PCA Maneuvers
The Peanut Corporation of America (PCA), responsible for over 630 illnesses and nine deaths from reactions to Salmonella infected peanuts, filed for bankruptcy liquidation. Culpability? The Consumer's Union (CU) reports that the bankruptcy will protect the company from lawsuits. The company listed one to ten million dollars in liabilities and coincidentally, one to ten million dollars in assets.1 The Washington Post elaborates that lawyers will move to have the stay preventing new lawsuits lifted. CU called on the Food and Drug Administration (FDA) to "oversee food processors so that unscrupulous behavior can be detected, prevented, and deterred".
But in order for that oversight to happen, the journal Nature writes, the FDA needs at least a new commissioner and more staff to replace those lost in the past 5 years. Said Michael Taylor, a former deputy commissioner for policy at the FDA: "Members on both sides of the aisle are getting that there is a system-wide problem here, that there has to be institutional change." Nature reports that even food corporations represented by 10 organizations have appealed to congress for food safety reforms enacted through the FDA. (Wadman, M. "Obama puts focus on FDA after peanut poisonings" Nature 457, 770-771 (2009) | doi:10.1038/457770a)
The agency has been significantly weakened in a worldwide spiderweb of pharma and food production companies that generate increasing threats to consumers and that need more oversight. The FDA however is failing to keep up, and has for years been routinely paraded across the news with systemic problems. The problem is cyclical. Nature's story about the weakened agency has strong similarities to the one told in 1989 by the New York Times.
In 1989 the FDA was "ailing", reported the NYT. Reagan had eviscerated the agency in his deregulatory zeal, and Dr. Samuel Thier, president of the Institute of Medicine in the National Academy of Sciences, told the newspaper: "the Food and Drug Administration is a demoralized group, being asked to do too much with too few resources.'' As was reported this week about the state of the FDA, 20 years ago the NYT reported with an air of dropped-jaw breathlessness: "the situation has gotten bad enough that the industry regulated by the agency has begun to press for a stronger agency".
In 1992 David Thessler was nominated to run the agency, which he did for six years, revitalizing the agency's regulatory authority and working to bring tobacco under FDA control, but drew ire from some businesses.
Privatizing Product Inspection: When It Doesn't Work
Reagan accelerated 'kill the FDA' policy trend, and organizations like Cato and politicians like Newt Gingrich pushed to make shrinking the FDA a public priority. Among their goals, they aimed to privatize inspections. The agency was a "monopoly", they said, responsible for millions of job losses in the US. Articles like Cato's 2001 "How FDA Regulation and Injury Litigation: Cripple the Medical Device Industry", helped convince legislators to loosen regulation and contract out important functions.
In the case of PCA, the FDA hadn't inspected the Georgia peanut company since 2001, because of agency budget shortfalls and staff reductions. Instead, according to the New York Times, PCA hired and paid its own auditors to procure the necessary documentation for its products. The Times wrote that Kellogg Company says it received audits from PCA in 2007 and 2008 that were conducted by the AIB International, which apparently gave the Blakely plant a "superior" rating (of course read with caution, Kellogg is on defense here).But an earlier NYT article reported that when the State Agriculture Department inspected the plant in 2007 and 2008, it found multiple problems, especially of food processing services "not cleaned or sanitized". Why was AIB's inspection lax?
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1 There's the movie "The Corporation". Seen it? It's been around for a few years and is available for download on Google.
Acronym Required has been writing about problems at the FDA since 2005, including posts on BPA and the FDA; Commisioner von Eschenbach's confirmation hearings in "The FDA'S 'Medical Ideology'"; on the beleaguered organization in general -- "Resuscitating The FDA"; the FDA in the wake of various fiascoes and staff turnover, at "FDA -- Calling Off The Dogs"; and about general issues recruiting scientists in "Ethics- The NIH and FDA".
