Right Wing Supreme Court Plans to Limit Citizens right to sue drug companies if FDA rubberstamp on drug

[...]
Legal experts say the cases could also affect lawsuits already filed by tens of thousands of Americans challenging the safety of blockbuster drugs such as Celebrex and Prempro and a host of medical devices.
[..]
The case before the court today was brought by the family of a New York man who suffered severe medical complications when a balloon catheter burst during a procedure to clear his arteries. The second case, involving claims for injuries allegedly caused by Rezulin, a now-withdrawn drug used to treat diabetes, will be heard in February.

Pharmaceutical manufacturers have long complained that the expense of defending injury claims has slowed research into new medications and driven up costs for patients. Because Congress granted the Food and Drug Administration the authority to determine whether products are safe and effective, manufacturers argue that state judges and juries should not be allowed to second-guess the FDA once a product is approved for use.
[...]

American Food Supply Unsafe in part because of Bush gutting FDA budgets

Say F.D.A.’s Flaws ( Conflict of Interets, Privatization, Bush Gutting) Put Lives at Risk

The report, made public on Friday, is the latest and perhaps most far-reaching in a string of outside assessments that have concluded that the F.D.A. is poorly equipped to protect the public health.

It was written by three members of the F.D.A. Science Board, an advisory panel that reports directly to the agency’s commissioner, Dr. Andrew C. von Eschenbach. The three authors in turn had 30 scientific advisers.

The report concludes that over the last two decades, the agency’s public health responsibilities have soared while its appropriations have barely budged. The result is that the F.D.A. is falling farther and farther behind in carrying out its responsibilities and understanding the science it needs to do its many jobs.

“F.D.A.’s inability to keep up with scientific advances means that American lives are at risk,” the report stated.

Sandy Walsh of the F.D.A. said the agency “values the evaluation done by the subcommittee members and the scientific experts that were consulted” but would not comment further.

Barbara J. McNeil, a professor of health care policy at Harvard Medical School and one of the report’s authors, said she was stunned at the agency’s sorry state.

“This was the first time that a group of people got together and really looked at all the areas that the F.D.A. has to cover,” Dr. McNeil said. “We were shocked at the scope of its responsibilities, we were shocked at how little its resources have increased, and we were surprised at the conditions those in the F.D.A. had to work under.”

The report notes that the agency’s computer systems are aging and prone to breakdowns, “most recently during an E. coli food contamination investigation.”

“Reports of product dangers are not rapidly compared and analyzed, inspectors’ reports are still handwritten and slow to work their way through the compliance system, and the system for managing imported products cannot communicate with customs and other government systems,” the report stated.

The agency often misses significant product arrivals because its computers are so poor that they cannot distinguish between shipments of road salt and those of table salt, the report said.

The Institute of Medicine, the nation’s most prestigious scientific advisory organization, concluded last year that the agency’s system for ensuring the safety of drugs needed an overhaul. Recent legislation enacted some of the institute’s recommendations.

More hearings regarding the F.D.A.’s oversight of food are in the offing, including one in the Senate on Tuesday. The report concluded that the “F.D.A.’s ability to provide its basic food system inspection, enforcement and rule-making functions is severely eroded, as is its ability to respond to outbreaks in a timely manner.”

Garret A. FitzGerald, a pharmacologist from the University of Pennsylvania and adviser to the authors, said the report was raising an alarm because “this is a crisis.” Dr. FitzGerald pointed to a series of food and drug scares that have demonstrated how little oversight the F.D.A. provides.

He blamed a “cabal of Congressional majorities and presidential administrations that has serially stripped the agency of assets.”