- FDA requests removal of Opana ER for risks related to abuse (fda.gov)FDA Seeks to Pull Pain Pill Off Market, Citing Risk of Abuse (bloomberg.com)
...the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse...The FDA’s decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). This decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks...
- Trump is promising big changes at the FDA — here’s how drugs are approved today (businessinsider.com)
At least one of President Trump's possible picks to head the Food and Drug Administration has a radical idea for when drugs should come to market...Jim O'Neill, managing director at Mithril Capital, has said that he is in favor of approving drugs that are proven to be safe, even before they're shown to be actually effective...Regardless of who Trump picks in the end, his interest in cutting regulation at the FDA is clear..."We're going to be cutting regulations at a level that nobody's ever seen before," Trump said in a meeting with pharma executives...As it exists right now, the FDA approval process can be a long and expensive…
- Non-Proprietary Naming of Biologics and Biosimilars: FDA Finalizes Guidance (raps.org)
In a departure from the way the WHO and Europe name biologics, the US Food and Drug Administration...finalized long-awaited guidance on how biosimilars and their biologic reference products’ names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name...The decision to finalize this guidance follows...but large opposition to the idea of using meaningless rather than meaningful suffixes that could make it easier to distinguish the manufacturers of the products...For example...Sandoz’s Zarxio, which includes a non-proprietary name with a meaningful suffix (Sndz for Sandoz): filgrastim-sndz...But FDA has said it will change Zarxio’s nonproprietary name from filgrastim-sndz to “filgrastim-bflm." And Amgen's Neupogen (filgrastim) would be changed to "filgrastim-jcwp."...But these suffix rules do not necessarily apply to all related biologics...some instances it has designated a proper name that includes an identifier attached as a prefix to distinguish the products from previously licensed biologics. For example, with ado-trastuzumab emtansine, FDA includes a unique prefix, which it says was necessary to minimize certain medication errors and to facilitate pharmacovigilance.
- China’s OxyContin Boom Is a Gold Mine for This Drugmaker (bloomberg.com)
With its harsh anti-narcotics laws and painful history with debilitating opium epidemics in the 19th-century, China wouldn’t spring to mind as a promising market for OxyContin, a painkiller that has been at the center of an opioid addiction outbreak in the U.S…Yet in China, powered by soaring cancer rates and an aging population, OxyContin is turning into a hit. And the drug company behind the brand is giving sales an added boost through an outreach push to physicians and by working with the most powerful of allies—the Chinese government...OxyContin is sold...by Mundipharma (China) Pharmaceutical Co., a company associated with...Purdue Pharma LP, the seller of the long-acting opioid in the U.S...China faces ever greater challenges in managing the use of inherently risky opioids within its sprawling, state-run health-care system.
- European countries offer goodies in bid to win EMA after Brexit (fiercepharma.com)
Even before European officials present the groundwork for relocating the bloc’s drug regulator, a fight has emerged between countries vying for the economic lift and status that come with hosting the authority, using perks like child care as ammo...Some 20 countries in Europe hope to host the European Medicines Agency after the U.K.’s vote to leave the union last summer...And even though the EU hasn’t announced its official criteria for the move, the countries aren’t hesitating to make their case by showcasing local lifestyle perks and more...Countries in Europe are offering language lessons, local scenery and child care as they push to win the EMA, according to the news service. They’re seeking to attract an agency that could bring an economic lift worth an estimated €1 billion and employs about 900 experts.
- The FDA targeted DTC, video, unapproved drug promotion in 2016 (mmm-online.com)
The FDA is taking a closer look at how drugmakers use channels like direct-to-consumer advertising and video, a shift that has raised questions for pharmaceutical marketers...On its face, the FDA's Office of Prescription Drug Promotion's batch of enforcement letters in 2016 seems par for the course, with the agency issuing a total of 11 letters, compared to 2014's and 2015's totals of nine each. But these letters contain important warnings for drugmakers about the FDA's evolving views on promotion, and what channels, tactics, and drugs it's examining closely…The OPDP...issued two enforcement letters for DTC TV ads developed by Sanofi for its insulin Toujeo and Celgene for its psoriasis drug Otezla. Regulators said the ads were distracting to viewers because they used frequent scene changes — and, in Otezla's case, abrupt changes in music — to distract viewers from presented risk information...These untitled letters were noteworthy because they signal a subtle shift in enforcement actions, with the FDA now examining tactics within DTC ads rather than focusing on bigger, more serious infractions, such as omitting risk information entirely…the FDA saying the viewer couldn't understand it because the imagery was too fast moving or the music was too catchy in the background...
- Nevada State Board of Pharmacy – Newsletter January 2017 (bop.nv.gov)
- Changing Faces
- Bowl of Hygeia Awarded to Adam Porath, PharmD
- No Prescription Needed!
- FDA Issues Final Rule Amending List of Drug Products That May Not Be Compounded
- Selected Medication Risks to Manage in 2017
- Environmental Factors, Workflow, and Staffing Patterns – Poor Quality Lighting
- DEA to Decrease Manufacturing Amount of Opioid Controlled Substances in 2017
- New CDC Brochure Offers Pharmacists Tips for Addressing Prescription Opioid Abuse and Overdose
- FDA Requires Boxed Warnings and Patient Focused Medication Guides Indicating Serious Risks Related to Combined Use of Certain Opioid Medications and Benzodiazepines
- FDA’s Division of Drug Information Offers CE Webinars for Students and Clinicians
- FDA Approves Labeling Changes for All Prescription Testosterone Products
- Latest FDA Drug Info Rounds Training Videos Available
- Inspector's Corner
- Ghost Towns and Medicines
- European Regulatory Roundup: EMA Drafts Guidelines on Controlling False Positives in Clinical Trials (raps.org)
The European Medicines Agency has released draft guidelines about multiplicity in clinical trials. The text deals with how to mitigate the risk of false positives arising when clinical trials look at multiple treatment groups and endpoints...EMA’s guideline is applicable to most clinical trials. Once a study design expands beyond having two treatment groups, one predefined null hypothesis and a single primary variable — or adds an interim analysis — its sponsor needs to control for false positives. EMA cites the example of a trial that analyzes five subgroups independently. If each subgroup has a significance level of 2.5%, the likelihood of the study finding a statistically significant false positive hits 12%. As biotechs are under pressure to succeed, there is a risk they will seize on anomalies as evidence a drug works...To ensure trial designs diminish the risk of this happening, EMA has released a 15-page guideline. The draft runs through the situations in which it is necessary to adjust for multiplicity, when it is possible to draw reliable conclusions from subgroup analyses, when success against secondary endpoints can form the basis for additional claims and how to handle composite endpoints.
- FDA calls for switching studies in draft interchangeability guidelines (biopharma-reporter.com)
The FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance...The recommendation – which is set out in long awaited draft guidance today – is that sponsors should submit data from a switching study, or studies, to the Food and Drug Administration in order to deem a biosimilar interchangeable with its reference product…The main purpose of a switching study or studies is to demonstrate that the risk in terms of safety or diminished efficacy of alternating or switching between use of the proposed interchangeable product and the reference product is not greater than the risk of using the reference product without such alternation or switch…prior to today’s draft guidance the US agency had not defined how a sponsor must go about generating such proof (interchangeability)...
- FDA releases guidance on electronic drug applications (biopharmadive.com)
The Food and Drug Administration is ironing out new rules for how drug companies can electronically submit medications for approval, and on Dec. 28 unveiled a draft of what they have planned so far…The draft largely focused on manufacturing establishment information (MEI) — things like a production facility's address, what it's manufacturing, how to reach the person in charge of scheduling inspections, as well as a unique facility identifier, which the agency uses to keep track manufacturing plants…The FDA is requiring companies to electronically submit MEI for each facility, but all in a single list. Companies must provide those lists for new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and any other supplemental materials… Once the final version of the guidance gains approval, drugmakers will have 24 months before the new rules become mandatory…The agency noted several reasons for the push toward electronic MEI submissions. The primary one was the convenience of having all the information on a single file versus non-electronic applications, where it can be scattered.