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) Important Victory in Opioid Abuse Deterrence http://drugwonks.com/blog/important-victory-in-opioid-abuse-deterrence Thu, 20 Nov 2014 12:46:10 -0600 http://drugwonks.com/blog/important-victory-in-opioid-abuse-deterrence Grubernomics http://drugwonks.com/blog/grubernomics Gruber got a pass from the media because his analysis reinforced the liberal narrative. Joe DiMasi, not so lucky Thu, 20 Nov 2014 11:52:35 -0600 http://drugwonks.com/blog/grubernomics PCMA on FDA and Biosimilars: Wrong, Wrong, and Wrong http://drugwonks.com/blog/pcma-on-fda-and-biosimilars-wrong-wrong-and-wrong The Pharmaceutical Care Management Association (PCMA), an organization that represents the nation's leading pharmacy benefit managers (PBMs), which administer prescription drug plans for over 210 million Americans, released a new white paper investigating FDA’s influence on drug prices and competition in the pharmaceutical marketplace. The PCMA argues that competition within branded drugs is undervalued in FDA priorities and that FDA’s structures and regulations fundamentally hinder competition.The report's bias and ignorance can be summed up via this segment, “Without a statutory and regulatory agenda for the FDA that carefully examines the agency’s effect on pharmaceutical competition, some consumer welfare may be unnecessarily lost.” Note to PCMA -- the FDA does not factor issues such as "competition" into it's regulatory calculations. Facts cannot be ignored because they are inconvenient. Thu, 20 Nov 2014 08:29:28 -0600 http://drugwonks.com/blog/pcma-on-fda-and-biosimilars-wrong-wrong-and-wrong Joe vs. the Volcano http://drugwonks.com/blog/joe-vs-the-volcano Much chatter about the Tuft’s Center’s new number for the cost of drug development. Here’s the thoughtful comment from those lovely folks at Médecins Sans Frontières,“The pharmaceutical industry-supported Tufts Center for the Study of Drug Development claims it costs US$2.56 billion to develop a new drug today; but if you believe that, you probably also believe the earth is flat.” NGO’s can poo-poo the important work of Joe DiMasi and crew this as much as they like – but serious analysis can’t just be tsk-tsked away by using the “industry-supported” evasion. Here’s the news – and it’s important. Wed, 19 Nov 2014 06:39:34 -0600 http://drugwonks.com/blog/joe-vs-the-volcano Pain advocates to Massachusetts Governor-Elect: "Listen up!" http://drugwonks.com/blog/pain-advocates-to-massachusetts-governor-elect-listen-up “Charlie Baker vows to tackle state opiate problem,” was the Boston Globe headline two days after Election Day. It’s good to hear from our newly elected governor that he plans to take steps to curb the ongoing problem with illegal use of prescription medication in our state. There’s little doubt that too many lives are being harmed by drug abuse and addiction. But in a quest to fix one problem, policymakers need to consider the potential unintended negative consequences for the patients for whom these medications are a lifeline. Gov.-elect Baker said in that Globe interview that he plans to convene a coalition of lawmakers, health care providers and labor leaders to confront the opioid crisis in our state. Representatives of the pain community — an estimated 1.2 million Massachusetts residents live with chronic pain — must be included in these discussions as well. Tue, 18 Nov 2014 06:19:23 -0600 http://drugwonks.com/blog/pain-advocates-to-massachusetts-governor-elect-listen-up FDA data at the base of the pharmacovigilance pyramid http://drugwonks.com/blog/fda-data-at-the-base-of-the-pharmacovigilance-pyramid A new article in the DIA's Therapeutic Innovation and Regulatory Science journal discusses the pitfalls and potential for the FDA's openFDA program. This past June, the FDA launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency.The crowd-sourcing of adverse event data may or may not yield interesting results, but it’s a good place to start. It represents an opportunity for the agency to begin designing a more evolved approach to 21st-century pharmacovigilance Mon, 17 Nov 2014 08:28:17 -0600 http://drugwonks.com/blog/fda-data-at-the-base-of-the-pharmacovigilance-pyramid All you need is a dollar and a dream http://drugwonks.com/blog/pfizer-shows-that-innovation-come-in-many-forms Together with the Bill & Melinda Gates Foundation and the Children’s Investment Fund Foundation, Pfizer has announced an agreement to expand access to it’s injectable contraceptive, Sayana Press (medroxyprogesterone acetate), for women most in need in 69 of the world’s poorest countries. Sayana Press will be sold for $1 per dose to qualified purchasers, who can help enable the poorest women in these countries to have access to the contraceptive at reduced or no cost. Bravo for Pfizer and partners. But the bigger story here is the creative redesign of legacy products for use in the developing world at low or no cost with NGO and other non-industry collaborators. It’s a model worth deeper investigation and broader implementation. Innovation comes in many forms. Fri, 14 Nov 2014 08:17:39 -0600 http://drugwonks.com/blog/pfizer-shows-that-innovation-come-in-many-forms Super Gruber Saves Stupid Americans http://drugwonks.com/blog/super-gruber-saves-stupid-americans No one could explain Obamacare to stupid American votes... until a superhero from academia appeared. Thu, 13 Nov 2014 18:11:33 -0600 http://drugwonks.com/blog/super-gruber-saves-stupid-americans My Regulatory Grand Tour http://drugwonks.com/blog/my-regulatory-grand-tour Like Johnny Cash said, “I’ve been everywhere” -- or at least it seems that way. Over the past few months I’ve visited with government health officials in China, the Philippines, Malaysia, Egypt, Algeria, Saudi Arabia, Jordan, the United Arab Emirates, Russia, Brazil, Columbia, South Africa, Kenya, and many other points in-between. And the only thing that’s grown more than my frequent flyer miles is my respect and admiration for those over-worked and under-appreciated civil servants toiling on the front lines of medicines regulation. Thu, 13 Nov 2014 07:36:34 -0600 http://drugwonks.com/blog/my-regulatory-grand-tour Clinical Trial by Jury http://drugwonks.com/blog/clinical-trial-by-jury The Indian government's top advisory panel on medicines has recommended waiving off of clinical trials for two new cancer drugs, allowing them to be sold without testing on Indian patients. This, according to the panel, is permitted to cater to unmet medical needs. The move is significant as it comes despite a recent directive from the Supreme Court asking the government to be careful while approving clinical trials as well as new medicines.The two medicines - Aflibercept and Trastuzumab emtansine - are used in treatment of metastatic colorectal cancer and metastatic breast cancer respectively. Tue, 11 Nov 2014 05:48:29 -0600 http://drugwonks.com/blog/clinical-trial-by-jury Jonathan Gruber: Obamacare Passed Because True Costs Hidden From 'Stupid' American Voter http://drugwonks.com/blog/jonathan-gruber-obamacare-passed-because-true-costs-hidden-from-stupid-american-voter How else would people be paying 17 percent of income on health care especially if they were sick and middle income. Mon, 10 Nov 2014 16:10:32 -0600 http://drugwonks.com/blog/jonathan-gruber-obamacare-passed-because-true-costs-hidden-from-stupid-american-voter Doctor Uses Back of the Napkin Math To Make Life and Death Decisions http://drugwonks.com/blog/doctor-uses-back-of-the-napkin-math-to-make-life-and-death-decisions Doctors are increasingly deciding what drug to use based on a one size fits all approach that devalues life. Mon, 10 Nov 2014 10:21:18 -0600 http://drugwonks.com/blog/doctor-uses-back-of-the-napkin-math-to-make-life-and-death-decisions Deterrence Strategy http://drugwonks.com/blog/deterrence-strategy According to Dr. Janet Woodcock, opioid abuse-deterrence technology is in its “infancy” and FDA is unlikely to remove opioids that lack abuse-deterrence features from the market soon. She said approved abuse-deterrent opioids are “version 1.0.” FDA has approved three abuse-deterrent formulations, including Embeda morphine sulfate extended-release capsules with sequestered naltrexone from Pfizer; and reformulations of OxyContin oxycodone and Targiniq ER oxycodone/naloxone from Purdue Pharma. Woodcock added that there will be a “long path” to travel before FDA would require the incorporation of abuse-deterrence features as a condition for marketing opioids. Rather than forcing conventional opioids off the market, FDA is focused on getting more abuse-deterrent products approved, she said. “We are seeking input on how to get to a point where many, at least, of the formulations on the market have deterrent properties.” Mon, 10 Nov 2014 06:22:37 -0600 http://drugwonks.com/blog/deterrence-strategy Don't make patients pay for insurers' mistakes http://drugwonks.com/blog/don-t-make-patients-pay-for-insurers-mistakes Don’t Make Patients Pay for Insurers’ Mistakes The health insurance industry continues to warn of financial ruin unless America institutes pharmaceutical price controls of the sort mainly found in Europe and Canada. Or, in the absence of regulatory action, insurers are simply sticking their customers with the tab through increased cost-sharing. It would be highly unfortunate if the insurance industry campaign sparked bad policy decisions that hinder pharmaceutical innovators’ ability to respond to the next epidemic, such as Ebola. Or to illnesses such as hepatitis C that afflict some three million individuals and can lead to cirrhosis or liver cancer – and costs that can reach nearly $600,000 for a liver transplant. Thu, 06 Nov 2014 07:40:51 -0600 http://drugwonks.com/blog/don-t-make-patients-pay-for-insurers-mistakes Saving Money through Innovation http://drugwonks.com/blog/saving-money-through-innovation Tue, 04 Nov 2014 07:52:19 -0600 http://drugwonks.com/blog/saving-money-through-innovation Mistruths and Half-Truths about Oncology Meds http://drugwonks.com/blog/mistruths-and-half-truths-about-oncology-meds There's been much legitimate consternation over the October 5th 60 Minutes segment on the cost of oncology meds. Hopefully the anger and indignation I've heard will drive some hard thinking toward smart and forceful actions to address the mistruths, half-truths, and straight-out lies presented during the program. But why is anyone surprised? Did anyone expect a “fair and balanced” story from the same media that was complicit in helping to legitimize vaccine denial? Mon, 03 Nov 2014 05:58:12 -0600 http://drugwonks.com/blog/mistruths-and-half-truths-about-oncology-meds Trumpeting Trumenda http://drugwonks.com/blog/meningitis-miracle If you have any doubts that vaccines are on the cutting edge of innovation consider this, Pfizer has just received FDA-approval (via the agency’s Breakthrough Therapy Designation and Priority Review programs) for Trumenda, a vaccine for the Prevention of Invasive Meningococcal B Disease in adolescents and young adults -- the first and only approved vaccine in the U.S. for the Prevention of Meningococcal Meningitis B. Fri, 31 Oct 2014 12:05:03 -0500 http://drugwonks.com/blog/meningitis-miracle Random Acts of Cruelty http://drugwonks.com/blog/random-acts-of-cruelty The FDA's obsession with statistical certainty and randomized trials delays progress again. Fri, 31 Oct 2014 10:44:03 -0500 http://drugwonks.com/blog/random-acts-of-cruelty Courting Biosimilars http://drugwonks.com/blog/courting-biosimilars In the first lawsuit filed by an originator company over a biosimilars application, Amgen alleged that Sandoz has unlawfully refused to follow the patent resolution protocol laid out by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
 The suit, filed in the U.S. District Court for the Northern District of California, concerns Sandoz's application to market a biosimilar version of Amgen's Neupogen filgrastim G-CSF, a recombinant methionyl human granulocyte colony-stimulating factor.
Under BPCIA, Sandoz was required to provide Amgen with its BLA and manufacturing information for the biosimilar within 20 days of FDA’s decision to accept the application for review. Fri, 31 Oct 2014 07:46:17 -0500 http://drugwonks.com/blog/courting-biosimilars 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