Public Safety in Ruins

posted by Frank Pasquale

In an interview with Terry Gross, Penn bioethicist Art Caplan claimed the the Bush Administration had severely compromised the nation’s capacity to deal with public health and safety threats. I was surprised by the strength of his language, but the more discussions of FDA, EPA, and OSHA I hear about in the last days of the Bush term, the more depressed I get. Consider these recent stories: :

1) Melamine Mania: James E. McWilliams reports on an FDA utterly adrift in the growing melamine scandal:

When Canada voiced concern over milk-powder imports from the United States in late September, an FDA spokeswoman gave a dismissive response: “The public health crisis is in China.” When, over the next several weeks, the administration finally discovered melamine in baby formula sold here in the United States, its first order of business was to set up a conference call to warn the companies that produce 90 percent of the world’s milk powder—Abbott Labs, Mead Johnson, and Nestlé. But when it came to the general public, the FDA remained silent—at least until the Associated Press filed a Freedom of Information Act request for the test results and published the news in late November.

McWilliams proposes several legislative fixes that should be near the top of Congress’s agenda.

2. Asleep on the Job: Via Crooked Timber, a WaPo story on Bush’s OSHA:

Current and former career officials at OSHA say that . . . political appointees ordered the withdrawal of dozens of workplace health regulations, slow-rolled others, and altered the reach of its warnings and rules in response to industry pressure. The result is a legacy of unregulation common to several health-protection agencies under Bush: From 2001 to the end of 2007, OSHA officials issued 86 percent fewer rules or regulations termed economically significant by the Office of Management and Budget than their counterparts did during a similar period in President Bill Clinton’s tenure, according to White House lists.

[By 2006, the Agency Director was] a South Carolina lawyer and former Bush fundraiser who spent years defending companies cited by OSHA for safety and health violations. [He] quickly acquired a reputation inside the Labor Department as a man who literally fell asleep on the job: Eyewitnesses said they saw him suddenly doze off at staff meetings, during teleconferences, in one-on-one briefings, at retreats involving senior deputies, on the dais at a conference in Europe, at an award ceremony for a corporation and during an interview with a candidate for deputy regional administrator.

His top aides said they rustled papers, wore attention-getting garb, pounded the table for emphasis or gently kicked his leg, all to keep him awake. But, if these tactics failed, sometimes they just continued talking as if he were awake. “We’ll be sitting there and things will fall out of his hands; people will go on talking like nothing ever happened,” said a career official, who spoke on the condition of anonymity because he was not authorized to talk to a reporter. In an interview, [he] denied falling asleep at work, although he said he was often tired and sometimes listened with his eyes closed. His goal, he said, was to create the best agency he could, partly by putting in place “performance metrics” not previously used at OSHA.

3) Innocents Abroad: Gardiner Harris reports on the FDA’s trivial efforts to police ever-growing Chinese drug exports:

When inspectors do go to China, their reports sometimes read like a bureaucratic rendering of Mark Twain’s “Innocents Abroad.” During a 2001 trip, for example, two F.D.A. inspectors visited a plant that was exporting acetaminophen to the United States. The plant had never been inspected. “The F.D.A. inspection team was met at the hotel in Wenzhou by representatives from Wenzhou No. 3 Pharmaceutical Factory and . . . transported by public ferry and then company vehicle to the manufacturing facility on Dong Tou Island off the coast of Wenzhou,” their report states. “There is no street address or plot number, and the address of the facility is given only by the county and province.”

Once the team arrived in what seemed like the middle of nowhere, the inspectors learned the drug was being manufactured at another plant — one that once had a similar name but had recently changed it. “In fact,” the report continues, “inspection found that there were initially three separate and independent firms operating under the names Wenzhou No. 1 Pharmaceutical Factory, Wenzhou No. 2 Pharmaceutical Factory and Wenzhou No. 3 Pharmaceutical Factory. The location of Wenzhou No. 1 Pharmaceutical Factory was also determined by the F.D.A. inspection team during the visit to Wenzhou, and it was learned that the firm is operating under a new Chinese name; however, the English translation of that name was not available.” So the two inspectors flew back to the United States — at taxpayers’ expense — never having inspected a thing.

The F.D.A.’s apparent inability to keep names straight is no trivial matter. One reason the agency failed to inspect the Changzhou plant that produced deadly heparin, for instance, was that someone mixed up the facility’s name and concluded that the plant had already been inspected. Chinese plant names, a vestige of its once strictly controlled economy, are often very similar, and translations can vary. For instance, there are 57 separate drug master files — the basic F.D.A. record of a plant’s name, location and approved product — with “Shanghai” in the name. Some are obvious repeats, like the ones for “Shanghai No. 6 Pharmaceutical Factory” and “Shanghai Number 6 Pharmaceutical Factory.” But others could be separate plants. Or maybe not. It’s just too hard to tell.

Compounding the problem is the F.D.A.’s antiquated technology. Its computer systems are so awful that officials have no way of knowing which names, or which plants, are real. To determine which factories need to be inspected, agency investigators must consult two incompatible databases, one of which lists 3,000 foreign drug plants exporting to the United States and the other 6,800. Which number is right? Nobody really knows.

And yet Bush’s FDA Commissioner, “Von Eschenbach, in several appearances before congressional committees, has declined to specifically seek more money for beefed-up foreign inspections.” One commentator on the Diane Rehm show linked above said that the Republican effort to keep FDA spending in check while imports from China boomed was analogous to telling one elementary school teacher to teach a class of 30,000 students.

Comically, at this late date, the RNC has apparently chosen to try to disassociate itself from Bush. Tragically, its aim seems to be to push the deregulatory, anti-government spirit of the administration ever-further. Observing these latter-day Robespierres, former Republican congressman James Leach has said that the current rump Republican party has no center. And you can count on the Murdoch Street Journals’s editorial page to argue that whatever failures that occurred under Bush are failures common to all regulation, everywhere–any data point confirms their anti-regulatory animus.

How big will the public health and safety disaster be before this kind of reflexive rejection of regulation becomes unworthy of public consideration? Or will we just slowly succumb to ever-rising melamine levels in food, ever-more-dangerous drugs, ever-worse workplaces–as a declining news media replaces the type of reporting that could alert us to it with panem et circenses?

 December 30, 2008 at 2:06 pm   Posted in: Administrative Law, Health Law    Print This Post

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