EDITORIAL

The FDA Wants to
“Restructure and Grow”

A s we know, the FDA now controls over 25% of the U.S. economy. And the results are rarely, if ever, good. Said another way, bureaucracies are not inventive or creative. So even when an action has some positive aspects, it is always accompanied by negative ones. And the FDA wants more control!

Recently, at a conference at The Aspen Institute at the end of June, six former commissioners of the FDA took to the stage to discuss how they improved the “public good” during their tenures, and how to advance the agency and make it more “effective.” All agreed that the FDA could be reshaped by reducing inefficiencies and making it more independent, even elevating it to cabinet status. All commissioners called on Congress to give the FDA more power. That may depend on the outcome of this fall’s election.

Scandal Laden

First to speak was Frank E. Young (commissioner from 1984 to 1989 under Reagan). His administration has been criticized for a slow response to the AIDS epidemic, the costly halt of imported Chilean fruit after discovery of two cyanide-laced grapes, the scandal over corruption in approval of generic drugs, the proliferation of misleading health claims on food packages and the newly emerging controversy over deaths and injuries from medical devices. All of these criticisms may be valid.

Blame the Patients

David Kessler was next (commissioner from 1990 to 1997 under Bush I and Clinton). In a recent New York Times op-ed on May 6, 2016, Dr. Kessler labeled chronic pain patients as addicts if they insist they need opioid painkillers like OxyContin to control debilitating pain.

This remarkable piece was supposedly about the failure of the medical profession to foresee the prescription opioid epidemic, but Mr. Kessler’s harshest words fell on patients. Was the FDA’s claim under Kessler that it was winning the battle against AIDS any different? According to the movie “Dallas Buyer’s Club,” the FDA fought any competition to solve the dilemma, stifling inventiveness and thereby making it worse.

Kessler said it was “pretty remarkable” that all six commissioners supported the idea of agency independence raised during the panel discussion. Remarkable? Bureaucrats never get together when they don’t argue for more bureaucracy.

Structural Problem

“The FDA is trapped in a structural problem,” said Andrew von Eschenbach, commissioner during the Bush administration from 2006 and 2009 and acting commissioner from 2005 into 2006. Yet, a 2007 congressional report concluded that the “FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.” Quoting from a paper, “The scientific mesh used by the [FDA] to sift through new drugs has more holes than the U.S. border with Mexico.”*

The impact of Congressional action in favor of a bigger and more powerful agency would be a travesty and both natural medicine and nutritional supplements would suffer.

The current commissioner, Robert M. Califf, did not directly participate, but he was at the conference. We bet he was in agreement with the panel. Beware of The Aspen Institute!


* Barlas S. FDA science base badly eroded: but will congress provide urgent new funding? P T. 2008 Mar;33(3):130.


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