Trying Times at the FDA

I thought this recent opinion piece in the New England Journal of Medicine, titled Trying Times at the FDA — The Challenge of Ensuring the Safety of Imported Pharmaceuticals, was a pretty good look at the issues facing the FDA. For those with an interest in pharma or the government's role in public health, this should be right up your alley.

This is particularly true when it comes to the author's proposed solutions for addressing these concerns, including increasing the fees paid by pharma companies to fund the drug approval process. Another option is to increase the responsibility of pharma companies:

The expectation that FDA approval can guarantee drug safety is naive, since drug trials can never uncover all risks. No drug is completely safe for everyone, nor are people entitled to drugs that are entirely safe. Rather, patients and physicians are entitled to know a drug's risks in order to weigh those risks against its expected benefits. FDA approval should not be interpreted as signaling an absence of risk.

Plenty of interesting information and ideas in this article, it's worth a read.