Next Tuesday, the Supreme Court will hear oral arguments in Mutual Pharmaceutical Co. v. Bartlett, a case that raises once again the troubling question of whether federal regulatory agencies should trump local juries in common law tort actions. The precise question at issue is whether the fact that the federal Food and Drug Administration (FDA) approved a name-brand drug many years ago precludes a state court jury from holding the manufacturer of the generic version of that drug strictly liable for damages to patients caused by marketing the drug.
The plaintiff in this case, Karen Bartlett, visited her doctor in December 2004 complaining of shoulder pain. Her doctor prescribed Clinoril, one of many non-steroidal anti-inflammatory drugs (NSAID) that are commonly used to treat arthritis, bursitis, and other painful conditions. When Ms. Bartlett’s pharmacist filled the prescription, however, it gave her the generic version of the drug sulindac, rather than the brand-name drug. Under federal law, the generic version of sulindac had to be chemically and biologically equivalent to the brand-name version that had been approved by the FDA.
Not long thereafter, Ms. Bartlett developed a horrific disease called SJS/TEN, which caused massive burns over 60-65 percent of her body. For the next year, her life was, in the words of her surgeon, a “hell on earth” as she spent 100 days in five hospitals and several months in a medically induced coma. During this time she was fed by tube, suffered two septic shock episodes, endured twelve eye surgeries, and became legally blind. Although she survived, she is severely disfigured, cannot eat normally due to esophageal burns, cannot have sexual relations, and cannot engage in aerobic activities because of burns to her lungs.Full text
This post was written by CPR President Rena Steinzor and Media Manager Ben Somberg.
The White House issued a fact sheet last Friday presenting “Examples of How the Sequester Would Impact Middle Class Families, Jobs and Economic Security.” The consequences of the impending budget cuts from the “sequester” are not some abstract problem; they’re serious dangers, like this one:
The Food and Drug Administration (FDA) could conduct 2,100 fewer inspections at domestic and foreign facilities that manufacture food products while USDA’s Food Safety and Inspection Service (FSIS) may have to furlough all employees for approximately two weeks. These reductions could increase the number and severity of safety incidents, and the public could suffer more foodborne illness, such as the recent salmonella in peanut butter outbreak and the E. coli illnesses linked to organic spinach, as well as cost the food and agriculture sector millions of dollars in lost production volume.
We applaud the White House for explaining to the public the importance of our food safety system.
But here’s the irony: the Administration is simultaneously moving forward with a separate plan that would weaken the food inspection system in the area of poultry processing. The USDA issued a proposed rule in January of last year that will take many federal food inspectors off the poultry lines, replacing their work in part with less-trained company inspectors, and the agency is on the verge of sending the final version to the White House for approval.Full text
Eighty percent of the antibiotics used in this country are given not to humans, but to animals destined for the human food supply. Most of these antibiotics are given to the animals not for the purpose of treating active infections, but for the purposes of promoting growth and preventing infection in the microbe-rich environment of the modern factory farm. For over 40 years, the Food and Drug Administration (FDA) has been collecting evidence that this agricultural practice contributes to the development of antibiotic-resistant infections in the human population. Based on such evidence, in fact, the agency proposed to withdraw its prior approvals for two antibiotics used in animal feed due to the risks they posed to human health. The agency promised to hold hearings on the matter. That was over 35 years ago. On Friday, the future of this issue will be debated in oral arguments in a key case before the Second Circuit Court of Appeals.
In the last 35 years, the FDA has continued to accumulate evidence of the link between administering subtherapeutic doses of antibiotics to food animals and the development of antibiotic-resistant infections in the human population. Indeed, the agency itself has repeatedly acknowledged the link between herd- and flock-wide administration of antibiotics to food animals and the development of antibiotic-resistant disease in humans. But still it has done nothing to take the drugs off the market. Not surprisingly, after watching the FDA sit still for decades, public health and environmental organizations eventually grew restless, and petitioned the agency to hold the hearings and to withdraw the relevant approvals.
In 2011, almost 35 years after finding that using antibiotics in animal feed was linked to antibiotic resistance in humans, the FDA finally answered the petitions. It denied them. The agency explained -- without a trace of irony -- that the process for withdrawing these approvals would simply take too long and that the agency was thus instead encouraging the animal feed industry to take voluntary measures to address the overuse of antibiotics. The FDA argued that the process for withdrawing approvals would take too long because the agency thought itself legally bound to offer formal, trial-type hearings on the question whether the relevant antibiotics were "safe" within the meaning of the relevant statute, the Food, Drug and Cosmetic Act.Full text
When I teach my environmental law and food safety law students how to go about ascertaining the meaning of implementing regulations, I tell them to start with the sections of the regulations devoted to definitions and exemptions. Quite frequently the most hard-fought controversies during the rulemaking process through which the agency promulgated the regulations were over the definitions and exemptions.
That certainly seems to be true in the case of the long-awaited Food and Drug Administration’s (FDA) proposed “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” which the Obama Administration, with much fanfare, issued on January 4. According to FDA’s analysis of the economic impact of the proposal, almost 80 percent of the country’s produce growers will not have to meet the standards because they are not covered in the definitions or are otherwise exempt.
The proposed rule, which was required by the landmark Food Safety Modernization Act of 2010, would for the first time establish legally enforceable standards for produce farmers. The standards set out requirements for sanitizing tools and equipment, for ensuring that agricultural water is safe and sanitary, for using animal-based fertilizers (e.g., compost) on food crops, for reducing contamination from domesticated and wild animals, and for training field workers and ensuring that they employ sound hygiene practices.Full text
The saga of the missing FDA food safety regulations continues with a new government filing in a lawsuit challenging FDA’s failure to promulgate regulations implementing three critical programs that Congress established in the Food Safety Modernization Act of 2011.
As I noted in a previous posting, the three sets of regulations are currently bottled up in the White House Office of Information and Regulatory Affairs (OIRA), where they have gathered dust for a year.
Well before the statutory deadlines, FDA sent OIRA proposed regulations requiring most food processors and manufacturers to come up with hazard analysis at critical control point (HACCP) programs, requiring growers to comply with “science-based” minimum sanitation standards, and for importers to verify that their products were produced under conditions that complied with FDA food safety requirements. But the deadlines came and went while OIRA sat on the regulations to avoid criticism from Republicans during the 2012 election season.
Last summer, the Center for Food Safety and the Center for Environmental Health sued FDA (and the White House) for failing to meet the deadlines and asked the court, the U.S. District Court for the Northern District of California, to order FDA to promulgate the rules by a date certain.Full text
One of the crowning legislative achievements of the Obama Administration’s first term was the enactment of the Food Safety Modernization Act.
Like any safety statute, however, the new law will have no practical bite until the implementing rules are issued. In this case, that’s until the Food and Drug Administration (FDA) promulgates regulations fleshing out the obligations of growers, producers and importers of food. Unfortunately, after almost two years, the regulations for the three most critical programs enacted by the new law have been written, but have not yet been promulgated.
On Thanksgiving Day, one set of implementing regulations will have been bottled up at the White House’s Office of Information and Regulatory Affairs (OIRA) for exactly one year. Two other critical sets of regulations will pass the one-year milestone between Thanksgiving and December 9.
Signed by President Obama in January 2011, the new law was enacted in response to a series of crises throughout the Bush Administration involving, among other things, peanuts contaminated with Salmonella during processing at a Georgia facility, fresh vegetables contaminated with an especially virulent form of E. coli bacteria, and Salmonella-contaminated imported jalapeno peppers.
The FSMA tells the Food and Drug Administration (FDA) to write regulations requiring most food processors and manufacturers to come up with hazard analysis at critical control point (HACCP) programs and to write “science-based” minimum sanitation standards for growers to follow during the production and harvesting of fruits and vegetables. The new law also told FDA to write regulations requiring importers to verify that their products were produced under conditions that complied with FDA food safety requirements.Full text
In the week before Christmas last year, 14-year-old Anais Fournier went to Valley Mall in Hagerstown, Maryland with some friends. While there she purchased and consumed a 24-ounce can of an energy drink manufactured by the Monster Beverage Corporation. She returned to the mall the next day and consumed another Monster energy drink. Later that evening, while she was watching a movie at home with her boyfriend, she went into cardiac arrest. She died four days later on the day before Christmas Eve. An autopsy concluded that she had died of “cardiac arrhythmia due to caffeine toxicity.”
Thanks to the efforts of her mother to get to the bottom of the matter, Anais’s untimely death may stimulate new efforts to regulate sports drinks and other potentially dangerous dietary supplements and to hold companies accountable in courts of law for their irresponsible marketing strategies.
Anais’s mother was convinced that the Monster energy drinks caused her daughter’s death. Last week, she and Anais’s father filed a lawsuit against the company, and on Monday the New York Times published documents she received in response to her Freedom of Information request for FDA’s adverse event reports on Monster drinks. It turns out that FDA had received reports of five deaths caused by those drinks since 2009. These reports are by no means definitive, and they do not establish a cause-effect relationship between the consumption of highly caffeinated sports drinks and increased mortality risk in humans.Full text
A host of concerned groups and individuals wrote to Secretary of Agriculture Tom Vilsack today urging him to withdraw proposed changes to poultry inspection rules until food safety and worker safety concerns are addressed. The letter was signed by a range of food safety and worker safety groups and individual signers, including CPR Member Scholars Martha McCluskey, Thomas McGarity, Sidney Shapiro, and Rena Steinzor.
The letter explains the food safety and worker safety issues at stake, and takes USDA to task for its rushed approach:
The Food Safety and Inspection Service (FSIS) developed the proposal with limited public input. The agency did not adequately consult with its inspection advisory committee, nor did the agency hold public meetings to solicit the views of the public. Previous agency proposals that sought to substantially change parts of the federal inspection program have been debated and discussed in public forums so that stakeholder input could be provided prior to announcing a formal proposal.
Previously in this space, Rena Steinzor explained USDA’s proposed rule and the potential food safety and worker safety consequences, and described how USDA’s de-regulatory proposal was not subject to the rigorous analysis or interagency review that most regulatory proposals are.Full text
Yesterday, the U.S. Food and Drug Administration (FDA) announced that it would amend an existing food additive regulation to prohibit the use of Bisphenol A (BPA) in “infant feeding bottles (baby bottles) and spill-proof cups, including their closures and lids, designed to help train babies and toddlers to drink from cups (sippy cups).” BPA, a chemical commonly added to polycarbonate resins (a fancy word for plastics), continues to raise concerns over its low-dose, endocrine-disrupting health effects. Despite these health and safety concerns, the FDA’s decision to ban BPA in these limited items responds to a petition from the American Chemistry Council (ACC), which cites abandonment as the reason for the regulation amendment—not safety.
The good news about FDA’s BPA ban: FDA finally took an affirmative step toward protecting some of the public from BPA. The bad news: the step is a meager one that establishes little more protection than state legislatures and grass-roots campaigns have already achieved through state bans and market pressures. FDA, in other words, permanently banned BPA from products that already have removed it.
As I explained in a previous blog posting concerning CPR Member Scholar Noah Sach’s and my comments on the ACC’s petition and in CPR’s previous white paper on BPA regulatory options, FDA can take much larger and more meaningful steps to protect the public. These steps begin with recognizing the safety and health risks associated with BPA and include implementing broader bans without regard to age and use limitations and mandating BPA labeling requirements.Full text
Cross-posted from Georgetown Law Faculty Blog.
When an agency defends over three decades of inaction on an important problem by saying that acting would take too long, one hopes a judge reviewing the agency's inaction will see through the pretense. This is exactly what happened this week, when a federal magistrate judge in New York ruled that the U.S. Food and Drug Administration had acted arbitrarily in citing time and resource constraints in declining to limit the use of antibiotics in animal feed.
Some 80 percent of the antibiotics used in the United States are given to animals destined to become part of our food supply. Most of these drugs are given not to sick but to healthy animals; they are used not to treat disease but to promote animal growth or to prevent bacterial infections from occurring. Both of these purposes are tied to the industrial nature of animal food production in this country. The economic imperatives of industrial food production reward faster animal growth, and the microbial realities of the modern animal food production facility -- in which animals are tightly confined in stressful, bacteria-rich (to put it nicely), infection-promoting conditions -- encourage herd-wide administration of antibiotics to prevent infections.
The widespread administration of antibiotics to food animals for non-therapeutic purposes has contributed to the development and spread of antibiotic-resistant strains of bacteria. When bacteria become resistant to an antibiotic, that antibiotic will no longer treat the infection the bacteria cause. Antibiotic resistance is to our wonder drugs what Kryptonite is to Superman.Full text