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 Tue, 19 Sep 2017 17:38:00 -0400 http://blogs.law.harvard.edu/tech/rss Structure CMS cpernice@psycloneinc.com (Christopher Pernice) PBM Transparency Legislation? How's Bayou? http://drugwonks.com/blog/pbm-transparency-legislation-how-s-bayou Louisiana is leading the nation in smart drug pricing transparency legislation. Last year, as in many other states, the issue was pharmaceutical manufacturer pricing. But many have learned that, by focusing on just one part of the ecosystem, partial transparency results in unhelpful opaqueness. Bravo to the Bayou State for understanding that real pricing transparency requires real transparency by all concerned. Consider two pieces of legislation that just passed both houses of the Louisiana legislature by unanimous votes. Fri, 18 May 2018 15:56:14 -0400 http://drugwonks.com/blog/pbm-transparency-legislation-how-s-bayou Arnold Foundation Funded Austin Frakt Falls Flat Flakking for ICER http://drugwonks.com/blog/arnold-foundation-funded-austin-frakt-falls-flat-flakking-for-icer Wed, 16 May 2018 15:00:39 -0400 http://drugwonks.com/blog/arnold-foundation-funded-austin-frakt-falls-flat-flakking-for-icer It's the healthcare ecosystem, stupid http://drugwonks.com/blog/it-s-the-healthcare-ecosystem-stupid Per Paul Krugman's op-ed, Just Saying Yes to Drug Companies -- anyone who was paying attention to President Trump's press conference or has read the White House Blueprint should understand that drug pricing is an ecosystem that includes manufacturers and multiple intermediaries. Games are being played and patients are (generally) the losers Tue, 15 May 2018 07:50:44 -0400 http://drugwonks.com/blog/it-s-the-healthcare-ecosystem-stupid Some Thoughts on President Trumps Plan on Lowering Drug Prices http://drugwonks.com/blog/some-thoughts-on-president-trumps-plan-on-lowering-drug-prices The good news is that experts are at the wheel. They’re focusing on free-market solutions. The ideas require an ecosystem approach. Nobody said it was going to be easy Fri, 11 May 2018 15:20:12 -0400 http://drugwonks.com/blog/some-thoughts-on-president-trumps-plan-on-lowering-drug-prices Trump Takes On the PBMs http://drugwonks.com/blog/trump-takes-on-the-pbms Fri, 11 May 2018 10:07:10 -0400 http://drugwonks.com/blog/trump-takes-on-the-pbms What President Trump Should Say in His Speech on Drug Prices http://drugwonks.com/blog/what-president-trump-should-say-in-his-speech-on-drug-prices Tue, 08 May 2018 09:43:22 -0400 http://drugwonks.com/blog/what-president-trump-should-say-in-his-speech-on-drug-prices The Big Cat Finds ROI Where the Sun Don't Shine http://drugwonks.com/blog/the-big-cat-finds-roi-where-the-sun-don-t-shine In the United States, the manufacturers of branded medications (on-patent, innovative drugs) represent 39% of gross net drug expenditures while the morass of non-manufacturer middleman -- Prescription Benefit Managers (PBMs), brokers, agents and assorted wholesalers and intermediaries -- are responsible for 42% of gross expenditures. What’s going on? Perhaps a better question is what’s not going on. Topping that list is a lack of transparency in the cost supply chain, leading to cloudy conflicts of interest. If sunshine is the best disinfectant, perhaps enlightened self-interest is the best medicine. Consider the case of Caterpillar. Mon, 07 May 2018 11:57:02 -0400 http://drugwonks.com/blog/the-big-cat-finds-roi-where-the-sun-don-t-shine Why Drug Prices Are Too Damn High http://drugwonks.com/blog/too-damn-high Wed, 02 May 2018 10:15:03 -0400 http://drugwonks.com/blog/too-damn-high Pharma Critics Ignore HHS Sec. Azar Call for Value in Favor of Forging Facts About Drug Prices http://drugwonks.com/blog/pharma-critics-ignore-hhs-sec-azar-call-for-value-in-favor-of-forging-facts-about-drug-prices Wed, 02 May 2018 00:05:48 -0400 http://drugwonks.com/blog/pharma-critics-ignore-hhs-sec-azar-call-for-value-in-favor-of-forging-facts-about-drug-prices Drug Prices Increase Below the Rate of Inflation http://drugwonks.com/blog/drug-prices-increase-below-the-rate-of-inflation It may not suit the cognitive mapping of some pols and pundits (or people at ICER), but, in 2017, the net price increase for branded products was lower than the Consumer Price Index. And, according to IQVIA, the overall US drug spend (including generics) increased just 0.6%. Mon, 30 Apr 2018 16:57:28 -0400 http://drugwonks.com/blog/drug-prices-increase-below-the-rate-of-inflation “It’s not only a cost, it’s an investment.” http://drugwonks.com/blog/it-s-not-only-a-cost-it-s-an-investment And, as with any investment, it’s impossible to understand the cost without proper consideration of the return. Wed, 25 Apr 2018 09:06:40 -0400 http://drugwonks.com/blog/it-s-not-only-a-cost-it-s-an-investment EMA Self-Immolation http://drugwonks.com/blog/ema-self-immolation A European decision to exclude Britain from the EU’s drug approval system from March 30 2019 - the day after Brexit - has raised alarm among drugmakers, who fear the abrupt change could disrupt medicine supplies to patients. Thu, 19 Apr 2018 09:53:54 -0400 http://drugwonks.com/blog/ema-self-immolation SPA Go! http://drugwonks.com/blog/spa-go The FDA finalized guidance on the special protocol assessment, which is the process by which sponsors of drug or biologic applications can meet with the agency to discuss the design and size of clinical or animal studies to determine if they can adequately support marketing approval. Mon, 16 Apr 2018 09:55:06 -0400 http://drugwonks.com/blog/spa-go Kaiser Health News, Attacks Patient Groups, Twists the Facts To Fit Arnold Foundation Political Agenda http://drugwonks.com/blog/kaiser-health-news-attacks-patient-groups-twists-the-facts-to-fit-arnold-foundation-political-agenda Tue, 10 Apr 2018 21:53:31 -0400 http://drugwonks.com/blog/kaiser-health-news-attacks-patient-groups-twists-the-facts-to-fit-arnold-foundation-political-agenda Buckeye State Eyes PBM Practices http://drugwonks.com/blog/buckeye-state-eyes-pbm-practices The Ohio Department of Insurance is now requiring insurers and pharmacy benefit managers to remove so-called “gag order” clauses that prevent pharmacists from disclosing to consumers the most affordable prescription drug option. Thu, 05 Apr 2018 09:50:01 -0400 http://drugwonks.com/blog/buckeye-state-eyes-pbm-practices "Dragon-Quality" Generics http://drugwonks.com/blog/dragon-quality-generics The Chinese government issued an ambitious statement about plans to encourage further research and availability of higher quality generic drugs. Wed, 04 Apr 2018 09:44:30 -0400 http://drugwonks.com/blog/dragon-quality-generics Lower Drug Prices Will Lead To Higher Drug Costs for Patients http://drugwonks.com/blog/lower-drug-prices-will-lead-to-higher-drug-costs-for-patients Tue, 03 Apr 2018 15:36:26 -0400 http://drugwonks.com/blog/lower-drug-prices-will-lead-to-higher-drug-costs-for-patients Former VA Chief David Shulkin:It shouldn’t be this hard to serve your country http://drugwonks.com/blog/former-va-chief-david-shulkin-it-shouldn-t-be-this-hard-to-serve-your-country Thu, 29 Mar 2018 15:02:41 -0400 http://drugwonks.com/blog/former-va-chief-david-shulkin-it-shouldn-t-be-this-hard-to-serve-your-country The Facts Always Missing in Drug Pricing Reporting http://drugwonks.com/blog/the-facts-always-missing-in-drug-pricing-reporting Wed, 28 Mar 2018 12:58:30 -0400 http://drugwonks.com/blog/the-facts-always-missing-in-drug-pricing-reporting Anti-Claw Law http://drugwonks.com/blog/anti-claw-law A group of House lawmakers introduced a bill that would prohibit pharmacy benefit managers from using gag clauses to prevent pharmacies from telling consumers that paying cash for a prescription might cost less than a health insurance co-payment Wed, 21 Mar 2018 09:52:55 -0400 http://drugwonks.com/blog/anti-claw-law Boston Globe Washington Bureau Chief Chris Rowland Teams Up with Generic Lobby To Smear Myeloma Survivor From Afar http://drugwonks.com/blog/boston-globe-washington-bureau-chief-chris-rowland-teams-up-with-generic-lobby-to-smear-myeloma-survivor-from-afar Tue, 20 Mar 2018 00:04:37 -0400 http://drugwonks.com/blog/boston-globe-washington-bureau-chief-chris-rowland-teams-up-with-generic-lobby-to-smear-myeloma-survivor-from-afar CREATES Act a Tort Torte http://drugwonks.com/blog/creates-act-a-tort-torte When members of the tort bar start to salivate over a piece of legislation, it’s worthwhile to find out where the red meat resides. In a rush to pass legislation to “lower drug prices” as a budgetary pay-for, lawmakers are pushing two pieces of parallel legislation, the Senate’s Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act and the House’s Fair Access for Safe and Timely (FAST) Generics Act. Fri, 16 Mar 2018 10:45:43 -0400 http://drugwonks.com/blog/creates-act-a-tort-torte Contract Killers: Inside the Secret World of PBM Practices http://drugwonks.com/blog/contract-killers-inside-the-secret-world-of-pbm-contracting A contract template used by Express Scripts, the largest pharmacy benefit manager in the U.S., provides a window into how pharmacy benefit managers — middlemen that manage drug coverage for businesses throughout the country — steer negotiations with drug companies to benefit their own financial interests. Thu, 15 Mar 2018 15:02:59 -0400 http://drugwonks.com/blog/contract-killers-inside-the-secret-world-of-pbm-contracting Fighting Illini Fight Non-Medical Switching http://drugwonks.com/blog/fighting-illini-fight-non-medical-switching lllinois lawmakers are considering a bill that would guard non-medical switching in the middle of a plan year. The proposed bill would prohibit commercial health insurers from modifying coverage of a drug during the plan year if it has previously approved the drug for a medical condition. Thu, 15 Mar 2018 12:13:12 -0400 http://drugwonks.com/blog/fighting-illini-fight-non-medical-switching Santa Claws http://drugwonks.com/blog/santa-claws If drug manufacturers are giving such large discounts for brand name medicines to Pharmacy Benefit Managers (PBMs); while prices of commonly used generics keep going down, why aren’t co-pays going down and why, in some circumstances, are they going up – even for generic medicines? In short, where’s the money going? Wed, 14 Mar 2018 14:45:42 -0400 http://drugwonks.com/blog/santa-claws FDA and the Digital Divide: The Battle of Proof & Predicate vs. Errors & Upgrades http://drugwonks.com/blog/fda-and-the-digital-divide-the-battle-of-proof-predicate-vs-errors-upgrades There is a yawning divide between regulatory science and digital development. Digiratti view regulators as stodgy while regulators view digital developers as trigger-happy. There is an unproductive cognitive disconnect. Tue, 13 Mar 2018 08:34:41 -0400 http://drugwonks.com/blog/fda-and-the-digital-divide-the-battle-of-proof-predicate-vs-errors-upgrades Cratering CREATES http://drugwonks.com/blog/cratering-creates The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act will not be included in the pending omnibus budget bill Fri, 09 Mar 2018 09:46:28 -0500 http://drugwonks.com/blog/cratering-creates Gottlieb call out "Kabuki Pricing" http://drugwonks.com/blog/gottlieb-call-out-kabuki-pricing U.S. Food and Drug Administration chief, Scott Gottlieb, criticized pharmacy benefit managers, health insurers and drugmakers on Wednesday for “Kabuki drug-pricing constructs” that profit the industry at the expense of consumers. Thu, 08 Mar 2018 09:52:58 -0500 http://drugwonks.com/blog/gottlieb-call-out-kabuki-pricing Will Price Transparency “Unintentionally Raise Costs” http://drugwonks.com/blog/will-price-transparency-unintentionally-raise-costs Here’s the PBM argument – blame drug companies for high prices and complain when they’re asked to be transparent about their own discounts. Per Express Scripts, transparency will “unintentionally raise costs.” Hm. Wed, 07 Mar 2018 10:24:16 -0500 http://drugwonks.com/blog/will-price-transparency-unintentionally-raise-costs Stem Cell Pioneer Bob Hariri:The Edison of Regenerative Medicine http://drugwonks.com/blog/stem-cell-pioneer-bob-hariri-launches-regenerative-medicine-company Fri, 16 Feb 2018 10:31:12 -0500 http://drugwonks.com/blog/stem-cell-pioneer-bob-hariri-launches-regenerative-medicine-company Express Scripts Prescription For Reducing Drug Spending: Increase Rebates and Limit Access to New Medicines for the Sickest Patients http://drugwonks.com/blog/express-scripts-prescription-for-reducing-drug-spending-increase-rebates-and-limitsaccess-to-new-medicines-for-the-sickest-patients Tue, 13 Feb 2018 14:02:39 -0500 http://drugwonks.com/blog/express-scripts-prescription-for-reducing-drug-spending-increase-rebates-and-limitsaccess-to-new-medicines-for-the-sickest-patients Fake Patient Group Publishes Fake Pharma Profit Study http://drugwonks.com/blog/p4ad-s-ljaarnold-funded-pharma-funding-fiction Fri, 09 Feb 2018 15:18:08 -0500 http://drugwonks.com/blog/p4ad-s-ljaarnold-funded-pharma-funding-fiction New Federal Budget Bill Blasts Medicare Part D http://drugwonks.com/blog/new-federal-budget-bill-blasts-medicare-part-d The latest federal funding bill could issue a huge blow to beneficiaries of Medicare Part D, the government program that subsidizes the cost of prescription drugs for 42 million seniors. Thu, 08 Feb 2018 15:10:35 -0500 http://drugwonks.com/blog/new-federal-budget-bill-blasts-medicare-part-d Mail Order Confusion http://drugwonks.com/blog/mail-order-confusion The recent announcement by Bezos, Buffett and Dimon that they're teaming up to address health care costs is interesting. They certainly bring a lot to the table. But there seems to be some confusion. Wed, 31 Jan 2018 10:52:30 -0500 http://drugwonks.com/blog/mail-order-confusion ICER Joins the Walking Dead http://drugwonks.com/blog/icer-joins-the-walking-dead Thu, 25 Jan 2018 15:44:01 -0500 http://drugwonks.com/blog/icer-joins-the-walking-dead FDA Transparency? WWPT? (What will Pharma think?) http://drugwonks.com/blog/fda-transparency-wwpt-what-will-pharma-think The Food and Drug Administration is taking steps to make it easier for doctors, patients and researchers to get access to clinical trial data amassed during the process of approving new drugs, Tue, 16 Jan 2018 13:27:59 -0500 http://drugwonks.com/blog/fda-transparency-wwpt-what-will-pharma-think Opioids: Fixing the Problem, Not the Blame http://drugwonks.com/blog/opioids-fixing-the-problem-not-the-blame Speaking of opioids and lawsuits, something very interesting just happened in the MDL (Multi-District Litigation) National Prescription Opiate Litigation case (MDL No. 2804, Case No. 1:17-CV-2804) – Presiding United States District Judge Dan A. Polster (United States District Court, Northern District of Ohio Eastern Division) made it clear to all parties that he intends to focus on fixing the problem, not the blame. Thu, 11 Jan 2018 10:21:46 -0500 http://drugwonks.com/blog/opioids-fixing-the-problem-not-the-blame All Budget "Pay Fors" are not CREATE(d) Equal http://drugwonks.com/blog/all-budget-pay-fors-are-not-create-d-equal In a rush to find “pay fors” to balance the budget package that Congress is working to pass by January 19th, some lawmakers are pushing forward the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. It’s a bad idea with dangerous unintended consequences. It’s time to take a breath – because the CREATES Act won’t speed a single drug to market or lower the cost of medicines for a single American. What it will most certainly provide is a windfall for the trial lawyers, raising legal costs for the pharmaceutical industry and threatening the incentives to invest in development programs for new medicines. Mon, 08 Jan 2018 07:34:03 -0500 http://drugwonks.com/blog/all-budget-pay-fors-are-not-create-d-equal CMPI Awards Billy Madison Pharma Idiocy Award to Yale University Professors http://drugwonks.com/blog/cmpi-awards-billy-madison-pharma-idiocy-award-to-yale-university-professors Wed, 03 Jan 2018 19:25:54 -0500 http://drugwonks.com/blog/cmpi-awards-billy-madison-pharma-idiocy-award-to-yale-university-professors FDA: Packaging a Punch for Opioids http://drugwonks.com/blog/fda-packaging-a-punch-for-opioids Good news! The FDA is interested in using opioid labels to mandate packaging standards, as well as offer claims similar to those available for abuse deterrent products. Wed, 13 Dec 2017 07:56:49 -0500 http://drugwonks.com/blog/fda-packaging-a-punch-for-opioids Different Pathways for Different Products http://drugwonks.com/blog/different-pathways-for-different-products “FDA understands that different products need different regulatory pathways, from both a science and a patient-need perspective,” said Peter Pitts, president of the nonprofit Center for Medicine in the Public Interest. Thu, 30 Nov 2017 18:47:59 -0500 http://drugwonks.com/blog/different-pathways-for-different-products Paving the Regenerative Medicine Pathway http://drugwonks.com/blog/paving-the-regenerative-medicine-pathway FDA unveiled a regenerative medicine framework aimed at speeding the development and review of cell and stem cell therapies and tissue-based products, while also cracking down on those that would game the system. The framework, which was outlined in two draft and two final guidances, builds on the agency's previous policy that took effect in 2005. Fri, 17 Nov 2017 15:19:33 -0500 http://drugwonks.com/blog/paving-the-regenerative-medicine-pathway Alex Azar rounds out HHS 'Dream Team' http://drugwonks.com/blog/alex-azar-rounds-out-hhs-dream-team Mon, 13 Nov 2017 11:08:08 -0500 http://drugwonks.com/blog/alex-azar-rounds-out-hhs-dream-team Insurers and PBMs Undermine Oral Parity Laws http://drugwonks.com/blog/insurers-and-pbms-undermine-oral-parity-laws Mon, 13 Nov 2017 11:02:25 -0500 http://drugwonks.com/blog/insurers-and-pbms-undermine-oral-parity-laws PBMs and Insurers Undermine Oral Parity http://drugwonks.com/blog/pbms-and-insurers-undermine-oral-parity Mon, 13 Nov 2017 11:02:06 -0500 http://drugwonks.com/blog/pbms-and-insurers-undermine-oral-parity Gottlieb to Pharma -- End the REMS "Shenanigans" http://drugwonks.com/blog/gottlieb-to-pharma-end-the-shenanigans FDA Commissioner Scott Gottlieb Wednesday called on branded drug companies to “end the shenanigans” they use to block generic competition, and announced new steps to rein in some anticompetitive practices. Wed, 08 Nov 2017 21:24:09 -0500 http://drugwonks.com/blog/gottlieb-to-pharma-end-the-shenanigans Patient For Affordable Drugs Founder Fails to Disclose Funding Source to FTC http://drugwonks.com/blog/patient-for-affordable-drugs-founder-fails-to-disclose-to-ftc Tue, 07 Nov 2017 21:15:28 -0500 http://drugwonks.com/blog/patient-for-affordable-drugs-founder-fails-to-disclose-to-ftc Taxing Orphans http://drugwonks.com/blog/taxing-orphans How do you spell "mistake?" The new tax bill would eliminate tax credits used to develop rare-disease drugs. Currently, drug makers get allowed a tax credit of up to 50 percent of certain research costs for rare-disease drugs. The new tax bill would repeal the credit, which falls under the Orphan Drug Act, “for certain drugs, for rare diseases or conditions” starting after this year. Fri, 03 Nov 2017 09:36:54 -0400 http://drugwonks.com/blog/taxing-orphans OW THAT’S A PATIENT-CENTERED VALUE FRAMEWORK http://drugwonks.com/blog/ow-that-s-a-patient-centered-value-framework Mon, 30 Oct 2017 12:24:37 -0400 http://drugwonks.com/blog/ow-that-s-a-patient-centered-value-framework Thank You For Your Service? VA-ICER Partnership Breaks Shulkin's Promise to Veterans http://drugwonks.com/blog/thank-you-for-your-service-va-icer-partnership-breaks-schulkin-s-promise-to-veterans Fri, 27 Oct 2017 14:01:21 -0400 http://drugwonks.com/blog/thank-you-for-your-service-va-icer-partnership-breaks-schulkin-s-promise-to-veterans Utah's Importation Jazz http://drugwonks.com/blog/utah-s-importation-jazz As it generally is with schemes to advance importation, “doggedly optimistic” = “deaf and dumb to reality.” Thu, 26 Oct 2017 12:44:18 -0400 http://drugwonks.com/blog/utah-s-importation-jazz The Similarity Conundrum http://drugwonks.com/blog/the-similarity-conundrum Martin Schiestl, chief science officer at Novartis' Sandoz, on Tuesday explained how the US Food and Drug Administration's (FDA) draft guidance on statistical approaches to evaluate analytical similarity poses risks that could end up causing true biosimilars to be rejected randomly. Wed, 25 Oct 2017 09:37:58 -0400 http://drugwonks.com/blog/the-similarity-conundrum Cigna Signals http://drugwonks.com/blog/cigna-signals Last week’s commentary on Cigna’s plan to replace Oxycontin ER with Xtampza ER on its core formulary (Is Cigna Trading Patient Choice for Hidden Profits?) resulted in a very open and honest chat with a senior Cigna executive. Wed, 18 Oct 2017 15:09:51 -0400 http://drugwonks.com/blog/cigna-signals Why indeed? Why do we need drug rebates, anyway? A top lawmaker wants to know http://drugwonks.com/blog/why-indeed-why-do-we-need-drug-rebates-anyway-a-top-lawmaker-wants-to-know Sen. Lamar Alexander has a question: why do we have drug rebates, anyway? “Why do we need rebates?” the Tennessee Republican asked a panel of pharmaceutical industry representatives at a Senate committee hearing. The Health, Education, Labor, and Pensions committee met Tuesday morning for the second of three hearings on drug pricing, and heard testimony from five interest groups representing companies that play different roles in getting medicines to patients. Tue, 17 Oct 2017 20:03:27 -0400 http://drugwonks.com/blog/why-indeed-why-do-we-need-drug-rebates-anyway-a-top-lawmaker-wants-to-know Gottlieb's Dueling Acronyms http://drugwonks.com/blog/gottlieb-s-dueling-acronyms If he departs now, Gottlieb will leave no mark behind at FDA, and there aren’t great prospects for advancing the public good at HHS. In contrast, based on his current trajectory, if he stays on the job, Gottlieb is on track to leave with a strong, positive legacy. Thu, 12 Oct 2017 07:28:54 -0400 http://drugwonks.com/blog/gottlieb-s-dueling-acronyms JAMA Jive http://drugwonks.com/blog/jama-jive Even the authors admit their selection criteria are a ‘critical limitation.’ That’s an understatement. Wed, 11 Oct 2017 11:15:35 -0400 http://drugwonks.com/blog/jama-jive Is Cigna Trading Patient Choice for Hidden Profits? http://drugwonks.com/blog/is-cigna-trading-patient-choice-for-hidden-profits Why is Cigna switching from from Oxycontin to Xtampza ER? Could it be that Cigna negotiated a better deal with Collegium than it had with Purdue Pharma (the manufacturer of Oxycontin)? Unfortunately, this decision appears to be more about pharmaceutical rebates than “guarding against opioid misuse.” Alas, Cigna’s hyperbole has been met with silence when it comes to pricing transparency. Mon, 09 Oct 2017 10:28:49 -0400 http://drugwonks.com/blog/is-cigna-trading-patient-choice-for-hidden-profits When it comes to Off-Label, let's not forget the role of Real World Evidence http://drugwonks.com/blog/when-it-comes-to-off-label-let-s-not-forget-the-role-of-real-world-evidence It's important to note that "not doing additional clinical trials," as I was quoted as saying, does not mean ignoring a more regular and robust use of electronically collected and validated real world data to ascertain the performance of off-label use. The FDA is required by the 21st Century Cures act to develop standard protocols for the use of real world data -- and nowhere is this more crucial than in determining the safe and effective use of medicines via off-label prescribing. Sun, 08 Oct 2017 22:47:59 -0400 http://drugwonks.com/blog/when-it-comes-to-off-label-let-s-not-forget-the-role-of-real-world-evidence Complex Generics Simplified ... Sort of http://drugwonks.com/blog/complex-generics-simplified-sort-of Complex drugs comprise high cost medicines like metered dose inhalers used to treat asthma, as well as some costly injectable drugs. These medicines generally have at least one feature that makes them harder to “genericize” under our traditional approaches. As a consequence, these drugs can face less competition. In some cases, costly, branded drugs that are complex drugs have lost their exclusivity, but are subject to no generic competition. Mon, 02 Oct 2017 12:46:21 -0400 http://drugwonks.com/blog/complex-generics-simplified-sort-of Qui cum canibus concumbunt cum pulicibus surgent http://drugwonks.com/blog/qui-cum-canibus-concumbunt-cum-pulicibus-surgent Is an insurer-driven monopoly good for patients? Will it lower the co-pay or co-insurance for a single patient? Sadly, these are rhetorical questions. Is it sounding anti-competitive yet? What about anti-patient? At a time when we are debating both the price and the value of medicines, what’s wrong with this picture? Thu, 21 Sep 2017 10:26:17 -0400 http://drugwonks.com/blog/qui-cum-canibus-concumbunt-cum-pulicibus-surgent War Against the Orphans http://drugwonks.com/blog/war-against-the-orphans Wed, 20 Sep 2017 13:29:23 -0400 http://drugwonks.com/blog/war-against-the-orphans Gottlieb Gets Real ... World Evidence http://drugwonks.com/blog/gottlieb-gets-real-world-evidence Yesterday, at a National Academy of Sciences workshop on Real World Evidence, FDA Commissioner Scott Gottlieb expressed the agency’s commitment to advancing the use of RWE, defended the idea that data from clinical experience should be incorporated into regulatory decisions, and acknowledged that the agency won’t have the last word when it comes to interpreting real world evidence. Wed, 20 Sep 2017 10:49:44 -0400 http://drugwonks.com/blog/gottlieb-gets-real-world-evidence Vinay Prasad's Fake Pharma Numbers http://drugwonks.com/blog/vinay-prasad-s-fake-pharma-numbers Tue, 19 Sep 2017 13:54:50 -0400 http://drugwonks.com/blog/vinay-prasad-s-fake-pharma-numbers Off-Label Comms and Vigorous Predictability http://drugwonks.com/blog/off-label-comms-and-vigorous-predictability Gottlieb-watchers understand his support of making sure physicians and patients have access to truthful accurate and non-misleading information about FDA-approved medicines –- both on and off-label. Time marches on and regulatory practices must evolve to better serve the public health. Mon, 18 Sep 2017 07:57:15 -0400 http://drugwonks.com/blog/off-label-comms-and-vigorous-predictability How PBMs are exacerbating the opioid epidemic http://drugwonks.com/blog/how-pbms-are-exacerbating-the-opioid-epidemic At a time when the United States is in the grip of an opioid epidemic, many insurers are limiting access to pain medications that carry a lower risk of addiction or dependence, even as they provide comparatively easy access to generic opioid medications. The reason, experts say: Opioid drugs are generally cheap while safer alternatives are often more expensive. Sun, 17 Sep 2017 20:30:01 -0400 http://drugwonks.com/blog/how-pbms-are-exacerbating-the-opioid-epidemic Why the Tort Bar Loves the CREATES Act http://drugwonks.com/blog/why-the-tort-bar-loves-the-creates-act When members of the tort bar start to salivate over a piece of legislation, it’s worthwhile to find out where the red meat resides. Thu, 14 Sep 2017 06:32:19 -0400 http://drugwonks.com/blog/why-the-tort-bar-loves-the-creates-act Causal Inference and RWE at FDA and EMA http://drugwonks.com/blog/causal-inference-and-rwe-at-fda-and-ema One of the most difficult items on the RWE list is causal inference Wed, 13 Sep 2017 10:44:47 -0400 http://drugwonks.com/blog/causal-inference-and-rwe-at-fda-and-ema Gottlieb: Speed Saves http://drugwonks.com/blog/gottlieb-speed-saves FDA Commissioner Scott Gottlieb on Monday laid out new clinical trial approaches and digital techniques that he said could get medicines to patients sooner and at a lower price by moving away from the time-honored, traditional three phases of clinical trials. Mon, 11 Sep 2017 18:00:47 -0400 http://drugwonks.com/blog/gottlieb-speed-saves Embedding CDER's Centaurs http://drugwonks.com/blog/embedding-cder-s-centaurs If you’re an FDA reviewer, ask yourself this question, which end of the centaur do you want to be? Perhaps the FDA needs a new position on its organizational chart – Centaur Director. Thu, 07 Sep 2017 09:34:58 -0400 http://drugwonks.com/blog/embedding-cder-s-centaurs Fahrenheit 483 http://drugwonks.com/blog/fahrenheit-483 Another victory for regulatory predictability. FDA Commissioner Scott Gottlieb has gotten the message – closing the loop on agency inspections is taking too long. Fri, 01 Sep 2017 10:54:00 -0400 http://drugwonks.com/blog/fahrenheit-483 A Real World Continuum http://drugwonks.com/blog/a-real-world-continuum In a JAMA Viewpoint piece, CDER director Janet Woodcock and colleagues reinforced FDA’s stance on the incorporation of real-world evidence into clinical trials, as well as the use of pragmatic studies pre or post-market to collect data on optimal dosing and treatment effects in subpopulations. Fri, 25 Aug 2017 06:46:47 -0400 http://drugwonks.com/blog/a-real-world-continuum CRISPR Questions http://drugwonks.com/blog/crispr-questions Cancer survivors can carry germline mutations that will be transmitted to their progeny. Today, many of these mutations have been identified and can be tracked. With the recent development of genome-editing technologies and CRISPR (clustered regularly interspaced short palindromic repeats), the possibility of genetically modifying the human germline—gametes and embryos—has never been closer. Thu, 24 Aug 2017 05:55:20 -0400 http://drugwonks.com/blog/crispr-questions Missouri, the Show Me (the money) State http://drugwonks.com/blog/missouri-the-show-me-the-money-state Why are Express Scripts and Gov. Greitens being complicit in an llogical PDMP design that is so contrary to the public health? Why the disregard and disrespect for physicians? Part of the answer must lie in the PBM’s historic distrust of doctors’ ability to prescribe what’s best for their patients — as opposed to what’s cheapest. Cui bono indeed — and at whose expense? The opioid epidemic cannot be controlled by disrespecting physicians and pharmacists. Wed, 23 Aug 2017 10:42:51 -0400 http://drugwonks.com/blog/missouri-the-show-me-the-money-state Faux Patient Group Peddles Falsehoods About CAR-T Funding Source http://drugwonks.com/blog/faux-patient-group-peddles-falsehoods-about-car-t-funding-source Tue, 22 Aug 2017 20:04:45 -0400 http://drugwonks.com/blog/faux-patient-group-peddles-falsehoods-about-car-t-funding-source Narrow Provider Networks: Not Who You Know But What They Do http://drugwonks.com/blog/narrow-provider-networks-not-who-you-know-but-what-they-do Sun, 20 Aug 2017 11:56:42 -0400 http://drugwonks.com/blog/narrow-provider-networks-not-who-you-know-but-what-they-do Expanded Access Sturm und Drang http://drugwonks.com/blog/expanded-access-strum-und-drang "This bill is not going to expedite, accelerate or ease the burden of a single patient getting access to experimental medicine," said Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, a nonprofit medical issues research group. Fri, 11 Aug 2017 16:20:34 -0400 http://drugwonks.com/blog/expanded-access-strum-und-drang Embracing Generic Complexity http://drugwonks.com/blog/embracing-generic-complexity “Generic” does not mean “identical” – nor does it mean “easy.” FDA Commissioner Scott Gottlieb understands these basic tenets of drug development and has created a working group of senior FDA staff that will look for ways to increase generic competition by embracing complexity. Wed, 09 Aug 2017 07:24:11 -0400 http://drugwonks.com/blog/embracing-generic-complexity David Mitchell's Misleading and Deceptive Attack on Celgene http://drugwonks.com/blog/david-mitchell-s-misleading-and-deceptive-attack-on-celgene Tue, 08 Aug 2017 11:42:35 -0400 http://drugwonks.com/blog/david-mitchell-s-misleading-and-deceptive-attack-on-celgene PBMs Perpetuate EpiPen Formulary Monoply To Maximize Rebates http://drugwonks.com/blog/pbms-perpetuate-epipen-formulary-monoply-to-maximize-rebates It's all about the money Mon, 07 Aug 2017 19:17:42 -0400 http://drugwonks.com/blog/pbms-perpetuate-epipen-formulary-monoply-to-maximize-rebates Celgene CEO on CNBC: Getting patients access to 'precision' medicines is crucial http://drugwonks.com/blog/celgene-proactively-partnering-with-plans-to-provide-personalized-medicine-to-patients Thu, 03 Aug 2017 13:23:31 -0400 http://drugwonks.com/blog/celgene-proactively-partnering-with-plans-to-provide-personalized-medicine-to-patients PBMs are worsening the opioid epidemic http://drugwonks.com/blog/pbms-are-worsening-the-opioid-epidemic When it comes to the US opioid epidemic, one overlooked culprit comes straight from our healthcare system: pharmacy benefit managers (PBMs). To improve their bottom line, they're blocking access to prescriptions that can help prevent overdoses. Thu, 03 Aug 2017 11:39:37 -0400 http://drugwonks.com/blog/pbms-are-worsening-the-opioid-epidemic Expanded Access App-ens http://drugwonks.com/blog/expanded-access-app-ens The Reagan-Udall Foundation has released an online tool to help patients and doctors find drugs that quality for the FDA program called expanded access, or compassionate use. Tue, 25 Jul 2017 10:42:53 -0400 http://drugwonks.com/blog/expanded-access-app-ens Wood to White Oak. The Rebirth of an Off-Label Debate? http://drugwonks.com/blog/wood-to-white-oak-the-rebirth-of-an-off-label-debate Former Sidley Austin partner and product liability specialist Rebecca Wood has been named FDA chief legal counsel. Wood represented multiple life science clients during her nearly 17 years at Sidley, and notably penned briefs in two highly watched U.S. Supreme Court product liability/federal preemption cases, Warner-Lambert v. Kent, Riegel v. Medtronic, Inc . and Wyeth v. Levine. Wed, 19 Jul 2017 08:36:31 -0400 http://drugwonks.com/blog/wood-to-white-oak-the-rebirth-of-an-off-label-debate Make PBMs Disappear, Not Just Transparent http://drugwonks.com/blog/make-pbms-disappear-not-just-transparent Instead of making PBMs transparent we need to make them disappear. Fri, 14 Jul 2017 10:40:42 -0400 http://drugwonks.com/blog/make-pbms-disappear-not-just-transparent Abuse-Deterrent Opioids and the Post-Approval Valley of Death http://drugwonks.com/blog/abuse-deterrent-opioids-and-the-post-approval-valley-of-death Although 10 new opioid products with abuse-deterrent formulations (ADF) have received regulatory approval in the United States, lack of willingness by insurers to reimburse patients for their use is seen as a primary challenge limiting ADF uptake, according to the Tufts Center for the Study of Drug Development. Fri, 14 Jul 2017 06:26:04 -0400 http://drugwonks.com/blog/abuse-deterrent-opioids-and-the-post-approval-valley-of-death ICER To "Prioritize" What Medicines Veterans Get http://drugwonks.com/blog/icer-to-prioritize-what-medicines-veterans-get Wed, 12 Jul 2017 17:02:47 -0400 http://drugwonks.com/blog/icer-to-prioritize-what-medicines-veterans-get Cutting through the (Us)din http://drugwonks.com/blog/cutting-through-the-us-din What a great combination – Steve Usdin interviews Scott Gottlieb. Mon, 26 Jun 2017 14:01:58 -0400 http://drugwonks.com/blog/cutting-through-the-us-din The Urgency of PDUFA http://drugwonks.com/blog/the-urgency-of-pdufa Thousands of Americans could die waiting for the FDA to approve new, lifesaving treatments if Congress fails to reauthorize a 25-year old law this summer. Tue, 20 Jun 2017 08:20:54 -0400 http://drugwonks.com/blog/the-urgency-of-pdufa The Maine Event http://drugwonks.com/blog/the-maine-event Maine lawmakers are advancing LD 1280, a bill that seeks to reduce patients' health care bills by speeding up the introduction of low-cost generic drugs. The bill has a noble goal. But it is terribly written Mon, 19 Jun 2017 08:06:51 -0400 http://drugwonks.com/blog/the-maine-event Gottlieb talks tech http://drugwonks.com/blog/gottlieb-talks-tech n a blog post Thursday, FDA Commissioner Scott Gottlieb outlined regulatory steps designed to promote development of digital health technologies. Fri, 16 Jun 2017 13:06:54 -0400 http://drugwonks.com/blog/gottlieb-talks-tech Wired Magazine Article Celebrates The New Eugenics http://drugwonks.com/blog/wired-magazine-article-celebrates-the-new-eugenics Wed, 14 Jun 2017 11:34:48 -0400 http://drugwonks.com/blog/wired-magazine-article-celebrates-the-new-eugenics Improving Patient Advocacy Across the Globe http://drugwonks.com/blog/improving-patient-advocacy-across-the-globe If you’re interested in the FDA’s Patient-Focused Drug Development program and attending next week’s BIO bash, hope you can attend (and participate) at this interactive panel discussion -- Improving Patient Advocacy Across the Globe. Wed, 14 Jun 2017 08:19:14 -0400 http://drugwonks.com/blog/improving-patient-advocacy-across-the-globe Regenerative Medicine Can Revitalize America! http://drugwonks.com/blog/regenerative-medicine-can-revitalize-america Mon, 12 Jun 2017 16:08:54 -0400 http://drugwonks.com/blog/regenerative-medicine-can-revitalize-america Regulatory Learnings from the Real World http://drugwonks.com/blog/regulatory-learnings-from-the-real-world In March, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSARM). voted 18-8 that Opana ER’s benefits do not outweigh its risks. And on June 8th, the other shoe dropped. Mon, 12 Jun 2017 07:46:50 -0400 http://drugwonks.com/blog/regulatory-learnings-from-the-real-world Managed Care Magazine Unleashes Attack on Orphans http://drugwonks.com/blog/managed-care-magazine-unleashes-attack-on-orphans Apparently, people with rare diseases should do without to appease the anti-pharma crowd Thu, 08 Jun 2017 19:11:10 -0400 http://drugwonks.com/blog/managed-care-magazine-unleashes-attack-on-orphans The economics of opioids http://drugwonks.com/blog/the-economics-of-opioids The Joint Economic Committee (JEC) will hold a hearing on June 8th to explore the economic aspects of the opioid crisis. We'll see. Thu, 08 Jun 2017 11:35:47 -0400 http://drugwonks.com/blog/the-economics-of-opioids Single Payer. All the news that's fit to print? http://drugwonks.com/blog/single-payer-all-the-news-that-s-fit-to-print Per, "The Single-Payer Party? Democrats Shift Left on Health Care," (NYT, June 3, 2017) it seems somewhat ham-handed to have only one paragraph, deep inside the page 16 jump of a Page One article, mentioning the enormous cost and tax consequences of the California legislation -- and no mention at all of the proposal's impact on patient choice and resource rationing. That's not fake news -- but it certainly isn't all the news that's fit to print. Sun, 04 Jun 2017 12:30:46 -0400 http://drugwonks.com/blog/single-payer-all-the-news-that-s-fit-to-print Let's partner with Canada to fight opioid abuse http://drugwonks.com/blog/let-s-partner-with-canada-to-fight-opioid-abuse One place to look for smart policy solutions is just north of the border, where medical experts and public health officials in Canada are also concerned about the abuse of prescription opioids. A study published by the Canadian Health Policy Institute (CHPI) estimates that if all prescription opioids in Canada were abuse deterrent formulations, societal costs could be substantially reduced. Tue, 30 May 2017 09:11:38 -0400 http://drugwonks.com/blog/let-s-partner-with-canada-to-fight-opioid-abuse Trumping FDA? http://drugwonks.com/blog/trumping-fda President Trump’s FY18 FDA budget request envisions cutting medical product safety funding by $17.8 million. The cuts would reduce the agency’s ability to ensure the safety of imported drugs and ingredients, and to conduct safety research the agency characterizes as “critical.”
FDA stated that the budget proposal would also curtail "proactive" activities to respond to global disease outbreaks. Thu, 25 May 2017 06:20:16 -0400 http://drugwonks.com/blog/trumping-fda Off-Label Use: TIme Marches On http://drugwonks.com/blog/off-label-use-time-marches-on In a recent Washington Post op-ed, Bill Schultz, the former deputy commissioner for policy of the Food and Drug Administration during the Clinton administration, incredulously offers that FDA policies developed 50 years ago are good enough for life in the 21st century (Trump’s new FDA commissioner has a huge decision to make). He’s wrong. Sat, 20 May 2017 12:04:50 -0400 http://drugwonks.com/blog/off-label-use-time-marches-on