For the first time, the FDA is requesting that a drug maker remove its product from the market for public health reasons. Endo Pharmaceuticals’ Opana ER—an opioid designed to continuously manage moderate to severe pain—has already faced scrutiny for being easy to abuse via snorting. Turns out addicts aren’t too fond of the ‘extended’ aspect of the drug. To combat this, the company added a coating that made the drug harder to crush… so abusers injected it instead. Not only did this reformulation not meet the FDA’s standards of officially being abuse-deterrent, but the rise in injection abuse is also tied to an HIV/Hep C outbreak caused by needle sharing. God save us from people who mean well.
If you’ve ever dropped something down the drain, you know how hard it can be to see around the drain’s curves or retrieve an object using straight, rigid tools. Spoiler alert: You pretty much can’t. Now imagine that drain is the colon of a patient who would really prefer you didn’t use a stiff, unbending surgical instrument to prod around inside their delicate organ. Luckily for these patients, Medrobotics has received FDA approval to use its Flex Robotic System involving “steerable and shapeable robotic products” in colorectal procedures. Basically, it’s a bendy surgical robot that surgeons guide through twisty areas using a joystick. Awesome. InsightCity imagines the surgeons will have fun reliving Nintendo’s glory days.
The FDA has approved the “chemo combo” of Merck & Co.’s Keytruda with Eli Lilly’s Alimta for treatment for patients with non-squamos non-small cell lung cancer who have not been previously treated. That’s great news for the patients, but not the best news for Bristol-Myers Squibb and AstraZeneca who have their own combo and are attempting to get it approved. The announcement brings “the first true endorsement of the general ‘chemo combo’ approach,” according to Bernstein analyst Tim Anderson. Anderson says it is “not yet clear” how BMS and AZ’s product will perform. What is clear? Merck is trying to pull far, far away from the competition.
The FDA has again delayed implementation of its requirement for food sellers (supermarkets, chain restaurants, etc.) to post calorie counts of food items on their menus. Originally set to go in effect on May 5, the affected businesses now have until May 7, 2018 to get calorie counts up. While some trade groups representing the industry are happy to see this get delayed, they’re also hoping that a regulation-averse White House will either weaken the requirement, or do away with it altogether. There are certainly some valid criticisms of the requirement, especially in regard to how the hell sellers without menus are supposed to be labeling their products (like convenience stores already starved for space,) however, there’s also things like this to consider.
Are you thinking about selling a product through your Instagram that claims to prevent or even cure cancer? Don’t. The FDA is cracking down on 14 companies illegally selling 65 fraudulent products through websites and social media making those same claims. A press release issued by the FDA states these products are being marketed for use in humans and pets and come in the form of “pills, topical creams, ointments, oils, drops, syrups, teas and diagnostics (such as thermography devices).” Warning letters have been sent to these companies, and not complying with these letters could result in criminal prosecution. Next time you see a product like this, or this, and think “well that sounds ridiculous,” trust yourself.
What do Michael J. Fox, Billy Graham and Billy Connolly (funny dude, swears a lot) have in common? Well, two things. One, Parkinson’s Disease and two, they finally have a new treatment option. That’s right, the US FDA has approved the first new Parkinson’s treatment in over a decade. Europe gave the thumbs up in 2015, but the FDA has been dragging its feet since 2010. The reluctance to green light it had something to do with abuse liability and withdrawal effects. Apparently, these aren’t issues in 2017. Patients receiving Newron’s drug, Xadago, experienced more “on” time (less uncontrollable, involuntary movement) when taken with the current treatment. With expected annual sales of $450M and heavy US contribution, expect to see a US celebrity face put to it soon.