Welcome to the New Drugwonks.com http://drugwonks.com/index DrugWonks.com | Debating Today's Drugs Policies en-us Thu, 06 Sep 2007 10:55:48 -0400 Sat, 03 Aug 2013 12:20:34 -0400 http://blogs.law.harvard.edu/tech/rss Psyclone WMS 4.4.9 info@drugwonks.com (drugwonks) cpernice@psycloneinc.com (Christopher Pernice) Truth in Biosimilar Labeling http://drugwonks.com/blog/truth-in-biosimilar-labeling Recently the FDA issued draft guidance on labeling for biosimilar products. In two words, no surprises – which for some is better news than for others. Tue, 24 May 2016 16:22:55 -0400 http://drugwonks.com/blog/truth-in-biosimilar-labeling Building EvGen http://drugwonks.com/blog/building-evgen There must be a common approach to how data is presented, reported and analyzed and strict methods for ensuring patient privacy and data security. Rules of engagement must be transparent and developed through a process that builds consensus across the relevant ecosystem and its stakeholders. To ensure support across a diverse ecosystem that often includes competing priorities and incentives, the system’s output must be intended for the public good and be readily accessible to all stakeholders. Mon, 16 May 2016 08:30:32 -0400 http://drugwonks.com/blog/building-evgen ICER (The Institute for Constantly Extracting Rebates) http://drugwonks.com/blog/icer-the-institute-for-constantly-extracting-rebates In its current form ICER stands for the Institute for Constantly Extracting Rebates. Fri, 13 May 2016 14:30:52 -0400 http://drugwonks.com/blog/icer-the-institute-for-constantly-extracting-rebates The Urgency of the TPP http://drugwonks.com/blog/the-urgency-of-the-tpp When it comes to global trade, there is no value to living in the past. We no longer trade in barter or beads. The Trans-Pacific Partnership (TPP) acknowledges that we live in a global village – and innovation is an essential commodity. Why are some people finding this so surprising? Thu, 12 May 2016 12:51:19 -0400 http://drugwonks.com/blog/the-urgency-of-the-tpp BILLIONS: Is ICER Enabling Illegal PBM Rip-off Racket? http://drugwonks.com/blog/billions-is-icer-enabling-illegal-pbm-rip-off-racket Wed, 11 May 2016 17:44:30 -0400 http://drugwonks.com/blog/billions-is-icer-enabling-illegal-pbm-rip-off-racket Peter Bach Values PBM Profits Over Patient's http://drugwonks.com/blog/peter-bach-values-pbm-profits-over-patient-s Inventing a fiction that enriches companies by taking from patients. Wed, 11 May 2016 17:17:11 -0400 http://drugwonks.com/blog/peter-bach-values-pbm-profits-over-patient-s Purple Reign http://drugwonks.com/blog/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. Wed, 11 May 2016 06:57:58 -0400 http://drugwonks.com/blog/purple-reign Medicare's Part B Experiment With Patient Lives http://drugwonks.com/blog/medicare-part-b-experiment-with-patient-lives Medicare Part B plays with human life to save money. Fri, 06 May 2016 17:06:09 -0400 http://drugwonks.com/blog/medicare-part-b-experiment-with-patient-lives Califf's Inclusive "We" http://drugwonks.com/blog/califf-s-inclusive-we At yesterday’s annual FDLI conference, FDA Commissioner Califf said that, “to achieve innovation, we must take risks.” And he wasn’t using the royal “we.” Fri, 06 May 2016 10:21:36 -0400 http://drugwonks.com/blog/califf-s-inclusive-we Opioids put LA Times in a World of Hurt http://drugwonks.com/blog/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. Fri, 06 May 2016 07:13:49 -0400 http://drugwonks.com/blog/opioids-put-la-times-in-a-world-of-hurt Opioids Auth-orization http://drugwonks.com/blog/opioids-auth-orization To paraphrase Peter Drucker, the information revolution will shift -- from the generation of data, to figuring out the meaning and purpose of the data with the patient’s perspective in mind. Welcome to the world of opioid REMS. Thu, 05 May 2016 07:18:54 -0400 http://drugwonks.com/blog/opioids-auth-orization Confirmation Bias Distorts Drug Price Research and Reporting http://drugwonks.com/blog/confirmation-bias-distorts-drug-price-research-and-reporting Tue, 03 May 2016 17:43:45 -0400 http://drugwonks.com/blog/confirmation-bias-distorts-drug-price-research-and-reporting Getting Real World About Outcomes Data http://drugwonks.com/blog/getting-real-world-about-outcomes-data A health technology assessment model for the 21st Century should reflect and measure individual response to treatment based on the combination of genetic, clinical, and demographic factors that indicate what keep people healthy, improve their health, and prevent disease. A rapidly aging society demands a new healthcare paradigm capable of providing for its needs in the 21st Century. Equality of care must be matched with quality of care. Fri, 29 Apr 2016 08:40:00 -0400 http://drugwonks.com/blog/getting-real-world-about-outcomes-data Buffalo Wings http://drugwonks.com/blog/buffalo-wings Keeping the feds out of price negotiations between private insurers and drug companies has worked wonders. Surveys indicate nine out of 10 seniors are satisfied with their Part D coverage; 96 percent report that their coverage works well. And because insurers have a financial incentive to attract enrollees by keeping plans affordable, the program cost $349 billion less than initially projected during its first decade. Thu, 28 Apr 2016 10:50:53 -0400 http://drugwonks.com/blog/buffalo-wings PBM and Insurer Funded Front Group Demands Bigger Rebates and Less Medical Innovation http://drugwonks.com/blog/pbm-and-insurer-funded-front-group-demands-bigger-rebates-and-less-medical-innovation The Coalition for Sustainable Drug Priceing is a payor funded grab for control over the development, pricing and access of medicines Mon, 25 Apr 2016 10:39:28 -0400 http://drugwonks.com/blog/pbm-and-insurer-funded-front-group-demands-bigger-rebates-and-less-medical-innovation TheStreet.com's Feurstein Fast and Loose With Remicade Pricing Truth http://drugwonks.com/blog/thestreet-com-s-feurstein-fast-and-loose-with-pricing-facts There is a reason we ask for the whole truth. Wed, 20 Apr 2016 15:52:42 -0400 http://drugwonks.com/blog/thestreet-com-s-feurstein-fast-and-loose-with-pricing-facts Wither "Cures?" http://drugwonks.com/blog/wither-cures Is the cure worse than the disease? A thoughtful and comprehensive overview in BioCentury (by one of our favorite industry cognoscenti, Steve Usdin), Can “Cures” be Cured, presents a blunt appraisal for either measured optimism or realpolitk pessimism. Mon, 18 Apr 2016 10:01:30 -0400 http://drugwonks.com/blog/wither-cures Most of the Increase in Drug Spending Pocketed By PBMs and Insurers http://drugwonks.com/blog/most-of-the-increase-in-drug-spending-pocketed-by-pbms-and-insurers Fri, 15 Apr 2016 15:19:13 -0400 http://drugwonks.com/blog/most-of-the-increase-in-drug-spending-pocketed-by-pbms-and-insurers Transparency isn't a one-way proposition http://drugwonks.com/blog/transparency-isn-t-a-one-way-proposition Transparency in medicine isn't a one-way street. The transparent truth is that the prices patients actually pay aren't set by drug manufacturers — they're determined by pharmacy benefit managers, insurers, hospitals and pharmacies. Sun, 10 Apr 2016 20:27:48 -0400 http://drugwonks.com/blog/transparency-isn-t-a-one-way-proposition In support of Pharma Pros -- not Pharma Bros http://drugwonks.com/blog/in-support-of-pharma-pros-not-pharma-bros There’s a torch and pitchfork sale underway in the nation’s capital — or so it would seem from Congress’ recent witch hunt targeting the pharmaceutical industry. Fri, 08 Apr 2016 11:36:15 -0400 http://drugwonks.com/blog/in-support-of-pharma-pros-not-pharma-bros