Are black box warnings inevitable?

A sociologist and health policy researcher has some stern language for drugmakers and their regulators. "Drug disasters are literally built into the current system of drug testing and approvals in the United States," Donald Light said in presenting his figures on new drugs to the American Sociological Association.

According to Light's data review, one in seven new drugs is superior to existing ones, but two in every seven end up emblazoned with a black box, an adverse reaction warning--or they're withdrawn.

And all those post-marketing adverse event reports and black box warnings? They're almost inevitable, given the fact that drugmakers test their products on patients that are typically healthier than the entire population actually targeted by the drugs. And trials are long enough only to pick up short-term side effects, Light said.

Some would argue that the uptick in drug warnings is actually a reflection of the FDA's newly cautionary stance rather than an indication that drug safety is slipping overall. Check out Light's data and see what you think.

- read the post at Pharmalot

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.