FDA Fails at Providing Risk Management Advice: Post

North Dakota State University economics professor Raymond March says there is a clear reason why FDA struggles to provide effective risk management guidance and seems to flounder when asked to manage risk for others: it can’t. Writing for the Independent Institute in an online post, March argues that “risk is best addressed by markets, not regulations or federal guidelines. FDA’s incentives run toward removing products and avoiding blame, not toward preserving patient access and physician judgment. Ironically, it’s a real risk to our health and the healthcare sector to imagine otherwise.”

The post says CDRH associate director for compliance Keisha Thomas recently told a conference that risk management should be “fluid, living, breathing, moving, evolving constantly” and “in a state of continuous improvement all the time.”

“Talk about a non-answer,” March comments. He uses his post to support his position by describing the agency’s activities in past years involving Accutane, the Natural Cycles contraceptive, and the Owlet Smart Sock.

“Private companies, whether making medical goods or anything else, flourish or fail by assessing risk well,” March writes. “FDA doesn’t face that discipline. The agency’s only real power is to remove products from the market or stop them from entering it. That is a blunt instrument applied to an incredibly dynamic market for medical goods. More importantly, accepting risk is a matter of personal preference and available alternatives, circumstances that differ for every person and cannot be aggregated into a one-size-fits-all standard without discarding what makes medical treatment effective in the first place.”