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) 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 No HELP http://drugwonks.com/blog/no-help It’s disappointing to say the least when our fine elected representatives place scoring transient political points in front of advancing the public health. Such is always the case with the perennial non-starter issue of drug importation. What makes it even more dangerous this time is how it could delay swift and clean PDUFA approval. Tue, 09 May 2017 18:02:34 -0400 http://drugwonks.com/blog/no-help FDA, JAMA, PV, RWE and other relevant acronyms http://drugwonks.com/blog/fda-jama-pv-rwe-and-other-relevant-acronyms Nearly one third of drugs newly approved by the US Food and Drug Administration (FDA) are affected by safety issues that were not known at the time of approval, a study has shown. Tue, 09 May 2017 14:54:35 -0400 http://drugwonks.com/blog/fda-jama-pv-rwe-and-other-relevant-acronyms BCBSA BS on Rx http://drugwonks.com/blog/bcbsa-bs-on-rx Tue, 09 May 2017 13:26:15 -0400 http://drugwonks.com/blog/bcbsa-bs-on-rx From the FDA.ke News Desk http://drugwonks.com/blog/from-the-fda-ke-news-desk In the wake of the unraveling scandal surrounding the agency’s television viewing habits, CDRH spokesperson Teng Kay has denied allegations they have been instructed by “unconfirmed alien contact” to reclassify TV remotes as Class II Medical devices. In a related story, Acting FDA Commissioner Rupert Murdoch has issued a list of “breakthrough therapy” entertainment for recommended viewing. The list is said to include: ANDA and the King of Siam, Complete Response Letters from Iwo Jima, and Fahrenheit 453. All programming has been deemed truthful, accurate, and non-misleading by the Shkreli Institute for Ethical Studies. Sat, 06 May 2017 15:31:42 -0400 http://drugwonks.com/blog/from-the-fda-ke-news-desk ICER’s GIGO http://drugwonks.com/blog/icer-s-gigo Fri, 05 May 2017 15:58:53 -0400 http://drugwonks.com/blog/icer-s-gigo QunitilesIMS Data to Digest http://drugwonks.com/blog/qunitilesims-data-to-digest The QuintilesIMS Institute has issued a very interesting new report, “Medicines Use and Spending in the US: A Review of 2016 and Outlook to 2021.” It’s a must-read for many reasons – not the least of which is its plethora of data. Fri, 05 May 2017 08:06:25 -0400 http://drugwonks.com/blog/qunitilesims-data-to-digest Dear Colleague: Let's Put Off-Label on the Legislative Table http://drugwonks.com/blog/dear-colleague-let-s-put-off-label-on-the-legislative-table Representative Morgan Griffith (R/VA) has introduced HR 1703, the Medical Product Communications Act. It’s legislation that would take a lot of the ambiguity out of the FDA’s biggest conundrum – regulatory clarity on the sharing of truthful accurate, and non-misleading off-label information. Thu, 04 May 2017 18:03:03 -0400 http://drugwonks.com/blog/dear-colleague-let-s-put-off-label-on-the-legislative-table The Dubai Declaration http://drugwonks.com/blog/the-dubai-declaration When it comes to 21st century pharmacovigilance, sometimes it’s important to look … backwards. According to the 10th century Arab physician, Ibn Sina, “The time of action must be observed, so that essence and accident are not confused.” Wed, 03 May 2017 08:58:13 -0400 http://drugwonks.com/blog/the-dubai-declaration Scott Gottlieb: Hope Over Hate http://drugwonks.com/blog/scott-gottlieb-hope-over-hate Thu, 27 Apr 2017 11:18:46 -0400 http://drugwonks.com/blog/scott-gottlieb-hope-over-hate Making Drug Manufacturing Great Again http://drugwonks.com/blog/making-drug-manufacturing-great-again President Trump wants to lower drug prices and reinvigorate domestic pharmaceutical manufacturing. Bravo. But standing in the way is the inside-the-Beltway gospel that preaches that regulators love ambiguity. Fri, 21 Apr 2017 13:25:53 -0400 http://drugwonks.com/blog/making-drug-manufacturing-great-again DTC Fair Balance ... for Lawyers! http://drugwonks.com/blog/dtc-fair-balance-for-lawyers House Judiciary Committee Chairman, Rep. Bob Goodlatte (R/VA.) wants drug side-effect ads that are run by lawyers to include a warning that patients should talk with their doctors before adjusting medication. Mon, 17 Apr 2017 09:19:34 -0400 http://drugwonks.com/blog/dtc-fair-balance-for-lawyers PDUFA Reauthorization. Discuss. http://drugwonks.com/blog/pdufa-reauthorization-discuss WASHINGTON, DC – The leaders of the Senate and House health committees today released a discussion draft of bipartisan legislation reauthorizing the Food and Drug Administration user fee agreements. Fri, 14 Apr 2017 17:54:01 -0400 http://drugwonks.com/blog/pdufa-reauthorization-discuss PIE Day http://drugwonks.com/blog/pie-day It's time to go beyond FDAMA 114. It's time for PIE. Wed, 12 Apr 2017 07:47:26 -0400 http://drugwonks.com/blog/pie-day Expediting Complex Geneics http://drugwonks.com/blog/expediting-complex-geneics It's not about speed, it's about predictability. Thu, 06 Apr 2017 09:18:48 -0400 http://drugwonks.com/blog/expediting-complex-geneics PV in the EU: Can the Doctor See You Now? http://drugwonks.com/blog/pv-in-the-eu-can-the-doctor-see-you-now European, national, and regional authorities should invest in awareness-raising campaigns to increase public knowledge about medicinal safety and adverse drug reaction (ADR) reporting. Thu, 06 Apr 2017 06:57:43 -0400 http://drugwonks.com/blog/pv-in-the-eu-can-the-doctor-see-you-now Scott STAT! http://drugwonks.com/blog/scott-stat “I think Scott is very much for good regulation, and very much against bad regulation,” Pitts said. “Importantly, he recognizes where FDA core mission stops, and where mission creep begins — and that’s an important finesse he’d bring to the commissioner’s chair.” Wed, 05 Apr 2017 22:05:01 -0400 http://drugwonks.com/blog/scott-stat Arizona and Off-Label. Heart in the right place. Brain -- not so much. http://drugwonks.com/blog/arizona-and-off-label-heart-in-the-right-place-brain-not-so-much In what some observers are calling a misguided effort, Arizona has become the first state in the nation to pass a law allowing drug makers to promote their medicines for so-called off-label uses — so long as the information given doctors is truthful. Thu, 30 Mar 2017 10:11:45 -0400 http://drugwonks.com/blog/arizona-and-off-label-heart-in-the-right-place-brain-not-so-much STAT News Tangled Treatment of Scott Gottlieb http://drugwonks.com/blog/stat-news-tangled-treatment-of-scott-gottlieb Wed, 29 Mar 2017 12:29:13 -0400 http://drugwonks.com/blog/stat-news-tangled-treatment-of-scott-gottlieb ICER Devalues People With Rheumatoid Arthritis http://drugwonks.com/blog/icer-devalues-people-with-rheumatoid-arthritis Wed, 29 Mar 2017 11:02:53 -0400 http://drugwonks.com/blog/icer-devalues-people-with-rheumatoid-arthritis Limpid Lipids http://drugwonks.com/blog/limpid-lipids Nothing is more illustrative of the price/value discussion than PCSK9s. Just what are they worth? What's innovation worth? Tue, 28 Mar 2017 10:25:13 -0400 http://drugwonks.com/blog/limpid-lipids Fake DTC news mustn't drive the healthcare debate http://drugwonks.com/blog/fake-dtc-news-mustn-t-drive-the-healthcare-debate When pundits, politicians, and policymakers speak about “sales and marketing,” the picture they are painting is of direct-to-consumer pharmaceutical advertising – the public face of Big Pharma. So, let’s set the record straight on that straight away. In 2016 $5.6 billion was spent on DTC. Same period R&D spending is roughly $70 billion. Amorous middle-aged couples in claw foot bathtubs are a lot sexier than excel spreadsheets, but facts as pesky things. Surprised? Mon, 27 Mar 2017 09:57:34 -0400 http://drugwonks.com/blog/fake-dtc-news-mustn-t-drive-the-healthcare-debate De-Commissioning Drug Importation http://drugwonks.com/blog/de-commissioning-drug-importation Four former FDA commissioners warn that proposals to allow importation of pharmaceuticals would create serious risks for consumer and patients, and would produce only minimal savings. Fri, 17 Mar 2017 07:35:01 -0400 http://drugwonks.com/blog/de-commissioning-drug-importation The Worst Drug Cost Article of the Year http://drugwonks.com/blog/the-worst-drug-cost-article-of-the-year Thu, 16 Mar 2017 10:31:20 -0400 http://drugwonks.com/blog/the-worst-drug-cost-article-of-the-year Wyden the PBM Investigation http://drugwonks.com/blog/wyden-the-pbm-investigation The ranking member of the Senate Finance Committee will roll out a proposal today to lower drug costs by targeting prescription benefit managers (PBMS) — middlemen who negotiate discounts on drugs with pharma companies and administer prescription drug coverage for health insurance companies. Wed, 15 Mar 2017 08:47:31 -0400 http://drugwonks.com/blog/wyden-the-pbm-investigation Scott Gottlieb: The Patient's FDA Commissioner http://drugwonks.com/blog/scott-gottlieb-the-patient-s-fda-commissioner Tue, 14 Mar 2017 11:26:41 -0400 http://drugwonks.com/blog/scott-gottlieb-the-patient-s-fda-commissioner Fighting Opioid Abuse with Regulatory Clarity http://drugwonks.com/blog/fighting-opioid-abuse-with-regulatory-clarity At the recent abuse deterrent opioids summit, CDER Deputy Director for Regulatory Programs Dr. Doug Throckmorton presented the FDA’s position. He said, “We must move on from older to newer technologies. Amen. But how? Tue, 14 Mar 2017 08:41:06 -0400 http://drugwonks.com/blog/fighting-opioid-abuse-with-regulatory-clarity Scott Gottlieb in the Pink (Sheet) http://drugwonks.com/blog/scott-gottlieb-in-the-pink-sheet Former deputy commissioner will also likely push increased use of biomarkers and more flexibility in off-label communication, among other reforms. President Donald Trump's choice of Scott Gottlieb to head the US FDA could signal efforts to bring reforms among a variety of fronts, perhaps none more notable than how the agency approves generic drugs. Mon, 13 Mar 2017 10:18:46 -0400 http://drugwonks.com/blog/scott-gottlieb-in-the-pink-sheet The Drug Pricing Ecosystem -- A NY State of Mind http://drugwonks.com/blog/the-drug-pricing-ecosystem-a-ny-state-of-mind Governor Cuomo’s budget aims to control drug pricing through price controls . While this is a good political sound bite, it’s bad public policy with dangerous unintended consequences – the worst of being that it won't lower prices but will reduce patient choice. Thu, 09 Mar 2017 07:53:52 -0500 http://drugwonks.com/blog/the-drug-pricing-ecosystem-a-ny-state-of-mind Bipartisan Sanity on Healthcare Transparency http://drugwonks.com/blog/bipartisan-sanity-on-healthcare-transparency Finally, some bipartisan sanity on healthcare transparency. Representatives Doug Collins (R-GA), Buddy Carter (R-GA), Dan Loebsack (D-IA), John Sarbanes (D-MD) and John Duncan (R-TN) have introduced the Prescription Drug Price Transparency Act. Mon, 06 Mar 2017 08:43:15 -0500 http://drugwonks.com/blog/bipartisan-sanity-on-healthcare-transparency Vampire Health Policy http://drugwonks.com/blog/vampire-health-policy Drug importation is a vampire issue — you can drive a stake through its heart, but it won’t die.” Wed, 01 Mar 2017 19:33:09 -0500 http://drugwonks.com/blog/vampire-health-policy Trump's FDA Reform Critics Rage Against Patients http://drugwonks.com/blog/trump-s-fda-reform-critics-rage-against-patients Wed, 01 Mar 2017 19:28:11 -0500 http://drugwonks.com/blog/trump-s-fda-reform-critics-rage-against-patients UN gets it wrong on drug access http://drugwonks.com/blog/un-gets-it-wrong-on-drug-access What's the best way to improve health care for billions of people in the developing world? If you answered, “Attack health care firms,” you qualify for a job with the United Nations. You'd also be dead wrong. Wed, 01 Mar 2017 01:41:12 -0500 http://drugwonks.com/blog/un-gets-it-wrong-on-drug-access ICER's Attack on Rare Diseases http://drugwonks.com/blog/icer-s-attack-on-rare-diseases Tue, 28 Feb 2017 17:24:35 -0500 http://drugwonks.com/blog/icer-s-attack-on-rare-diseases Pharma Cap on Price Increases Benefit Insurers Not Consumers http://drugwonks.com/blog/pharma-cap-on-price-increases-benefit-insurers-not-consumers Tue, 28 Feb 2017 13:00:33 -0500 http://drugwonks.com/blog/pharma-cap-on-price-increases-benefit-insurers-not-consumers Mooning Healthcare http://drugwonks.com/blog/mooning-healthcare An interesting post at OhMD discusses a new study showing that “96% of patients report leaving their doctor’s office with limited knowledge of how to use the patient portal. Of the 40% of patients who said they had attempted to use the patient portal in 2016, 83% said it was too complicated to use.” That means only 7% of patients find it simple enough to use, and actually care to use it. Mon, 27 Feb 2017 07:18:00 -0500 http://drugwonks.com/blog/mooning-healthcare ProPublica Hides Own Conflicts While Challenging Others http://drugwonks.com/blog/propublica-hides-own-conflicts-while-challenging-others Fri, 24 Feb 2017 14:45:06 -0500 http://drugwonks.com/blog/propublica-hides-own-conflicts-while-challenging-others USA Today: Patient Groups That Get Money Anywhere But Pharma are Conflict Free. http://drugwonks.com/blog/usa-today-patient-groups-that-get-money-anywhere-but-pharma-are-conflict-free Wed, 22 Feb 2017 13:55:12 -0500 http://drugwonks.com/blog/usa-today-patient-groups-that-get-money-anywhere-but-pharma-are-conflict-free A Virtual Ounce of Prevention http://drugwonks.com/blog/a-virtual-ounce-of-prevention The gathering and appraisal of real world evidence can expedite identification of problems before they become deadly. If we can identify misuse earlier, we can help eradicate abuse and addiction.Apps present us with just that opportunity – a virtual ounce of prevention. Tue, 21 Feb 2017 07:40:27 -0500 http://drugwonks.com/blog/a-virtual-ounce-of-prevention ICER’s policy prescriptions will cripple MS patients http://drugwonks.com/blog/icer-s-policy-prescriptions-will-cripple-ms-patients Thu, 16 Feb 2017 21:03:37 -0500 http://drugwonks.com/blog/icer-s-policy-prescriptions-will-cripple-ms-patients