Archive for the ‘Consumer Protection’ Category

February9

FDA, Congress should fill the wide gap of responsibility over generic drug safety

By: Christine Hines

A sign advertising generic drugs.A woman walks into a pharmacy to fill a prescription. She is offered either premium-priced drug Brand Name-X or Generic Drug Y, which offers the same treatment at a significantly lower price. She understandably chooses Generic Drug Y. She is not alone, as more than 75 percent of all prescriptions are filled by generic versions of drugs, largely because states require generic substitution which lower health care costs. But many patients are unaware of the lack of accountability that generic drug manufacturers have to warn of safety risks associated with their products.

The manufacturers are not entirely to blame. The federal oversight agency, the Food and Drug Administration (FDA), has created regulatory obstacles preventing manufacturers from adequately warning patients when the manufacturers become aware of potential hazards associated with their products that are not currently addressed on the generic drugs’ labeling. Second, and compounding this safety problem, patients harmed by generic drugs are barred from suing manufacturers of generic drugs. The result is a significant gap in generic drug safety and manufacturer accountability.

In August 2011, Public Citizen submitted a citizen petition (PDF) to the FDA urging it to address the problem. The petition asked the agency to amend its regulations so that manufacturers of generic drugs could revise their products’ labeling to add new information about risks and contraindications, through a revision process currently permitted only for brand-name drug manufacturers.
As experts have noted, all the risks associated with a particular medication are not identifiable until after the product has been on the market for several years. In addition, the majority of approved drugs with distinct ingredients, delivery routes, and strengths are available in generic form. In fact, many drugs are available solely in generic form. Because of their expanding market share, generic drug manufacturers likely receive substantial reports of safety incidents, and have the tools to be fully aware of information suggesting previously unknown risks or other inadequacies in the current labeling.

Unfortunately, the FDA’s failure to keep regulations in pace with the growth of the generic drug market creates a gap in drug safety. 

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Posted in: Congress, Consumer Protection, Health, Pharmaceuticals, Product Safety0 comments

February3

Public Citizen’s Commercial Alert: Taking on commercialism at every juncture

By: Elizabeth Ben-Ishai

Breakfast cereals equivalent in nutritional value to Twinkies are heavily marketed to children using cartoon mascots and online “advergames.” Schools display advertisements for everything from fast food to the U.S. Army on every available surface, from lockers to flat-screen televisions in cafeterias to report cards. Corporations hire student “brand ambassadors” on college campuses to subtly push their product on classmates and friends. Public art galleries, subway stops, and roadways are named for the highest corporate bidder. Historic bridges and parks are draped with advertisements. Infant formula makers market their products in doctors’ offices and hospitals.Photo by Christopher Chan, Flickr

These examples are all evidence of the rapidly growing space that commercial culture has come to occupy within our society. As large a space as they may already inhabit in our lives, corporations are seeking still more facets of our society that can be put up “for sale,” never mind the higher values that get trampled in the process – values like family, community, environmental integrity, and democracy. That’s why Commercial Alert, a project of Public Citizen, has no shortage of work to do.

Ralph Nader and Gary Ruskin founded Commercial Alert in 1998, seeking to keep commercial culture within its proper sphere. Since then, Commercial Alert has fought to lay down boundaries that preserve crucial spaces in our culture as commercial-free. Commercial Alert has stood up for children’s rights to be free of commercialism in schools, parks, libraries, and other public spaces. We’ve demanded that government be a vehicle for democracy, not commercial advertising, fighting back against plans to advertise on government vehicles, history-laden bridges and buildings, and in cultural institutions. We’ve decried the number one public health disaster of our times – marketing-related diseases, including obesity, smoking-related illnesses, diabetes, and many more.

Despite successes along the way, the fight is far from over. As those intent on putting everything and everyone up for sale wage their war on our culture, Commercial Alert continues to resist the spread of commercial culture – now as an important part of Public Citizen. We’re confident that supporters of Public Citizen will find that Commercial Alert’s upcoming campaigns address crucial issues that are important to them – issues that fit well with Public Citizen’s historic concerns about unchecked corporate power and consumer protection. And supporters of Commercial Alert who have been eagerly awaiting our return to action after a brief hiatus will be excited to see the powerful connections between Public Citizen’s work and Commercial Alert’s goals, connections that will enable us to combat excessive commercial culture even more effectively.

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Posted in: Activism, Campaign Finance, Commercialism, Consumer Protection, Ethics, Financial Reform1 comments

February1

Another survey, no surprise: Small business owners do not consider regulations to be a major concern

By: Rich Robinson

We’ve seen several surveys on the subject, and today’s findings are not a surprise. In a report released by the American Sustainable Business Council, Main Street Alliance and the Small Business Majority, a vast majority of small business owners do not see regulations as a major concern. In fact by a wide margin, “weak customer demand” is most troubling to small businessmen.

courtesy Small Business Majority

This goes against all the rhetoric spewed by the U.S. Chamber of Commerce, Big Business advocates and their supporters in Congress, all of whom have never allowed facts to get in the way of a convenient talking point. The truth is, the great zeal to roll back the standards and safeguards that protect us from health, safety, environmental and financial disaster is not to help small businesses to create jobs, but to give wealthy corporate interests a free hand to skirt rules in pursuit of larger profits. Jobs for us regular folks, much less our health and well being, is really not part of their equation.

Here’s a look into the numbers from the Small Business Majority:

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Posted in: Consumer Protection, Environment, Financial Reform, Product Safety, Regulation, Uncategorized2 comments

January12

Hospitals, heed this lesson from a football coach

By: Christine Hines

"medical errors" "HHS study" "hospital errors"“When you make a mistake, admit it; learn from it and don’t repeat it.”

These words were apparently uttered by legendary college football coach, Paul W. “Bear” Bryant. While the advice is applicable to just about any person or subject matter, a recent federal government report shows that U.S. hospitals are in dire need of a reminder.

According to a Department of Health and Human Services study, hospitals are failing to document their medical errors. The study, an examination of Medicare patients’ records, found that hospital staff failed to report 86 percent of “adverse events,” (harm done to patients as a result of medical care) to their respective internal incident reporting systems.

This systematic failure of hospitals is worrying in a number of ways.

Due to the severe underreporting of incidents, the number of actual injuries and deaths from medical errors is probably significantly higher than the oft-quoted estimate, 98,000 deaths annually, reported by an Institute of Medicine report over a decade ago.

Failure to acknowledge medical errors probably also means that hospitals are failing to give victims of medical errors critical information about what caused their injuries. Consequently, hospitals and their staffs are evading accountability for their actions. That is, hospitals are likely failing to acknowledge and compensate patients for injuries caused by errors, particularly preventable ones. And medical providers are not appropriately disciplined for these errors.

Moreover, hospital staffs are likely committing the same errors repeatedly because, if they fail to acknowledge the existence of errors, then they are also failing to change their policies and practices to prevent similar future errors. In fact, the study found that only five reported incidents led to policy or practice changes at a hospital.  Quite succinctly, these findings reflect the perilous conditions for patients in hospitals.

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Posted in: Activism, Consumer Protection, Health, Regulation, Social Justice, Uncategorized0 comments

January7

To The Chamber: Is that all you’ve got?

By: Taylor Lincoln

Earlier this week, the branch of the U.S. Chamber of Commerce that seeks to limit consumers’ access to the courts published a brief description of what it deemed the 10 “most egregious examples of frivolous and abusive litigation” from 2011. The list is meant to support its argument that the legal system is “packed with frivolous suits.” According to the Chamber, such litigation is an oppressive burden on business (particularly small business) and inflicts a “devastating impact” on society.

But after reviewing the Chamber’s examples of the most egregious abuses of the legal system, we couldn’t help but ask, “Is that all you’ve got?”

The Chamber’s list includes a grand total of zero cases against small businesses.

We also couldn’t find a single instance among the Chamber’s examples in which the plaintiff was actually awarded damages, although we had to look beyond the Chamber’s brief summaries, which conveniently omitted the results of the cases. If businesses really are suffering significant losses from unfounded claims, don’t you think the Chamber would give us some examples?

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Posted in: Activism, Congress, Consumer Protection, Ethics, Health, Litigation, Social Justice, Uncategorized, Workplace Health & Safety2 comments

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