Food and Drug Safety
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Secrecy protects only laggards: why the FDA should disclose which drug companies volunteer for its “judicious use” policy for livestock antibiotics

The Food and Drug Administration (FDA) recently recommitted itself to its lame proposal to address the profligate use of antibiotics in livestock by enlisting the voluntary participation of the drug companies that make the antibiotics.  Two documents issued last month reveal the details of the agency’s current plans.   The first is a final guidance document describing the FDA’s process for handling drug sponsors’ voluntary efforts to phase out “production uses” of antibiotics in animal feed and water and to bring the remaining uses under the oversight of a veterinarian. The second is a draft rule relaxing the requirements for veterinarians in exercising this oversight.  Production uses are aimed at promoting growth and improving feed efficiency, not at treating active infections.  The FDA will continue to allow mass medication of whole herds and flocks of livestock for purposes of preventing infection.

The FDA has, in internal documents, conceded that “all” of the relevant drug companies must participate in order to make its approach work.  But there is no guarantee that even a significant number of these companies will voluntarily give up production uses simply because the FDA asks them to.  Even if some do – Zoetis and Elanco have said they intend to – there is no guarantee that other companies will not step in to capture the market share given up by the volunteers.  And even if they do not – note the piling of hope upon hope required to believe the FDA’s policy might succeed – these companies will, under the FDA’s approach, still be allowed to feed antibiotics to whole herds and flocks of food-producing animals so long as they call it “disease prevention” rather than “growth promotion” or “feed efficiency.”  Not surprisingly, criticisms of the FDA’s proposal have been withering

Previous critiques of the FDA’s approach have, however, missed a key aspect of the agency’s approach, one that is both troubling and fixable: the near-complete opacity of the FDA’s program.  In its recent guidance document explaining its policy on livestock antibiotics, the FDA promises just three measures to keep the public apprised of its work.  First, the agency promises to post on its website a list of the drug products initially affected by its guidance document; the agency has already done this.  Second, the agency says that it will, after the three-month period in which drug sponsors are to inform the agency if they will take part in the agency’s voluntary initiative, “publish summary information to provide an indicator of the level of engagement of affected drug sponsors in the voluntary process.” Third, the FDA will notify the public “of completed changes to affected products through publication of approval of supplemental new drug applications” – or, in other words, it will tell the public when it has approved any drug companies’ requests to remove production uses from the list of indicated uses for their products.  

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Democratic Senators eager to screw African-American and Hispanic poultry workers

Many Senate Democrats try to paint themselves as defenders of working people. They rail against their colleagues who are “in the pockets of corporations and the rich.”  But what they say, and what they do are two different things. This time, seven Democratic Senators are ready to screw poultry workers to please the owners of the poultry companies.

We’ve been writing for nearly two years on the USDA’s plan to “modernize poultry inspection” (e.g., hereherehere, here). It’s a plan that will give Tyson, Perdue, Pilgrims’ Pride and other poultry producers an additional $250 million a year in revenue. It will allow USDA to eliminate 800 inspectors, and it won’t improve, and could make worse, food safety. To “sell” poultry companies on the plan, USDA will allow them to increase line speeds up to 175 birds per minute.

The industry and USDA are well aware that poultry workers already suffer disabling repetitive motion injuries from the unrelenting speed of the dis-assembly lines. A recent study by the CDC revealed that more than 40 percent of poultry workers at one Pilgrims’ Pride plant suffer from carpal tunnel syndrome. USDA’s plan will make this very bad situation even worse.

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Anti-science and anti-democratic: House Republicans’ farm bill rider seeks to tie up critical safeguards indefinitely

It’s like a Russian nesting doll of bad policy:  House Republicans have contrived to take one of the most anti-science bills in memory and then place it inside one of the most anti-democratic legislative vehicles available.  It’s part of an attempt to ram through into law new rulemaking requirements that would benefit the already-healthy bottom lines of their corporate benefactors at the devastating expense of the health, safety, pocketbooks, and perhaps even lives of the American public.  That’s what is at stake with an obscure three-page rider—Section 12307, euphemistically entitled “Ensuring High Standards for Agency Use of Scientific Information”—in the 700-page House version of the Farm Bill (H.R. 2642, the Federal Agriculture Reform and Risk Management Act of 2013) that is currently undergoing conference committee consideration to resolve differences between it and the Senate version of the Farm Bill.  (See page 654 of the bill for the rider—seriously, page 654!—which is available here; warning, this is a huge PDF.)

This anti-science rider began life as a stand-alone anti-science bill (also) euphemistically entitled the “Sound Science Act” (H.R. 1287), originally introduced by Rep. Stephen Fincher, a Tennessee Republican.  If enacted, it would require all agencies (including independent agencies) to develop a conspicuously complex set of guidelines, which would purportedly improve agencies’ use of “science” in “policy decisions,” a term the rider defines very broadly to include virtually any type of agency activity, including non-legally binding guidance documents.  The rider states that these policy decisions may not take effect unless they are in strict compliance with those guidelines.  The rider appears to make this requirement judicially enforceable by declaring that policy decisions that fail to comply with an agency’s guidelines are “arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with law.”  (Because this section of the rider is so amateurishly drafted, it’s not entirely clear how this mechanism will work in practice.  What is clear, though, is that if the rider becomes law, this section is sure to invite lots of costly, time-consuming, and wasteful litigation.)

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Another Skirmish in the Preemption War: Does FDA Approval Trump Strict Liability?

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.

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Administration Warns of Food Inspectors Being Furloughed From Budget Sequester -- But Moving Forward Separate Plan to Unilaterally Take Poultry Inspectors Off the Job

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.

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Antibiotic Resistance and Agency Recalcitrance

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.

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FDA's New Produce Safety Rules: Somewhat Less Than Meets the Eye

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.

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FDA's Excuses to Court on Food Safety Rule Delays Are Unconvincing

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.

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Critical Food Safety Rules Still in Regulatory Limbo, Now Stuck at White House for a Full Year

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 yearTwo 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.

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It's Time to Regulate Energy Drinks

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.

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