Kratom crap-shoot

Kratom’s back in the news and—big surprise—not in a positive light. While there’s no research to support what people claim it does, proponents of the plant say it can help with opioid addiction, relieve pain and increase energy. But this isn’t actually an article to debunk another junk medicine, because that’s not the reason the FDA’s mad about it (this time.) The agency has used their mandatory recall power for the first time to warn consumers about kratom products made by Triangle Pharmanaturals, which are apparently rife with salmonella. Multiple cases of infection have been traced back to consuming kratom in the past couple years, and apparently the FDA’s finally had enough. Figures that a company hawking a dubious product can’t even make it properly.

Time to take a dive, nicotine

480,000 Americans die from smoking each year according to FDA commissioner Scott Gottlieb. Well it’s time to take another big swing at preventing those deaths, at least that’s what’s behind the FDA’s new move to cut nicotine levels down in cigarettes. In the US, cigarettes are typically made with a nicotine dose of around 1.1-1.7 milligrams. The regulatory agency wants to cut that to a maximum of 0.4 milligrams, which could help 5 million Americans quit smoking within a year. The move is focused on combustible cigarettes which probably give you the most bang for your buck in terms of ways they can kill you, as opposed to newer vaping products which have pretty high nicotine levels themselves. Presumably, the FDA doesn’t want to impinge on the very cool emerging field of vape tricks.

The right-to-try again

Last week proposed legislation dubbed the “right-to-try” bill failed to pass the US House of Representatives, despite a lopsided 259-140 vote in favor of the law. Republicans who submitted the bill used a process that required a two-thirds majority to pass and the numbers fell just short of that. The new submission will require on a simple majority to pass—and it will. Here’s Austin Powers in a nutshell. More importantly, here’s the law in a nutshell… critically ill patients can gain access to experimental drugs if their physician and the drug company agree to it. The FDA would no longer need to sign off. Supporters say the law removes red tape. Critics say the FDA already approves 99% of requests and, according to Scott Gottlieb, FDA Commish, requests are usually approved immediately or within a few days anyway. So, where’s the beef?

Why you gotta be so mean?

Yes, that’s a TSwift “Mean” reference. Not saying we’re proud of it and not saying we’re not. Speaking of mean, FDA Commissioner Scott Gottlieb was mean this week. Using phrases like “rigged payment scheme” and “team up with payors” and “insidious barrier” Gottlieb took aim at PBMs, distributors, drug stores and pharmaceutical companies talking about how these entities “effectively split monopoly rents” instead of passing on savings to consumers. These comments came during a speech where he pointed out that 9 biosimilars have been approved by the FDA and only 3 are for sale. (see InsightCity’s Biosimilar HealthyDose) You’ll be shocked to know that the insurance companies blame the pharma companies and the PBMs blamed the insurance companies. Perfect. BTW, Europe has seen drug prices fall as much as 60% with the introduction of biosimilars. Not too shabby.

$1.23 per person in the US

Earlier this week FDA Commissioner Scott Gottlieb outlined the FDA’s request for additional funding. In summary, “additional resources will help advance initiatives to support novel medical technology and public health priorities such as generic drug development, pharmacy outsourcing, and novel domestic manufacturing capabilities.” Cool. $400 million worth of cool, or just $1.23 per individual in the US. Count me in. The current US 2019 budget would boost funding for the FDA to ~$5.8 billion from the current level of $5.1 billion, so the $400M request is really just asking for a 7.8% increase. If you are really interested/bored, you can view the “brief” version of the HHS budget here, all $95.4B of it. Want to see what you can fill your Amazon cart with for $1.23, look no further.

Invented (not Made) in China, there’s a big difference

Pop quiz: When was the last time China produced a new drug for the global pharmaceutical industry? The answer: The early 1970s. The product was artemisinin and it treated malaria. Times, they are a changin’. According to a New York Times article, “20 or 30 Chinese-made drugs could seek Phase 3 trials in the United States within the next five years.”  If you think about the R&D and early clinical development needed to get ~25 compounds into Phase III, you can see that Chinese drug developers have been working hard for a while. A little perspective: Jiangsu Hengrui has the largest research budget of all Chinese drug firms, but its $180M annual outlay pales in comparison with the $7.8B Pfizer spent in 2016. True, but a journey of a thousand miles begins with a single step (and other deep thoughts from Lao-Tzu).