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) ICERs Sins of Omission http://drugwonks.com/blog/icers-sins-of-omission Tue, 30 Aug 2016 17:47:28 -0400 http://drugwonks.com/blog/icers-sins-of-omission JAMA's Pizza Principle http://drugwonks.com/blog/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. Tue, 30 Aug 2016 12:55:56 -0400 http://drugwonks.com/blog/jama-s-pizza-principle Today's Mylan Moment: Drug Prices Are Rigged By PBMs and Insurers http://drugwonks.com/blog/today-s-mylan-moment-drug-prices-are-rigged-by-pbms-and-insurers Mon, 29 Aug 2016 12:07:49 -0400 http://drugwonks.com/blog/today-s-mylan-moment-drug-prices-are-rigged-by-pbms-and-insurers Bee Smart About Drug Pricing http://drugwonks.com/blog/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 financial pain many Americans feel at the pharmacy counter is the fault of insurers – not drug companies. Second, the obsessive focus on cost obscures the vastly higher value of new drugs. Mon, 29 Aug 2016 11:13:34 -0400 http://drugwonks.com/blog/bee-smart-about-drug-pricing EpiPen 'Outrage' Update http://drugwonks.com/blog/epipen-outrage-update Thu, 25 Aug 2016 14:33:51 -0400 http://drugwonks.com/blog/epipen-outrage-update Why Is The Media Sticking It to the EpiPen http://drugwonks.com/blog/why-is-the-media-sticking-it-to-the-epipen Once again the Big Pharma narrative trumps truth Wed, 24 Aug 2016 16:08:26 -0400 http://drugwonks.com/blog/why-is-the-media-sticking-it-to-the-epipen Mylan's "Perfect Storm of Stupidity" http://drugwonks.com/blog/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. Wed, 24 Aug 2016 15:53:58 -0400 http://drugwonks.com/blog/mylan-s-perfect-storm-of-stupidity If you’re taking a biologic, you’ve got a friend in Pennsylvania http://drugwonks.com/blog/if-you-re-taking-a-biologic-you-ve-got-a-friend-in-pennsylvania When it comes to protecting and advancing the public health, some states are leaders, others laggards. Consider biosimiars. On July 20, Pennsylvania Governor Tom Wolf signed into law Senate Bill 514, which allows pharmacists to substitute for a brand name biological product a less expensive biosimilar product that has been deemed interchangeable by the FDA. Pennsylvania is the twenty third state to enact such a law. Wed, 17 Aug 2016 11:06:24 -0400 http://drugwonks.com/blog/if-you-re-taking-a-biologic-you-ve-got-a-friend-in-pennsylvania Embracing Satan's PDUFA http://drugwonks.com/blog/satan-s-pdufa Yesterday’s public meeting on the FDA’s PDUFA VI Commitment Letter was a love-fest (mostly) – but as Theresa Mullin, Director of CDER’s Office of Strategic Programs, wisely noted, “the devil is in the details. Indeed. Tue, 16 Aug 2016 08:23:21 -0400 http://drugwonks.com/blog/satan-s-pdufa Why ICER Can't Be Trusted http://drugwonks.com/blog/why-icer-can-t-be-trusted ICER generates mythical facts and hides the truth about drug spending Mon, 15 Aug 2016 11:59:06 -0400 http://drugwonks.com/blog/why-icer-can-t-be-trusted Bayer exonerated per Essure. Where's the MSM coverage? http://drugwonks.com/blog/bayer-exonerated-per-essure-where-s-the-msm-coverage A federal judge in White Plains has dismissed 1,225 lawsuits against Bayer Healthcare Pharmaceuticals that were filed by women who claimed that the company’s contraceptive device injured them. Fri, 12 Aug 2016 14:13:00 -0400 http://drugwonks.com/blog/bayer-exonerated-per-essure-where-s-the-msm-coverage Danger in drugs from Canada http://drugwonks.com/blog/danger-in-drugs-from-canada When it comes to health care reform, Hillary Clinton and Donald Trump have something in common — and it’s dangerously wrong. They support drug importation “from Canada.” It’s a sound-bite solution that won’t offer lower prices but will result in a public health calamity. Thu, 11 Aug 2016 14:27:24 -0400 http://drugwonks.com/blog/danger-in-drugs-from-canada Patient Assistance Programs Are a Response To Government Interference in Drug Pricing http://drugwonks.com/blog/patient-assistance-programs-are-a-response-to-government-interference-in-drug-pricing Wed, 10 Aug 2016 15:58:58 -0400 http://drugwonks.com/blog/patient-assistance-programs-are-a-response-to-government-interference-in-drug-pricing Interchangeability and the Totality of Evidence http://drugwonks.com/blog/interchangeability-and-the-totality-of-evidence The American College of Rheumatologists’ position statement says that patients should be informed if they’re switched to biosimilars to cut costs and their physician should sign off on it. “Over time, biosimilars can save the health system billions, but only if they’re adopted and only if patients and clinicians and policymakers develop and support mechanisms that promote their adoption." Thu, 04 Aug 2016 14:10:09 -0400 http://drugwonks.com/blog/interchangeability-and-the-totality-of-evidence Bloomberg News Launches Fictional Series: Drug Companies Using Charities to Launder Money http://drugwonks.com/blog/bloomberg-news-launch-fictional-series-portraying-drug-companies-as-using-patients-to-launder-money Thu, 04 Aug 2016 11:06:58 -0400 http://drugwonks.com/blog/bloomberg-news-launch-fictional-series-portraying-drug-companies-as-using-patients-to-launder-money PhRMA and BIO put Off-Label on the Table http://drugwonks.com/blog/phrma-abd-bio-put-off-label-on-the-table In a set of joint principles, BIO and PhRMA emphasized that companies should be able to communicate "truthful, non-misleading" information outside of an FDA-approved label to insurance providers, PBMs and government healthcare programs as they consider reimbursement decisions. Thu, 28 Jul 2016 06:57:41 -0400 http://drugwonks.com/blog/phrma-abd-bio-put-off-label-on-the-table CDRH and Real World Evidence http://drugwonks.com/blog/cdrh-and-real-world-evidence In a new draft guidance, FDA outlined its thinking on the use of real-world evidence in making regulatory decisions about medical devices. The agency described factors it would consider when evaluating the relevance, reliability and quality of real-world evidence, and suggests when it might use such data to make decisions about devices. Wed, 27 Jul 2016 06:10:52 -0400 http://drugwonks.com/blog/cdrh-and-real-world-evidence Associated Press Excludes Facts in Medicare Drug Spending Article http://drugwonks.com/blog/associated-press-excludes-facts-in-medicare-drug-spending-article Why is the AP hiding the truth of drug prices? Tue, 26 Jul 2016 13:06:24 -0400 http://drugwonks.com/blog/associated-press-excludes-facts-in-medicare-drug-spending-article RWE: The times they are a (slowly) changin' http://drugwonks.com/blog/rwe-the-times-they-are-a-slowly-changin Per the FDA’s PDUFA VI "commitment letter," the agency will face some real world deadlines to advance the use of real world evidence. But, since we’re dealing with the real world, let’s get real – guidance is unlikely until the end of 2022 at the earliest. (That's the timeline agreed to via the PDUFA VI negotiations.) Mon, 25 Jul 2016 15:44:22 -0400 http://drugwonks.com/blog/rwe-the-times-they-are-a-slowly-changin ICER Hires More Human Shields For Rationing http://drugwonks.com/blog/icer-hires-more-human-shields-for-rationing ICER recruits true believers of price controls and rationing to pose as patient advocates Fri, 22 Jul 2016 15:34:01 -0400 http://drugwonks.com/blog/icer-hires-more-human-shields-for-rationing