Barring any additional delays, the Consumer Product Safety Commission (CPSC) will vote tomorrow on the final rule for the much-anticipated product incident database. It couldn’t have happened at a more appropriate or symbolic time – a day before the start of the holiday (toy!) season – because it will be the last shopping season that consumers will lack a powerful consumer protection tool, the online product incident database.
The Commission’s vote to approve the database rule should have occurred last week, but it was delayed at the request of Commissioner Anne Northrup, who, along with Commissioner Nancy Nord, opposes it. These product incident database opponents offered an alternative proposal – one that seemed to be more of a tool to protect businesses, rather than consumers.
If all goes well tomorrow (notwithstanding the expected opposition), the database will launch in March 2011, ushering in a new era for consumer empowerment and improved product safety.
The database is expected to significantly lessen the amount of time dangerous products remain on store shelves. So by the time next year’s holiday shopping season comes around, shoppers will be able to search the database to determine whether products they hope to buy were reported as potentially harmful, and share their experiences with others as well.
Recent actions by Congress and federal regulators have led to improved product safety, but product recalls and reported injuries still remain high. The CPSC said last week that toy-related injuries are increasing (pdf). And Illinois’ attorney general released a long list of recently recalled toys and other children’s products to alert buyers of their potential to harm. I’ll surmise that if consumers could have shared and researched these incidents themselves through a vigorous online database, a number of unnecessary injuries would have been avoided.
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For too long, some manufacturers have tried to keep information about their defective products under wraps and away from consumers, unnecessarily increasing the risk associated with, and number of injuries and deaths caused by, these products. Wednesday could mark the beginning of the end of that practice and the start of a new chapter in product safety.
That’s when the Consumer Product Safety Commission (CPSC) will issue its final rule on the building and maintenance of an online, searchable incident database – a critical piece of the landmark Consumer Product Safety Improvement Act of 2008. Expected to be launched in March, the database promises to hand over tremendous purchasing and reporting control to consumers. While consumers have long been able to report product incidents to the commission, with the online database, they can publicly submit reports (more…)
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The FDA has announced that it will revoke approval of a medical device for injured knees because, as Public Citizen testified in 2008, the Menaflex device made by New Jersey-based ReGen Biologics should never have been approved in the first place.
Public Citizen researchers told the FDA there was no scientific evidence to support the device’s approval. Subsequent events revealed how political pressure from some New Jersey members of Congress forced the device through the FDA approval process. Dr. Jonas Hines, the Public Citizen researcher who appeared before the FDA, said that political shenanigans “cast a shadow on the ostensibly objective approval process.” The FDA’s decision to revoke the ReGen approval should be the agency’s first step in overhauling the medical device approval process.
“Although we are pleased that the FDA acknowledges its mistake in clearing the ReGen Menaflex, this decision is long overdue,” Jonas said. “We hope this represents the beginning of a new era in medical device approval, one in which the health of Americans supersedes any industry threat of the stifling effect on innovation of improvements in regulation.”
Gardiner Harris in the NYT writes that the FDA “had never before admitted that it approved a drug or device mistakenly, never rescinded such an approval without citing new information about the product, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.”
So is it a “new day” at the FDA? It might be a little premature to bust out the champagne, but following the decision earlier this month to pull the dangerous diet pill Meridia from the shelves, we will go so far to say that October has been a good month for patients.
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Last week, the Food and Drug Administration took the inadequate measure of restricting the sale of the dangerous diabetes drug Avandia. Public Citizen has long been pushing the FDA to ban Avandia, much like its European counterparts recently did.
Now comes this troubling look at the extent to which GlaxoSmithKline, the maker of Avandia, covered up the life-threatening side effects of its diabetes medication. Paul Thacker, who was the leading investigator for Sen. Chuck Grassley’s Finance Committee, writes in Mother Jones what he learned during his three-year investigation:
During that time, my colleagues and I combed through over 250,000 pages of internal GSK documents and interviewed dozens of witnesses and whistleblowers. What emerged was a troubling picture of a company that had placed corporate profits over patient safety. While suppressing inconvenient evidence about the risks of its top-selling drug, the company even began to develop another drug to treat the very side effect Avandia has been linked to.
Yes, you read that right — Instead of recalling Avandia, which was linked to causing heart attacks in patients, GlaxoSmithKline decided the better thing to do was to develop another drug that could treat the condition caused by Avandia.
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