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) Did The FDA Delay Ebola Cures? http://drugwonks.com/blog/did-the-fda-delay-ebola-cures We have technology to potentially control Ebola and other viral outbreaks today. But the federal bureaucracy refuses to catch up with 21st-century science. Mon, 20 Oct 2014 10:15:41 -0500 http://drugwonks.com/blog/did-the-fda-delay-ebola-cures Opioid Abuse Deterrence and a Step in the Right Direction http://drugwonks.com/blog/opioid-abuse-deterrence-and-a-step-in-the-right-direction Abuse deterrence will take many forms. In advance of the FDA’s upcoming two-day meeting on opioid pain medicines and abuse-deterrent technologies, some good news. The agency has approved an updated label for the opioid pain medicine Embeda to include abuse-deterrence studies. It's an important step in the right direction. Sun, 19 Oct 2014 18:11:05 -0500 http://drugwonks.com/blog/opioid-abuse-deterrence-and-a-step-in-the-right-direction The Dangerous Myth of Sci-Fi Innovation http://drugwonks.com/blog/the-dangerous-myth-of-sci-fi-innovation Innovation doesn’t happen in a vacuum. People make it happen – and it’s an ecosystem: academics, manufacturers, physicians, patients, pharmacists, hospitals, caregivers, and government. If we allow ourselves to believe that innovation happens in bursts of “eureka” moments, we do a disservice to those who advance progress through a lifetime of work and through important failures. Innovation happens incrementally – and it’s expensive. The myth of “eureka innovation” is dangerous science fiction. Fri, 17 Oct 2014 06:10:24 -0500 http://drugwonks.com/blog/the-dangerous-myth-of-sci-fi-innovation Truth, Justice, and -- Copaxone http://drugwonks.com/blog/truth-justice-and-copaxone 
In addition to the complicated question of FDA regulation of Non-Biologic Complex Drugs (NBCDs), there's the legal morass of patent legislation. Per the latest on that front, BioCentury reports thatU.S. Supreme Court justices on Wednesday voiced skepticism about arguments from both sides in the petition by Teva to overturn an appeals court decision that invalidated the company’s process patent for multiple sclerosis blockbuster drug Copaxone. Thu, 16 Oct 2014 07:38:30 -0500 http://drugwonks.com/blog/truth-justice-and-copaxone PBMs and the Pine Tree State http://drugwonks.com/blog/pbms-and-the-pine-tree-state It's rare to hear a business praise its state's regulations, but a Portland pharmacy is relying in part on Maine law to gain a stronger foothold in the growing market for specialty medication. By volume, the market is dominated by major national mail-order pharmacies, but the founders at Apothecary By Design see things shifting in their direction, making Maine one battleground between regional and national pharmacies selling specialty pharmaceuticals. Mon, 13 Oct 2014 14:33:14 -0500 http://drugwonks.com/blog/pbms-and-the-pine-tree-state The Republicans Caused Ebola http://drugwonks.com/blog/the-republicans-caused-ebola Democrats are blaming Ebola on budget cuts to NIH made by Republicans. Francis Collins agrees. They may not be in cahoots but they are both way wrong. Mon, 13 Oct 2014 13:26:31 -0500 http://drugwonks.com/blog/the-republicans-caused-ebola Cutting Biologic IP Protection Is A Dangerous Idea http://drugwonks.com/blog/cutting-biologic-ip-protection-is-a-dangerous-idea The proposal to let the FDA hand over clinical data developed by innovators to generic companies whenever it feels like is dangerous and dumb. Mon, 13 Oct 2014 11:59:40 -0500 http://drugwonks.com/blog/cutting-biologic-ip-protection-is-a-dangerous-idea Spears Speaks http://drugwonks.com/blog/spears-speaks In 1992, Congress created a program -- known as "340B" -- to help caregivers serving disproportionately large numbers of low-income beneficiaries and uninsured patients. However, some 340B participants are exploiting the program and the vulnerable patient populations 340B was intended to help are often still stuck struggling to gain access to affordable pharmaceuticals. Fri, 10 Oct 2014 04:23:54 -0500 http://drugwonks.com/blog/spears-speaks The Well-Informed Policies of Opioid Management http://drugwonks.com/blog/the-well-informed-policies-of-opioid-management In case you missed the FDA’s Viewpoint commentary in JAMA, here it is, “The problem of opioid overdose demands well-informed policies.”Not knee-jerk. Not political. Not bowing to threats. Well-informed policies. Attention must be paid. Thu, 09 Oct 2014 07:22:28 -0500 http://drugwonks.com/blog/the-well-informed-policies-of-opioid-management CMPI Responses To 60 Minutes Hit Job on Cancer Innovation http://drugwonks.com/blog/cmpi-responses-to-60-minutes-hit-job-on-cancer-innovation Leading medical innovation think tank claims CBS is ‘dead wrong’ Wed, 08 Oct 2014 12:14:06 -0500 http://drugwonks.com/blog/cmpi-responses-to-60-minutes-hit-job-on-cancer-innovation The Shocking Truth About Cancer Drugs 60 Minutes Covered Up http://drugwonks.com/blog/the-shocking-truth-about-cancer-drugs-60-minutes-covered-up The 60 Minutes segment on cancer drug costs hid this important truth.. Tue, 07 Oct 2014 09:24:40 -0500 http://drugwonks.com/blog/the-shocking-truth-about-cancer-drugs-60-minutes-covered-up FDA, Impact, and Opioids http://drugwonks.com/blog/fda-impact-and-opioids The Center for Medicine in the Public Interest is honored to join the US Pain Foundation and other patient-centered organizations in offering our support to the FDA in general and Commissioner Hamburg specifically for savvy and strategic management of pain medicine regulation. Why now? Well for starters because of the unfair, unbalanced, ad hominem and just plain erroneous attacks on the agency’s efforts. Mon, 06 Oct 2014 07:48:09 -0500 http://drugwonks.com/blog/fda-impact-and-opioids Data Transparency "Over There" http://drugwonks.com/blog/data-transparency-over-there The EMA's management board unanimously adopted its clinical data transparency policy, to be introduced in two phases starting Jan. 1, 2015. 
In the first phase, EMA will publish clinical reports supporting MAA submissions while excluding individual patient level data. 
The policy will apply to any MAA submitted after Jan. 1, 2015.The agency noted that as a practical matter, this would mean the first data for newly approved medicines would become available in 18 months, allowing for review time and approval by the European Commission. Fri, 03 Oct 2014 07:01:52 -0500 http://drugwonks.com/blog/data-transparency-over-there DEA, CME and the Hamburg Manifesto http://drugwonks.com/blog/dea-cme-and-the-hamburg-manifesto One thing that remains absent in the debate over opioid pain medicines is the Hamburg Manifesto – enhanced physician education. Now it's time for the DEA to play its part and step up to the plate and mandate specific education as a must-have for prescribing rights. Thu, 02 Oct 2014 07:07:52 -0500 http://drugwonks.com/blog/dea-cme-and-the-hamburg-manifesto The Ups and Downs of Sunshine http://drugwonks.com/blog/the-ups-and-downs-of-sunshine Collaborations between physicians and industry are fundamental to advancing medicine. Without in any way diminishing the governmental and non-profit agencies that support research, it is the partnership between physicians and industry that has created many, if not most, of the major medical breakthroughs that have reduced the rates of death and other serious outcomes in recent years – as any literature search of major medical journals will quickly confirm. Wed, 01 Oct 2014 07:46:19 -0500 http://drugwonks.com/blog/the-ups-and-downs-of-sunshine The Drug Shortage Ecosystem http://drugwonks.com/blog/the-drug-shortage-ecosystem The media frenzy surrounding drug shortages has vanished. Why? Because, due in no small measure to efforts from the FDA, the problem is being successfully addressed and ameliorated. Unfortunately, that’s not news – but it should be. Here are some interesting points. The FDA’s strategy in addressing the issue is to enlarge and empower a drug shortage ecosystem. Rather than seeking more Federal dollars (a fool’s errand), the FDA undertook to combine the resources of the constituent players, manufacturers, hospitals, and large-scale purchasers such as GPOs. Combined with appropriate and savvy use of enforcement discretion, the FDA has taken leadership of the drug shortage ecosystem and is driving a sustainable solution. Mon, 29 Sep 2014 07:37:04 -0500 http://drugwonks.com/blog/the-drug-shortage-ecosystem USP endorses INN suffix for biologics http://drugwonks.com/blog/usp-endorses-inn-suffix-for-biologics USP endorses INN suffix for biologics The U.S. Pharmacopeial Convention (USP) endorsed a draft World Health Organization (WHO) proposal to create a unique suffix for biologic drugs, including biosimilars. A WHO working group proposed a voluntary scheme to create unique identification codes, called "biological qualifiers," that would be distinct from international non-proprietary names (INN). The BQs would be random four-letter codes that would be linked in a WHO-maintained database to the product's INN, trade name, name and address of the manufacturer, and regulatory status. According to the WHO, the scheme could facilitate decision making about substitution and interchangeability and help regulators and physicians track patients' responses to products with the same INN. Thu, 25 Sep 2014 06:19:04 -0500 http://drugwonks.com/blog/usp-endorses-inn-suffix-for-biologics NICE in context http://drugwonks.com/blog/nice-in-context Superb analysis of the recent NICE draft technology appraisal against the use of Abraxane from the folks at Context Matters. Well worth the read. Tue, 23 Sep 2014 06:52:48 -0500 http://drugwonks.com/blog/nice-in-context The Continuing Battle for Innovation http://drugwonks.com/blog/the-continuing-battle-for-innovation Winston Churchill famously described an appeaser as "one who feeds a crocodile, hoping it will eat him last." Today, in a very different context, his remark captures the plight of the American pharmaceutical industry. Mon, 22 Sep 2014 08:36:40 -0500 http://drugwonks.com/blog/the-continuing-battle-for-innovation The Social Media Red Thread http://drugwonks.com/blog/the-social-media-red-thread Despite what you might think, the various actions and directives emanating from White Oak tell a very liner story with very steady red thread – and that thread is the difference between communications and marketing.To many in pharmaceutical company marketing and regulatory review departments it may seem a distinction without a difference. But that’s a fundamental misunderstanding of the FDA’s mindset when it comes to social media. As Casey Stengel used to say, “Let’s look at the record.” Thu, 18 Sep 2014 07:39:35 -0500 http://drugwonks.com/blog/the-social-media-red-thread