type: blogs
The Five Facts About Drug Pricing HHS (and the media) Missed
More misleading material on drug prices (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - March 15, 2016 Category: Pharmaceuticals Source Type: blogs
More Drug Pricing BS From Fierce Pharma
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - March 14, 2016 Category: Pharmaceuticals Source Type: blogs
The Single Payer Fantasy
In an attempt to halt Bernie Sanders’ rise in the polls, Hillary Clinton is waging a campaign against his single-payer health plan. Remarkably, one of Clinton’s main criticisms is that Sanders’ scheme would undermine the cause of federally controlled health care by giving too much power to the states. Yes, we must be in an election year. The real problem with a single-payer system, however, is much simpler: The approach has failed everywhere it has been tried — from Europe to Canada to Sanders’ own state of Vermont. In almost every instance, government-run health care has suppressed medical innovation and made it...
Source: drugwonks.com Blog - March 8, 2016 Category: Pharmaceuticals Source Type: blogs
Rare Disease Day Has No Friend in ICER’s Steve Pearson
The person seeking to limit drug spending believes there are too many orphan drugs (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - February 29, 2016 Category: Pharmaceuticals Source Type: blogs
RC Coda
The good news is that Rob Califf has been confirmed as FDA Commissioner. Dr. Califf is the right man in the right place at the right time. Better late than never. At a crucial moment in American (indeed global) healthcare, he brings a vision for FDA as an innovation accelerator, steward of post-market safety, guarantor of quality, and first among equals when it comes to leading the agency’s intramural partnerships on a plethora of issues with its many constituencies. Perhaps most importantly, is Califf's role as agenda-setter and cheer leader at an agency comprised of highly educated and dedicated (and career) public ser...
Source: drugwonks.com Blog - February 24, 2016 Category: Pharmaceuticals Source Type: blogs
Jimmy Carter Inspires Legislation Providing Open Access To Cancer Cures
Cancer is a non-partisan issue (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - February 24, 2016 Category: Pharmaceuticals Source Type: blogs
CVS Increases Profits by Rationing Drugs
It's easy to make money when you get paid to deny access to your products. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - February 24, 2016 Category: Pharmaceuticals Source Type: blogs
