We gotta get outta this place

If it’s the last thing we ever do. That’s the refrain from seven former FDA commissioners who say the agency should be separated from the Department of Health and Human Services. The former commissioners argue in a piece published in Health Affairs that the change would allow the agency to “… [keep] the agency as up-to-date and effective as possible” by freeing it from partisan politics. You can certainly say that the FDA is in that affected position right now, considering 41% of the agency isn’t working due to a protracted government shutdown. That has consequences like the current FDA commissioner not being able to make his keynote address at this year’s JP Morgan Healthcare Conference, and food inspections being put on hold. Who’s ready for the next romaine outbreak?

Med device mania

The FDA is revamping their medical device clearance process after a week of none-too-flattering press coverage related to med device issues. The current process for med device approval can be accelerated if companies demonstrate their product is substantially equivalent to already approved products. Trouble is that technology evolves every once in a while (in infographic form here), so the new process puts a ten-year limit on using a reference product. The agency is pursuing these changes after stories like this which allege that medical devices have caused 80,000+ deaths since 2008. Other stories included ‘export-only’ devices made in the US without FDA approval causing injuries abroad, and Health Canada changing their clearance process after similar criticisms. Looks like a change is gonna come. Here are 2018’s 10 most innovative medical devices.

Konnichiwa, Dublin

Japan and Ireland have a history of mutual investment and medicine exchange, and an upcoming merger could be the latest and greatest chapter. Osaka-based Takeda announced in May that it would acquire the Dublin-based Shire for $62B, and it looks like its last regulatory hurdle with the EU will be cleared. Unlike these hurdles. Officials are slightly concerned about an IND in Shire’s pipeline that could treat Crohn’s Disease, which would overlap with Takeda’s biggest selling drug Entyvio. But Takeda’s happy to lose that investigational drug if it means closing the deal. After all, the new company would instantly become a global top 10 drugmaker. Keep your head on a swivel though, a few Takeda investors are still against the deal, citing the considerable debt Takeda will have to take on to make the purchase.

Out of their mind(fulness)

As you know, the FDA is not too happy with JUUL for improper marketing practices aimed at America’s youth. Essentially, the agency alleges that by making vaping “cool,” they’re trying to get the next generation addicted to nicotine. Well the marketing geniuses at JUUL must have mistaken their foot for their vapes, because one of their “solutions” involved offering schools up to $20,000 to use an anti-vaping curriculum they developed. Hey y’all? That’s not a good look. After all, the tobacco industry tried to do the same in the eighties, and those education programs may have caused more students to smoke. JUUL’s version of the course would’ve included the science behind e-cigs, blaming teen use on peer pressure and, uh, mindfulness through telekinesis?? Yeah, why vape when you can move clouds with your mind (audio required)?

Oh, Canada okays Kush

Put on some Snoop Dogg (do we even have to say NSFW) and your favorite Bob Marley shirt, Canada is now the world’s largest legal marijuana market. Canada is the second country in the world behind Uruguay to legalize recreational use of cannabis, but unlike Uruguay, it won’t have to deal with the financial restrictions of using US dollars to sell the stuff. The safe regulatory environment means Canada will likely turn into the world’s center for agricultural research into the plant, on everything from increasing the potency of its compounds, to the genetic sequencing of its different varieties like “CBD God Bud” and “Cold Creek Kush.” If you want to get in on the reefer madness and make the trip up to the Great White North for some weed tourism, just make sure you do your own research beforehand.

Show me the drug money

While any DTC drug commercial will likely include shots of people happily hiking and a list of side effects longer than the symptoms of the disease it’s curing, one thing you won’t see advertised is the price of the prescription. New federal policy could change that for drugs covered under Medicare and Medicaid, forcing companies to disclose list prices in TV advertisements. While most patients don’t typically pay the full price for their prescriptions, Health and Human Services Secretary Alex Azar says, “They deserve to know if the drug company has pushed their prices to abusive levels.” PhRMA says their members would be willing to include a link to a website that has pricing information in advertisements, to which Azar pretty much replied, that’s not what I meant.

E-cig epidemic enforcement incoming

The FDA is getting serious about e-cigarette enforcement. In a statement released last week, the agency announced a crackdown on 1,300+ retailers and five manufacturers who make up 97% of the US market. That includes JUUL, which has been widely criticized for making vaping cool (Editor note: LOL is this really that cool?) and itself accounts for over half the US market. The FDA says vape use has increased to epidemic levels in teens, and it is intent to not “allow a whole new generation to become addicted to nicotine.” The agency expects the manufacturers to submit plans within 60 days to explain how they’ll stop teens from getting addicted to their products. If not, the agency could pull e-cigs from the market, a move which Big Tobacco is a fan of.

Hacks that hurt

We’re used to vulnerabilities in data systems leading to massive personal data breaches (cool visualization of those here.) But there’s an even darker side to hacking that can put peoples’ lives directly at risk. We’re talking medical device hacks. Two “white-hat” (good) hackers identified vulnerabilities in pacemakers and insulin pumps which “black-hat” (bad) hackers could use to injure patients. One scenario put forth is a pacemaker being manipulated to deliver too many or too few electric shocks, which obviously could lead to negative patient outcomes. The researchers shared their findings with the device manufacturer and relevant regulatory bodies, but they say these authorities are playing down the risks. They apparently considered bringing in a pig they could kill with an app to make their point, so we should probably take them seriously.