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) CDC's Flawed Opioid Efforts. Attention must be paid. http://drugwonks.com/blog/cdc-s-flawed-opioid-efforts-attention-must-be-paid When it comes to the CDC’s new opioid guidelines, attention must be paid -- immediately and publicly. This is the message from a growing constituency of physicians, patients and policy experts concerned and upset about both the CDC’s conflict-ridden, secretive process and, even more importantly, the guidelines themselves. Thu, 08 Oct 2015 10:38:54 -0400 http://drugwonks.com/blog/cdc-s-flawed-opioid-efforts-attention-must-be-paid The Latest Gems on REMS http://drugwonks.com/blog/the-latest-gems-on-rems The US Food and Drug Administration (FDA) has announced a four-month pilot to make Risk Evaluation and Mitigation Strategies (REMS) easier to share and integrate with existing pharmacy and health information systems. Wed, 07 Oct 2015 13:31:47 -0400 http://drugwonks.com/blog/the-latest-gems-on-rems The Expanded Access Ecosystem http://drugwonks.com/blog/the-expanded-access-ecosystem Right to Try legislation is an outcry by the patient community to get some access some way, some how. The Right to Try bills I’ve read, are variable but in general have no real meat on them that give you the pathway to get what you’re looking for. There’s a lot left on the table that is not understood by the patient community. Tue, 06 Oct 2015 09:11:12 -0400 http://drugwonks.com/blog/the-expanded-access-ecosystem Bernie's Papal Indulgences http://drugwonks.com/blog/bernie-s-papal-indulgences When you examine the WHO’s model Essential Drug List, very few of the 400 or so drugs deemed essential are new, or patented or were ever patented in the world’s poorest countries. In category after category, from aspirin to Zithromax, in almost every case and in almost every country, these medicines have always been (or have been for many years) in the public domain. That is, the medicine is fully open to legal and legitimate generic manufacture. Tue, 29 Sep 2015 10:39:53 -0400 http://drugwonks.com/blog/bernie-s-papal-indulgences Patient-Focused Drug Development: Is the Past Prologue? http://drugwonks.com/blog/patient-focused-drug-development-is-the-past-prologue PDUFA V introduced incentives for rare disease development but other key questions were unaddressed: how to include the patient voice and what is the proper role of advocacy groups, agencies, and industry? In the recent past, the patient voice was limited to teary anecdotes. Parent Project Muscular Dystrophy (PPMD), however, has made groundbreaking strides introducing the patient voice into the Duchenne muscular dystrophy development process – and giving other disease communities a blue print to follow. I had the opportunity to moderate a panel discussion with Pat Furlong, the Founding President and CEO of PPMD, about this topic and I’d like to share some of this exchange. Mon, 28 Sep 2015 09:23:08 -0400 http://drugwonks.com/blog/patient-focused-drug-development-is-the-past-prologue There's a new Cop (Cha) in Town http://drugwonks.com/blog/there-s-a-new-cop-cha-in-town A savvy move from FDA – choosing someone who understands quality from the other side of the proposition. Only the most recent way that FDA is working to redefine 3D quality and pharmacovigilance. Fri, 25 Sep 2015 16:15:12 -0400 http://drugwonks.com/blog/there-s-a-new-cop-cha-in-town Why people don't trust drug makers http://drugwonks.com/blog/why-people-don-t-trust-drug-makers Americans think price-gouging on prescription medicines is rampant. This isn’t surprising, since the pharmaceutical industry has done a poor job of explaining why drugs cost what they do. More than three-quarters of Americans support mandatory limits on the price of certain drugs. And 86 percent want drug firms to disclose how, exactly, they set prices. The best way for drug firms to quell this outrage is to give Americans what they’re asking for: more information. Specifically, the industry needs to shed light on the huge sums they spend on research, their rising research-and-development failure rates and the refusal of insurers and pharmacy-benefit managers to pass on manufacturer discounts to patient Fri, 25 Sep 2015 06:55:19 -0400 http://drugwonks.com/blog/why-people-don-t-trust-drug-makers Opioids and Sunshine at the CDC http://drugwonks.com/blog/opioids-and-sunshine-at-the-cdc When a federal agency tries to hide what should be an open and transparent process, sunshine has a way of breaking though the curtains. Here for the first time (and from inside the belly of the beast) is the CDC’s confidential document, “CDC Guideline for Prescribing Opioids for Chronic Pain.” It includes a complete list of the Core Expert Group. Thu, 24 Sep 2015 07:45:31 -0400 http://drugwonks.com/blog/opioids-and-sunshine-at-the-cdc Turing is NOT Pharma http://drugwonks.com/blog/turing-is-not-pharma Tue, 22 Sep 2015 16:41:50 -0400 http://drugwonks.com/blog/turing-is-not-pharma CDC gets it transparently wrong on opioids http://drugwonks.com/blog/cdc-gets-it-transparently-wrong-on-opioids The pain community is not happy with the CDC. And who can blame them? Mon, 21 Sep 2015 13:42:56 -0400 http://drugwonks.com/blog/cdc-gets-it-transparently-wrong-on-opioids The Califf Regime and the Critical Path to Confirmation http://drugwonks.com/blog/the-califf-regime-and-the-critical-path-to-confirmation Califf is the right leader and "precisely the right guy" to handle the knotty challenges ahead for the US regulatory agency – declaring the former Duke University professor's nomination was "the most important health care act the president has undertaken," even more so than getting the Affordable Care Act enacted. Thu, 17 Sep 2015 09:15:11 -0400 http://drugwonks.com/blog/the-califf-regime-and-the-critical-path-to-confirmation RE: Rob Califf -- CQ on the QT http://drugwonks.com/blog/cq-on-the-qt-on-rob-califf Califf, according to several former FDA officials, is a believer in new technology and involving the voice of the patient in the drug development process. "He understands what the future of health care looks like," said Peter Pitts, who led FDA external relations during the George W. Bush administration. Wed, 16 Sep 2015 09:41:52 -0400 http://drugwonks.com/blog/cq-on-the-qt-on-rob-califf FDA puts up its Dukes http://drugwonks.com/blog/fda-gets-ready-to-put-up-its-dukes Tue, 15 Sep 2015 19:25:16 -0400 http://drugwonks.com/blog/fda-gets-ready-to-put-up-its-dukes The Merlion in Summer http://drugwonks.com/blog/the-merlion-in-summer I've just returned from Singapore where I spent some quality time with Raymond Chua (the director of the Singapore HSA -- their version of the FDA) and his senior staff. We covered a wide variety of issues ranging from "what's new at the USFDA?" (Answer -- a lot!), global regulatory convergence, and much in between (such as Singapore as a regulatory “third way” in addition to the FDA and EMA). Mon, 14 Sep 2015 07:10:14 -0400 http://drugwonks.com/blog/the-merlion-in-summer Zeke Emanuel's Final Solution For Drug Prices http://drugwonks.com/blog/zeke-emanuel-s-erroneous-drug-price-op-ed Drugs provide an incredible value. Don't tell that to the man who knows everything Thu, 10 Sep 2015 13:32:45 -0400 http://drugwonks.com/blog/zeke-emanuel-s-erroneous-drug-price-op-ed Cry 'Hemorrhoids!', and let slip the dogs of war http://drugwonks.com/blog/cry-hemorrhoids-and-let-slip-the-dogs-of-war What do the Caronia, Vascepa, and Pacria cases have in common? Well, for one thing all the plaintiffs are small companies, largely dependent on the sales of a single product for their revenues. Suing the FDA used to be considered a high-stakes gamble, but recent rulings – and the lack of action on the part of the agency to put forward new draft guidance – seem to have changed the risk/benefit analysis. At least for small companies. Thu, 10 Sep 2015 09:28:03 -0400 http://drugwonks.com/blog/cry-hemorrhoids-and-let-slip-the-dogs-of-war Not "The Donald" Goes Bass Fishing at the Boston Business Journal http://drugwonks.com/blog/not-the-donald-goes-bass-fishing-at-the-boston-business-journal One journalist defends the honor of a sleazy hedge fund manager's attack on drug patents. Thu, 03 Sep 2015 15:09:31 -0400 http://drugwonks.com/blog/not-the-donald-goes-bass-fishing-at-the-boston-business-journal Biosimilar Prices Bode Well For Innovation http://drugwonks.com/blog/biosimilar-prices-bode-well-for-innovation Can we say authorized generic? Thu, 03 Sep 2015 14:24:49 -0400 http://drugwonks.com/blog/biosimilar-prices-bode-well-for-innovation A Framework For Patient Harm http://drugwonks.com/blog/a-framework-for-patient-harm Tue, 01 Sep 2015 15:40:30 -0400 http://drugwonks.com/blog/a-framework-for-patient-harm Happy 10th Anniversary To C-Path!! http://drugwonks.com/blog/happy-10th-anniversary-to-c-path C-Path has paved the way for personalized medicine Fri, 28 Aug 2015 13:14:52 -0400 http://drugwonks.com/blog/happy-10th-anniversary-to-c-path