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.
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.
In a more positive biohacking story, a group of diabetics and hackers are using vulnerabilities in their medical devices to make their lives easier. Diabetes is notoriously annoying to monitor, sometimes making patients or their caregivers wake up at night to check glucose levels and dose insulin accordingly. To avoid that, patients are willing to cobble together their own artificial pancreases using hacked insulin pumps, glucose monitors, a small Bluetooth-connected computer with open-source code, and a smartphone app. The system works in concert to automatically deliver a calculated dose of insulin from the pump to moderate glucose levels. To be very clear, this is not regulated in the slightest. But it’s cheap. And it shows that if these the market isn’t addressing these patients’ needs, they’re happy to circumvent it.
Chinese parents are understandably angry after the emergence of a third vaccine safety scandal in about as many years. Regulators announced last Friday that Changsheng Bio-tech (which ironically means “long life” in Chinese) had sold over 250k low-quality DPT vaccines to a Chinese public health agency responsible for 100M citizens. Hey, at least that’s better than the over 400k subpar DPT vaccines produced by a different Chinese manufacturer which authorities uncovered last November. Or the spoiled vaccines illegally sold in 24 provinces in 2016. Authorities are also sick of the scandals, so on Wednesday they announced an audit of China’s entire vaccine production system. Until that’s done, you might not see consumers springing for vaccines Made in China for a bit.
Drug shortages are nothing new, that’s why the FDA updates their list of shortages daily. But things seem a little worse than normal—9 in 10 physicians say their emergency departments lack critical medicines. That includes mainstays like diltiazem (a go-to treatment for hypertension) and morphine. You can blame market forces and manufacturing issues. Most of the drugs in shortage are sterile injectables, which can be difficult to both make and make a profit on. Those low margins can lead to less incentive to maintain the quality of sterile injectable manufacturing facilities as they age, which in turn leads to issues with the quality of the drug products. It’s things like that which can cause cardboard to contaminate batches of “sterile” injectables. If only they had contaminated them with cash instead…
The FDA’s Compassionate Use program helps patients that seek access to medications still in the development pipeline. But legislation signed into law this week allows patients to completely bypass the regulatory agency should they so choose. The “Right to Try” bill gives patients access to investigational drugs with the permission of just their physician and the drug manufacturer. It also shields those drug companies from the legal risks involved. Critics, including the American Cancer Society, say the bill gives false hope to patients, and champion the current process of compassionate use and clinical trials. After all, the FDA approves 99% of compassionate use applications, and can even do approvals over the phone. When asked for comment, some formerly prominent musicians said “You gotta fight for your right… to paaaaaaaaarty.”
Does your company currently have open US Pediatric Research Equity Act (PREA) or European Paediatric Investigation Plan (PIP) commitments?
Whatever they end up calling themselves, Bayer and Monsanto have finally crossed the last big regulatory hurdle in the way of their proposed merger. The US Department of Justice gave Bayer permission to go through with the $62.5B deal on Tuesday. It’s one of the largest mergers on record (list of those here), and the new company will have control of over 25% of the world’s seeds and pesticides. Get ready for a future where Mbayto branded trees litter the landscape. The companies claim that the merger will allow them to increase spending on R&D, but Business Insider reports that they’ll only really be spending about $500M more than when they were separate. With that much of the market cornered there’s probably a better reason the deal will benefit the companies…