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) JAMA Publishes Fake Science Study of Industry Influence of Patient Groups http://drugwonks.com/blog/jama-publishes-fake-science-study-of-industry-influence-of-patient-groups Closer to libel than truth Fri, 20 Jan 2017 08:11:47 -0500 http://drugwonks.com/blog/jama-publishes-fake-science-study-of-industry-influence-of-patient-groups Off Label back on the table http://drugwonks.com/blog/off-label-back-on-the-table FDA has released two new documents that address off-label communications about medical products. A draft guidance outlined questions and answers regarding communication with payers about healthcare economic information, including information concerning unapproved uses of medical products. A separate memorandum described the agency's position on sharing information about off-label use of approved drugs. Thu, 19 Jan 2017 00:56:58 -0500 http://drugwonks.com/blog/off-label-back-on-the-table FDA marches towards interchangeability http://drugwonks.com/blog/fda-marches-towards-interchangeability The FDA’s new draft guidance on interchangeability of biosimilars will require most biosimilars' sponsors to conduct studies showing that switching between a biosimilar and its reference product poses no greater risk than continuing to use the reference product. The guidance recommended designs for switching studies, as well as integrated trials to show that a compound is both biosimilar to and interchangeable with its reference biologic. Tue, 17 Jan 2017 23:45:42 -0500 http://drugwonks.com/blog/fda-marches-towards-interchangeability Trump Can Reduce Drug Prices Without Price Controls http://drugwonks.com/blog/trump-can-reduce-drug-prices-without-price-controls Tue, 17 Jan 2017 11:33:59 -0500 http://drugwonks.com/blog/trump-can-reduce-drug-prices-without-price-controls And the word on biosimilar nomenclature is ... Suffix http://drugwonks.com/blog/and-the-word-on-biosimilar-nomenclature-is-suffix In final guidance released Thursday on naming of biologic drugs, FDA reiterated that each biologic should receive a non-proprietary "core name" plus a unique four-letter suffix that is devoid of meaning. Each biologic and biosimilar would receive a hyphenated "proper name" joining the core name with the suffix. Fri, 13 Jan 2017 08:09:55 -0500 http://drugwonks.com/blog/and-the-word-on-biosimilar-nomenclature-is-suffix Trump’s Anti-Vaccine Views Rooted in Media's Fake Science http://drugwonks.com/blog/trump-s-anti-vaccine-views-rooted-in-media-s-fake-science Thu, 12 Jan 2017 13:55:26 -0500 http://drugwonks.com/blog/trump-s-anti-vaccine-views-rooted-in-media-s-fake-science Deadly Swap: PBMs, Health Plan Drug Switching To Save Money http://drugwonks.com/blog/deadly-swap-pbms-health-plan-drug-switching-to-save-money Insurers hurt patients by switching drugs to save money. Mon, 09 Jan 2017 10:57:55 -0500 http://drugwonks.com/blog/deadly-swap-pbms-health-plan-drug-switching-to-save-money The Perennial Political Poppycock of Drug Importation http://drugwonks.com/blog/the-perennial-political-poppycock-of-drug-importation The truth does not cease to be the truth because it isn't politically expedient. Thu, 05 Jan 2017 08:10:29 -0500 http://drugwonks.com/blog/the-perennial-political-poppycock-of-drug-importation Keep the Feds out of Drug Pricing http://drugwonks.com/blog/keep-the-feds-out-of-drug-pricing Allowing the federal government to negotiate drug prices, as suggested by Minnesota Sen. Amy Klobuchar’s column “Let’s work with Trump to reduce drug prices,” would result in prices going up and patient choice going down. Tue, 20 Dec 2016 07:32:56 -0500 http://drugwonks.com/blog/keep-the-feds-out-of-drug-pricing Solving for Drug Prices Exacts A High Human Cost http://drugwonks.com/blog/solving-for-drug-prices-exacts-a-high-human-cost Taming cancer drug prices will come at a heavy human cost Fri, 16 Dec 2016 11:43:30 -0500 http://drugwonks.com/blog/solving-for-drug-prices-exacts-a-high-human-cost New FDA Commisioner: Change Agent, not Bomb Thrower http://drugwonks.com/blog/new-fda-commisioner-change-agent-not-bomb-thrower "It is important for the commissioner to be a change agent, not a bomb thrower," Thu, 15 Dec 2016 08:21:29 -0500 http://drugwonks.com/blog/new-fda-commisioner-change-agent-not-bomb-thrower ​21st Century Cures could be the tipping point for Alzheimer’s research http://drugwonks.com/blog/21st-century-cures-could-be-the-tipping-point-for-alzheimer-s-research Wed, 14 Dec 2016 17:35:34 -0500 http://drugwonks.com/blog/21st-century-cures-could-be-the-tipping-point-for-alzheimer-s-research Gray Goose http://drugwonks.com/blog/gray-goose As Abraham Lincoln said, “Patents add the fuel of interest to the passion of genius.” Wed, 14 Dec 2016 09:08:45 -0500 http://drugwonks.com/blog/gray-goose "Elusive" RWE http://drugwonks.com/blog/elusive-rwe A great deal of work will be required to pave the road for the use of real world evidence in regulatory decisions, wrote FDA Commissioner Robert Califf and 14 other FDA staff members in a commentary published Thursday in the New England Journal of Medicine. The article sets a tone of caution just as the 21st Century Cures Act and PDUFA reauthorization goals commit the agency to create a framework for the use of real-world evidence to make decisions about post-approval studies of drugs and their approval in supplementary indications. Thu, 08 Dec 2016 22:10:17 -0500 http://drugwonks.com/blog/elusive-rwe So-called Progressives vs Medical Progress http://drugwonks.com/blog/so-called-progressives-vs-medical-progress Thu, 08 Dec 2016 22:05:57 -0500 http://drugwonks.com/blog/so-called-progressives-vs-medical-progress Who's next for the White Oak corner office? http://drugwonks.com/blog/who-s-next-for-the-white-oak-corner-office Who might be the next FDA Commissioner? Wed, 07 Dec 2016 22:09:41 -0500 http://drugwonks.com/blog/who-s-next-for-the-white-oak-corner-office WSJ Gets It Half Right On Drug Prices http://drugwonks.com/blog/wsj-gets-it-half-right-on-drug-prices Competition is about innovating to increase profits, not about lowering prices. Wed, 07 Dec 2016 11:25:10 -0500 http://drugwonks.com/blog/wsj-gets-it-half-right-on-drug-prices 21st Century Cures: PDUFA Jr. or PDUFA Plus? http://drugwonks.com/blog/21st-century-cures-pdufa-jr-or-pdufa-plus The 21st Century Cures Act provides a legal foundation for regulatory innovations including approving supplemental indications based on real-world evidence and approving antimicrobial drugs for limited populations. The bill also would help FDA recruit and retain staff by creating mechanisms for it to pay salaries that are competitive with those offered in the private sector. Other key provisions include ... Wed, 07 Dec 2016 02:03:30 -0500 http://drugwonks.com/blog/21st-century-cures-pdufa-jr-or-pdufa-plus Two Patients Overcome Illness To Take On ICER http://drugwonks.com/blog/two-patients-overcome-illness-to-take-on-icer Sun, 20 Nov 2016 23:48:11 -0500 http://drugwonks.com/blog/two-patients-overcome-illness-to-take-on-icer CREATES Act should be created equal http://drugwonks.com/blog/creates-act-should-be-created-equal Lawmakers are pushing forward with the Creating and Restoring Equal Access to Equivalent Samples (Creates) Act. The bill’s sponsors hope a series of new legal provisions will make it easier for drug companies to introduce generic alternatives, thus spurring competition and bringing down prices. The bill is well-intentioned. Unfortunately, it’s also worded extremely poorly. Instead of bringing generics to market sooner, the bill could endanger patients’ lives and encourage costly, needless litigation. Tue, 15 Nov 2016 08:28:58 -0500 http://drugwonks.com/blog/creates-act-should-be-created-equal