Food, Drug and Product Safety

Safety 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.

Safety Depends on Strong Regulation

In early 2010, 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 (FDA).  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.

The hollow FDA has proven equally unable to ensure that the foods we eat are safe from contamination. The CDC estimates that each year 48 million Americans (one in six) suffer from foodborne illness, resulting in 128,000 hospitalizations and more than 3,000 deaths. A substantial portion of these illnesses are caused by produce, processed foods, and seafood under the FDA’s jurisdiction, much of it imported from developing countries with ineffective regulatory systems. And yet in 2011, the FDA was able to inspect only 0.4 percent of foreign food facilities and check just 2 percent of food imports at the border. In the final days of 2010, Congress passed the Food Safety Modernization Act (FSMA) in an effort to overhaul the nation’s food safety system and shift the FDA’s focus from reaction to prevention. But the FDA’s attempts to implement the law were soon met with long delays at the White House, vigorous opposition from sectors of the food industry, and resistance from House Republicans. CPR is monitoring the law’s implementation to ensure the resulting rules provide the maximum benefits to public health and safety.

Food Safety Modernization Regs

In 2012, the FDA sent to the White House Office of Information and Regulatory Affairs (OIRA) two rules to implement parts of the Food Safety Modernization Act. OIRA is required to limit its reviews to no more than 120 days, but these rules sat with OIRA for 13 months, a not uncommon scenario. When OIRA finally returned the rules to FDA, they were, in the words of CPR's Thomas McGarity and Policy Analyst Michael Patoka, "gutted." In November 2013, McGarity and Patoka joined CPR Member Scholars Lisa Heinzerling, Sidney Shapiro and Rena Steinzor, in filing comments on the proposed rules, one on raw produce, and the other on preventive controls for human food production.

The proposed produce rule addresses some of the most likely sources of contamination on farms, including tools and equipment, water used in agricultural activities, and worker health and hygiene. But according to a careful analysis by CPR, contained in the scholars' comments, the cost-benefit analysis conducted for the rule badly exaggerates the costs to industry of complying. As an example, the comments note that the post-OIRA version of the rule calculates the cost of workers washing their hands before handling food, at the beginning of the day, after touching a farm animal, or after going to the bathroom. The calculated cost: $113.5 million. As Lisa Heinzerling writes, "the FDA effectively reverses this common-sense presumption [that people should wash their hands after visiting the bathroom] by treating hand washing as a departure from the existing norm and, as such, an imposition of costs on the farm worker’s employer.  Reversing the presumption in favor of hand washing makes even less sense when one recalls that most farms are already required to allow their workers 'reasonable use' of hand-washing facilities."

That is one of several remarkable elements of the FDA proposal as revised by OIRA. In a blog post, Patoka outlines a series of errors, omissions, and various other reality-stretching provisions. Read the Member Scholars' comments on raw produce, and the preventive controls for human food production.

Cars, Drugs, More

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:

• Comments to FDA. On March 10, 2014, by Thomas McGarity, Sidney Shapiro and James Goodwin in support of its proposal to revise regulations governing the procedures for changing product labeling.
• Comments on Food Safety Regs. Read Member Scholars' November 2013 comments on FDA's proposed regulations on raw produce, and the preventive controls for human food production. Read blog posts on the comments: Benefits of food safety rules much greater than even FDA suggests by Michael Patoka; Deeply flawed economic analysis exaggerates the cost of FDA’s produce rule, by Lisa Heinzerling; FDA’s preventive controls rule: hollowed out by OIRA, and less costly than the agency suggests, by Thomas McGarity and Patoka.
• Poultry Processing.  On April 9, 2013, CPR Member Scholar Rena Steinzor and CPR Policy Analyst Michael Patoka sent a letter to the Acting Head of the Office of Information and Regulatory Affairs about the unexamined environmental implications of a USDA proposal to replace government inspectors on poultry processing lines with company employees, while speeding up the processing line to 175 birds per minute.
• BPA. Read about CPR Member Scholars work on bisphenol A, the dangerous substance found in baby bottles, food cans, and more.
• 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 Critical Food Safety Rules Still in Regulatory Limbo, Now Stuck at White House for a Full Year, FDA's Excuses to Court on Food Safety Rule Delays Are Unconvincing, and FDA's New Produce Safety Rules: Somewhat Less Than Meets the Eye by Thomas McGarity; and Three Food Safety Rules Grow Moldy at OIRA, as Import-Related Outbreaks Continue and Analysts Mislead in Their Push to Weaken FDA’s Produce Rule by Michael Patoka.
• 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.