Robert Califf said it when he was serving as FDA commissioner. Patient advocates have said it when testifying before Congress or commenting at public meetings. And this week, experts on the FDA’s Psychopharmacologic Drug Advisory Committee (PDAC) said it again: Doctors don’t read drug labels. Yet drug companies continue to invest millions of dollars on aspects of clinical trials that are designed to inform labeling, and FDA reviewers spend untold hours scouring the data to ferret out what should be included in the prescriber information as contraindications, warnings and cautions, boxed warnings, the mechanism of action and clinical trial findings....

Dirt. Excrement. Glass. Hair. Insects. Mold. Rodent infestation. Scouring pad fibers. Unknown particulates. They’re words too often mentioned in FDA warning letters that describe manufacturing conditions for supposedly sterile drugs. A few years ago when I was a cancer patient hooked up to an I.V. drip for three to four hours every two weeks, I found reading those warning letters a horrifying experience. With a cocktail of generic and brand drugs coming from who knows where being pumped into the port resting a few inches from my heart, I cringed at the thought of what might be entering my vein....

Watson Health is working hard to demonstrate the seriousness of its ongoing efforts in oncology, highlighting its research and customers at the recent American Society of Clinical Oncology (ASCO) conference. The Boston-based IBM business had six presentations at ASCO based on its data and touted that its oncology product is being used at more than 55 cancer centers globally. But experts in the field of machine learning suggest that the real innovation and value-add for machine learning in oncology is in the analysis of radiology images, which are not addressed by the medical record and...

Unintended consequences. It’s a term that’s bandied about all too often in Washington these days, as it’s become the PC way for lawmakers and agencies like the FDA to save face when they have to admit, “Oops, we didn’t think that one through very well” when confronted with the negative impacts of the laws and regulations they’ve created. A new unintended consequence could be in the offing as the FDA extends its practice of label carve-outs to biosimilars. A familiar feature of the generics scene, carve-outs have allowed the agency to approve a knock-off even though the reference drug may...

You have to hand it to the cancer lobby. It really has the U.S. federal government wrapped around its little finger. Some will say I'm overstating the case, but is that really a solid argument? Let's examine the evidence. Mortality, economic impact boxes? Not checked First, let's look at overall mortality in the U.S. According to the National Center for Health Statistics, heart disease was responsible for more than 614,000 deaths in 2013, while the various cancers claimed fewer than 592,000 lives. If you add cerebrovascular deaths (more than 133,000) into the...

As the saga of Martin Shkreli continues to unfold in all its obnoxious glory, with every tweet and smirk signifying the former biopharma CEO’s apparent aspirations to a level of sheer jerkiness heretofore unseen on planet Earth, there’s one question that I – and probably a lot of other folks – can’t help but ask: Is this guy for real? I mean, seriously? From his gleefully unapologetic, 5,500-percent price hike for an in-licensed, generic drug, to his now-infamous gray-hoodied perp walk following his arrest on charges of securities fraud, to his juvenile Twitter taunts – not to mention his outlandish...

Duchesnay Inc.’s 15-minutes of fame for its morning sickness drug arguably turned into a few hours’ worth by time the drugmaker complied with an FDA warning letter demanding a corrective ad to offset the omission of risk information in paid social media endorsements by She-Who-Must-Not-Be-Named in the serious biopharma world. The first 15 minutes for Diclegis (doxylamine succinate and pyridoxine hydrochloride)came with You-Know-Who’s tweets and posts to her millions of followers on Facebook and Instagram. That fame increased exponentially when the FDA handed down the warning letter last month, daring to name the infamous reality TV maven and setting mainstream...

Patients have come a long way to get a say in the drug development and approval process. But there’s still some ground to cover if they’re going to move from the passive subject role to a 50-50 partnership that reminds researchers, drugmakers and regulators that, “Hey, this is all about us!” While major drugmakers have been hiring senior-level staff to connect and interact with patients and to incorporate the patient perspective into their R&D for a while now, the regulatory field is making slim – albeit positive – advances in that direction. In the past, patients often testified during the...

It’s not every day that drugmakers get a chance to take on an entirely new market. Biosimilars are offering that opportunity. And hundreds of drugmakers, research institutions and governments are hoping to make the most of it. The result is more than 700 follow-on biologics (FOBs) already approved or in the global pipeline, according to a new report by BioWorld. Those entering the field are as diverse as the FOBs they’re developing. Biologics pioneers, big pharma and generic drugmakers are being joined by “pure-play” start-ups, conglomerates, public-private consortia, contract manufacturers, contract research organizations, government agencies, nonprofits and research institutions. Some...

For more than five years, the FDA was criticized for failing to provide clear guidance on how drug developers could use social media without running afoul of its marketing restrictions. Last month, the agency finally came through with two crucial draft guidances. A webinar Thursday afternoon aimed at providing more color around the social media regulatory framework could only be described as an #EPICFAIL. The webinar, for which registration reportedly closed early due to overwhelming demand, suffered problems from the get-go, with many registrants unable to log in at all. Almost immediately, slides started crashing, prompting the agency to pause...