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.

Why is it always lettuce?

The US celebrated Thanksgiving last week, and many did so without including romaine lettuce, which is the source of yet another E. coli outbreak. That’s three in the last year for those keeping score at home. As of Friday, the FDA has identified that the tainted greens likely came from California… dang, can that state get a break? While the west half of the country has the objectively wrong choice for favorite Thanksgiving side dish, they should at least be able to enjoy it on that hallowed day. California also had the highest share of affected persons, totaling 10 of the 32 cases. FDA Commissioner Scott Gottlieb noted that they’re working to get date labels on “post-purge” (so, unaffected) produce, something that could evolve into a standard practice anyway.

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)?

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.

These dogs dig their dystrophin

Duchenne’s Muscular Dystrophy, or DMD, has been in the news a lot recently. It’s the most common form of muscular dystrophy and was most recently featured in the Right to Try fight. The FDA also approved the first treatment of DMD’s symptoms in 2017, but a new paper published in Science points to a possible treatment of the root cause of the disorder. Scientists used a system-wide application of CRISPR to efficiently restore dystrophin expression in four dogs, a result that “exceeded [the lead author’s] most optimistic expectations.” There’s a ton of hurdles this treatment would have to pass to be a real therapy in humans, but this could be huge for DMD patients. Also, hey, it’s Labor Day weekend, maybe consider donating to the Muscular Dystrophy Association for Jerry’s Kids.

Pfizer calls out peers

Pfizer filed a Citizen Petition with the FDA requesting regulators issue guidance to “…ensure truthful and non-misleading communications by sponsors concerning the safety and effectiveness of biosimilars….” With lagging performance from its Remicade copy, Inflectra, as the backdrop, Pfizer is calling BS on innovators’ communications regarding biosimilars, which Pfizer believes intentionally confuse consumers and prescribers and erode confidence biosimilars. Specifically, Pfizer notes how J&J describes that biosimilars act in a “similar” way to Remicade when, in fact, they employ the same mechanism of action. Amgen claims that switching to a biosimilar “carries risk” if your current product is working. And Genentech states that biosimilars are “highly similar but not identical” to branded products. Pfizer claims that’s only half the story. While Pfizer’s motives are almost certainly not altruistic in nature, they probably have a point about intentional marketing half-truths.

Gottlieb: “we’re not going to play regulatory whack-a-mole”

In last week’s He said, she said InsightCity article we talked about how regulators in Britain don’t think the price of biosimilar products is low enough. FDA Commissioner Scott Gottlieb has kicked it up a bit. In prepared remarks, Gottlieb blasts the pharma industry. Some quotes: “the FDA approved 11 biosimilars, only 3 are marketed in the U.S.” – “competition is, for the most part, anemic.” – “if Americans had the opportunity to purchase successfully marketed, FDA-approved biosimilar prescription drugs, they could have saved more than $4.5 billion in 2017.” – “branded drug makers thwart competition by dangling big rebates to lock up payors in multi-year contracts right on the eve of biosimilar entry.” All this was part of FDA releasing their Biosimilars Action Plan and the final guidance on biosimilar labeling. Might be time to keep your head down.

Real-Time Oncology Review

Earlier this week, FDA granted its first approval as a part of two new pilot programs that aim to make the development and review of cancer drugs more efficient. The drug is Novartis’ Kisqali and the two programs are the Real-Time Oncology Review (allows for the FDA to review much of the data earlier, after the clinical trial results become available and the database is locked) and the Assessment Aid Pilot Project (used by sponsors to organize their submission into a structured format to facilitate FDA’s review of the application). FDA Commissioner Gottlieb says, “With today’s approval, FDA used these approaches to allow the review team to start analyzing data before the submission of the application and help guide sponsor’s analysis of the top-line data.” Looking for a heavyweight fight? Watch sales of Pfizer Ibrance vs. Novartis Kisqali.