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) Vouching for Ebola http://drugwonks.com/blog/vouching-for-ebola Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and Ranking Member Lamar Alexander (R-TN) announced their intention to introduce a bill to speed the development of treatments and vaccines for Ebola by adding Ebola to FDA’s priority review “voucher” program, a program at the Food and Drug Administration (FDA) designed to incentivize the development of new drugs for neglected tropical diseases. Currently Ebola is not listed as a qualifying tropical disease. The Harkin-Alexander bill, which will be introduced when Congress reconvenes, will seek to add Ebola as a qualifying disease under the program. Wed, 29 Oct 2014 18:39:38 -0500 http://drugwonks.com/blog/vouching-for-ebola Milwaukee Journal Sentinel and MedPage Win Pulitzer For Getting the Facts Wrong http://drugwonks.com/blog/milwaukee-journal-sentinel-and-medpage-win-pulitzer-for-getting-the-facts-wrong Once again the lame stream media screws the truth to get a good headline.. Wed, 29 Oct 2014 12:08:34 -0500 http://drugwonks.com/blog/milwaukee-journal-sentinel-and-medpage-win-pulitzer-for-getting-the-facts-wrong The Salk Mythology http://drugwonks.com/blog/the-salk-mythology The story of the polio vaccine has been rewritten to jive with anti-drug company narratives. The truth is more complex and more fascinating Tue, 28 Oct 2014 18:58:17 -0500 http://drugwonks.com/blog/the-salk-mythology There ain't nothin' like a name http://drugwonks.com/blog/there-ain-t-nothin-like-a-name Here’s the headline -- The GPhA now acknowledges the importance of differential nomenclature for biosimilars. And now here’s the spin. The Generic Pharmaceutical Association (GPhA), out-flanked, out-thought, out of its league, and on the wrong side of history, has proposed a bizarre naming scheme for biosimilars – and shared it with the FDA last January. The GPhA’s brainstorm is, rather than the WHO concept (also supported by the US The Pharmacopeia), attaching the company name as a suffix to the INN without changing the INN as a way to distinguish between products. Tue, 28 Oct 2014 00:15:22 -0500 http://drugwonks.com/blog/there-ain-t-nothin-like-a-name Sunshine on my shoulders makes me happy? http://drugwonks.com/blog/sunshine-on-my-shoulders-makes-me-happy Sun, 26 Oct 2014 15:09:38 -0500 http://drugwonks.com/blog/sunshine-on-my-shoulders-makes-me-happy NYC Doctor Flunks Ebola Vaccine Test http://drugwonks.com/blog/nyc-doctor-flunks-ebola-vaccine-test What if your doctor was responsible for killing off development of an Ebola vaccine? Fri, 24 Oct 2014 11:47:16 -0500 http://drugwonks.com/blog/nyc-doctor-flunks-ebola-vaccine-test Tap Dancing to Therapeuic Failure http://drugwonks.com/blog/tap-dancing-to-therapeuic-failure Tue, 21 Oct 2014 20:20:15 -0500 http://drugwonks.com/blog/tap-dancing-to-therapeuic-failure 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