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) BioBummer http://drugwonks.com/blog/biobummer The FDA has decided to postpone the March 17th meeting of the Arthritis Advisory Committee. The adcomm was supposed to discuss Celltrion’s infliximab biosimilar application. The Pink Sheet proclaimed this a “Biosimilar Bummer.” A bummer for Celltrion to be sure, but the lesson to be learned is that the filgrastim adcomm, viewed by many as a FDA love-fest should not be viewed as a broader predictive regulatory response to every biosimilar application. Many saw it as such because they wanted it to be true. Bummer? Not if you understand that the decision tree for biosimilars is quite different from the Hatch-Waxman pathway. And that for the foreseeable future, each biosimilar application is going to be an important learning experience for FDA reviewers and senior division staff. Fri, 27 Feb 2015 08:03:39 -0600 http://drugwonks.com/blog/biobummer I left my heart (medication) in San Francisco http://drugwonks.com/blog/i-left-my-heart-medication-in-san-francisco California State Assemblyman David Chiu (D-San Francisco) has introduced a bill in that would require the manufacturer of any drug priced higher than $10,000 per year to report operational costs and profits associated with the product. 
 Wed, 25 Feb 2015 06:42:41 -0600 http://drugwonks.com/blog/i-left-my-heart-medication-in-san-francisco The Cancer Doctor Who Wants To Kill New Cancer Drugs http://drugwonks.com/blog/the-cancer-doctor-who-wants-to-kill-new-cancer-drugs Hagap Kantarjian wants lower drug prices and he's willing to let people die to get them. Tue, 24 Feb 2015 15:34:02 -0600 http://drugwonks.com/blog/the-cancer-doctor-who-wants-to-kill-new-cancer-drugs PD3: Patient-Driven Drug Development http://drugwonks.com/blog/pd3-patient-driven-drug-development When it comes to the patient voice (or any voice), the plural of anecdote isn't data. But the plural of data is science. Patient passion is important to share. When combined with data and a more dispassionate understanding of regulatory paradigms, a patient-driven pathway can is, and must evolve into a tool used to impact regulatory decision-making. Tue, 24 Feb 2015 06:35:43 -0600 http://drugwonks.com/blog/pd3-patient-driven-drug-development BIO members "can't get no satisfaction" http://drugwonks.com/blog/bio-members-can-t-get-no-satisfaction A new BIO survey finds that more drug sponsors are not seeking special protocol assessment for drug development because they do not believe it improves their chances of getting a product approved. (The survey represents 165 companies and 240 individual clinical development programs.) According to BIO’s Executive VP for Emerging Companies Section, Cartier Esham, “The reason cited is that they don’t see any objective evidence that utilization is improving chances of success.” Question: Does that speak to a problem with the pathway or in the design of any given clinical program? One cannot be blamed for the other. SPAs were never meant to promise speed-to-market. Could it be a case of inappropriate sponsor expectations? Just asking. Mon, 23 Feb 2015 15:49:46 -0600 http://drugwonks.com/blog/bio-members-can-t-get-no-satisfaction PBMS Cash In On Chronically Sick Patients: The Sequel http://drugwonks.com/blog/pbms-cash-in-on-chronically-sick-patients-the-sequel Reorganize getting paid in the drug industry? That’s a problem Fri, 20 Feb 2015 14:55:41 -0600 http://drugwonks.com/blog/pbms-cash-in-on-chronically-sick-patients-the-sequel Big Pharma, Social Media, and Ferris Bueller http://drugwonks.com/blog/big-pharma-social-media-and-ferris-bueller Here's a question you hear a lot, "Has Big Pharma figured out social media yet?” That question lacks granularity. Big Pharma marketers understand (and correctly so) that social media is a long-term play. It doesn’t deliver ROI in the same timeframe as DTC or couponing or any of the more traditional tools of the trade. “Mobile,” as crucial as it is to any successful marketing effort, isn’t social media. It is one platform on which social media exists.Have pharma brand marketers “figured out” social media? Yes. They have figured out that it is not ready for prime time. Tue, 17 Feb 2015 09:31:34 -0600 http://drugwonks.com/blog/big-pharma-social-media-and-ferris-bueller Senator Warren's Bell Jar http://drugwonks.com/blog/senator-warren-s-bell-jar Will expanded government extortion result in fewer settlements? Will the NIH have to admit to its true role in drug development? Fri, 13 Feb 2015 06:20:12 -0600 http://drugwonks.com/blog/senator-warren-s-bell-jar PBMS Cash In On Chronically Sick Patients.. http://drugwonks.com/blog/pbms-cash-in-on-chronically-sick-patients Why can't the media connect the dots? Thu, 12 Feb 2015 17:25:22 -0600 http://drugwonks.com/blog/pbms-cash-in-on-chronically-sick-patients Read About This FDA Action That Could Save Thousands of Lives http://drugwonks.com/blog/read-about-this-fda-action-that-could-save-thousands-of-lives FDA takes steps towards right to try.. Wed, 11 Feb 2015 14:47:51 -0600 http://drugwonks.com/blog/read-about-this-fda-action-that-could-save-thousands-of-lives Rob Califf IS the Short List http://drugwonks.com/blog/rob-califf-is-the-short-list Respected cardiologist Dr. Robert Califf appears to be a top candidate to be the next head of the Food and Drug Administration but may face heated Senate queries over close ties to pharmaceutical companies if nominated for the post. “I have a short list of one person, and that is Robert Califf,” Peter Pitts, president of the think tank Center for Medicine in the Public Interest, told the Washington Examiner. Pitts, a former FDA associate commissioner, said Califf would have bipartisan appeal. He was interviewed for the top job during the Bush administration and the Obama administration. Wed, 11 Feb 2015 07:28:54 -0600 http://drugwonks.com/blog/rob-califf-is-the-short-list Chloe Jones 1 Medicaid 0 PBMs -1 http://drugwonks.com/blog/chloe-jones-1-medicaid-0-pbms-1 The era of denying people precision meds will be over.. Mon, 09 Feb 2015 15:38:22 -0600 http://drugwonks.com/blog/chloe-jones-1-medicaid-0-pbms-1 Peggy Hamburg: A Complete Response http://drugwonks.com/blog/peggy-hamburg-a-complete-response The FDA is not a monolithic entity. The agency is comprised of over 16,000 dedicated public servants whose areas of expertise and responsibilities range from pharmaceuticals to food, veterinary products, cosmetics, medical technology, dietary supplements, and beyond. No one person calls all the shots – but the Commissioner is in charge and sets the tone and direction of the body that regulates more than a quarter of the American economy. A really good commissioner is measured by the impact he continues to have once she has departed. By that measure Peggy Hamburg rates an “A.” Fri, 06 Feb 2015 06:31:39 -0600 http://drugwonks.com/blog/peggy-hamburg-a-complete-response How President Obama can spur ‘precision medicine’: Stop PBMs From Rationing Them http://drugwonks.com/blog/how-president-obama-can-spur-precision-medicine-stop-pbms-from-rationing-them PBMs under Obamacare are choking off access to precision medicine Thu, 05 Feb 2015 20:01:52 -0600 http://drugwonks.com/blog/how-president-obama-can-spur-precision-medicine-stop-pbms-from-rationing-them Peggy Hamburg: FDA's 21st Century Commissioner http://drugwonks.com/blog/peggy-hamburg-fda-s-first-21st-century-commissioner News today that FDA Commissioner Hamburg will resign tomorrow. More on this to be sure – but for now let’s just say that she’s leaving the agency in a better place than she found it. She set the tone for the 21st Century FDA -- an impressive and gutsy millennial course. Much on the horizon for her successor, beginning with working to shape PDUFA VI. And who better to do this than … Rob Califf. Thu, 05 Feb 2015 06:43:40 -0600 http://drugwonks.com/blog/peggy-hamburg-fda-s-first-21st-century-commissioner A Wish For World Cancer Day: Higher Drug Prices http://drugwonks.com/blog/a-wish-for-world-cancer-day-higher-drug-prices Because they are the only way to ensure access to cancer care for all. Wed, 04 Feb 2015 17:14:50 -0600 http://drugwonks.com/blog/a-wish-for-world-cancer-day-higher-drug-prices The Urban Myths of Expanded Access http://drugwonks.com/blog/the-urban-myths-of-expanded-access Today, senior FDA officials and representatives from leading patient and health policy organizations are meeting in Washington, DC to discuss the urgent and contentious issues surrounding expanded access to investigational drugs. Yesterday I keynoted the “Expanded Access Programs: New Models for Stakeholder Collaboration, Program Design, Supply Equity and Access for Investigation Drugs” conference. I was pleased to share the day with colleagues such as Richard Klein (Patient Liaison Program Director, FDA’s Office of Health and Constituent Affairs) and Diane Dorman (Vice President for Public Policy at NORD). The full program can be found at www.cbinet.com/eap. Some points from the conference worth mentioning: Wed, 04 Feb 2015 06:01:19 -0600 http://drugwonks.com/blog/the-urban-myths-of-expanded-access Warren Down the Rabbit Hole http://drugwonks.com/blog/warren-down-the-rabbit-hole When it comes to myths about healthcare, one of the great shibboleths is that Big Pharma profits from innovation “that comes primarily from the NIH.” It’s never been true – and now a new study confirms it. A study in Health Affairs by Bhaven N. Sampat and Frank R. Lichtenberg (What Are The Respective Roles Of The Public And Private Sectors In Pharmaceutical Innovation?) http://content.healthaffairs.org/content/30/2/332.full.html puts the issue in a data-driven perspective that gives the NIH its due – but in the proper frame of reference. Tue, 03 Feb 2015 15:26:04 -0600 http://drugwonks.com/blog/warren-down-the-rabbit-hole Is Chris Christie An Anti-Vaccine Wingnut? http://drugwonks.com/blog/is-chris-christie-an-anti-vaccine-wingnut Look at the record.. if you can handle the truth. Tue, 03 Feb 2015 10:08:23 -0600 http://drugwonks.com/blog/is-chris-christie-an-anti-vaccine-wingnut Optimizing Patient Safety -- It's all about the base http://drugwonks.com/blog/optimizing-patient-safety-it-s-all-about-the-base A joke inside the FDA is that the Brief Summary is like the Holy Roman Empire: neither brief nor a summary. But it's an important jump start for a serious question—namely, how can safety information be made more user-friendly? For an answer, I turn to one of my favorite doctors, Dr. Seuss: “Sometimes the questions are complicated and the answers are simple.” Mon, 02 Feb 2015 06:24:40 -0600 http://drugwonks.com/blog/optimizing-patient-safety-it-s-all-about-the-base