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Americans Right to Sue Weakening

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Americans Right to Sue Weakening

The White House and the courts may be stripping Americans of Their Right to Sue

Throughout the history of the Food and Drug Administration, US citizens have always had the right to bring a manufacturer – responsible for producing faulty products – to justice in a court of law.

pharmaceuticals companies1 Americans Right to Sue Weakening

But with the FDA seriously underfunded in its role of assuring the safety of foods and drugs, plus the political ideologues in the agency pushing for more industry prerogatives, the White House and the courts are now on the verge of stripping Americans of their right to sue.

In Feb, the Supreme Court ruled in an 8-1 decision, that most people using medical devices do not have the right to sue manufacturers. David C. Vladeck, a Georgetown Law School professor says,

“Consumers are getting the worst of both worlds,
“They don’t get the protection the FDA promises because the agency is incapable these days of truly providing a safeguard for the drugs we get. And at the same time, the FDA is claiming that if we’re injured by a product falling through this quite penetrable safety net, all our rights to compensation are cut off by virtue of the FDA’s regulations inadequate though they may be.”

The funding problems surrounding the FDA’s situation have been gaining concerns and a 180-member umbrella committee that includes academics, former government officials, and business and consumer groups are pushing for more funding.

At a hearing of a House energy and commerce subcommittee held in late January, the panel announced that, due to a weakness in staff, organization and information technology, “the FDA cannot fulfill its mission.”

Peter Barton Hutt, a former FDA counsel who has chronicled the history of the agency estimated that the FDA would need a 50 percent increase in its $2-billion budget over the next two years,

“Science at the Food and Drug Administration today is in a precarious position…”

“In terms of both personnel and the money to support them, the agency is barely hanging on by its fingertips,” he explains,

“FDA has become the paradigmatic example of the hollow government syndrome; an agency with expanded responsibilities, stagnant resources and the consequent inability to implement or enforce its statutory mandates.”

At the same hearing, Andrew C. von Eschenbach Commissioner of the FDA acknowledged that the agency was having problems meeting its responsibilities.

The FDA oversees about $1 trillion in products around 25 cents on every dollar we spend. Yet despite an ever expanding mission, its budget has shrunk over the past three decades. The agency’s staff also has dropped from 1,300 employees to around 700-800.

Unsurprisingly, this has seriously affected the FDA’s ability to maintain the health and safety of foods and drugs.

House Energy and Commerce chairman Rep. John D. Dingell (D-Mich.) said,

“I’ve had telephone calls with FDA commissioners over the years in which they said, ‘Oh, we’re going to be leaner and meaner, we’ll do more with less….

“On the basis of my experience, they’re capable only of doing much less with the much less which they’ve been given.”

To help resolve this situation the Senate passed a better budget resolution last month, giving the FDA an additional 20 percent increase – approx $375 million – compared to the 3 percent proposed by the Bush administration.

Despite their efforts, the problem still remains. The FDA relies mostly on passive reporting systems for drug adverse events, and it also lacks the power to recall a drug unless it can show eminent peril.

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