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) The Globetrotting Regulator http://drugwonks.com/blog/the-globetrotting-regulator I am putting in a lot of miles on behalf of international regulatory fraternity. Over the last few months I’ve visited Egypt, Indonesia, Vietnam, Taiwan, Mexico, and Brazil, where I’ve had privilege to meet with regulatory and healthcare officials. (And boy, are my arms tired.) Many things were discussed and shared, but the red thread was the urgency of quality. Fri, 22 May 2015 08:53:28 -0500 http://drugwonks.com/blog/the-globetrotting-regulator Greasing the skids for 21st Century Cures http://drugwonks.com/blog/greasing-the-skids-for-21st-century-cures Bipartisan House committee leaders on Thursday announced a $13 billion deal to pay for the cost of a measure to speed the approval of new medical cures. The 21st Century Cures measure, aimed at streamlining the FDA’s approval process for new drugs, has received bipartisan support in the Energy and Commerce Committee, easily passing a subpanel last week on a voice vote. Thu, 21 May 2015 09:12:46 -0500 http://drugwonks.com/blog/greasing-the-skids-for-21st-century-cures Speaking Truth to Scour http://drugwonks.com/blog/speaking-truth-to-scour Eli Lily's John Lechleiter tells it like it is. And as John Adams said, "Truth is a pesky thing," Debunking The Five Big Myths About 'Big Pharma' If you are a regular reader of politically oriented commentaries on the pharmaceutical industry then you are familiar with, and perhaps even subscribe to, what I call “the Big Five”—myths about this industry that routinely poison debates, obscure genuine problems, and distort policy recommendations on health care. These myths have been all over the public arena again recently, and it’s time to confront them systematically. Thu, 21 May 2015 06:57:52 -0500 http://drugwonks.com/blog/speaking-truth-to-scour 21st Century Bioequivalence: How do you spell "Integrity?" http://drugwonks.com/blog/21st-century-bioequivalance-how-do-you-spell-integrity Much discussion about pharmaceutical quality at the FDA of late (Drug Quality: If you can’t measure it, it doesn’t count, The silent “n” of PDUFA) – and specifically about a more 21st century view of bioequivalence. And appropriately so. But is the agency doing the right thing the right way? Consider Concerta. Will the courts follow the chevron deference route or tell the FDA to put it on paper? Mon, 18 May 2015 06:12:52 -0500 http://drugwonks.com/blog/21st-century-bioequivalance-how-do-you-spell-integrity Express Scripts Super Spenders Study Is Super Misleading http://drugwonks.com/blog/express-scripts-super-spenders-study-is-super-misleading Another effort to perpetuate discrimination against the very sick. Fri, 15 May 2015 09:52:21 -0500 http://drugwonks.com/blog/express-scripts-super-spenders-study-is-super-misleading Drug Quality: If you can't measure it, it doesn't count http://drugwonks.com/blog/drug-quality-if-you-can-t-measure-it-it-doesn-t-count The FDA is offering two grants of up to $600,000 each over three years in exchange for data to establish statistically based pharmaceutical quality standards — a further sign of the agency’s commitment to using quality metrics. The proposed projects, announced Friday, will evaluate batch-to-batch and unit-to-unit variability of companies’ products, capturing data on such quality chemical and physical attributes as tablet weight, assay, content uniformity and dissolution. The data will be used to create a risk-based lifecycle approach that measures quality over every step of the manufacturing process, Peter Pitts, president and founder of the Center for Medicine in the Public Interest and a former FDA associate commissioner, tells DID. Thu, 14 May 2015 10:14:51 -0500 http://drugwonks.com/blog/drug-quality-if-you-can-t-measure-it-it-doesn-t-count The Silent "n" of PDUFA http://drugwonks.com/blog/not-the-beginning-of-the-end-but-the-n-of-the-beginning Statistics are like a bikini. What they show you are interesting, but what they conceal is essential. Late last month the FDA’s Bioresearch Monitoring (“BIMO”) Program released its annual report on inspections from the previous fiscal year. In light of many key issues and initiatives, some of the results are, well … thought provoking. Wed, 13 May 2015 09:58:43 -0500 http://drugwonks.com/blog/not-the-beginning-of-the-end-but-the-n-of-the-beginning Express Scripts CEO To Kids With Cystic Fibrosis: Find Another Way To Stay Alive http://drugwonks.com/blog/express-scripts-ceo-to-kids-with-cystic-fibrosis-find-another-way-to-stay-alive Tue, 12 May 2015 16:46:57 -0500 http://drugwonks.com/blog/express-scripts-ceo-to-kids-with-cystic-fibrosis-find-another-way-to-stay-alive Woodcock WebEx on FDA's Office of Pharmacutical Quality http://drugwonks.com/blog/woodcock-webex-on-fda-s-office-of-pharmacutical-quality Sign up now for this exclusive question-and-answer webinar with FDA veteran Peter Pitts, President and Co-founder of the Center for Medicine in the Public Interest, as he speaks with Dr. Janet Woodcock, Director of CDER and the driving force behind the formation of the OPQ and Dr. Lawrence Yu, Acting Director of CDER’s Office of Pharmaceutical Science, to help you understand all the changes that will effect you. Tue, 12 May 2015 10:48:39 -0500 http://drugwonks.com/blog/woodcock-webex-on-fda-s-office-of-pharmacutical-quality PDUFA Jr. funding theory DOA http://drugwonks.com/blog/pdufa-jr-funding-theory-doa The U.S. House Energy & Commerce Committee staff have asked the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) to offset some or all of the cost of the proposed 21st Century Cures Act, according to individuals involved in the discussions. According to a report in BioCentury The trade associations adamantly refused to consider the proposal in a conversation with E&C staff this week. Sat, 09 May 2015 07:05:19 -0500 http://drugwonks.com/blog/pdufa-jr-funding-theory-doa The other kind of fair balance and adequate provision http://drugwonks.com/blog/the-other-kind-of-fair-balance-and-adequate-provision In response to a May 4, 2015 story in the New York Times about Essure permanent birth control, Bayer submitted the following letter to the editor, which the New York Times refused to publish in its entirety. The Gray Lady’s space considerations notwithstanding, this is an issue of both fairness and accuracy. Sat, 09 May 2015 06:55:06 -0500 http://drugwonks.com/blog/the-other-kind-of-fair-balance-and-adequate-provision Something fishy in the off-label conversation http://drugwonks.com/blog/something-fishy-in-the-off-label-conversation Unless the FDA takes control of the off-label conversation firmly and swiftly. Things are not going to be pretty. Case in point -– a company jumping on the off-label bandwagon because of an FDA decision they didn’t like? Dangerous times. Fri, 08 May 2015 06:08:57 -0500 http://drugwonks.com/blog/something-fishy-in-the-off-label-conversation Off Label Communications gets a Buzz Cut http://drugwonks.com/blog/off-label-communication-s-gets-a-buzz-cut A somewhat slanted viewpoint on off-label communication? You be the judge. Wed, 06 May 2015 23:56:42 -0500 http://drugwonks.com/blog/off-label-communication-s-gets-a-buzz-cut Seeking Clarity on Complexity http://drugwonks.com/blog/seeking-clarity-from-complexity A new bill introduced by Rep. Michael Burgess (R-Texas), the Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 (H.R. 1576), is an effort to get ahead of the curve on complexity. Rep. Burgess’ legislation would have the Government Accountability Office (GAO) study some of the unique challenges presented by the Food and Drug Administrations’s evaluation of generic versions of complex drug products. These challenges are as important to serving the public health as they are complicated when it comes to regulati Wed, 06 May 2015 09:23:56 -0500 http://drugwonks.com/blog/seeking-clarity-from-complexity A Little 21st Century Cures Rah Rah http://drugwonks.com/blog/a-little-21st-century-cures-rah-rah Congress must encourage the 21st Century Cures Initiative By Peter J. Pitts Over 200,000 American heart attack survivors will have another heart attack this year. Fortunately, the FDA recently approved Zontivity -- a medicine that prevents blood clots in people who have already suffered a heart attack. In clinical trials, the new drug significantly reduced the rate at which survivors experience another heart attack. Wed, 06 May 2015 00:39:13 -0500 http://drugwonks.com/blog/a-little-21st-century-cures-rah-rah The Gray Lady & the Non-Interference Clause http://drugwonks.com/blog/the-gray-lady-the-non-interference-clause Allowing the Federal government to negotiate drug prices (Runaway Drug Prices, May 5, 2015) would result in prices going up and patient choice going down. That’s why the Non-Interference Clause, the legislation that prohibits Federal price negotiation was created in the first place. It’s interesting and important to note that the legislative language was drafted by Senators Ted Kennedy and Tom Daschle. Tue, 05 May 2015 06:24:24 -0500 http://drugwonks.com/blog/the-gray-lady-the-non-interference-clause Off-Label: Fish or Fowl? http://drugwonks.com/blog/off-label-fish-or-fowl In years past, pharmaceutical companies had to check themselves before conveying off-label product information – even though many of those uses had long since become standards of care. But in recent months, the FDA has signaled a willingness to open the off-label floodgates – at least somewhat. What does is all mean? Mon, 04 May 2015 07:10:47 -0500 http://drugwonks.com/blog/off-label-fish-or-fowl Alexander's Nagtime Band http://drugwonks.com/blog/alexander-s-nagtime-band Senate health committee chair Lamar Alexander (R-TN) led a group of Republican senators in expressing anxiety about unresolved questions concerning FDA's implementation of the biosimilar pathway, saying the agency's “failure” to resolve fundamental questions -- such as naming -- before approving the first biosimilar last month “raises a number of serious concerns.” The senators especially take aim at FDA's authority around using a “placeholder” name for the first biosimilar approved in March. The lawmakers say: “FDA has not provided sufficient guidance on important issues relating to the review and approval of license applications for biosimilar products, such as naming, interchangeability, and production of patent information.” Fri, 01 May 2015 08:19:11 -0500 http://drugwonks.com/blog/alexander-s-nagtime-band For all you Biosimilar nomenclature clock watchers http://drugwonks.com/blog/for-all-you-biosimilar-nomenclature-clock-watchers Per a report in BioCentury, the FDA has added to its agenda of new and revised draft guidances that its Center for Drug Evaluation and Research (CDER) intends to publish in 2015 an item titled "Nonproprietary naming for biological products," intended to clarify the agency's thinking on biosimilar naming. Stay tuned. Thu, 30 Apr 2015 07:26:08 -0500 http://drugwonks.com/blog/for-all-you-biosimilar-nomenclature-clock-watchers 21st Century Cures and Real World Data http://drugwonks.com/blog/21st-century-cures-and-real-world-data "Calling for the FDA to use this data is pretty revolutionary," said Peter Pitts, a former FDA associate commissioner for external relations and co-founder of the industry-funded Center for Medicine in the Public Interest. "In the past this kind of data was not considered gold standard." Thu, 30 Apr 2015 07:17:17 -0500 http://drugwonks.com/blog/21st-century-cures-and-real-world-data