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.”
Just ask Pfizer. This week Pfizer ran into a couple “issues” surrounding drug manufacturing. Ok, to be honest, Tris Pharm—a CMO—was issued the FDA warning letter, but it was for a Pfizer ADHD product (Quillivant XR) and Pfizer was named in the FDA letter. This is also not just an issue for Pfizer, but for patients. For example, 6.1% of American children are on ADHD medication. To add insult to injury, Quillivant was recently listed as a drug that is in short supply. Our advice, stock up on Quillivant. Also this week, the FDA released a Complete Response Letter (CRL) for the company’s proposed trastuzumab biosimilar. Using normal words; no soup for you as the FDA highlighted the need for additional technical information and does not relate to safety or clinical data submitted in the application. Hopefully next week will be better.
Listen up, innovators. FDA head Scott Gottlieb is sick of your games (live footage here.) Specifically, he’s sick of companies that won’t provide samples of their products to generic producers, which slows down their research into developing a cheaper alternative. This essentially boils down to a non-patent-based approach to maintaining market exclusivity, and it looks like it won’t be tolerated for much longer. Not only is the FDA sounding off on the practice, but so is the FTC and even Congress. Innovators argue that regulation isn’t needed, considering the FDA approved a record number of 1,027 generics last year. The agency shot back saying it’s received over 150 inquiries from generic companies who couldn’t get the samples they needed. So what is the truth?
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.
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?
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.
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.