What Grounded Boeings and FDA Have in Common

[Commentary by Jim Dickinson] Aviation experts have been quick to point out a cause of Boeing’s current crisis that’s been in plain sight ever since Ronald Reagan deregulated the industry and spread that success through the rest of the government – including FDA. In a word: Coziness. Regulated industries have too much sway with the federal agencies that regulate them. With the supine awareness of the Federal Aviation Administration, Boeing deliberately kept its top-selling 737 Max jets in the air as long as it could, even as safety red lights were flashing after the Lion Air crash.

Medical companies do the same with the supine awareness of FDA when their products get into safety trouble, as Purdue Pharma most recently did in trying to keep its best-selling opioids in the air, exactly like many others had serially done before. The line is long, all the way back to Reagan – Bayer’s Essure permanent birth control device, Lilly’s Darvon, Merck’s Vioxx, Parke-Davis’s Rezulin, ReGen Biologics’ Menaflex Collagen Scaffold, Wyeth’s fen-phen, to name just a notorious few of scores.

FDA’s behavior at a mid- to low-managerial level has almost always been exemplary when dealing with industry. It’s when companies get worried that their relationships are getting difficult that they have been increasingly seeking higher-level policy involvement to advance their product’s progress. Proof of long-term safety is usually expensive and likely to run into delays. Short, easier reviews are desired.

With medical devices, the costly and lengthy PMA route is to be avoided. Cooperative FDA reviewers can be persuaded to have a flexible approach to the applicability of predicate devices for use of the easier, faster and less-expensive 510(k) approach.

The same motives impel both generic and innovator companies when negotiating drug reviews. Do you really need more than 800 subjects in this clinical study, when 80 would demonstrate the same profile? And won’t in vitro evidence of bioequivalence be all that’s needed, rather than in vivo?

Before Reagan, FDA had a worldwide reputation for slowness in product reviews, and hostility to corporate overtures and complaints. It was the era of the infamous “drug lag,” in which other countries always did it faster. Industry was divided into two camps: the larger companies that had the resources to play whatever games FDA reviewers and managers expected, and smaller companies that often tried – mostly unsuccessfully – to get around the whims and demands of reviewers and field investigators.

Before Reagan, you did things “by the book” with FDA, whether you felt it necessary or not. Many companies felt their quality and process standards were superior to what was in FDA’s “book,” but they humored FDA anyway. Going over the heads of your FDA official contacts would bring reprisals. This had been the cardinal rule in dealing with FDA, forever. Many in industry actually approved – the tougher FDA was, the better their products became as a result of the discipline FDA imposed.

After Reagan, the changes he and his appointees had brought continued through Democratic and Republican administrations alike. As with the airline industry and especially Boeing, industry was no longer the adversary that the American consumer had to be protected from. The medical industry was now FDA’s “customer” (later “partner”) in bringing needed products to suffering patients.

Without this closeness to regulators and policy makers in Washington, you could hardly survive commercially.

The change did not happen overnight. It took many years to alter the attitudes of FDA careerists, a bolus of whom began retiring after long tenures, to be replaced by people who did not have those attitudes and who could be relied upon to follow political appointees’ orders.

As the shift took root, former (Nixon) commissioner Alexander Schmidt came out of retirement to express his concern in an address to the Association of Food and Drug Officials in July, 1985. Addressing what was widely seen then as Reagan’s politicization of the agency, Schmidt boasted that he had maintained his independence as commissioner.

“I kept the secretary and the assistant secretaries informed, certainly, especially if what we intended to do held the interest of the public or of some politicians,” he said. “But never once was I told to do something or not do something that I or other agency leaders thought not right. Had that happened, I’m quite certain that I and (chief counsels) Peter Hutt or Dick Merrill would simply have refused, and then been fired or quit.”

Could FDA commissioners today say the same?