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…
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.
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.
PM Theresa May wants the UK to remain in the European Medicines Agency post-Brexit. She’s essentially arguing that allowing the UK to contribute will be beneficial due to the nation’s prestigious universities and its regulatory body which assesses more medicines than any EU member. Staying in would mean UK patients get faster access to newly approved EMA medicines. But being part of the agency would mean following its rules, paying dues, and possibly being subject to its legal authority via the European Court of Justice instead of national UK courts. That’s a big no-no for May and pro-Brexit factions in the UK, so they’re trying to avoid that part of the deal. British biopharma is behind May’s stance—they still want some cake from this Great British Break Off.
Homeopathy is based on the idea that you can treat sick people with diluted versions of substances that would cause the sick person’s symptoms in a healthy person. So, we guess it’s something like building up an immunity to iocane powder, except without any clinical evidence. In the US, homeopathy is a multibillion dollar industry and the FDA has taken notice. They’ve kind of let homeopathic solutions do their own thing for years now but homeopathic teething products, recently implicated in 400 adverse events, including the deaths of 10 children, have the FDA a bit more ready to take action. The agency is getting serious about getting the most dangerous homeopathic products off the market, which will hopefully help to avert these tragedies in the future.