Who Strangled the FDA?

By Greg Anrig, The American Prospect. Posted January 16, 2008.

It's possible to read all 300-plus horrifying pages of a new Food and Drug Administration subcommittee report describing the agency's slow asphyxiation by prolonged budgetary constraints without learning who is responsible for its decline.

Subcommittee member and attorney Peter Barton Hutt, who served as FDA chief counsel during the Nixon and Ford administrations, pointed his finger at the American public in his own supplemental contribution to the report: "It is not a problem caused by partisan politics. The administrations of President Clinton and President Bush have been equally unresponsive to FDA's needs ... The country cannot withhold the requisite scientific resources from FDA and then complain that the agency is incapable of meeting our expectations."

But if everyone is to blame, then no one is. Recent fiascoes like the Melamine-tainted pet food and lead-laced Mattel toys, both imported from China, are sure to continue in the absence of meaningful accountability. The truth is that the carnage described in the report is as much a conservative-movement accomplishment as the creation of the FDA was a great progressive-era triumph.

For many decades, the right has been about as hostile toward the FDA as it has been toward Social Security -- another long-standing success story that undercuts the worldview that government is the problem rather than the solution. In a 1975 roundtable at the American Enterprise Institute, for example, Ronald Reagan claimed that the FDA was needlessly killing Americans. Referring to the drug Rifampin, he said, "I think something more than 40,000 tuberculars alone have died in this country who conceivably could have been saved by a drug that has been widely used the past few years throughout Europe." In fact, Rifampin had already been on the market in the U.S. for four years, approved by the FDA five months after the manufacturer submitted the application.

The network of conservative and libertarian think tanks that began to sprout in the years leading up to Reagan's presidency, blossoming in full during his eight years in office, continued to hammer away at his theme of FDA as murderer, pointing to its purportedly unreasonable delays in approving drugs and medical devices. The evidence they marshaled in support of that claim wasn't much stronger than Reagan's Rifampin fiction, but over time the sheer repetition of the argument gained traction. It's worth noting that many of those same right-wing institutions demonstrated considerably less concern for the public's health when they incongruously chastised the agency for its unfair harassment of tobacco companies.

Another persistent line of attack was most concisely expressed by Newt Gingrich, who dubbed the FDA the "number-one job killer in America." That accusation was applauded by the pharmaceutical, medical-device, and food industry funders of both the Republican Party and conservative think tanks, reinforcing their threats to relocate to countries with less stringent regulatory oversight.

Charting the phases of the FDA's decline lays bare the responsibility borne by movement conservatism. The first phase was the two terms of the Reagan presidency, when the FDA's staff declined by 30 percent. After a reprieve from 1988 to 1994, when more moderate presidents and a Democratic Congress provided ample boosts in the agency's budget and staffing, the FDA's garroting resumed with a vengeance in the wake of the 1994 Republican landslide that catapulted Gingrich to the House Speaker's chair. He led a highly effective jihad against the agency, pushing to privatize many of its activities. The onslaught continued under George W. Bush and the Republican Congress. From 1994 to 2007, according to former FDA chief counsel Hutt, the agency's appropriated personnel declined from 9,167 to 7,856, while its funding increased by only two-thirds of the amount that would have been needed to keep up with inflation.

As with virtually every other regulatory agency under Bush, the FDA henhouse has been guarded by foxes. That is, for top leadership positions the administration chose political appointees with close ties to the industries they regulate. That strategy of stifling nonpolitical career civil servants, not incidentally, conforms with recommendations the Heritage Foundation made to Bush at the outset of his term. One example at the FDA was chief counsel Dan Troy, a longtime opponent of FDA regulation who had previously represented Pfizer.

What does it look like when an agency assigned to protect public health and safety drowns in a bathtub? Some snippets from the report:

• IT systems fail frequently, and even e-mail systems are unstable -- most recently during an E. coli food contamination investigation. More importantly, reports of product dangers are not rapidly compared and analyzed, inspectors' reports are still hand written and slow to work their way through the compliance system, and the systems for managing imported products can not communicate with Customs and other governmental systems (and often miss significant product arrivals because the system cannot even distinguish, for example, between road salt and table salt).



• During the past 35 years, the decrease in FDA funding for inspection of our food supply has forced FDA to impose a 78 percent reduction in food inspections, at a time when the food industry has been rapidly expanding and food importation has exponentially increased. FDA estimates that, at most, it inspects food manufacturers once every 10 years.



• Even as the number of "adverse events" from prescription drugs has increased by 146 percent from 1996 to 2006 -- to 471,679 last year -- there has been no increase in FDA personnel to review those reports.

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