TOPIC: Product Safety


The Food and Drug Administration regulatory cop has been off the beat so long that some food producers have hired their own inspectors, reports Andrew Martin of the New York Times:

For many years, the food industry lobbied against initiatives that would have strengthened the F.D.A.’s oversight. But industry attitudes are changing as food-borne pathogens turn up repeatedly in foodstuffs once regarded as safe, like peanuts and pistachio nuts, costing those industries millions in lost sales.

This raises an interesting anti-regulation point: companies do have a market incentive to hire their own regulators, because no company wants to be the next Georgia Peanut Corporation or (for those nostalgic for FDA news of the 90′s) Jack in the Box. But the self-policing introduces a conflict of interest — for example, unlike federal inspectors, companies would not likely go public if they discovered rampant health and safety violations, particularly those inflicting company workers.

Ultimately, companies actually benefit from a strong FDA. They don’t have to pay for food inspectors. And they don’t have to compete with companies that take advantage of weak regulation by brazenly ignoring minimal health safeguards.-MB


It’s strange to read about a product recall when the product hasn’t already killed or maimed someone.  Unfortunately, the reality is usually just that gruesome — a child is killed by a crib or a high chair, or an adult suffers lung damage from a hazardous home cleaning product, and then the Consumer Product Safety Commission weighs in and orders a recall.  But today’s Washington Post features an odd news item:  a product recall was ordered even though there have been no injuries reported.  It was found that a "Serta zipper-covered foam-core mattress" does not "meet federal standards to prevent them from igniting in the presence of open flames."  Turns out there are standards and CPSC can stop products from getting to the marketplace and hurting people.  As Matt Blake’s report on the CPSC makes clear, more product recalls are the likely result if CPSC gets aggressive about using the standards it already has on the books.  -NH


The Food and Drug Administration yesterday announced the beginning of a new program called the Sentinel Initiative that will begin monitoring how medicines already in the marketplace are affecting people’s health.  As Gardiner Harris of the New York Times reports, the effort was accelerated after  widely-prescribed drugs like Vioxx were found to cause significant health problems.  Though encouraged, most experts believe it will be years before FDA can actually monitor side effects and potentially dangerous medicines effectively.  The agency will begin by testing drugs with recognized side effects, and then expand to watching new medicines.  Harris quotes a Harvard Medical School professor as saying that if the Sentinel Initiative succeeds, "the use of drugs and vaccines will be safer and better."  Read Harris here.  EH


The Huffington Post’s Linda Cronin-Gross flags a report that recalls done by the Consumer Product Safety Commission are at an all-time high this year. According to the advocacy group Consumers Union, the independent federal agency is on track to recall 800 products this year—70 percent more than in 2007.

Cronin-Gross says this means that the danger from importe products is higher than ever. there’s something to that, though increased recalls show the agency may be getting better at identifying dangerous imports the market. either way, the agency’s public problems linger even after last year’s Thomas the Tank Engine headlines have faded.  Read Cronin-Gross here.  MB


At a Congressional hearing Tuesday, Democratic leaders declared that the FDA should get $300 million to inspect foreign manufacturers of drugs. It now gets $10 million. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said at the hearing that $250 million would be sufficient to do foreign inspections. In other words, it’s less than Congress’s number — but an admission the agency needs much, much more money than it’s getting.

But the Wall Street Journal’s Alicia Mundy reports that at a hearing yesterday Woodcock backed off on her statement. Perhaps someone reminded Woodcock that it’s impolitic to recognize regulatory agencies often don’t have the money to perform their mandate.  Read Mundy here.  MB


Since November, House leaders John Dingell (D-Mich.) and Bart Stupak (D-Mich.) have relentlessly admonished the Food and Drug Administration for not fulfilling its regulatory mission.

Yesterday the lawmakers held a hearing that focused on the agency’s current inability to inspect importe drugs. the wall street journal’s Corey Boles reports that the FDA’s Janet Woodcock thinks that $250 million would be enough money for the agency to inspect every foreign drug manufacturer. Dingell and Stupak propose $300 million. The current money allocated for foreign inspectors is $10 million.  Read Boles here. MB


The Washington Post’s Lyndsey Layton reported yesterday on an under-resourced Food and Drug Administration bowing to industry wishes. More than 100 studies have reported health concerns about bisphenol A, a chemical compound found in many everyday plastics.

But the FDA has decided not to regulate the plastic, citing a conflicting study by the American Plastics Council, which is part of the multibillion-dollar plastics industry. The agency also appears to be unduly swayed by the Weinberg Group. The law firm has successfully worked with industry in the past to delay government regulation on—among other products—tobacco, Teflon and agent orange.  Read Layton here.  MB


A tight budget can be a good tool for fiscal discipline, but when you’re talking about safe food and medicines, a little more funding can help.  Still, Food and Drug Administration Commissioner Andrew C. von Eschenbach is coming down on the side of economy.  Both Democrats and Republicans on the Senate committee that approves funding for the FDA agreed yesterday that the agency needs $375 million or 20 percent more funding than it’s currently receiving.

But as the New York Times’ Gardiner Harris reports, Eschenbach told the committee yesterday that the agency couldn’t appropriately respond to that scale of funding increase. Eschenbach is requesting additional funding for more employees and overseas inspectors in China.  But he doesn’t agree with the assessments by Congress and the agency’s own Scientific Advisory Panel that the FDA is too strapped of cash to perform its basic regulatory mandate.  Read Harris here.  MB


The National Institute’s of Health Toxicology Program released a report yesterday that bisphenol A, a chemical found in 93 percent of all U.S. patients’ urinary tracts, could lead to everything from cancer to stunted growth. The chemical is found in plastic containers from baby bottles to the linings of soda cans. 

What now bears monitoring, reports the Washington Post’s Lyndsey Layton, is whether the Environmental Protection Agency and Food and Drug Administration act on the NIH findings and regulate the chemical. Or will action during what remains of the Bush administration be limited to the states?  Read Layton here. MB


The Food and Drug Administration never inspected a Chinese plant that was making the blood thinner heparin. The result is around 20 deaths and example 1A of an agency crying out for more staff and a strategy to deal with testing drug imports. 

The FDA has since directed some of its meager resources to finding out exactly what was in the heparin. The Washington Post’s Marc Kaufman reports that the agency has now identified the contaminant as a modified form of a dietary supplement, which could have enabled the product to be produced more cheaply.  Read Kaufman here.    MB