Regulation wasn’t always bad: Steinberg

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One evil is so clear to Republicans that it didn’t need to be discussed during their presidential debate in Cleveland last week: government regulation.

The 10 candidates jostled each other to condemn bureaucratic meddling.

“We cut regulation by one-third of what my predecessor put in place,” bragged New Jersey Gov. Chris Christie.

“You get in and change every aspect of regulations that are job-killers,” said Jeb Bush.

“We need to have a regulatory budget in America that limits the amount of regulations on our economy,” said Marco Rubio.

By an odd coincidence, one of the better known of those demonized regulators, Dr. Frances Kelsey, died the next day, at age 101.

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In September 1960, Kelsey, a graduate of the University of Chicago Medical School, class of 1950, was a new hire at the Food and Drug Administration in Washington, D.C., when a trio of three-ring binders, each the size of a phone book, landed on her desk.

It was an application from William S. Merrell, an Ohio drug company, that wanted to sell a drug it called Kevadon in the United States. Kevadon was a sedative, effective against nausea in pregnant women. Approval was expected to be routine: the drug was already being sold all over the world.

But as she began to read, Kelsey began thinking, “There was something a little different about this one.”

According to law, the FDA had just 60 days to register an objection. Without it, Merrell could go ahead and sell the drug in the United States. It was already giving free samples to U.S. doctors; eventually some 1,200 would get them, and those doctors handed out pills without telling patients they were unapproved, all completely legal.

But before the 60-day limit passed, Kelsey wrote to Merrell saying its research was “incomplete.” She had questions.

Merrell howled. Executives hurried to Washington to complain about the “stubborn bureaucrat.” They sent letters to her superiors, made phone calls, placed editorials in medical publications denouncing “dilatory tactics which certainly cause a loss to the industry of millions of dollars . . . and even loss of life.” Kelsey was being “unreasonable and irresponsible.” Language any Republican presidential candidate of today knows by heart.

While Kelsey was engaged in what Scott Walker would call “out-of-control regulation,” a letter was published in the February 1961 issue of the British Medical Journal noting reports of “a possible toxic hazard” with the drug. Merrell wondered if they could sell their drug with a warning label. As 1961 dragged on, the company expressed concerns it would “miss the Christmas market.”

But by Christmas the struggle was over. Reports in West Germany linked an epidemic of malformed children to the drug, which was sold under 50 brand names, but generically known as thalidomide. Tens of thousands of children around the world were born with severely malformed limbs, sometimes resembling flippers, or no limbs at all.

But not in the United States, except for a few babies whose mothers got those free samples. President John F. Kennedy gave Kelsey a medal. Laws were tightened. She worked for the FDA for nearly 45 years. Long enough for the thalidomide story to fade from the public mind.

I don’t want to let one dramatic story goad me into extremism. The flip side of the “Frances Kesley ethic” is that valuable drugs are sometimes needlessly delayed. There can be too much government interference in business, as the advent of Uber demonstrates. Certain trades, such as hair braiding, are licensed that shouldn’t be licensed at all.

Nuance might not play well in a campaign speech, but in real life there is balance or should be between caution and expediency. We need the government to rein in business because otherwise it’ll sell thalidomide and put 12-year-olds to work in thread factories. They’ve done it before. We need to realize that though government regulators make mistakes, they also do enormous good, and don’t deserve the sneering, blanket contempt Republican candidates unthinkingly heap upon them. Nor does the public deserve it.

Thousands of those watching the GOP presidential debate were 54-year-old businessmen and tea party grandmothers, jaws clenched in righteous anger at the foolishness of government meddling, unaware that they owe their arms and legs, their hands and feet, to one stubborn FDA bureaucrat, Frances Kelsey. They have no idea of the truth underlying their entire lives. You have to wonder, if they knew, would they still believe the things they do?

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