This week in biotech, regulators ran amok.
The FDA also moved this week to regulate LDTs (laboratory developed tests) more closely. Most direct-to-consumer (DTC) genetic tests fall into this category, and a series of letters from the FDA to DTC manufacturers last week is evolving into broader action.
Health Canada also took action this week, with the goal of soliciting reports of adverse drug reactions directly from patients. Unfortunately, the benefits of this approach will be hard to realize unless they develop a consumer-friendly form to go along with the new policy.