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Despite lawsuits, whistleblowers and government investigations, the FDA continues to ignore its mission of protecting consumers against dangerous food and medicine products. Senate Finance Committee Chairman Charles Grassley, R-Iowa, recently criticized the Food and Drug Administration for failing to adequately monitor the safety of drugs after they are approved for the market, saying:
"We get press releases listing accomplishments rather than a meaningful revamping of the way things work inside the FDA. My staff investigators continue to hear from FDA employees who believe in their agency and ... want to do the right things, but experience intimidation, suppression and reassignments when they raise concerns about the integrity of the FDA's work."
Grassley and House Energy and Commerce Committee Chairman Joe Barton, R-Texas, requested an investigation by the Government Accountability Office (GAO) into the FDA's drug oversight practices after hearing complaints that the FDA was sluggish to pull harmful drugs -- like Vioxx -- off the market. The GAO finished its study in mid-April and came to the conclusion that the "FDA lacks clear and effective processes for making decisions about, and providing management oversight of, post-market safety issues. The process has been limited by a lack of clarity about how decisions are made and about organization roles, insufficient oversight by management and data constraints. GAO observed that there is a lack of criteria for determining what safety actions to take and when to take them."
The GAO report suggested that authority be given to the FDA to require drug makers to conduct safety studies on drugs already approved and on the market. Grassley also urged passage of legislation that would allow FDA researchers to conduct independent post-market studies of drugs.
The FDA's response to the investigation and criticism was a statement from its Center for Drug Evaluation and Research, calling the report "well done," and saying the "conclusions reached are reasonable and consistent with actions we already have underway or planned."
However, one might wonder if those actions would ever come to fruition if it wasn't for Grassley's investigation shedding light on the FDA's inefficiencies. In fact, the GAO study isn't the first time Grassley has delved into the deep-rooted troubles of the FDA. Back in late 2004, when news of the damages caused by the drug-safety catastrophe known as Vioxx was just beginning to reach the public, Grassley led a Senate Committee on Finance hearing, calling into question the FDA's role in the Merck/Vioxx fiasco.
In his opening statement for that hearing, Grassley said, "One of my concerns is that the FDA has a relationship with drug companies which is too cozy. That's exactly the opposite of what it should be. The health and safety of the public must be the FDA's first and only concern."
As it stands now, the FDA's "first and only concern" seems to be protecting the financial interests of the pharmaceutical industry at seemingly any cost -- including the lives of the American citizens it is supposed to protect.
Grassley went on to say, "When the FDA approves a drug, it's considered a 'Good Housekeeping Seal of Approval.' However, what's come to light about Vioxx since Sept. 30, 2006 (when Merck withdrew Vioxx from the worldwide market) makes people wonder if the FDA has lost its way when it comes to making sure drugs are safe ... The bottom line is consumers should not have to second guess the safety of what's in their medicine cabinets. The public should feel confident that when the FDA approves a drug, you can bank on it being safe, and if a drug isn't safe, the FDA will take it off the market."
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Saturday, November 24, 2007
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