Welcome to the New Drugwonks.com http://drugwonks.com/index DrugWonks.com | Debating Today's Drugs Policies en-us Thu, 06 Sep 2007 09:55:48 -0500 Sat, 03 Aug 2013 11:20:34 -0500 http://blogs.law.harvard.edu/tech/rss Psyclone WMS 4.4.9 info@drugwonks.com (drugwonks) cpernice@psycloneinc.com (Christopher Pernice) Much ado about the WHO biosimilar review http://drugwonks.com/blog/much-ado-about-the-who-biosimilar-review New biosimilar working paper from the WHO. (PROPOSED ADDENDUM TO: WHO TRS 987, Annex 4. Guidelines on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant DNA technology APPENDIX 7. REGULATORY) Wed, 29 Jul 2015 05:52:01 -0500 http://drugwonks.com/blog/much-ado-about-the-who-biosimilar-review Putting Part D Spending in Perspective http://drugwonks.com/blog/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 Tue, 28 Jul 2015 16:57:45 -0500 http://drugwonks.com/blog/putting-part-d-spending-in-perspective Transforming Medicine: The Elizabeth Kauffman Institute Launched to Match People with Life-Threatening Illnesses to the Best Treatments in Real Time http://drugwonks.com/blog/transforming-medicine-the-elizabeth-kauffman-institute-launched-to-match-people-with-life-threatening-illnesses-to-the-best-treatments-in-real-time CMPI is proud to be part of this new effort to turn the phrase patient-centered drug development into reality. Mon, 27 Jul 2015 13:35:16 -0500 http://drugwonks.com/blog/transforming-medicine-the-elizabeth-kauffman-institute-launched-to-match-people-with-life-threatening-illnesses-to-the-best-treatments-in-real-time Cancer Docs Price Control Prescription Is Misinformed http://drugwonks.com/blog/cancer-docs-price-control-prescription-is-misinformed Cancer docs claim drug prices are too high and that price controls are the answer..Wrong on both counts Mon, 27 Jul 2015 10:43:04 -0500 http://drugwonks.com/blog/cancer-docs-price-control-prescription-is-misinformed Price vs. Value: The Story and the Rest of the Story http://drugwonks.com/blog/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." Mon, 27 Jul 2015 10:41:48 -0500 http://drugwonks.com/blog/price-vs-value-the-story-and-the-rest-of-the-story Price vs. Value. A Distinction with a Difference http://drugwonks.com/blog/price-vs-value-a-distinction-with-a-difference Per Drug Prices Soar, Prompting Calls for Justification (NYT, July 23, 2015), while opaque and seemingly arbitrary drug pricing deserves immediate attention, the value of innovation must not be ignored. Fri, 24 Jul 2015 11:02:48 -0500 http://drugwonks.com/blog/price-vs-value-a-distinction-with-a-difference Medical Journals Are Practicing Economics Without A License http://drugwonks.com/blog/medical-journals-are-practicing-economics-without-a-license When doctors practice economics it can be hazardous to our health Wed, 22 Jul 2015 19:19:16 -0500 http://drugwonks.com/blog/medical-journals-are-practicing-economics-without-a-license Bam! FDAMN http://drugwonks.com/blog/bam-fdamn The pharmacenti were gathered. Policy experts, provider organizations and patient groups, industry, academics and FDA brass. The clock in the White Oak Great Room struck 9AM. The room fell silent. Smart phones were (mostly) on silent mode.Welcome to PDUFA VI.The first public meeting on reauthorization of the Prescription Drug User Fee Act (PDUFA) held few surprises but made it clear that this time around there will be more creative tension. Thu, 16 Jul 2015 10:56:25 -0500 http://drugwonks.com/blog/bam-fdamn "J" is for Janus http://drugwonks.com/blog/j-is-for-janus The Biosimilars Forum represents many of the leading voices against differential nomenclature -- except when it comes to Medicare coding. Fri, 10 Jul 2015 07:17:26 -0500 http://drugwonks.com/blog/j-is-for-janus The FDA's Quality Revolution http://drugwonks.com/blog/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.” Thu, 09 Jul 2015 08:18:08 -0500 http://drugwonks.com/blog/the-fda-s-quality-revolution ASCO Value Framework Belittles Cancer Patients Seeking Weeks or Months More of Life http://drugwonks.com/blog/asco-value-framework-belittles-cancer-patients-seeking-weeks-or-months-more-of-life Compare what ASCO thinks of the value of life to how Zach Sobieth measures it. Wed, 08 Jul 2015 13:42:22 -0500 http://drugwonks.com/blog/asco-value-framework-belittles-cancer-patients-seeking-weeks-or-months-more-of-life For FDA and Amarin, "Terrific" is in the eyes of the beholder http://drugwonks.com/blog/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. Wed, 08 Jul 2015 09:20:03 -0500 http://drugwonks.com/blog/for-fda-and-amarin-terrific-is-in-the-eyes-of-the-beholder Biosimilar Nomenclature? WHO Cares. http://drugwonks.com/blog/biosimilar-nomenclature-who-cares WHO further clarifies ‘biological qualifier’ system for naming biological active substances The fight over how to name biosimilars has taken a turn toward further clarification, with the WHO (World Health Organization) offering another, updated draft of its intended policy on "biological qualifiers" (BQ). Nearly identical to the previous draft , which the USP endorsed , the WHO says the BQ system would not just be for biosimilars but “all biological active substances.” The scheme would assign four random consonants to an active substance, but it would not replace the INN (international nonproprietary name) scheme. Instead it would support INNs to “better harmonise international pharmacovigilance efforts,” as well as to avoid the “proliferation of separate and distinct national qualifier systems.” Tue, 07 Jul 2015 07:07:06 -0500 http://drugwonks.com/blog/biosimilar-nomenclature-who-cares PDUFA VI -- Do Ask. Do Tell. http://drugwonks.com/blog/pdufa-vi-do-ask-do-tell Something that bothered me a lot about the Fifth Prescription Drug User Free Act (PDUFA V) was that when you asked people in industry, what does success look like to you, almost unanimously insiders said, “success means getting it done early and having it done clean.” That’s just punting on an amazing opportunity. If success means fast and clean, you miss the rare chance to bargain hard when the agency is really listening. Mon, 06 Jul 2015 19:33:11 -0500 http://drugwonks.com/blog/pdufa-vi-do-ask-do-tell Insurers’ Dirty Tricks Are Undermining a Central Promise of Obamacare http://drugwonks.com/blog/insurers-dirty-tricks-are-undermining-a-central-promise-of-obamacare HMOs Break Their Promise To Patients Fri, 26 Jun 2015 12:58:09 -0500 http://drugwonks.com/blog/insurers-dirty-tricks-are-undermining-a-central-promise-of-obamacare Temple of Wisdom or Wisdom of Temple? http://drugwonks.com/blog/temple-of-wisdom-or-wisdom-of-temple The FDA is taking steps toward getting more patient input during the drug development process, a move that puts the agency more in line with its EU counterparts, agency officials said at the DIA annual meeting. Thu, 25 Jun 2015 08:55:02 -0500 http://drugwonks.com/blog/temple-of-wisdom-or-wisdom-of-temple ASCO Cost Tool Abandons Hippocratic Oath and Cancer Patients http://drugwonks.com/blog/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 Wed, 24 Jun 2015 17:27:47 -0500 http://drugwonks.com/blog/asco-cost-tool-abandons-hippocratic-oath-and-cancer-patients Bass Hole http://drugwonks.com/blog/bass-hole The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office has accepted a request from Celgene to consider sanctions against the Coalition for Affordable Drugs, an entity controlled by hedge fund manager Kyle Bass. Mon, 22 Jun 2015 05:09:02 -0500 http://drugwonks.com/blog/bass-hole PDUFA VI -- Are you ready to rumble? http://drugwonks.com/blog/pdufa-vi-are-you-ready-to-rumble Did somebody say “PDUFA VI?” With the upcoming PDUFA renewal, 21st Century Cures uncertainty, and a leadership transition at FDA, it is a dynamic and uncertain time in the biopharma industry. The outcomes of these key policy debates, along with others, will impact how industry pursues drug development and works with patients and regulators to improve public health. Fri, 19 Jun 2015 09:48:02 -0500 http://drugwonks.com/blog/pdufa-vi-are-you-ready-to-rumble Biotech Investment, Sound Regulatory Policy, and Nazaha http://drugwonks.com/blog/biotech-investment-sound-regulatory-policy-and-nazaha At the recent BIO confab in Philly I was honored to moderate the panel on “Public Sector Biotech Initiatives in Middle East and North Africa.”A key take-away was that one of the key drivers of biotech investment in the region (and, indeed, any region) is sound regulatory policy. Thu, 18 Jun 2015 08:54:16 -0500 http://drugwonks.com/blog/biotech-investment-sound-regulatory-policy-and-nazaha