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) Making Drug Manufacturing Great Again http://drugwonks.com/blog/making-drug-manufacturing-great-again President Trump wants to lower drug prices and reinvigorate domestic pharmaceutical manufacturing. Bravo. But standing in the way is the inside-the-Beltway gospel that preaches that regulators love ambiguity. Fri, 21 Apr 2017 13:25:53 -0400 http://drugwonks.com/blog/making-drug-manufacturing-great-again DTC Fair Balance ... for Lawyers! http://drugwonks.com/blog/dtc-fair-balance-for-lawyers House Judiciary Committee Chairman, Rep. Bob Goodlatte (R/VA.) wants drug side-effect ads that are run by lawyers to include a warning that patients should talk with their doctors before adjusting medication. Mon, 17 Apr 2017 09:19:34 -0400 http://drugwonks.com/blog/dtc-fair-balance-for-lawyers PDUFA Reauthorization. Discuss. http://drugwonks.com/blog/pdufa-reauthorization-discuss WASHINGTON, DC – The leaders of the Senate and House health committees today released a discussion draft of bipartisan legislation reauthorizing the Food and Drug Administration user fee agreements. Fri, 14 Apr 2017 17:54:01 -0400 http://drugwonks.com/blog/pdufa-reauthorization-discuss PIE Day http://drugwonks.com/blog/pie-day It's time to go beyond FDAMA 114. It's time for PIE. Wed, 12 Apr 2017 07:47:26 -0400 http://drugwonks.com/blog/pie-day Expediting Complex Geneics http://drugwonks.com/blog/expediting-complex-geneics It's not about speed, it's about predictability. Thu, 06 Apr 2017 09:18:48 -0400 http://drugwonks.com/blog/expediting-complex-geneics PV in the EU: Can the Doctor See You Now? http://drugwonks.com/blog/pv-in-the-eu-can-the-doctor-see-you-now European, national, and regional authorities should invest in awareness-raising campaigns to increase public knowledge about medicinal safety and adverse drug reaction (ADR) reporting. Thu, 06 Apr 2017 06:57:43 -0400 http://drugwonks.com/blog/pv-in-the-eu-can-the-doctor-see-you-now Scott STAT! http://drugwonks.com/blog/scott-stat “I think Scott is very much for good regulation, and very much against bad regulation,” Pitts said. “Importantly, he recognizes where FDA core mission stops, and where mission creep begins — and that’s an important finesse he’d bring to the commissioner’s chair.” Wed, 05 Apr 2017 22:05:01 -0400 http://drugwonks.com/blog/scott-stat Arizona and Off-Label. Heart in the right place. Brain -- not so much. http://drugwonks.com/blog/arizona-and-off-label-heart-in-the-right-place-brain-not-so-much In what some observers are calling a misguided effort, Arizona has become the first state in the nation to pass a law allowing drug makers to promote their medicines for so-called off-label uses — so long as the information given doctors is truthful. Thu, 30 Mar 2017 10:11:45 -0400 http://drugwonks.com/blog/arizona-and-off-label-heart-in-the-right-place-brain-not-so-much STAT News Tangled Treatment of Scott Gottlieb http://drugwonks.com/blog/stat-news-tangled-treatment-of-scott-gottlieb Wed, 29 Mar 2017 12:29:13 -0400 http://drugwonks.com/blog/stat-news-tangled-treatment-of-scott-gottlieb ICER Devalues People With Rheumatoid Arthritis http://drugwonks.com/blog/icer-devalues-people-with-rheumatoid-arthritis Wed, 29 Mar 2017 11:02:53 -0400 http://drugwonks.com/blog/icer-devalues-people-with-rheumatoid-arthritis Limpid Lipids http://drugwonks.com/blog/limpid-lipids Nothing is more illustrative of the price/value discussion than PCSK9s. Just what are they worth? What's innovation worth? Tue, 28 Mar 2017 10:25:13 -0400 http://drugwonks.com/blog/limpid-lipids Fake DTC news mustn't drive the healthcare debate http://drugwonks.com/blog/fake-dtc-news-mustn-t-drive-the-healthcare-debate When pundits, politicians, and policymakers speak about “sales and marketing,” the picture they are painting is of direct-to-consumer pharmaceutical advertising – the public face of Big Pharma. So, let’s set the record straight on that straight away. In 2016 $5.6 billion was spent on DTC. Same period R&D spending is roughly $70 billion. Amorous middle-aged couples in claw foot bathtubs are a lot sexier than excel spreadsheets, but facts as pesky things. Surprised? Mon, 27 Mar 2017 09:57:34 -0400 http://drugwonks.com/blog/fake-dtc-news-mustn-t-drive-the-healthcare-debate De-Commissioning Drug Importation http://drugwonks.com/blog/de-commissioning-drug-importation Four former FDA commissioners warn that proposals to allow importation of pharmaceuticals would create serious risks for consumer and patients, and would produce only minimal savings. Fri, 17 Mar 2017 07:35:01 -0400 http://drugwonks.com/blog/de-commissioning-drug-importation The Worst Drug Cost Article of the Year http://drugwonks.com/blog/the-worst-drug-cost-article-of-the-year Thu, 16 Mar 2017 10:31:20 -0400 http://drugwonks.com/blog/the-worst-drug-cost-article-of-the-year Wyden the PBM Investigation http://drugwonks.com/blog/wyden-the-pbm-investigation The ranking member of the Senate Finance Committee will roll out a proposal today to lower drug costs by targeting prescription benefit managers (PBMS) — middlemen who negotiate discounts on drugs with pharma companies and administer prescription drug coverage for health insurance companies. Wed, 15 Mar 2017 08:47:31 -0400 http://drugwonks.com/blog/wyden-the-pbm-investigation Scott Gottlieb: The Patient's FDA Commissioner http://drugwonks.com/blog/scott-gottlieb-the-patient-s-fda-commissioner Tue, 14 Mar 2017 11:26:41 -0400 http://drugwonks.com/blog/scott-gottlieb-the-patient-s-fda-commissioner Fighting Opioid Abuse with Regulatory Clarity http://drugwonks.com/blog/fighting-opioid-abuse-with-regulatory-clarity At the recent abuse deterrent opioids summit, CDER Deputy Director for Regulatory Programs Dr. Doug Throckmorton presented the FDA’s position. He said, “We must move on from older to newer technologies. Amen. But how? Tue, 14 Mar 2017 08:41:06 -0400 http://drugwonks.com/blog/fighting-opioid-abuse-with-regulatory-clarity Scott Gottlieb in the Pink (Sheet) http://drugwonks.com/blog/scott-gottlieb-in-the-pink-sheet Former deputy commissioner will also likely push increased use of biomarkers and more flexibility in off-label communication, among other reforms. President Donald Trump's choice of Scott Gottlieb to head the US FDA could signal efforts to bring reforms among a variety of fronts, perhaps none more notable than how the agency approves generic drugs. Mon, 13 Mar 2017 10:18:46 -0400 http://drugwonks.com/blog/scott-gottlieb-in-the-pink-sheet The Drug Pricing Ecosystem -- A NY State of Mind http://drugwonks.com/blog/the-drug-pricing-ecosystem-a-ny-state-of-mind Governor Cuomo’s budget aims to control drug pricing through price controls . While this is a good political sound bite, it’s bad public policy with dangerous unintended consequences – the worst of being that it won't lower prices but will reduce patient choice. Thu, 09 Mar 2017 07:53:52 -0500 http://drugwonks.com/blog/the-drug-pricing-ecosystem-a-ny-state-of-mind Bipartisan Sanity on Healthcare Transparency http://drugwonks.com/blog/bipartisan-sanity-on-healthcare-transparency Finally, some bipartisan sanity on healthcare transparency. Representatives Doug Collins (R-GA), Buddy Carter (R-GA), Dan Loebsack (D-IA), John Sarbanes (D-MD) and John Duncan (R-TN) have introduced the Prescription Drug Price Transparency Act. Mon, 06 Mar 2017 08:43:15 -0500 http://drugwonks.com/blog/bipartisan-sanity-on-healthcare-transparency