 Food, Drug and Product SafetySafety First!
How safe is the food we eat? How safe and effective are the drugs we take and the medical devices we use? What about the cars we drive and the consumer products we buy? These are questions one might expect various agencies of the federal government -- the U.S. Department of Agriculture, the Food & Drug Administration, the National Highway Traffic Safety Administration, and the Consumer Product Safety Commission -- to answer with quick and reassuring replies. Unfortunately, examples of unsafe products in recent years have been far too common, and in some cases, all too deadly.
In early 2010, for example, auto manufacturer Toyota was forced to recall millions of vehicles because of life-threatening safety problems -- some of the cars accelerated out of control, other cars refused to respond promptly to braking. The problems had begun to emerge years earlier and had been reported to the National Highway Traffic Safety Administration. But the agency failed to act in a meaningful way, exposing drivers to years of unnecessary risk.
Similar problems have plagued the Food and Drug Administration. In late 2004, pharmaceutical manufacturer Merck & Co. Inc. announced that it was voluntarily withdrawing its blockbuster pain medication, Vioxx. The company revealed that a clinical trial had demonstrated that long-term use of the pain-relief product resulted in a nearly doubled risk of heart attack or stroke. Some 20 million people had taken drug by then. Should the Food & Drug Administration have known earlier? Should it have recognized the risks, and denied approval to the product, or at the very least insisted on more research to rule out the possibility? According to The Hidden Lesson of the Vioxx Fiasco: Reviving a Hollow FDA, a 2005 report from CPR’s Rena Steinzor and Margaret Clune Giblin, FDA failed to protect the public in the Vioxx case because it had become an example of a “hollow government” agency – lacking the resources to do its job adequately, and missing the political will to fight for those resources and to reign in companies eager to take excessive risks.
Another conspicuous regulatory failure gave rise to the Mad Cow controversy of 2003-04. In that instance, Department of Agriculture officials rushed to the aid of the beef industry after an instance of the deadly and contagious disease turned up in an American herd of cattle. Rather than clamping down on the industry to make sure it was following safe practices, the Department launched what CPR’s Tom McGarity described as a series of public relations efforts aimed at bolstering confidence in American beef, whether that confidence was warranted or not.
Other examples abound. Tainted peanut butter, toxic drywall, lead-laden imported toys, and more. Such instances of unsafe food, drugs, automobiles and products are all too dangerous evidence of a failed system of regulation and enforcement. Often the failure is the result of neglect – a lack of political will to spend the money required to conduct meaningful research and enforcement. Sometimes the cause is ideological: a conviction that government should “get off industry’s back,” because such regulation is unnecessary, that the “rare” instances of unsafe products are self-correcting for the manufacturer, because they would suffer economic consequences. That argument likely holds little appeal to the families of the estimated 88,000 or more Americans who suffered heart attacks because they took Vioxx, or whose loved ones were harmed or killed by unsafe food, cars or consumer products.
Learn about CPR Member Scholars’ work to ensure the safety and efficacy of the nation’s drugs and medical devices, and the safety of the nation’s food supply:
- Toyota Recalls. On February 9, 2010, CPR Member Scholars Rena Steinzor and Sidney Shapiro sent a letter to the House Oversight and Government Reform Committee outlining important questions it should put to the National Highway Traffic Safety Administration, in the wake of its failure to force speedy action on safety problems with several Toyota models. Read the letter. Or read Steinzor and Shapiro's February 22, 2010 editorial memo on the same subject.
- Fifty FDAs? Read "Fifty FDAs”: An Argument for Federal Preemption of State Tort Law that Is Less than Meets the Eye (800 kb download), CPR White Paper 911, by CPR Member Scholars William Buzbee, William Funk, Thomas McGarity, and Sidney Shapiro, with CPR Policy Analysts James Goodwin and Matthew Shudtz, October 2009.
- Senate Testimony: Medical Devices. CPR's Thomas McGarity testified before the Senate HELP Committee on August 4, 2009, declaring that current FDA regulation of medical devices was inadequate in the absence of a the right to sue for damages in state civil courts. Read the news release. Read the testimony.
- Blogging Food Safety. Recent CPRBlog posts on food safety issues include Tom McGarity's post on the Waxman food safety bill, and posts from Matt Shudtz and others on the continuing saga of BPA contamination of baby bottles and other plastic food containers.
- Austin American Statesman Op-Ed, 2008. Read "Court Takes Up Preemption Doctrine," by CPR Member Scholar Thomas McGarity, published in the November 28, 2008 Austin American Statesman.
- Hollow Government and the FDA. Read "The Hidden Lesson of the Vioxx Fiasco: Reviving a Hollow FDA," by Rena Steinzor and Margaret Clune Giblin. (CPR White Paper #514, October 2005) Or read CPR's news release on "The Hidden Lesson of the Vioxx Fiasco." Or read CPR's Tom McGarity's January 2005 letter to the USDA protesting an effort by the peach and nectarine industry to drive up prices for its product by banning from the marketplace fruit that has purely cosmetic flaws.
- Mad Cow. Read about Thomas McGarity’s work on Mad Cow disease.
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