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Last Updated: Nov 12th, 2006 - 20:38:00 |
A Government Accountability Office report released on Monday has said the Food and Drug Administration is doing an inadequate job as far as ensuring the safety of the drugs approved by it is concerned. The review added that the FDA does not follow clear guidelines on how to handle problems associated with drug safety and sometimes overlooks its best safety experts in these matters.
The GAO report says that the Congress must think seriously about expanding the authority of the FDA so that the agency can compel drug companies to conduct safety reviews on the drugs already on the market. Many drug companies have been tardy in this aspect. They do promise to conduct follow-up studies to gain the FDA approval, but once that was forthcoming, forget all about their pledges.
"FDA lacks clear and effective processes for making decisions about and providing management oversight of, post-market safety issues," the report said. "We observed that there is a lack of criteria for determining what safety actions to take and when to take them."
The report said that this lack was acutely visible in the way the agency handled safety issues associated with the cholesterol-lowering drug Baycol, the painkiller Bextra, the rheumatoid arthritis drug Arava, and the heartburn drug Propulsid.
All the above-mentioned drugs except Arava were pulled off the market, but the GAO review said that the process was delayed due to infighting and disorganization within the FDA.
The GAO report was commissioned in 2004 in the aftermath of several high-profile drug safety cases, most notably Merck's arthritis pill Vioxx, which was found to have adverse effects like heart attacks and strokes on long-term use. Such cases raised concern on whether the FDA was competent enough in handling post-market drug safety issues.
Senator Charles E. Grassley, an Iowa Republican and Representative Joe Barton, Republican of Texas had requested the GAO investigation after Vioxx was withdrawn from the market in September 2004. "This report provides solid evidence that everything is not all right at the FDA and calls for long-overdue reform. The FDA's problems are systemic and cultural, not isolated or easily fixed," Grassley said.
Last year, Senator Grassley and Senator Christopher Dodd had pushed for a legislation that gives the FDA the power to require drug companies to carry out post market study on their available drugs. But the FDA recently revealed that of the 1,231 studies that companies promised to undertake, nearly two-thirds have not even begun as of September 30 last year.
Since 2000, around 10 drugs have been pulled from the market after safety issues arose. Critics say that these drugs should never have received approval in the first place. The Bush administration's stand on the issue has been that the FDA does not require more powers. However, FDA officials have told many Congressional committees over the years that they need more power to hold drug companies accountable.
"One senior F.D.A. official and several outside drug safety experts told us that F.D.A. needs greater authority to require such studies," the report confirmed, adding that there was also a funding problem, which needed to be addressed if an effective system to monitor drug safety is to be put in place.
It is widely known that most of the agency's funding comes from drug companies, who have naturally opposed using their funds for post-market safety studies. The administration and the Congress have also not looked into the funding aspect. The GAO report said that the budget required by the FDA to commission its own safety studies was $1 million from 2002 to 2005 and was estimated to rise to $1.1 million till 2010.
After the Vioxx fiasco, the FDA has begun posting hitherto withheld information of the drugs, which are considered likely to influence their safety.
The FDA has also tried to rectify these issues. It asked the Institute of Medicine, part of the National Academy of Sciences to review the drug safety process. That report is due in July this year. It also set up a Drug Safety Oversight Board in 2005 to report on the agency's handling of companies' commitments to post-marketing studies.
Reacting cautiously to the GAO report, Susan Bro, an F.D.A. spokeswoman, said, "The F.D.A. welcomes the G.A.O. report and is currently leading a comprehensive and timely effort to transform the methods our medical and scientific staff use to manage safety issues."
Caroline Loew, senior vice president of the Pharmaceutical Research and Manufacturers of America said that the FDA was taking "the post-market surveillance of prescription drugs seriously and has taken additional steps over the past couple of years to help ensure that patient safety cannot be compromised." Consequent to these steps only 3 percent of approved drugs have been withdrawn, she added.
Alistair Wood of Vanderbilt University told the New York Times that the GAO report was a pointer to the fact that more authority is needed, "It confirms that the current system needs fixing," he said. But he felt that there were several shortcomings in the report since it did not recommend any sanctions if drug companies don't complete post-marketing studies.
© 2004-2005 by foodconsumer.org unless otherwise specified
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