Yes, The FDA Is In Trouble, But The New York Times’ Prescription Would Make It Worse
A recent New York Times editorial about the Food and Drug Administration reflects a systematic weakness at the once-venerable Gray Lady: The members of the editorial board often rely on sloganeering and popular wisdom instead of substantive evidence.
The editorial was headlined, “The FDA Is in Trouble. Here’s How to Fix It.” The agency is in trouble. But it’s due to the very kinds of “fixes” the Times recommends.
The FDA is highly bureaucratic and risk averse, leading to a slow and expensive drug approval process—at last count, more than $2.5 billion to bring a new drug to market. Yet the armchair quarterbacks at the Times want to slow it down even more and increase the cost and risks of innovating.
Supposedly, too many drugs are being approved “with too little data on how safe or effective they are,” according to the editorial. More specifically, regulators have supposedly made “compromises” by accepting “surrogate evidence” of efficacy.
In fact, there are good reasons that the clinical testing of new drugs can be accomplished with fewer and smaller trials. We are entering the era of precision, or personalized, medicine, the mantra of which is “the right dose of the right drug for the right patient at the right time.”
It reflects that treatments are gradually shifting from a relatively imprecise one-size-fits-all approach to a more personalized one, so patients can be matched to the best therapy based on their genetic makeup, the specific characteristics of their illness, and other predictive factors. This enables doctors to avoid prescribing a medication that is unlikely to be effective or that might cause serious side effects in certain patients.