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) For an Opioid Non-Interference Clause http://drugwonks.com/blog/for-an-opioid-non-interference-clause The bill calling for an FDA Accountability for Public Safety Act is a slippery slope towards political interference in the drug approval process. If the FDA must defend its approvals of opioids today, will it have to defend its decisions not to approve cancer drugs tomorrow? Should the agency have to explain its decisions to Congress when it approves a drug via an expedited approval pathway too? Thu, 16 Apr 2015 02:35:08 -0500 http://drugwonks.com/blog/for-an-opioid-non-interference-clause Pazdur Speaks! http://drugwonks.com/blog/pazdur-speaks Love him or hate him (and many people do both), Dr. Richard Pazdur -- director of the FDA's Office of Hematology and Oncology Products-- is the world's most important cancer drug regulator. In an exclusive web interview, Dr. Pazdur tells BioCentury why the agency is racing to approve new cancer drugs. He says new targeted drugs and immunotherapies with unprecedented efficacy are the payoff from 20 years of basic science. He calls for greater patient engagement in drug development, says compassionate access should be improved, and predicts rapid uptake of biosimilars. Thu, 16 Apr 2015 01:18:15 -0500 http://drugwonks.com/blog/pazdur-speaks Bee Cautious or Be Smart? http://drugwonks.com/blog/bee-cautious-or-be-smart You’ve likely seen the hysterical headlines about the “Bee-pocalypse” caused by neonicotinoid pesticides (aka: "neonics"). That’s not the Precautionary Principle – that’s a total misrepresentation of the scientific reality. Wed, 15 Apr 2015 02:50:33 -0500 http://drugwonks.com/blog/bee-cautious-or-be-smart How do you say "Outcomes" in Arabic? http://drugwonks.com/blog/how-do-you-say-outcomes-in-arabic I’ve just finished three fascinating days in Sharm El Sheikh at the Second Arab Conference on Food & Drugs. It was all business – and I didn’t even mind not getting any time to enjoy the Red Sea beaches. Delegates from the Levant to Morocco had a lot to say and share. The fundamental take-away was that the Arab world is serious about coordinating their efforts in healthcare in general and in regulatory affairs specifically. “Convergence” and “harmonization” were the two key words of the event -- but talk is cheap. Tue, 14 Apr 2015 03:20:24 -0500 http://drugwonks.com/blog/how-do-you-say-outcomes-in-arabic If compulsory licensing is the answer, what's the question? http://drugwonks.com/blog/if-compulsory-licensing-is-the-answer-what-s-the-question A new article in Nature Medicine challenges one of the biggest myths of the global healthcare debate. The title says it all: Questions raised about whether compulsory licenses get best prices. For those who follow the facts rather than the rhetoric, the findings are not surprising -- he use of compulsory licenses by developing countries to obtain cheaper drugs for HIV and AIDS by circumventing patents has not been the best strategy for achieving the lowest prices over the past decade Fri, 10 Apr 2015 13:14:11 -0500 http://drugwonks.com/blog/if-compulsory-licensing-is-the-answer-what-s-the-question America's Healthcare Arsonist http://drugwonks.com/blog/america-s-healthcare-arsonist The Wall Street Journal writes, “A well-known hedge-fund manager is taking a novel approach to making money: filing and publicizing patent challenges against pharmaceutical companies while also betting against their shares.”That person is Kyle Bass. His strategy is akin to buying gasoline and matches and then advising arsonists to invest in fire insurance. Thu, 09 Apr 2015 10:25:34 -0500 http://drugwonks.com/blog/america-s-healthcare-arsonist Should the tort bar write drug labels? http://drugwonks.com/blog/should-the-tort-bar-write-drug-labels It's time to remind those in the public health community that the FDA’s most potent weapon in the battle for accurate, timely, “rational” prescribing is clear, approved labeling. And yet the debate over who should make decisions about safety and efficacy – and on what evidence those choices should be made is still blazing. Today, the FDA has the responsibility to determine approvals and labeling language based on a scientific review of the evidence. Should this authority be ceded to the tort bar? Wed, 08 Apr 2015 08:33:41 -0500 http://drugwonks.com/blog/should-the-tort-bar-write-drug-labels Accutane Agonistes http://drugwonks.com/blog/accutane-agonistes Roche adequately warned of the risks of ingesting acne drug Accutane after April 10, 2002, a New Jersey judge ruled last week, resolving lawsuits filed by people in the state who used the product since that date.The ruling should act as a teaching moment for patients and doctors that labeling is important, that all drugs have risks and that those risks need to be carefully explained to patients, says Peter Pitts, president of the Center for Medicine in the Public Interest. “This ruling reinforces the need for significant tort reform. These ultimately come down to the category of being frivolous lawsuits. Obviously, people took the drug and had negative effects, but that is completely predictable and it’s part of the proposition of taking any drug.” Tue, 07 Apr 2015 08:02:38 -0500 http://drugwonks.com/blog/accutane-agonistes The Gain in Pain Lies Mainly in Explain http://drugwonks.com/blog/the-gain-in-pain-lies-mainly-in-explain A federal advisory group has released a draft version of its National Pain Strategy, which seeks to redefine the way pain is perceived and treated in the U.S. Mon, 06 Apr 2015 08:21:29 -0500 http://drugwonks.com/blog/the-gain-in-pain-lies-mainly-in-explain E-Cigs, the FDA, and the second best and the almost brightest http://drugwonks.com/blog/e-cigs-the-fda-and-the-second-best-and-the-almost-brightest Should experts who support smoking cessation drugs be banned from the e-cigarette debate? Thu, 02 Apr 2015 07:01:28 -0500 http://drugwonks.com/blog/e-cigs-the-fda-and-the-second-best-and-the-almost-brightest FDA, Opioids, and the Theory of Evolution http://drugwonks.com/blog/fda-opioids-and-the-theory-of-evolution The FDA gets it exactly right -- and the key word is "evolving." FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids The U.S. Food and Drug Administration today issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties. Wed, 01 Apr 2015 18:02:44 -0500 http://drugwonks.com/blog/fda-opioids-and-the-theory-of-evolution The rhetoric of re-importation http://drugwonks.com/blog/the-rhetoric-of-re-importation Senator David Vitter (R, LA) is, once again, trying to fool his colleagues (and the American public) about drug importation. Let’s go, once again, into the abyss and set the facts straight. Wed, 01 Apr 2015 06:54:39 -0500 http://drugwonks.com/blog/the-rhetoric-of-re-importation Lost in the Reeds http://drugwonks.com/blog/lost-in-the-reeds Senator Jack Reed (D, RI) wants to repeal the Non-Interference Clause. He thinks it will lower the government’s prescription drug bill. He’s wrong. Let’s look at the record. Tue, 31 Mar 2015 08:11:26 -0500 http://drugwonks.com/blog/lost-in-the-reeds ANVISA: The War is in the Store http://drugwonks.com/blog/anvisa-the-war-is-in-the-store Many nations in the developing world look to Brazil’s drug licensing agency, the National Agency of Sanitary Vigilance (ANVISA), as a model to emulate. Last week, the outgoing president of ANVISA, Jaime Oliveira, said ANVISA should decrease the time it takes to analyze the registration of new products and spend more time monitoring “what is on the pharmacy counter.” Mon, 30 Mar 2015 13:56:01 -0500 http://drugwonks.com/blog/anvisa-the-war-is-in-the-store Opioid Abuse. Don't Fix the Blame, Fix the Problem http://drugwonks.com/blog/opioid-abuse-don-t-fix-the-blame-fix-the-problem Mark Twain quipped, “For every complex problem there is usually a simple answer – and it is usually wrong.” Welcome to the debate over opioid pain medications. What those seeking to solve the problem with one-shot solutions have ignored is that pain in America is a medical problem of enormous proportion. Fri, 27 Mar 2015 07:53:53 -0500 http://drugwonks.com/blog/opioid-abuse-don-t-fix-the-blame-fix-the-problem Telling the truth about biosimilar nomenclature http://drugwonks.com/blog/telling-the-truth-about-biosimilar-nomenclature In a recent op-ed piece on The Hill’s Congress Blog (“More must be done to improve access to biosimilar drugs,” March 19), Ike Bannon erroneously argues that the use of unique international non-proprietary names (INN) for biosimilar medicines would slow the entry of this new class of drugs into the U.S. market. On the contrary, names that clearly differentiate biosimilars from one another and the original biologic medicine will enhance transparency and build physician confidence in this class of medicine, without which robust utilization is not possible. Thu, 26 Mar 2015 08:54:27 -0500 http://drugwonks.com/blog/telling-the-truth-about-biosimilar-nomenclature The steeping tea leaves of biosimilar nomenclature http://drugwonks.com/blog/the-steeping-tea-leaves-of-biosimilar-nomenclature USP and FDA debate their respective roles and responsibilities regarding biosimilar nomenclarure -- and the regulatory fur flies. Mon, 23 Mar 2015 11:14:21 -0500 http://drugwonks.com/blog/the-steeping-tea-leaves-of-biosimilar-nomenclature Cancer Doctors Who Choose Health Plans Over Patient Well-Being http://drugwonks.com/blog/cancer-doctors-who-choose-health-plans-over-patient-well-being Why are cancer docs defending health plan and government rationing of new medicines? Tue, 17 Mar 2015 10:36:08 -0500 http://drugwonks.com/blog/cancer-doctors-who-choose-health-plans-over-patient-well-being In global healthcare policy, no good deed goes unpunished http://drugwonks.com/blog/in-global-healthcare-policy-no-good-deed-goes-unpunished First Big Pharma was advised to adopt free or differential pricing to developing nations – now the mask is off and it’s all about middle-income countries after all. But wasn’t this entirely predictable, that companies would be criticized for doing what the activists had asked for in the first place? In healthcare, as in life – no good deed goes unpunished. Tue, 17 Mar 2015 08:15:11 -0500 http://drugwonks.com/blog/in-global-healthcare-policy-no-good-deed-goes-unpunished Hamburg to Alexander -- "Don't Rag on the FDA" http://drugwonks.com/blog/hamburg-to-alexander-don-t-rag-on-the-fda According to a report in BioCentury, Senator Lamar Alexander (R/TN) is leading the Senate down a narrower, slower path to 21st Century Cures legislation than the House is taking. Responding to Alexander’s request for top legislative priorities, Hamburg called for greater investment in “regulatory science to develop the knowledge, tools and strategies that allow us to assess in an efficient way the safety, efficacy and performance of medical products.”
Taking aim at a white paper Alexander and Senator Richard Burr (R/NC) released in January outlining the committee's goals for legislation to promote medical innovation, Hamburg argued against assuming that "FDA regulation is the principal obstacle to the development of innovative treatments, and that FDA’s authorities and procedures should be fundamentally reconsidered." She also cautioned "against solutions that seek to lower the safety and effectiveness standards for approval of the medical products on which Americans rely." Wed, 11 Mar 2015 06:29:51 -0500 http://drugwonks.com/blog/hamburg-to-alexander-don-t-rag-on-the-fda