Mel, you really think the FDA should be disbanded?

The private sector will run their own quality controls and stuff?  

From Websters Dictionary

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But most agree that there's at least a problem of perception, and perhaps more than that, caused by the growing chunk of the agency's budget that comes directly from drug companies. Industry dollars now pay for more than half of the FDA's drug-review budget; in five years, that proportion is expected to jump to 70 percent.

The agency’s transformation started in the 1980s, when AIDS and cancer activists pushed for quicker access to potentially life-prolonging drugs for severely ill patients. But that acceleration was subsequently applied to all medicines, including those for problems that aren’t life-threatening as well as for “me too” drugs, which offer little or no advantage over existing medicines whose risks are well known.

In 1992 Congress passed the Prescription Drug User Fee Act (PDUFA), which forced a sea change at the FDA. The law imposed tight deadlines for drug evaluation and required companies to pay fees earmarked for hiring more reviewers. In fiscal year 2004 the FDA collected some $250 million from drug companies, almost half of its drug-review budget. That year, the agency boasted in a report to the president and Congress that “drug-approval time has been cut almost in half” since the advent of PDUFA.

FDA advisers tied to industry


An article by Dennis Cauchon, the USA TODAY Newspaper

Sept. 25, 2000

According to a USA Today study, more than half of the experts hired to advise the government on the safety and effectiveness of medicine have financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions. These experts are hired to advise the Food and Drug Administration on which medicines should be approved for sale, what the warning labels should say and how studies of drugs should be designed. The experts are supposed to be independent, but USA TODAY found that 54% of the time, they have a direct financial interest in the drug or topic they are asked to evaluate. These conflicts include helping a pharmaceutical company develop a medicine, then serving on an FDA advisory committee that judges the drug.

The conflicts typically include stock ownership, consulting fees or research grants.

Federal law generally prohibits the FDA from using experts with financial conflicts of interest, but according to the article, the FDA has waived the restriction more than 800 times since 1998.

These pharmaceutical experts, about 300 on 18 advisory committees, make decisions that affect the health of millions of Americans and billions of dollars in drugs sales. With few exceptions, the FDA follows the committees' advice.

The FDA reveals when financial conflicts exist, but it has kept details secret since 1992, so it is not possible to determine the amount of money or the drug company involved.

cont...

Fram LMAO -- If that happened you'd be calling all the guys in the neighborhood, yellin' "Ya ain't gonna believe this!"

Hugs BD

You guys should all take a trip through one of the major meat-packing plants in this country and see how good of a job your FDA and USDA are doing.............