This writer is confused. Is the government in the business of deregulating drug use (i.e., marijuana, i.e., the sticky icky) or regulating drug use? The FDA has announced its desire to lower the amount of nicotine in cigarettes in an effort to decrease addiction, reduce smoking, and improve health. At the same time, The Washington Post reports that the FDA is delaying its regulation of trendy smoking alternatives such as e-cigarettes, hookah, and vape thingies that all the cool kids are using. The hope is that keeping these smoking alternatives easily available and less regulated will give smokers ready access to “safer” alternatives to taking in their nicotine. Here is a list of the 20 most destructive drugs, as reported in The Economist. Yikes.
When a medical device malfunctions, it is up to the doctor to alert the hospital, the hospital to alert the device maker, and the device maker to alert the FDA 30 days later. Not exactly a fast process. Well the US House of Representatives just approved a renegotiated agreement between the FDA and device industry that would push this 30 days back to three months. While device makers are happy because this agreement also includes lowering the proposed annual user fees, it has some watchdog groups and critics up in arms and bringing up all the bad memories the device industry wishes they could forget. Who knows, maybe malfunctioning trends will become more apparent with this extension, but it certainly doesn’t scream “patient safety.”
…are the words you really never want to hear, unless you are Amicus Therapeutics. In a rare reversal, the FDA, under the leadership of Scott Gottlieb, told Amicus Therapeutics they didn’t have to run expensive and lengthy safety studies before seeking FDA approval. Under the previous FDA leadership, Amicus was told to conduct extra safety studies, namely for GI symptoms, for their Fabry disease candidate migalastat. Many in the pharma industry are heralding this as a new era at the FDA. It’s a good time to be a biotech lately. As of press time, the iShares Nasdaq Biotechnology Index (IBB) is up 5.4% the past month, 7.1% over the past three months and 16.8% on the year. Can you hear that? That’s the sound of the VC community raising more money.
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.