Ned Barnett

Hail the heroic bureaucrats

The Washington Post

In the United States, there are likely thousands of people born in 1961 or 1962 who came into the world healthy and are alive today because of the stubbornness of a Washington bureaucrat.

They are all, in a sense, the unknowing children of Dr. Frances Oldham Kelsey, a former regulator with the Food and Drug Administration who died on Aug. 7 at 101. Her death was reported on the front page of The New York Times under a headline that described her as “An F.D.A. stickler.”

Kelsey was not a traditional celebrity, not a politician, athlete, stateswoman, artist, actor, author or business leader. Rather she came to prominence because of her performance in a warren of anonymity, the federal bureaucracy.

A former South Dakota family doctor and a pharmacologist, she joined the FDA in 1960. Her job was to evaluate applications from companies seeking FDA approval to market new drugs. What distinguished her immediately was her exactitude and her defense of process. Those admirable qualities are often derided in regulators by those who agree with Ronald Reagan’s view that government is not a source of solutions but is itself a problem, an impediment not only to free enterprise but to freedom itself.

We hear the same sentiments now from Republican Gov. Pat McCrory who vowed to root out “seat warmers” in state government, U.S. senators who rail against IRS managers and EPA rulemakers, and presidential candidates like Scott Walker and Chris Christie who blast public employee unions as the protectors of the incompetent. In North Carolina, there is a push to cut regulations and have regulators be more flexible toward the industries they regulate.

Kelsey heard “bureaucrat” used as an epithet, too. The charges came from the William S. Merrell Co. of Cincinnati, a company eager in 1960 to market the drug Kevadon as a treatment for morning sickness. The drug had been effective as a sedative and sleep aid, but the company saw a market in Kevadon’s unanticipated effect: It eased the nausea that sometimes accompanies pregnancy. The drug was already being widely used for that purpose in Europe and elsewhere and had been distributed to 1,000 U.S. doctors for use on an “investigative” basis. Kevadon was better known by its generic name, thalidomide.

Kelsey had doubts about approving Kevadon. She insisted on more proof from Merrell that it was safe for pregnant women. The company complained to her superiors, saying she was nothing more than a petty bureaucrat. Kelsey and her colleagues held their ground. Then came a cascade of reports late in 1961 that mothers who took the drug were giving birth to babies with flipperlike arms and legs. Some had no limbs at all.

The drug was never approved in the United States, although 17 children exposed to its experimental use suffered birth defects. Kelsey was later honored as a hero who kept the thalidomide scourge out of the United States.

President John F. Kennedy, who was pushing for greater regulation of new drugs, honored Kelsey in 1962 with the nation’s highest civilian service award – the President’s Award for Distinguished Federal Service. He said of Kelsey, “Her exceptional judgment in evaluating a new drug for safety for human use has prevented a major tragedy of birth deformities in the United States.”

Kelsey went on to become the director of the FDA’s Office of Scientific Investigations and spent 45 years with the agency. She helped strengthen standards for medical testing and improved protections against medical conflicts of interest.

Kelsey’s story of abiding by standards despite pressure from commercial interests has occurred many times, but rarely with such drama and recognition. Government employees and bureaucrats have saved lives by insisting that the letter of the law and the intent of the rule be honored. Those who faithfully inspect structures, review designs and enforce regulations keep bridges and buildings from collapsing. They ensure the purity of food and the safety of drugs. Theirs is a thankless task that deserves a nation’s gratitude.

Kelsey died with honors, but the regulatory vigilance she demonstrated remains under assault. Companies and candidates keep demanding less and looser government regulation. No doubt, some regulation is excessive, but better to err on that side than raising risks.

On Kelsey’s passing, many should be grateful that she and her colleagues did their jobs. And that her efforts fostered better drug regulation that protects Americans today.

The next time you hear a politician complain about “petty bureaucrats” who slow down business, think of Dr. Frances Oldham Kelsey and what she didn’t let happen.

Editorial page editor Ned Barnett, 919-829-4512, or nbarnett@newsobserver.com

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