Critic say the Prescription Drug User Fee Act, is in large part to blame, for the current problems within the FDA. The Act allows the agency to collect a fee from a drug company seeking approval for a new drug. In return, the FDA is expected complete the review process within 12 months.
User fees now account for about 40% of the approval process, which means the FDA is dependent on drug companies for nearly half of its funding. This situation creates a major conflict of interest according to Dr Graham: "This culture views the pharmaceutical industry it is supposed to regulate as its client. It overvalues the benefits of the drugs it approves, and seriously undervalues, disregards and disrespects drug safety," he told members of Congress.
Another problem he said is that even when the FDA does try to take measures to limit harm, the agency lacks the authority to force drug companies to comply. For example with Vioxx, he said, it took more than 2 years to get Merck to add the increased risk of heart attack and stroke on the label.
Then there is the matter of the conflicts of interests involving the FDA panels that advise the agency on which drugs should be approved, what their warning labels should say, and how studies should be conducted.
The approximately 300 experts on the 18 committees make decisions that affect billions of dollars in sales and with very few exceptions the FDA follows their advice.
Members of the panels are supposed to be free of conflicts of interest relating to products they consider but they rarely are. For example, in February 2005, when the hearings were held to determine whether the COX-2 inhibitors should be allowed to remain on the market, a panel mired with conflicts was exposed. Out of the 32 voting members, ten had served as consultants to Merck and Pfizer in recent years.
This revelation prompted Senator Mike Enzi, (R-WY), the chairman of the Health, Education, Labor and Pensions Committee, along with Senators, Edward Kennedy (D-MA), and Richard Durbin (D-IL), to ask the General Accounting Office to look into the FDA's practice of letting scientists serve on panels when they have conflicts of interest.
"We are concerned about the process that supports FDA's decisions to waive conflicts of interest rules for scientists with financial ties to the manufacturers of the products under consideration, or their competitors," said their letter to the GAO in September 2005.
"These practices appear to have undermined the public's faith in the objectivity and fairness of FDA's advisory committees," they wrote. The Senators specifically referred to the conflicts among the panels that studied the Cox-2 inhibitors like Vioxx.
According to Ms Menziess, "The FDA's preemption argument, if successful, would take away the sole means by which American consumers may obtain compensation for drug-induced injuries caused by a drug company's failure to warn."
"Civil lawsuits uncover internal company documents to which not even the FDA has access," she explains.
"The tort system provides an important check on the regulatory process and on drug companies' compliance with law."
"Preemption," Ms Menzies warns, "would close off one of the few avenues by which we learn of safety and efficacy information that pharmaceutical companies do not publish or hide from FDA."
More information can be found at Lawyers and Settlements.com
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