Peter Pitts

Scott Gottlieb’s Predictable Imaginarium

Scott Gottlieb’s still nascent tenure as Food and Drud Administration commissioner has, to date, been defined by two terms not generally associated with the agency that regulates more than a third of the U.S. economy — predictability and imagination.

ICER Perpetuates the Opioid Crisis

Last year, a week before Christmas in Kernville, Pa., 5-month-old Summer Chambers died in her crib from dehydration and starvation. Her parents — Jason Chambers, 27, and Chelsea Cardaro, 19 — had died about four days earlier from a non-abuse-deterrent opioid overdose.

A Sanitary Democracy Manifesto

Countries around the world are struggling to adequately monitor the quality of medicines available to their citizenry. From more regular manufacturing inspections, to risk-based investigations into the sourcing of ingredients, to a rethinking of post-marketing surveillance (pharmacovigilance), there isn’t one single solution — and efforts to reach international “harmonization” are part of the problem.

21st Century Pharmacovigilance and the Role of Artificial Intelligence

Artificial intelligence has an unimaginable potential. Within the next couple of years, it will revolutionize every area of our life, including medicine — and pharmacovigilance. Usually, we make sense of the world around us with the help of rules and processes that build up a system. The world of Big Data is so huge that we will need artificial intelligence to be able to keep track of it.

FDA’s Seven-Year Itch

Almost seven years to the day of the FDA’s November 2009 two-day Part 15 hearing on social media, a new Part 15 meeting on off-label communications, Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing, will be held.