Trump's FDA Reform Critics Rage Against Patients
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - March 2, 2017 Category: Pharmaceuticals Source Type: blogs
ICER’s policy prescriptions will cripple MS patients
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - February 17, 2017 Category: Pharmaceuticals Source Type: blogs
Psst -- Wanna see some DNA?
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - February 16, 2017 Category: Pharmaceuticals Source Type: blogs
Bad Ad Program a Waste of FDA Time and Resources
Pitts called the original bad ad program "a complete waste of time," maintaining that FDA never really determined what was a bad ad, and that FDA should instead be focusing on regulating safety and efficacy. "FDA does not regulate creativity," Pitts added. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - January 23, 2017 Category: Pharmaceuticals Source Type: blogs
An Off-Label Regualtory Temper Tantrum
“This memo is a regulatory temper tantrum,” said Peter Pitts, a former FDA associate commissioner who heads the Center for Medicine in the Public Interest, a think tank that is funded, in part, by industry. “The memo is written to show that allowing the sharing of truthful, accurate, and non-m isleading of information will cause the earth to stop spinning on its axis, research into new indications to cease, and misleading and misbranded communications to proliferate.” (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - January 23, 2017 Category: Pharmaceuticals Source Type: blogs
So-called Progressives vs Medical Progress
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - December 9, 2016 Category: Pharmaceuticals Source Type: blogs
Fact Checking Hillary on Drug Pricing
Both Donald Trump and Hillary Clinton get a lot of flak for lying. But in Secretary Clinton ’s latest speech on healthcare reform, she didn’t lie — she just got all her facts wrong. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - October 24, 2016 Category: Pharmaceuticals Source Type: blogs
Insurance is Just Another Word For Nothing Left to Lose
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - October 21, 2016 Category: Pharmaceuticals Source Type: blogs
Sarepta and the Value of Adaptive Clinical Trials
Here ’s a new op-ed from the Cleveland Plain Dealer. It speaks directly to today’s FDA approval of Sarepta. Consider what the editor chose to add to my attribution at the bottom of the article:\, “Peter J. Pitts, a former FDA associate commissioner, is the president and co-founder of the Center for Medicine in the Public Interest. CMPI receives some funding from biopharmaceutical firms, which could benefit from adaptive trials.” I suggested that he also add that adaptive trials benefit patients. He declined. I wonder what the parents of children with Duchenne muscular dystrophy would say? (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - September 19, 2016 Category: Pharmaceuticals Source Type: blogs
JAMA's Pizza Principle
Drug firms have discovered a powerful new mind-control technology that threatens to topple our healthcare system: a free slice of pizza. That ’s the implication — but not the actual findings — of a new study in JAMA Internal Medicine. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - August 30, 2016 Category: Pharmaceuticals Source Type: blogs
Bee Smart About Drug Pricing
Republican voters hate Obamacare, but they hate high prescription drug prices even more. Health care scholar Avik Roy recently pointed to the polls as a reason the GOP must develop a “clear plan to tackle the high and rising price of branded prescription drugs.” He proposed a number of measures aimed at reining in supposedly greedy pharmaceutical firms. But Roy, like many others who have weighed in on the cost of medicines, overlooks two key points. First, the very real fina ncial pain many Americans feel at the pharmacy counter is the fault of insurers – not drug companies. Second, the obsessive focus on cost obscur...
Source: drugwonks.com Blog - August 29, 2016 Category: Pharmaceuticals Source Type: blogs
Mylan's "Perfect Storm of Stupidity"
It ’s as though Turingfreude never made it to Mylan HQ. Dramatically raising prices on Epipen during a political cycle? Really? That’s the new dictionary definition of (among other things) being tone deaf. And to make matters even worse, the head honcho at Mylan, Heather Bresch is the daughter of US Senator Joe Manchin (D, WVA). That’s gotta be embarrassing. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - August 24, 2016 Category: Pharmaceuticals Source Type: blogs
Much Congressional ado about ADOs
Potent report language on Abuse Deterrent Opioids (ADOs) from the House Labor HHS Appropriations Subcommittee Report for Fiscal 2017.
ADOs can't help if patients don't have access to them. It's that simple. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - July 14, 2016 Category: Pharmaceuticals Source Type: blogs
CREATing a generic "get out of jail free" card
CREATES Act a “get out of jail free card” for generics makers. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - June 23, 2016 Category: Pharmaceuticals Source Type: blogs
When it comes to Biosimilars -- Knowledge is Safety
Safety and trust are exactly why transparency-in-labeling is needed. As Sumant Ramachandra, Senior Vice President and Chief Scientific Officer at Pfizer’s Hospira unit, has said, “Communications fosters confidence.” (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - June 14, 2016 Category: Pharmaceuticals Source Type: blogs
