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) Insurers’ Dirty Tricks Are Undermining a Central Promise of Obamacare http://drugwonks.com/blog/insurers-dirty-tricks-are-undermining-a-central-promise-of-obamacare HMOs Break Their Promise To Patients Fri, 26 Jun 2015 12:58:09 -0500 http://drugwonks.com/blog/insurers-dirty-tricks-are-undermining-a-central-promise-of-obamacare Temple of Wisdom or Wisdom of Temple? http://drugwonks.com/blog/temple-of-wisdom-or-wisdom-of-temple The FDA is taking steps toward getting more patient input during the drug development process, a move that puts the agency more in line with its EU counterparts, agency officials said at the DIA annual meeting. Thu, 25 Jun 2015 08:55:02 -0500 http://drugwonks.com/blog/temple-of-wisdom-or-wisdom-of-temple ASCO Cost Tool Abandons Hippocratic Oath and Cancer Patients http://drugwonks.com/blog/asco-cost-tool-abandons-hippocratic-oath-and-cancer-patients a framework that ignores and belittles patient preferences and the evidence of long term value is a cover-up, not a calculator Wed, 24 Jun 2015 17:27:47 -0500 http://drugwonks.com/blog/asco-cost-tool-abandons-hippocratic-oath-and-cancer-patients Bass Hole http://drugwonks.com/blog/bass-hole The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office has accepted a request from Celgene to consider sanctions against the Coalition for Affordable Drugs, an entity controlled by hedge fund manager Kyle Bass. Mon, 22 Jun 2015 05:09:02 -0500 http://drugwonks.com/blog/bass-hole PDUFA VI -- Are you ready to rumble? http://drugwonks.com/blog/pdufa-vi-are-you-ready-to-rumble Did somebody say “PDUFA VI?” With the upcoming PDUFA renewal, 21st Century Cures uncertainty, and a leadership transition at FDA, it is a dynamic and uncertain time in the biopharma industry. The outcomes of these key policy debates, along with others, will impact how industry pursues drug development and works with patients and regulators to improve public health. Fri, 19 Jun 2015 09:48:02 -0500 http://drugwonks.com/blog/pdufa-vi-are-you-ready-to-rumble Biotech Investment, Sound Regulatory Policy, and Nazaha http://drugwonks.com/blog/biotech-investment-sound-regulatory-policy-and-nazaha At the recent BIO confab in Philly I was honored to moderate the panel on “Public Sector Biotech Initiatives in Middle East and North Africa.”A key take-away was that one of the key drivers of biotech investment in the region (and, indeed, any region) is sound regulatory policy. Thu, 18 Jun 2015 08:54:16 -0500 http://drugwonks.com/blog/biotech-investment-sound-regulatory-policy-and-nazaha Deliberately Sensational Reporting About Drug Costs http://drugwonks.com/blog/deliberately-sensational-reporting-about-drug-costs Increased spending on drugs is a good thing and still a small share of costs.. everywhere. Wed, 17 Jun 2015 14:50:30 -0500 http://drugwonks.com/blog/deliberately-sensational-reporting-about-drug-costs PV and PatientsLikeMe http://drugwonks.com/blog/pv-and-patientslikeme PatientsLikeMe Inc. has granted FDA access to its patient-reported data, which the agency said it will use to identify risks and benefits of drugs. The agency said PatientsLikeMe's adverse event data have the potential to supplement existing sources, including data that sponsors are obligated to report and data from FDA's Adverse Event Reporting System (FAERS), to address safety issues that arise postmarket.
 PatientsLikeMe said FDA will have access to more than 110,000 adverse event reports on 1,000 different drugs at no cost. Tue, 16 Jun 2015 05:58:16 -0500 http://drugwonks.com/blog/pv-and-patientslikeme Obama gets a D in Part D economics http://drugwonks.com/blog/obama-gets-a-d-in-part-d-economics A new federal report misleadingly estimates the cost of the Medicare Part D program at $103 billion. That figure is bunk. Nonetheless, it will give President Barack Obama more ammunition for his assault on Part D - a program that provides affordable prescription drug insurance to more than 2 million Texas seniors. Fri, 12 Jun 2015 05:46:11 -0500 http://drugwonks.com/blog/obama-gets-a-d-in-part-d-economics Patent Death Squads vs. Innovation http://drugwonks.com/blog/patent-death-squads-vs-innovation Patents, according to Abraham Lincoln, “add the fuel of interest to the passion of genius.” The Patent Trial and Appeal Board was supposed to make the system better. It hasn’t.To that point, a new op-ed from today's edition of the Wall Street Journal. Thu, 11 Jun 2015 05:45:33 -0500 http://drugwonks.com/blog/patent-death-squads-vs-innovation The Pharm-ers Almanac http://drugwonks.com/blog/the-pharm-ers-almanac From the brilliant, witty, and acerbic mind of Dr. TIm Franson, former head honcho of all things regulatory at Eli Lilly & Company, current President of the USP, board member of the Critical Path Institute, and Chief Medical Director at YourEncore, comes the Pharm-ers Almanac: 10 Pharma Trends to Navigate Now. (Some animals are more equal than others.) It's an important, timely, fun -- and a must read pre BIO and DIA. Wed, 10 Jun 2015 08:12:00 -0500 http://drugwonks.com/blog/the-pharm-ers-almanac WWJD -- What Would Janet Do? http://drugwonks.com/blog/wwjd-what-would-janet-do Amarin got some bad regulatory advice. The FDA has loudly signaled that it is going to act with increased regulatory discretion on off-label communications. This was either missed or ignored by Amarin. A meeting with the agency would have addressed their concerns. [As for the FDA], “exercising regulatory discretion is a smart move as it takes the matter out of the hands of a judge. A free speech ruling would make things much more difficult for the agency. The FDA opted for strategic retreat rather than face a potential sledgehammer legal decision. Tue, 09 Jun 2015 15:38:12 -0500 http://drugwonks.com/blog/wwjd-what-would-janet-do Wierd Science At NIH http://drugwonks.com/blog/wierd-science-at-nih Every organization needs one core competence: innovation Tue, 09 Jun 2015 14:54:54 -0500 http://drugwonks.com/blog/wierd-science-at-nih The Biosimilar Name Game http://drugwonks.com/blog/the-biosimilar-name-game Tue, 09 Jun 2015 04:39:47 -0500 http://drugwonks.com/blog/the-biosimilar-name-game The Scarlet Letter of Biosimilars? http://drugwonks.com/blog/the-scarlet-letter-of-biosimilars It seems that AbbVie Inc. (“AbbVie”) – which, interestingly, starts with the letter “A” – took note of the Scarlet Letter change as well. In a June 2, 2015 Citizen Petition (Docket No. FDA-2015-P-2000) that popped up on regulations.gov earlier this afternoon (June 3rd), the company requests FDA to require the approved labeling for biological products licensed under PHS Act § 351(k) to contain (if applicable) certain statements and descriptions that would differentiate biosimilars from their reference product counterparts. Thu, 04 Jun 2015 06:40:18 -0500 http://drugwonks.com/blog/the-scarlet-letter-of-biosimilars AARP's Hypocritical Study on Drug Prices http://drugwonks.com/blog/aarp-s-hypocritical-study-on-drug-prices Insurers and drug benefit plans are hiking out of pocket drug costs. AARP is one of them. Tue, 02 Jun 2015 15:57:02 -0500 http://drugwonks.com/blog/aarp-s-hypocritical-study-on-drug-prices Let's Meet at MENA http://drugwonks.com/blog/let-s-meet-at-mena Going to BIO? Join me on June 16th for “Public Sector Biotech Initiatives in Middle East and North Africa. I’ll be moderating a panel of experts and government officials discussing government and public sector initiatives designed to attract biotech research and development in the MENA region. We’ll discuss tax incentives, regulatory, reimbursement and IP policies as well as government investments that key MENA countries have implemented to attract biotech companies. Tue, 02 Jun 2015 07:54:15 -0500 http://drugwonks.com/blog/let-s-meet-at-mena Lenny Saltz Goes Crazy About Drug Prices http://drugwonks.com/blog/lenny-saltz-goes-crazy-about-drug-prices We should pay even more if 90 percent of people who die from cancer could live 2 year or more. Mon, 01 Jun 2015 11:04:07 -0500 http://drugwonks.com/blog/lenny-saltz-goes-crazy-about-drug-prices Guts & Chutzpah ... in short supply? http://drugwonks.com/blog/guts-chutzpah-in-short-supply When it comes to communication, the 21st Century Cures Act is stuck in the 20th century. The sweeping biomedical innovation bill aims to speed up development of medical treatments by taking advantage of the latest in science and technology. But provisions meant to update the FDA’s regulations on drug advertising were dropped. Mon, 01 Jun 2015 08:10:07 -0500 http://drugwonks.com/blog/guts-chutzpah-in-short-supply FiercePharma's Factless Farce http://drugwonks.com/blog/fiercepharma-s-factless-farce Journalism is not just paraphrasing corporate blogs Fri, 29 May 2015 15:23:00 -0500 http://drugwonks.com/blog/fiercepharma-s-factless-farce