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?
When a medical device malfunctions, it is up to the doctor to alert the hospital, the hospital to alert the device maker, and the device maker to alert the FDA 30 days later. Not exactly a fast process. Well the US House of Representatives just approved a renegotiated agreement between the FDA and device industry that would push this 30 days back to three months. While device makers are happy because this agreement also includes lowering the proposed annual user fees, it has some watchdog groups and critics up in arms and bringing up all the bad memories the device industry wishes they could forget. Who knows, maybe malfunctioning trends will become more apparent with this extension, but it certainly doesn’t scream “patient safety.”
Oklahoma recently became the fourth US state to file a lawsuit against opioid manufacturers, and they won’t be the last. States like Delaware have even begun asking for RFPs from private law firms. The uptick in lawsuits against opioid producers has many drawing comparisons to lawsuits against Big Tobacco in the 90s. Those ended up costing the involved companies over $200 billion. If there’s something similar coming down the road for “Big Pharma” (which is not only a conspiracy theory, but also apparently a game?) then it won’t be a mere drop in the bucket. The entire pharma industry made $778 billion in prescription sales last year, so a similar fine against a small group of companies could leave them hurting.
The formula for rising healthcare costs in the US is filled with a bunch of pointed fingers lately. One finger is being pointed at drug maker Kaléo (no, not that Kaleo) by pharmacy benefit manager Express Scripts. They’re suing Kaléo over its price hikes on a heroin/painkiller overdose treatment. According to Express Scripts, these hikes triggered price protection rebates owed to Express Scripts, which total around $14 million—most of the lawsuit. The PBM has successfully sued larger drug companies like Horizon, so Kaléo may be at a bit of a disadvantage here. Especially since Express Scripts could use the extra cash to deal with the fingers pointed at it, including one $15B lawsuit by its (soon-to-be former) largest customer, the insurance provider Anthem.
It’s one thing to make a profit but it’s another to excessively charge uninsured patients nearly double the amount for the same diagnostic tests that insured patients receive. Two separate lawsuits filed in New Jersey and North Carolina allege that diagnostics firms, LabCorp and Quest Diagnostics purposefully made their billing forms difficult to interpret and routinely overcharged uninsured patients at rates far above the market price. Ouch. Plaintiffs are seeking reimbursement of fees and damages. Both lab companies maintain they haven’t engaged in any shenanigans. Is this where we begin to analyze the difference between what’s “legal,” “immoral,” and “amoral?”
One high profile lawsuit is a crisis for a drug manufacturer but 5,000 is a catastrophe! Three years after a federal judge dismissed lawsuits against Fosamax, an osteoporosis prevention drug from Merck, (apparently 5,000 fractured femurs didn’t constitute ‘clear evidence’ of a negative side effect) an appeals court has ruled that Merck will indeed be back in the courtroom. Ouch. It’s not like Merck hasn’t been here before, settling for more than $27 million with 1,200 patients who endured jawbone necrosis while taking Fosamax. Instead of the “cure,” perhaps a pound of prevention—in the form of these foods—is in order?
Drug pricing continues to be a hot topic, and now it will have its day in court (barring settlements). The Sergeants Benevolent Association Health & Welfare Fund, a union representing NYPD sergeants, has filed lawsuits against a group of drug makers including Novartis AG’s generic drug unit, Perrigo Co., Wockhardt Ltd., and Taro Pharmaceutical Industries Ltd. The lawsuits allege the companies “colluded to raise prices on two dermatological creams as much as 1,000 percent,” according to a Bloomberg article, and come on the heels of an investigation from the U.S. Justice Department. Since that filing, four other unions have filed similar suits, two of which add Actavis as a defendant. One thing is certain, the crackdown bandwagon is filling up!