Peter Pitts

Understanding CRISPR

The debate over CRISPR-based engineering is generally framed from an ethical and scientific perspective. The economic dimension is often overlooked.

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.

Sarepta and the Regulation of Hope

FDA’s approval of Sarepta’s Exondys 51 (for Duchenne muscular dystrophy) is controversial and important. More importantly, it is a teachable moment for 21st-century regulatory science.