Over the past year, the Bush administration's FDA has been the focus of non-stop investigations and with the Democrats in control of Congress, a long overdue overhaul of the agency is in the cards.
The Government Accountability Office has identified serious problems within the FDA. In an April 21, 2006, report, the GAO found the FDA's performance "disorganized," "bureaucratic," and undermined by infighting between drug evaluation administrators whose allegiance is with the pharmaceutical industry, and the Office of Drug Safety.
According to the GAO, the drug safety office is under-funded, lacks independence and lacks decision-making responsibility. It also criticized the way FDA scientists were prevented from speaking at advisory committee meetings on drugs they were studying.
Investigators point to a major conflict within the Office of New Drugs because it is not only responsible for approving a drug in the first place, it is also responsible for taking regulatory action related to the safety of drugs once they are on the market.
The GAO report said that day-to-day oversight of safety issues is still hampered by poor information, lack of legal authority to order drug company studies, and bickering between the powerful FDA bureau that reviews drugs for approval and a smaller safety office.
To improve postmarketing safety, the GAO recommends that Congress expand the FDA's authority to require drug companies to conduct studies when additional data is needed.
Another report was released on June 26, 2006, titled, "Prescription for Harm: The Decline in FDA Enforcement Activity," after an investigation was commissioned by the House Committee on Government Reform to evaluate the FDA's enforcement activities related to the pharmaceutical industry under the Bush administration.
When requesting the investigation, Rep. Waxman, wrote to the committee Chairman specifically asking for "attention to cases where career investigators believed official action to protect the public health was warranted but could not proceed."
For the investigation, in addition to reviewing the FDA documents, the investigators obtained information from current and former FDA officials and independent experts.
The experts consulted included Dr. Jerry Avorn, Professor of Medicine at Harvard Medical School; Dr. Michael Wilkes, Vice Dean of Medical Education at the University of California at Davis School of Medicine; and Sammie Young, former Director of Compliance at FDA's Bureau of Biologics and a 29-year veteran of the agency.
As to methods available for enforcement, when a serious violation of FDA standards is found during an inspection, the FDA has the statutory authority to seize or recall products, impose civil fines, or initiate criminal action.
However, most often the FDA will send the manufacturer either a "warning letter" or a "notice of violation," which is also called an "untitled letter." A warning letter notifies a company of violations, requires a written response, and warns that failure to correct the violations can lead to additional enforcement action.
Under FDA procedures, the agency must evaluate the response to a warning letter to determine whether the violations have been corrected. If the firm's response is inadequate, the agency must take other enforcement action "as necessary to achieve correction."
An untitled letter is less serious and informs a company of the violations but does not require a written response or warn that enforcement action may follow if violations are not corrected. An untitled letter also does not require an FDA follow-up.
The Prescription for Harm investigation found that there has been a sharp decline in FDA enforcement actions against pharmaceutical companies since December 2001. After reviewing the records, in a May 25, 2006, letter, Dr. Avorn told the Reform Committee, "In all of FDA's once-proud recent history, I cannot recall a time of greater concern about its work on the part of doctors, patients, and policy researchers."
"In overview," he said, "there appears to have been a sharp drop-off in the number of warning letters FDA has issued in recent years, from an average well over 1,000 for the period 1992 - 2001 to an average of only about 700 for the years 2002 - 2004."
who don't have some stock in big pharmaceutical companies in their portfolios.
Of course they don't know what's in their portfolios, because they are in escrow or behind a firewall, like Dick Cheney's Halliburton profits, so they don't actually have a conflict of interest.
So when they don't overhaul the FDA it will just be a coincidence, see?
And if they pretend to try to overhaul the FDA, and Bush vetoes their efforts, it won't be because they refused to impeach him, it will be Ralph Nader's fault. If he and his damned consumer-safety anti-corporate agenda hadn't been on the ballot in 2000 and 2004, the Democrats could have put their efforts into opposing Bush, instead of having to spend millions to oppose Nader. Not that they would have, but theoretically they could have.
The FDA isn't feeling any heat. Only an arrogant, selfish, airhead like Nader would try to prevent them from approving drugs that kill people. The Democrats and their Republican colleagues are much too bipartisan to do anything like that.
--Mark
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Mark E. Smith (21 articles, 30 quicklinks, 100 diaries, 1325 comments) on Thursday, Jan 18, 2007 at 7:15:13 AM
Maybe the FDA isn't feeling the heat and legislators' financial portfolios are always going to be more important to them than public safety. But if the legislators are aware of the public demand that the FDA be reformed or dismantled, this public dissatisfaction is not going to go away. If such dissatisfaction is not enough heat then maybe the discontent has to be larger and more in the face of the legislators through stepped up alternative media exposure. It seems only logical to be cynical about this but increasingly broad public dissatisfaction with the FDA cannot be ignored indefinitely and legislators will at some point be called to account because they will finally come to find out they have been on the wrong side of the issue all along. If something is extremely oppressive to the public, it cannot remain in place forever. That is just a basic of human existence.
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larrybone (0 articles, 0 quicklinks, 0 diaries, 8 comments) on Friday, Jan 19, 2007 at 10:45:54 AM
Conflicts of interest are always a problem, and the first step in dealing with them is to declare conflcts openly. Ms. Pringle, do you have any interests or associations with law firms that handle litigation in the area of drugs, vaccines, etc.?
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Heraldblog (0 articles, 0 quicklinks, 0 diaries, 25 comments) on Friday, Jan 19, 2007 at 7:20:09 AM
I have no hidden conflicts of interest. I clearly state at the bottom of the article that a law firm sponsored a series of litigation articles.
If the insinuation is that I somehow have the ability to instigate or influence investigations of the FDA its ridiculous. But I do have the ability to follow up on the investigations and report on their findings.
I have nothing but praise for any law firm that will take on cases from American citizens who would not stand a chance of going up against the corrupt pharmaceuticl industry if left on their own.
If the mainstream press was not bought off by industry advertising dollars, which amounts to the same as bribes or blackmail to not publish studies, reports or warnings on pharmaceutical industry, and was doing its job of adequately warning the public about dangerous products and our corrupt regulatory agencies, a journalist like me would not have to find alternative ways to educate the public.
Cheers,
Evie
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Evelyn Pringle (181 articles, 0 quicklinks, 0 diaries, 10 comments) on Friday, Jan 19, 2007 at 10:40:39 AM
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