HRSA's 340B Fix
HHS's Health Resources and Services Administration (HRSA) has issued draft guidance on the 340B program that addresses some of industry's concerns with the program. The guidance includes a clearer definition of 340B-eligible patients.
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - August 28, 2015 Category: Pharmaceuticals Source Type: blogs
Another Survey Says Americans Want Price Controls on Health Care..What A Shock
Ask someone if they want to spend less money on healthcare and they will say yes.. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - August 20, 2015 Category: Pharmaceuticals Source Type: blogs
Wither Off-Label?
The debate over off-label communications doesn’t begin or end with the Caronia or Amarin decisions. It’s a continuing dialogue between manufacturers and the FDA, between doctors and patients, between doctors and academics, between lawyers and judges, and between advocates on all sides. And the red thread that ties these conversations together is responsible off-label communications. Not sales strategies. Not DTC tactics. Not managed market negotiations – the responsible sharing of truthful and accurate information. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - August 14, 2015 Category: Pharmaceuticals Source Type: blogs
Essuring safe use
Do women deserve choice when it comes to contraception? On September 24th, the FDA will hold a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization. It’ll make for some strange bedfellows (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - August 10, 2015 Category: Pharmaceuticals Source Type: blogs
Drug Imporatation. No! No! 1000X No!
Drug importation is a deeply misguided idea. It exposes consumers to counterfeit drugs of unknown origins, and undermines the public's long-term health by weakening biopharmaceutical companies' incentives to invest in future treatments and cures. Congress should uphold laws that prohibit widespread drug importation. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - July 31, 2015 Category: Pharmaceuticals Source Type: blogs
Putting Part D Spending in Perspective
Medicare Rx spending is not climbing out of control. And it's still reducing the rate of Medicare spending overall (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - July 28, 2015 Category: Pharmaceuticals Source Type: blogs
Price vs. Value: The Story and the Rest of the Story
You've read the spin -- now here's the rest of the story. As John Adams quipped, "Facts are pesky things." (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - July 27, 2015 Category: Pharmaceuticals Source Type: blogs
The FDA's Quality Revolution
Let it be said that the spark that ignited the flame was when FDA leadership asked, “Do we know enough about the quality of drugs that are sold in the United States.” (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - July 9, 2015 Category: Pharmaceuticals Source Type: blogs
For FDA and Amarin, "Terrific" is in the eyes of the beholder
Yesterday, Manhattan District Judge Paul Engelmayer asked some very probing – and some very naive questions regarding Amarin’s request for a preliminary injunction allowing it to tell doctors about the unapproved use of its Vascepa (icosapent) fish oil pill. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - July 8, 2015 Category: Pharmaceuticals Source Type: blogs
ASCO Cost Tool Abandons Hippocratic Oath and Cancer Patients
a framework that ignores and belittles patient preferences and the evidence of long term value is a cover-up, not a calculator (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - June 24, 2015 Category: Pharmaceuticals Source Type: blogs
Deliberately Sensational Reporting About Drug Costs
Increased spending on drugs is a good thing and still a small share of costs.. everywhere. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - June 17, 2015 Category: Pharmaceuticals Source Type: blogs
Patent Death Squads vs. Innovation
Patents, according to Abraham Lincoln, “add the fuel of interest to the passion of genius.” The Patent Trial and Appeal Board was supposed to make the system better. It hasn’t.To that point, a new op-ed from today's edition of the Wall Street Journal. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - June 11, 2015 Category: Pharmaceuticals Source Type: blogs
Lenny Saltz Goes Crazy About Drug Prices
We should pay even more if 90 percent of people who die from cancer could live 2 year or more. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - June 1, 2015 Category: Pharmaceuticals Source Type: blogs
Express Scripts Pricing Scheme Would Restrict Patient Access and Discourage Innovation: Will ASCO Endorse?
ASCO wants it's drug value scorecard to push down Rx prices by paying less for meds that do less. That's exactly what the Express Scripts pricing scheme would do. For hard to treat patients with no effective treatments, that's a death sentence. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - May 28, 2015 Category: Pharmaceuticals Source Type: blogs
Huckabee Fails Importation 101
Those hot TV lights must be affecting Mike Huckabee’s cognition or, di minimis, his awareness of sloppy staff work. "Americans should have the freedom to purchase safe drugs from Canada," Huckabee wrote in the Orlando Sentinel. "It just makes sense." Alas not. Let’s start here – there is a difference between the high quality, well regulated medicines Canadians get from their local pharmacies and those products sold to Americans via wildcat Canadian internet pharmacies. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - May 28, 2015 Category: Pharmaceuticals Source Type: blogs
