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) Trumping FDA? http://drugwonks.com/blog/trumping-fda President Trump’s FY18 FDA budget request envisions cutting medical product safety funding by $17.8 million. The cuts would reduce the agency’s ability to ensure the safety of imported drugs and ingredients, and to conduct safety research the agency characterizes as “critical.”
FDA stated that the budget proposal would also curtail "proactive" activities to respond to global disease outbreaks. Thu, 25 May 2017 06:20:16 -0400 http://drugwonks.com/blog/trumping-fda Off-Label Use: TIme Marches On http://drugwonks.com/blog/off-label-use-time-marches-on In a recent Washington Post op-ed, Bill Schultz, the former deputy commissioner for policy of the Food and Drug Administration during the Clinton administration, incredulously offers that FDA policies developed 50 years ago are good enough for life in the 21st century (Trump’s new FDA commissioner has a huge decision to make). He’s wrong. Sat, 20 May 2017 12:04:50 -0400 http://drugwonks.com/blog/off-label-use-time-marches-on No HELP http://drugwonks.com/blog/no-help It’s disappointing to say the least when our fine elected representatives place scoring transient political points in front of advancing the public health. Such is always the case with the perennial non-starter issue of drug importation. What makes it even more dangerous this time is how it could delay swift and clean PDUFA approval. Tue, 09 May 2017 18:02:34 -0400 http://drugwonks.com/blog/no-help FDA, JAMA, PV, RWE and other relevant acronyms http://drugwonks.com/blog/fda-jama-pv-rwe-and-other-relevant-acronyms Nearly one third of drugs newly approved by the US Food and Drug Administration (FDA) are affected by safety issues that were not known at the time of approval, a study has shown. Tue, 09 May 2017 14:54:35 -0400 http://drugwonks.com/blog/fda-jama-pv-rwe-and-other-relevant-acronyms BCBSA BS on Rx http://drugwonks.com/blog/bcbsa-bs-on-rx Tue, 09 May 2017 13:26:15 -0400 http://drugwonks.com/blog/bcbsa-bs-on-rx From the FDA.ke News Desk http://drugwonks.com/blog/from-the-fda-ke-news-desk In the wake of the unraveling scandal surrounding the agency’s television viewing habits, CDRH spokesperson Teng Kay has denied allegations they have been instructed by “unconfirmed alien contact” to reclassify TV remotes as Class II Medical devices. In a related story, Acting FDA Commissioner Rupert Murdoch has issued a list of “breakthrough therapy” entertainment for recommended viewing. The list is said to include: ANDA and the King of Siam, Complete Response Letters from Iwo Jima, and Fahrenheit 453. All programming has been deemed truthful, accurate, and non-misleading by the Shkreli Institute for Ethical Studies. Sat, 06 May 2017 15:31:42 -0400 http://drugwonks.com/blog/from-the-fda-ke-news-desk ICER’s GIGO http://drugwonks.com/blog/icer-s-gigo Fri, 05 May 2017 15:58:53 -0400 http://drugwonks.com/blog/icer-s-gigo QunitilesIMS Data to Digest http://drugwonks.com/blog/qunitilesims-data-to-digest The QuintilesIMS Institute has issued a very interesting new report, “Medicines Use and Spending in the US: A Review of 2016 and Outlook to 2021.” It’s a must-read for many reasons – not the least of which is its plethora of data. Fri, 05 May 2017 08:06:25 -0400 http://drugwonks.com/blog/qunitilesims-data-to-digest Dear Colleague: Let's Put Off-Label on the Legislative Table http://drugwonks.com/blog/dear-colleague-let-s-put-off-label-on-the-legislative-table Representative Morgan Griffith (R/VA) has introduced HR 1703, the Medical Product Communications Act. It’s legislation that would take a lot of the ambiguity out of the FDA’s biggest conundrum – regulatory clarity on the sharing of truthful accurate, and non-misleading off-label information. Thu, 04 May 2017 18:03:03 -0400 http://drugwonks.com/blog/dear-colleague-let-s-put-off-label-on-the-legislative-table The Dubai Declaration http://drugwonks.com/blog/the-dubai-declaration When it comes to 21st century pharmacovigilance, sometimes it’s important to look … backwards. According to the 10th century Arab physician, Ibn Sina, “The time of action must be observed, so that essence and accident are not confused.” Wed, 03 May 2017 08:58:13 -0400 http://drugwonks.com/blog/the-dubai-declaration Scott Gottlieb: Hope Over Hate http://drugwonks.com/blog/scott-gottlieb-hope-over-hate Thu, 27 Apr 2017 11:18:46 -0400 http://drugwonks.com/blog/scott-gottlieb-hope-over-hate 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