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) ICER's Moral Vision: Repair Potholes Instead of Rescuing Lung Cancer Patients http://drugwonks.com/blog/icer-s-moral-vision-repair-potholes-instead-of-rescuing-lung-cancer-patients Thu, 23 Jun 2016 15:34:09 -0400 http://drugwonks.com/blog/icer-s-moral-vision-repair-potholes-instead-of-rescuing-lung-cancer-patients CREATing a generic "get out of jail free" card http://drugwonks.com/blog/creating-a-generic-get-out-of-jail-free-card CREATES Act a “get out of jail free card” for generics makers. Thu, 23 Jun 2016 15:03:47 -0400 http://drugwonks.com/blog/creating-a-generic-get-out-of-jail-free-card JAMA Peddles Rx Payment Propaganda Posing as Research http://drugwonks.com/blog/jama-peddles-rx-payment-propaganda-posing-as-research Wed, 22 Jun 2016 17:35:21 -0400 http://drugwonks.com/blog/jama-peddles-rx-payment-propaganda-posing-as-research The CREATES Act: Avoiding Unintended Consequences and Hidden Agendas http://drugwonks.com/blog/the-creates-act-avoiding-unintended-consequences-and-hidden-agendas The road to Hell is paved with good intentions -- and often hidden agendas. More careful consideration needs to be inserted into the CREATES Act design so that it more clearly addressed its intent and avoids unintended consequences or hidden agendas. Patient safety, public health, and healthcare innovation mustn't become innocent victims. Mon, 20 Jun 2016 06:49:59 -0400 http://drugwonks.com/blog/the-creates-act-avoiding-unintended-consequences-and-hidden-agendas Besmirching White Oak http://drugwonks.com/blog/besmirching-white-oak A very upsetting story about an FDA official who sold information to an investor. This person should go to jail. For a long stretch. For shame. Thu, 16 Jun 2016 09:11:26 -0400 http://drugwonks.com/blog/besmirching-white-oak ICER: A Cancer Survivor/Marathon Runner's Perspective http://drugwonks.com/blog/icer-a-cancer-survivor-marathon-runner-s-perspective ICER guidelines violate the Hippocratic Oath Wed, 15 Jun 2016 15:27:14 -0400 http://drugwonks.com/blog/icer-a-cancer-survivor-marathon-runner-s-perspective When it comes to Biosimilars -- Knowledge is Safety http://drugwonks.com/blog/when-it-comes-to-biosimilars-knowledge-is-safety Safety and trust are exactly why transparency-in-labeling is needed. As Sumant Ramachandra, Senior Vice President & Chief Scientific Officer at Pfizer’s Hospira unit, has said, “Communications fosters confidence.” Tue, 14 Jun 2016 06:15:03 -0400 http://drugwonks.com/blog/when-it-comes-to-biosimilars-knowledge-is-safety TIme to wake up to Antibiotic Resistance http://drugwonks.com/blog/time-to-wake-up-to-antibiotic-resistance For the first time, a person in the U.S. has been infected with bacteria resistant to an antibiotic used as a last resort. The woman, who is from Pennsylvania, is recovering after it was discovered she was carrying a strain of E. coli resistant to the antibiotic colistin. But public officials say this should serve as a wake-up call for everyone. Fri, 10 Jun 2016 14:32:59 -0400 http://drugwonks.com/blog/time-to-wake-up-to-antibiotic-resistance Peter Loftus Lead Astray By ICER On Cancer Drug Costs http://drugwonks.com/blog/peter-loftus-lead-astray-by-steve-pearson Once again, ICER combines factoids with fiction to claim new drugs are too expensive. Tue, 07 Jun 2016 15:30:56 -0400 http://drugwonks.com/blog/peter-loftus-lead-astray-by-steve-pearson Serepta and the Final Furlong http://drugwonks.com/blog/serepta-and-the-final-furlong Sarepta Therapeutics said the U.S. Food and Drug Administration has requested for additional data from an ongoing study for its muscle-wasting treatment as the agency decides whether to approve the drug or not. "We believe there is a good chance these data will demonstrate required dystrophin production and recommend shares ahead of a regulatory decision, which could come in 2016," they said in a note to clients. Tue, 07 Jun 2016 13:30:43 -0400 http://drugwonks.com/blog/serepta-and-the-final-furlong Expediting Expanded Access http://drugwonks.com/blog/expediting-expanded-access The FDA clarified its expanded access policies in a series of documents including a Q&A that outlines the process of obtaining expanded access, guidance that describes how companies may charge for therapies given under expanded access programs, and a new form to request access to investigational drugs.
FDA Commissioner Robert Califf said the agency hoped to simplify and streamline the process to reduce "procedural burdens on physicians and patients." Fri, 03 Jun 2016 08:35:11 -0400 http://drugwonks.com/blog/expediting-expanded-access ICER Involved in Unlawful Hep C Drug Rationing Scheme? http://drugwonks.com/blog/icer-involved-in-unlawful-hep-c-drug-rationing-scheme Thu, 02 Jun 2016 13:48:53 -0400 http://drugwonks.com/blog/icer-involved-in-unlawful-hep-c-drug-rationing-scheme It's the Volume Stupid..and the Rebates http://drugwonks.com/blog/it-s-the-volume-stupid-and-the-rebates Most media accounts miss the important impact of insurer imposed cost sharing Thu, 02 Jun 2016 13:09:39 -0400 http://drugwonks.com/blog/it-s-the-volume-stupid-and-the-rebates ASCO Value Task Force Takes Two Steps Towards Patients, Slaps ICER, Abacus http://drugwonks.com/blog/asco-value-task-takes-two-steps-towards-patients-slaps-icer-abacus Wed, 01 Jun 2016 12:09:07 -0400 http://drugwonks.com/blog/asco-value-task-takes-two-steps-towards-patients-slaps-icer-abacus ICER's Multiple Myeloma Treatment Evaluation Regards Patients As Side Effects http://drugwonks.com/blog/icer-s-multiple-myeloma-treatment-evaluation-regards-patients-as-side-effects Tue, 31 May 2016 18:30:18 -0400 http://drugwonks.com/blog/icer-s-multiple-myeloma-treatment-evaluation-regards-patients-as-side-effects Off-Label Intramural http://drugwonks.com/blog/off-label-intramural “HHS leadership doesn’t trust industry to do the right thing … HHS leadership believes off-label speech will lead to more aggressive marketing of new products that will raise costs to [Medicare and Medicaid]. They are allowing both their prejudices [industry as the bad guy] and priorities [keeping spending down] to get in the way … The White House shares these fears, and as a result the FDA’s desire to issue guidance is stymied.” Tue, 31 May 2016 07:22:03 -0400 http://drugwonks.com/blog/off-label-intramural After the ICER Storm http://drugwonks.com/blog/after-the-icer-storm Blind Misleading the Blind Fri, 27 May 2016 15:27:10 -0400 http://drugwonks.com/blog/after-the-icer-storm 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