Archive for the ‘Product Safety’ Category

The now widely publicized outbreak of life-threatening fungal meningitis in back-pain patients linked to steroid injections prepared by a compounding pharmacy highlights the failure of the Food and Drug Administration’s (FDA’s) regulatory oversight of drugs prepared and sold by such pharmacies. What is particularly tragic for the families of those who have been sickened or killed by the tainted drug is that this situation was completely avoidable.

The steroid injections, distributed by the New England Compounding Center in Framingham, Mass., have been linked to at least 119 infections in 10 states, and as many as 13,000 people have been exposed. The contaminated injections have been recalled, along with all other products distributed by the New England Compounding Center.

The large-scale production of a drug — in this case, a drug that is intended to be sterile and injected into patients — appears to have crossed the line from the traditionally narrow role filled by local compounding pharmacies into one that clearly involves drug manufacturing and the release of products into interstate commerce.

Indeed, prior warning letters from the FDA to the New England Compounding Center and other compounding pharmacies appear to indicate that the agency considered these pharmacies to be engaged in drug manufacturing. The pharmacies were therefore considered subject to the safety and effectiveness standards required for approval of new drugs, as well as the rigorous manufacturing standards designed to ensure that drugs are sterile and uncontaminated with such germs as bacteria or fungi before being sold and distributed.

However, the FDA failed to take action to ensure that the New England Compounding Center adhered to these drug standards, which are essential for protecting the health of patients. By not aggressively enforcing regulations related to drug manufacturing by compounding pharmacies, the FDA has perpetuated a double standard: Traditional drug manufacturers must adhere to rigorous drug-safety standards intended, for example, to prevent the contamination of their products. But so-called compounding pharmacies engaging in large-scale drug production do not. This double standard has resulted in the unfolding public health catastrophe involving hundreds and potentially thousands of patients who received steroid injections for back pain.

Congress should conduct an investigation into this tragic situation and hold oversight hearings as soon as possible. If current statutes and regulations provided the FDA with authority to prevent this disaster, senior FDA officials should be held accountable. If holes in the agency’s existing legal authority are identified, Congress should act immediately to pass legislation to remedy the situation.

Dr. Michael Carome, Deputy Director of Public Citizen’s Health Research Group


Flickr by USDA

The Obama administration’s Food Safety and Inspection Service (FSIS) would like the public to believe that a third of a second is ample time to inspect a chicken for bacteria, feces and other food-borne illnesses.

We think otherwise.

On January 27, 2012, the FSIS proposed a rule, “Modernization of Poultry Slaughter Inspection” (77 FR 4408). The rule would increase the speed of the poultry assembly line from between 75 and 91 chickens per minute to a mind-boggling 175 chickens per minute. If this takes effect, inspectors will be given just a third of a second to inspect each chicken before it starts its journey to your plate. Wanna see how fast that is? Just click here (really, it’s pretty amazing).

What can you do in a third of a second? Probably not much. Certainly not ensure a chicken is safe to eat.

Increased line speeds are nothing short of reckless and, if implemented, would jeopardize public health and worker safety. Less inspection time easily translates to a greater likelihood that contaminated chicken will end up in your grocer’s market or nearby restaurant.

The proposed rule also removes United States Department of Agriculture inspectors from the inspection process. Consumers would place their health in the hands of the poultry industry.

When Herbert Hoover campaigned on the message of feeding America and promised “a chicken for every pot,” it’s a pretty safe bet that this is not what he was envisioning.

Chicken processing is one of the fastest growing industries in the United States, both in the number of birds processed and workers required to perform processing duties. According to Priyanka Pathak of Georgians for Pastured Poultry, “Worker health and safety is a significant problem in poultry industry processing plants, where workers use repetitive motions 20,000 to 30,000 times a day on an assembly lines used to process, on average, 200,000 birds per day.”

If the newly proposed rule is adopted, workers can expect even harsher conditions.

Americans count on a safe food supply. The food-borne illness outbreaks that frequently make the news show that our safety net still has holes. Rather than make food less safe to eat and harm workers’ health in the process, the Obama administration should be working to make our food safer. Only one word can characterize this proposal: irresponsible.

Learn more about this issue by visiting: and please spread the word that today, September 27th at 3pm @USDA will be hosting a Twitter town hall. Follow @RegsRock on Twitter and see how you can engage in the conversation using the hashtag #AskUSDA.

Keith Wrightson, @SafeWorkers, is Public Citizen’s worker safety and health advocate.

An effort by some congressional lawmakers to let mortgage lenders off the hook for violating rules and offering shoddy mortgages to consumers is an irresponsible appeal that could upend much-needed mortgage reforms before they even take effect."Christine Hines"

Led by U.S. Rep. Shelley Capito, (R-W.Va.), 108 lawmakers sent a letter to Consumer Financial Protection Bureau (CFPB) Director Richard Cordray, arguing for legal immunity for mortgage lenders. The lawmakers were commenting on a proposed rule for determining borrowers’ “ability-to-repay” and the definition of a qualified mortgage, required under the 2010 Dodd–Frank Wall Street Reform and Consumer Protection Act.

The proposed rule leaves open the question of legal liability for bad practices. The bureau must decide whether to allow mortgage lenders to be completely shielded from lawsuits, i.e. give them a “safe harbor,” or whether to protect them with a standard that presumes their compliance with the rules, but gives vulnerable borrowers the opportunity to provide evidence of the lenders’ wrongdoing.

Talk about short memories.

It was just five years ago that the U.S. economy imploded partly because toxic mortgages were given to mostly unaware borrowers. Mortgage lenders were able to hide their untenable risk-taking from the public and government oversight until it was too late. This irresponsible behavior led to the shutdown of large financial institutions, record home foreclosures and high unemployment. Now, unbelievably, lobbyists have convinced some lawmakers that bankers should be shielded from lawsuits, returning us to that place where perilous actions would remain in the dark and borrowers would be barred from seeking redress in court for their lenders’ wrongdoing.

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Keith Wrightson, Public Citizen workplace safety expert

During the Progressive Era, President Theodore Roosevelt sent a team of inspectors to Chicago’s meatpacking industry in response to Upton Sinclair’s graphic novel The Jungle. Sinclair’s famous account depicted the gruesome conditions inside of meatpacking facilitates. After the inspectors reported deplorable conditions, Congress passed the Federal Meat Inspection Act (FMIA) which Roosevelt signed into law on June 30, 1906. Strong regulations to implement the law and protect both workers and the public followed.

Government regulations such as the FMIA have paved the way for healthy food consumption and production in the United States and have influenced agencies such as the Food and Drug Administration.  For the past 106 years, the FMIA has helped enable all Americans to enjoy meat and poultry safely in their homes.

But now, the Obama administration has placed the Meat Inspection Act in the regulatory crosshairs.  Newly proposed regulations by the Obama administration’s Food Safety Inspection Service (FSIS) would let poultry companies conduct their own inspections of chickens and dramatically boost the number of birds threat workers must process each hour.  According to the American Federation of Government Employees, “The proposed rule places emphasis on quantity and quickness over quality.”

The FMIA provides safeguards for consumers, helps ensure uncontaminated meat for consumers and sets reasonable rates for proper meat inspection on the production line. With this rule change, there is no doubt that the intent of the FMIA is being undermined. According to Priyanka Pathak of Georgians for Pastured Poultry, “Worker health and safety is a significant problem in poultry industry processing plants, where workers use repetitive motions 20,000 to 30,000 times a day on an assembly lines used to process, on average, 200,000 birds per day.” If the proposed rules are adopted, workers can expect even harsher working conditions.

The Jungle became required reading for High School students for a reason; the lessons learned should not be forgotten. The administration would do well to remember and keep these key consumer and worker protections intact.

Follow @RegsRock for more on commonsense safeguards.

Co-authored by Anthony So, professor of the practice of public policy and global health, director, program on global health and technology access at Duke University

The World Health Organization’s Director-General recently warned of the growing challenge of antibiotic resistance in the starkest terms: “A post-antibiotic era means, in effect, an end to modern medicine as we know it. Things as common as strep throat or a child’s scratched knee could once again kill.” In the case of tuberculosis, many infections are already resistant to first-line therapy, and second-line therapy costs between 50 and 200 times more. For methicillin-resistant Staphylococcus aureus (MRSA), an antibiotic-resistant infection that claims more lives than AIDS in the U.S. each year, the costs of these infections to hospitals may reach as high as $4 billion annually.

Responding to this challenge, existing antibiotics must be conserved and novel antibiotics developed. To preserve the effectiveness of antibiotics for human use, Europe banned feeding antibiotics to livestock for growth promotion in 2006. In Denmark, where such use of antibiotics had been phased out more than a decade ago, drug-resistant pathogens in livestock are down while industry output is up. Yet a bill to restrict such use here — The Preservation of Antibiotics for Medical Treatment Act — languishes in the U.S. Congress.

Instead, the Generating Antibiotic Incentives Now, or GAIN, Act has piggybacked into the FDA bill reauthorizing user fees for drug approval. GAIN would provide five more years of monopoly protections for new antibiotics. Already receiving three to seven years of exclusivity, some antibiotics may receive up to 10 years of protection after market approval. This measure defies both the economics and biology of antibiotic resistance.

Resistance to an antibiotic increases as the drug is used more frequently, so the use of new antibiotics must be reserved for resistant infections. However, monopoly protections conflict with the need for preservation by encouraging companies to sell as much of the new drug as possible. Further, this incentive does little to defray the upfront costs of R&D but risks imposing a heavy cost on consumers, both here and abroad. Rationing antibiotics by monopoly pricing will not ensure appropriate use by doctors or patients. Lengthening the monopoly period will not lead to firms forfeiting today’s profit for preserving tomorrow’s antibiotic effectiveness. In fact, the same drug companies do not even reserve classes of antibiotics important for treating human disease from non-therapeutic use in growth promotion in animals. And there is no profit from drugs kept in reserve.

Multiple drugs used in combination are the mainstay of treatment for diseases like tuberculosis. Yet extended exclusivity may thwart the innovation and access to such combination therapy. Consider the lessons from Abbott’s hold over ritonavir, a drug that boosts the effectiveness of other HIV drugs used in combination. In 2003, Abbott hiked the price of ritonavir by 400 percent — except when used for its own combination product, Kaletra — placing other combination treatments relying on this booster drug at a market disadvantage. So does this incentive approach lead to GAIN — or just greed?

Worse yet, the bill fails to address the serious scientific bottlenecks in the pipeline. The customary approaches to identify novel drug candidates have produced dismal results. The experience of a leading drug company suggests that it would take 80 times the number of screens of potential drug compounds to yield one antibiotic launch compared to one drug launch in other therapeutic areas. Throwing just any incentives at antibiotic R&D is not going to work. The solution to the faltering antibiotic pipeline is not an extra dose of data exclusivity.

We need to get back to the basics — the 3Rs — sharing resources, risks and rewards. Greater public support for new models of R&D collaboration would help share resources and risks with the private sector. Bolstering such efforts, like those at NIH’s National Center for Advancing Translational Sciences, might help lower the barriers to bringing forward new antibiotics to clinical trials. One method of sharing rewards — offering prizes — could enable companies to recuperate their R&D investments without relying just on revenues from the quantity of antibiotics sold.

In these austere economic times, where might such monies come? Leading all sectors in defrauding the federal government under the False Claims Act, the pharmaceutical industry has paid $23 billion in settlements and fines to federal and state governments over the past two decades, some portion of which might have been directed to a foundation that would support innovation and access to such life-saving medicines.

The failure to find suitable incentives reflects a poverty of policy imagination. The greatest cost, though, may be the complacency that comes with believing that Congress addressed antibiotic resistance with this measure. Even with the GAIN Act’s passage, this public health challenge will still remain: Tomorrow’s infections will not be cured with this expensive placebo.

For more by Robert Weissman, click here.

For more by Anthony So, click here.

For more health news, click here.

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