.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
23 Sep, (foodconsumer.org) - The drug safety system in the US is in need of a major upheaval as most of the available resources are devoted in the pre-approval of medicines rather than post-approval follow-up studies, a scientific panel said in a new report on Friday.

The 15-member panel was convened at the request of the Food and Drug Administration following the withdrawal of popular painkiller Vioxx. The panel recommended that the FDA Commissioner needs to have a fixed term, while drug companies could reduce advertising their products.

Among the 25 recommendations of the Institute of Medicine panel was a measure that called for the placement of a warning on newly approved drugs, cautioning consumers that enough post-approval data was unavailable.

The report is likely to stir up debate on the efficiency of the FDA especially as far as the post-market studies are concerned. These concerns flared up after Merck was forced to withdraw its arthritis drug Vioxx in September 2004 after several studies linked the drug with increased risk of heart attacks and strokes.

The panel also highlighted a "dysfunctional" FDA structure with no fixed period for the top bosses. "FDA's reputation has been hurt by a perceived lack of transparency and accountability to the public, a legacy of organization changes that have not been completed or sustained, and an apparent slowness in addressing lack of (drug company) compliance," the report said.

These findings were echoed in a Government Accountability Office report released in April, which said the FDA did not have enough powers to force drug companies to conduct adequate post-approval studies so that safety data could be updated.

The report had blasted the FDA was lacking set criteria in determining what safety actions needed to be taken and exactly when to take these actions.

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 Institute of Medicine addressed these issues and said that there was "an imbalance in the regulatory attention and the resources available before and after approval of new drugs."

Panel chairwoman Sheila Burke chief operating officer of the Smithsonian said, "Staff and resources devoted to pre-approval are substantially greater than those available post-approval."

As with the GAO report, the panel asked the administration to confer greater legal authority for FDA regulators so that drug companies are compelled to produce post-approval studies within the required timeframe.

Some of the other recommendations are"
* Newly approved drugs should display a black triangle on their labels that will warn consumers that their safety is questionable.

* The F.D.A. should thoroughly review the safety of drugs at least once every five years and the F.D.A. commissioner should be appointed to a six-year term.

* Drug advertisements should be restricted in the initial two years after a drug has been approved.

* Drug manufacturers must publicly release all results of human trials conducted for a particular drug.

Earlier reviews have also called for vesting more authority with the FDA so drugmakers will be required to release post-market findings.

A review by the inspector general for the Health and Human Services Department released in July said that post-market studies were not a priority with the FDA.

The report found that around 35 percent of status reports that drug makers were to file in 2004 were either missing entirely or did not contain the required information. The report said the FDA must improve its tracking system by asking manufacturers to provide better information.

These post-approval trials are necessary to monitor how a drug behaves after it is used for a long time. The FDA does ask for mandatory clinical studies, but the number of participants involved is invariably small.

Additionally a wider base of population is not included. Hence the FDA frequently asks drug makers to conduct postmarketing studies. However the FDA does not have any knowledge of where these studies stand and whether they have indeed begun.

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.

On Friday, FDA officials were wary of commenting on the Institute of Medicine report. Acting Commissioner Andrew C. von Eschenbach praised the effort of the panel and said that it would take some time to review the findings.

"I am committed to taking additional steps and will look to the initiatives recommended by the Institute of Medicine, to ensure we continue to fulfill our mission," he said.

"All drugs have risks. Our challenge is to uncover these risks as soon as possible. Through initiatives like Critical Path and Personalized Medicine, we are also working to improve the tools we use, to more effectively evaluate new products and processes."

Senator Charles E. Grassley, Republican of Iowa, who has led the effort to overhaul the drug approval process said the report's recommendations were nothing new, “The new report validates what the watchdog community has been saying for the last two years,” he said. “Problems are systemic, and solutions must reflect a new mind-set by the agency leadership.”

Dr. Raymond L. Woosley, president of the Critical Path Institute said the report did not address some hurdles in developing drugs for diseases such as Alzheimer's. "Many of the things in the report are right on target, but they do not address the broader question of the role of the FDA in getting better healthcare from science," he said.

The drug industry had a more reserved reaction. Caroline Loew, senior vice president of the Pharmaceutical Research and Manufacturers of America said, “Though there is always room for improvements, it would be a mistake to accept the notion that the F.D.A. drug safety system is seriously flawed.”

© 2004-2008 by foodconsumer.org unless otherwise specified

Top of Page

	Web foodconsumer.org

Search Consumer-friendly Health Sites

Watch the latest videos on YouTube.com