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) Rheums with a View http://drugwonks.com/blog/rheums-with-a-view Today the FDA’s Arthritis Advisory Committee heard presentations on whether or not the agency should approve a BLA from Celltrion Inc. for CT-P13, a biosimilar of Remicade infliximab from Johnson & Johnson. Despite open public comment from patients and physicans concerned about extrapolation issues, the vote was 21-3 in the affirmative. Tue, 09 Feb 2016 17:10:23 -0500 http://drugwonks.com/blog/rheums-with-a-view Opioids Minus the Politics http://drugwonks.com/blog/opioids-minus-the-politics If you're following the opioids debate and want to cut through the political rhetoric and get right to the meat of the policy debate, here's a conference you should plan on attending the Abuse-Deterrent Formulations Summit. Tue, 09 Feb 2016 10:29:10 -0500 http://drugwonks.com/blog/opioids-minus-the-politics Addressing Markey's Marker http://drugwonks.com/blog/salving-the-opioids-priblem Mon, 08 Feb 2016 10:53:55 -0500 http://drugwonks.com/blog/salving-the-opioids-priblem Biosimilar Sins of Omission http://drugwonks.com/blog/biosimilar-sins-of-omission On Friday, FDA posted briefing documents ahead of the Feb. 9 meeting of its Arthritis Advisory Committee to discuss a BLA from Celltrion Inc. for its CT-P13, a biosimilar of Remicade infliximab from Johnson and Johnson. What's just as interesting is what's not in the package. Mon, 08 Feb 2016 09:15:46 -0500 http://drugwonks.com/blog/biosimilar-sins-of-omission FDA's Opioid Manifesto http://drugwonks.com/blog/fda-s-opioid-manifesto The FDA has announced a far-reaching action plan to reassess the agency's approach to opioid medications. The plan will focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief. Importantly, the FDA's strategies and tactics are not adverse to the well-being of pain patients and avoid measures (such as mandatory advisory committees for abuse deterrent formulations) that would have the negative consequence of chilling investment in the science of abuse deterrence. Fri, 05 Feb 2016 07:49:20 -0500 http://drugwonks.com/blog/fda-s-opioid-manifesto Biosimilar BLA Blah Blah http://drugwonks.com/blog/biosimilar-bla-blah-blah Thu, 04 Feb 2016 09:13:23 -0500 http://drugwonks.com/blog/biosimilar-bla-blah-blah BIO's Value-Based Values http://drugwonks.com/blog/bio-s-value-based-values Thu, 04 Feb 2016 08:45:15 -0500 http://drugwonks.com/blog/bio-s-value-based-values The Real Story Is Generic Price Increases (Not Really) http://drugwonks.com/blog/the-real-story-is-generic-price-increases-not-really Wed, 03 Feb 2016 13:20:23 -0500 http://drugwonks.com/blog/the-real-story-is-generic-price-increases-not-really Drug Price Reporting Reaches New Low http://drugwonks.com/blog/drug-price-reporting-reaches-new-low Wed, 03 Feb 2016 11:58:47 -0500 http://drugwonks.com/blog/drug-price-reporting-reaches-new-low Compound Fracture http://drugwonks.com/blog/compound-fracture Mark Baum’s self serving op-ed in the Wall Street Journal (New Prescription for Lower Drug Prices) that compounded drug makers can bring inexpensive, off patent medicines to market, “if the FDA will let them” omits a key issue in the debate, public safety. Mon, 01 Feb 2016 06:16:37 -0500 http://drugwonks.com/blog/compound-fracture Hoosier Healthcare Hospitality http://drugwonks.com/blog/healthcare-hoosier-hospitality Sleeping with the Enemy? Hardly. Eli Lilly and Co. has announced an important collaboration with an unlikely bedfellow, their Hoosier neighbor, Anthem. The goal is to help develop common ground on policy solutions related to cost and value. Finally, two important players understand that they are, in fact, on the same team. Sat, 30 Jan 2016 09:21:47 -0500 http://drugwonks.com/blog/healthcare-hoosier-hospitality Wockhardt and get ahead? http://drugwonks.com/blog/wockhardt-and-get-ahead Indian drugmaker Wockhardt hid the results of failed tests and deleted data from its systems at a plant in western India, according to a report by the U.S. Food and Drug Administration. Sat, 30 Jan 2016 08:28:11 -0500 http://drugwonks.com/blog/wockhardt-and-get-ahead Califf feels The Berne http://drugwonks.com/blog/califf-feels-the-berne If Senator Sanders thinks that having one of our nation's keenest clinical trial design experts working with industry is a reason to place a hold on his nomination, then it's time for him to step back and reconsider his position. When it comes to clinical trials that investigate safety and efficacy, we can't afford to use only the second best and almost brightest. Wed, 27 Jan 2016 08:11:23 -0500 http://drugwonks.com/blog/califf-feels-the-berne The Biosimilar Qualifier http://drugwonks.com/blog/the-biosimilar-qualifier The World Health Organization has posted a final version of its proposed biologics naming policy. Wed, 27 Jan 2016 07:32:54 -0500 http://drugwonks.com/blog/the-biosimilar-qualifier Friends with (Pharmacy) Benefits http://drugwonks.com/blog/friends-with-pharmacy-benefits A new report by the Pharmacy Benefit Management Institute (PBMI) makes some very interesting points about the value of PBMs to employers and employees. Here are some highlights. Tue, 26 Jan 2016 07:19:13 -0500 http://drugwonks.com/blog/friends-with-pharmacy-benefits Who Are the Real Data Parasites? http://drugwonks.com/blog/who-are-the-real-data-parasites Mon, 25 Jan 2016 14:41:52 -0500 http://drugwonks.com/blog/who-are-the-real-data-parasites CDER House Rules http://drugwonks.com/blog/cder-house-rules The recent mega-storm allowed many of us drugwonks to curl up with a new work of action non-fiction... from the FDA: Guidance Agenda: New and Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2016. It's worth perusing in its entirety, but here are a few items to tickle your regulatory palate: Mon, 25 Jan 2016 10:05:35 -0500 http://drugwonks.com/blog/cder-house-rules Markey's Mark http://drugwonks.com/blog/markey-s-mark Senator Edward Markey (D, MA) is using Senate rules to block the nomination of Rob Califf in an attempt to force the agency to rescind its approval of a prescription opioid for children and change its regulatory practices. Senator Markey is rightly concerned about opioids remaining atop the FDA's list of "must address" items. But his "hold" on the Califf nomination will, if anything, hold back the agency from making progress on this urgent issue. Mon, 25 Jan 2016 09:14:58 -0500 http://drugwonks.com/blog/markey-s-mark Turingfreude http://drugwonks.com/blog/turingfreude How to manage this out-of-control Turingfreude? One way is for the innovative pharmaceutical industry to do a better job communicating the value message (I know, this is a recording) and both PhRMA and BIO are preparing to ramp up their messaging efforts. This is important beyond the rhetoric of a political season since many states have transparency initiatives that can only be successfully argued through the lens of relentless science and the potency of value. Wed, 20 Jan 2016 09:15:57 -0500 http://drugwonks.com/blog/turingfreude BIO CEO Makes Case For Innovation http://drugwonks.com/blog/bio-ceo-makes-case-for-innovation Thu, 14 Jan 2016 13:29:05 -0500 http://drugwonks.com/blog/bio-ceo-makes-case-for-innovation