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) The Drug Shortage Ecosystem http://drugwonks.com/blog/the-drug-shortage-ecosystem The media frenzy surrounding drug shortages has vanished. Why? Because, due in no small measure to efforts from the FDA, the problem is being successfully addressed and ameliorated. Unfortunately, that’s not news – but it should be. Here are some interesting points. The FDA’s strategy in addressing the issue is to enlarge and empower a drug shortage ecosystem. Rather than seeking more Federal dollars (a fool’s errand), the FDA undertook to combine the resources of the constituent players, manufacturers, hospitals, and large-scale purchasers such as GPOs. Combined with appropriate and savvy use of enforcement discretion, the FDA has taken leadership of the drug shortage ecosystem and is driving a sustainable solution. Mon, 29 Sep 2014 07:37:04 -0500 http://drugwonks.com/blog/the-drug-shortage-ecosystem USP endorses INN suffix for biologics http://drugwonks.com/blog/usp-endorses-inn-suffix-for-biologics USP endorses INN suffix for biologics The U.S. Pharmacopeial Convention (USP) endorsed a draft World Health Organization (WHO) proposal to create a unique suffix for biologic drugs, including biosimilars. A WHO working group proposed a voluntary scheme to create unique identification codes, called "biological qualifiers," that would be distinct from international non-proprietary names (INN). The BQs would be random four-letter codes that would be linked in a WHO-maintained database to the product's INN, trade name, name and address of the manufacturer, and regulatory status. According to the WHO, the scheme could facilitate decision making about substitution and interchangeability and help regulators and physicians track patients' responses to products with the same INN. Thu, 25 Sep 2014 06:19:04 -0500 http://drugwonks.com/blog/usp-endorses-inn-suffix-for-biologics NICE in context http://drugwonks.com/blog/nice-in-context Superb analysis of the recent NICE draft technology appraisal against the use of Abraxane from the folks at Context Matters. Well worth the read. Tue, 23 Sep 2014 06:52:48 -0500 http://drugwonks.com/blog/nice-in-context The Continuing Battle for Innovation http://drugwonks.com/blog/the-continuing-battle-for-innovation Winston Churchill famously described an appeaser as "one who feeds a crocodile, hoping it will eat him last." Today, in a very different context, his remark captures the plight of the American pharmaceutical industry. Mon, 22 Sep 2014 08:36:40 -0500 http://drugwonks.com/blog/the-continuing-battle-for-innovation The Social Media Red Thread http://drugwonks.com/blog/the-social-media-red-thread Despite what you might think, the various actions and directives emanating from White Oak tell a very liner story with very steady red thread – and that thread is the difference between communications and marketing.To many in pharmaceutical company marketing and regulatory review departments it may seem a distinction without a difference. But that’s a fundamental misunderstanding of the FDA’s mindset when it comes to social media. As Casey Stengel used to say, “Let’s look at the record.” Thu, 18 Sep 2014 07:39:35 -0500 http://drugwonks.com/blog/the-social-media-red-thread Drug Quality and the Heart of Darkness http://drugwonks.com/blog/drug-quality-and-the-heart-of-darkness Can there be a floor and a ceiling for global drug safety and quality? Even as we move toward differential pricing, should we allow some countries to have lower standards than others “based on local situations?” When it comes to the safety of pharmaceuticals and medical devices, can one man’s ceiling be another man’s floor? Mon, 15 Sep 2014 18:31:57 -0500 http://drugwonks.com/blog/drug-quality-and-the-heart-of-darkness Getting serious about NBCDs http://drugwonks.com/blog/getting-serious-about-nbcds Let’s talk about Non-Biologic Complex Drugs (NBCD). If you look at the FDA’s recent actions relative to raising the issue of quality and performance of generic products and working with outside partners to seriously investigate the problem, you’d think that NBCDs are an obvious top of mind agenda item for the agency to consider and act on via Guidance. But, as with many difficult regulatory questions, predictability comes at the expense of ambiguity – and regulators have a penchant for embracing ambiguity. When it comes to NBCDs (as with so many other issues), predictability is power in pursuit of the public health. Sun, 14 Sep 2014 10:10:35 -0500 http://drugwonks.com/blog/getting-serious-about-nbcds Upton's Accelerated Pathway http://drugwonks.com/blog/upton-s-accelerated-pathway The fact-finding phase is over. At the September 10th 21st Century Cures Initiative roundtable, E and C Chairman Fred Upton (R/MI), said that committee staff will now begin developing draft legislation. “We intend to release a Cures legislative discussion draft in early January 2015 and will look to swiftly move the legislation early in the next Congress.” Sat, 13 Sep 2014 06:38:16 -0500 http://drugwonks.com/blog/upton-s-accelerated-pathway ASCO Continues Work On Rationing Cancer Drugs http://drugwonks.com/blog/asco-continues-work-on-rationing-cancer-drugs Are they dumb or playing dumb when it comes to 'me-too' drugs? Thu, 11 Sep 2014 13:42:14 -0500 http://drugwonks.com/blog/asco-continues-work-on-rationing-cancer-drugs The Golden Rule of Healthcare http://drugwonks.com/blog/the-golden-rule-of-healthcare The economics of American healthcare are dictated by the Golden Rule: "He who has the gold makes the rules.” And those rules reward corporate greed at the expense of physician empowerment and patient care. The gold in this case is the money leveraged by pharmacy benefit managers (PBMs) to reimburse patients for their medicines. And it’s a golden hammer used to negotiate lower prices from pharmaceutical companies. But where do those savings go, and what is the impact on a physician's ability to practice medicine and — most importantly, therapeutic outcomes for patients? Wed, 10 Sep 2014 06:36:48 -0500 http://drugwonks.com/blog/the-golden-rule-of-healthcare Janet and her purple crayon http://drugwonks.com/blog/janet-and-her-purple-crayone Welcome to “the Purple Book” – FDA’s “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.” Tue, 09 Sep 2014 14:18:01 -0500 http://drugwonks.com/blog/janet-and-her-purple-crayone Pain Point/Counterpoint http://drugwonks.com/blog/pain-point-counterpoint Lawsuits over marketing practices? “In asking this court to decide scientific and policy matters that fall squarely within the province of, and are currently being addressed by, the FDA, the city has jumped the gun by suing before the FDA has resolved those issues,” the defendants’ motion states. “As multiple courts have done, this court should dismiss or stay this action to allow the FDA to first address these matters within the framework it has defined and is currently implementing.” Tue, 09 Sep 2014 07:54:31 -0500 http://drugwonks.com/blog/pain-point-counterpoint Access to Innovation: Obstacles and Opportunities http://drugwonks.com/blog/access-to-innovation-obstacles-and-opportunities Healthcare innovation saves lives, saves money, promotes economic growth, and provides hope for hundreds of millions of people (both patients and care-givers) in the United States and around the world. But innovation isn’t easy. The issue of access to innovation is crucial – and the topic of a new paper from the Center for Medicine in the Public Interest, “Access to Medical Innovation: Obstacles and Opportunities.” Mon, 08 Sep 2014 05:48:26 -0500 http://drugwonks.com/blog/access-to-innovation-obstacles-and-opportunities The Fight Against Cancer http://drugwonks.com/blog/the-fight-against-cancer Fri, 05 Sep 2014 12:30:48 -0500 http://drugwonks.com/blog/the-fight-against-cancer Cognito ergo IPR http://drugwonks.com/blog/cognito-ergo-ipr The biggest roadblock to American pharmaceutical innovation isn’t science. It’s intellectual property rights. Drug companies are struggling to finance the research and development of new treatments. And their difficulties are being seriously exacerbated by some of America’s closest trading partners. Foreign officials are repeatedly violating basic intellectual property protections and siphoning away valuable investment capital. These abuses need to stop. The drug industry is a crucial part of the American economy. We can’t afford for it to cease innovating. Fri, 05 Sep 2014 12:00:04 -0500 http://drugwonks.com/blog/cognito-ergo-ipr Getting schooled on drug pricing http://drugwonks.com/blog/getting-schooled-on-drug-pricing Biopharma's brightest minds are hard at work discovering and developing breakthrough medicines. It will be a pitiful shame if patients are denied access because the industry's brightest marketing minds are not creative enough to devise models that will enable healthcare systems to pay for these transformations in healthcare. What industry needs are brave individual first-movers to get to work on new pricing models that will preempt a cost-plus system and preserve incentives for innovation. Thu, 04 Sep 2014 06:26:28 -0500 http://drugwonks.com/blog/getting-schooled-on-drug-pricing Raising the stakes for fakes http://drugwonks.com/blog/raising-the-stakes-for-fakes EU agents seize more than €10M worth of counterfeit drugs, arrest 12 Authorities from 8 European Union countries, backed by Europol and Eurojust, have arrested a dozen suspects and seized more than €10 million worth of counterfeit drugs, mostly fakes of erectile dysfunction drugs that an organized crime group was selling online. The raid, announced Monday, came after an investigation that lasted nearly two years. Wed, 03 Sep 2014 08:31:39 -0500 http://drugwonks.com/blog/raising-the-stakes-for-fakes The ultimate in regulated speech http://drugwonks.com/blog/the-ultimate-in-regulated-speech FDA's Center, for Drug Evaluation and Research (CDER) is searching for exceptional candidates for the position of Director of the Office of Communications (OCOMM). The Office currently has over 100 employees. OCOMM is the central hub for communication expertise, in CDER, focused on the development of consistent messaging to inform and educate the multiple audiences. The Office has a variety of responsibilities including the planning, coordination and evaluation of the policies, procedures, programs in the strategic outreach and communication about drug-related requests. Tue, 02 Sep 2014 11:34:00 -0500 http://drugwonks.com/blog/the-ultimate-in-regulated-speech FDA: Let's talk about pain http://drugwonks.com/blog/fda-let-s-talk-about-pain Much chatter about a pending FR notice announcing an FDA public meeting on pain medications. Good idea or bad idea? Well, as the Beltway saying goes, where you stand depends on where you sit. On the one hand there’s the side of science and the public health. Is open public debate useful? Absolutely. And timely. Mon, 01 Sep 2014 10:23:48 -0500 http://drugwonks.com/blog/fda-let-s-talk-about-pain Nomenclatura http://drugwonks.com/blog/nomenclatura If you're looking for some light beach reading over the long weekend, may I recommend the lastest Policy Forum paper from the Food Drug and Law Institute (FDLI). The title, Biosimilar Nomenclature: Can We Achieve the Truth, the WHole Truth, and Nothing but the Truth? says it all. Thu, 28 Aug 2014 07:49:38 -0500 http://drugwonks.com/blog/nomenclatura