Report Blasts FDA's System To Track Drugs

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BlankReport Blasts FDA's System To Track Drugs

Consultant Says Mission Is Hobbled by Missteps;

Agency Disputes Claims

By ANNA WILDE MATHEWS

March 3, 2007; Page A1

The Food and Drug Administration has bungled its effort to build a new system

for detecting the side effects of medicines after they go on the market,

delaying its implementation by at least four years, according to a report

commissioned by the agency itself.

As a result, the agency must continue to rely on its existing " dysfunctional "

computer system as a primary tool for tracking the safety of medications sold in

the U.S., according to the November 2006 report, which hasn't been made public.

The situation is " frustrating and undermining...the post-marketing drug safety

work " of its staff " because they lack some of the basic tools they need to

perform their jobs, e.g. a computing system that meets their requirements, " says

the report. It was prepared by the Breckenridge Institute, a research and

consulting firm in Breckenridge, Colo.

The FDA's drug-tracking system, called the Adverse Event Reporting System,

consists of a database and other software and hardware that amass and help sift

reports of potential side effects that have been filed by drug makers, doctors

and others. The data are the FDA's main way to detect drug-related hazards, and

can lead to changes in label warnings or even withdrawals of drugs from the

market.

But, the report says, FDA safety experts waste time -- an average of 45 minutes

per day -- dealing with the inefficiencies and snags caused by the current

software. The Adverse Event Reporting System is overwhelmed by the growing

volume of adverse-event reports, which exceeds 400,000 a year, the report says.

The FDA track record on drug safety has faced harsh scrutiny in the wake of

major problems, including the 2004 withdrawal of the painkiller Vioxx after it

was linked to cardiovascular problems. Such incidents underscore the importance

of monitoring drugs after they go on the market, where some end up being

prescribed to millions of patients. In clinical trials conducted before FDA

approval, drugs typically are tested on thousands of people at most -- not

enough to turn up every potential danger.

The FDA has sought to upgrade the technology used in its safety-tracking program

for years. But efforts that date back at least to 2003 haven't produced the

planned successor to the Adverse Event Reporting System, dubbed AERS II.

Instead, the Breckenridge report says a new system isn't likely to be up and

running until 2009 at the earliest, and that the FDA has wasted an estimated $25

million on its efforts. The report argues that the FDA could have had a new

Adverse Event Reporting System working in 2005 if it had simply relied on

off-the-shelf software.

A document prepared by FDA officials in response to the report, which is marked

as a draft, said it is " riddled with editorial conclusions based on misleading

or incorrect facts. " Throckmorton, deputy director of the agency's drug

center, said the current Adverse Event Reporting System " is a system that is

working " despite " exploding " amounts of data. " Is it the best it can be? Of

course not, " he said. The FDA wants to develop a replacement " as quickly as

anyone else does, but we want it to be done right. "

Echoing other recent outside examinations of the FDA, the Breckenridge analysts

say the " root cause " of the problems can be found in the culture of the agency's

drug regulators. More specifically, the report largely blames a " lack of

effective leadership and management " by the center's Office of Information

Technology, which it says mishandled the initiative through bureaucratic

infighting, flawed planning and duplicative work performed by outside

contractors.

Mark Bodnarczuk, executive director of the Breckenridge Institute, said he

stands by the contents of the document. After it was completed, the FDA asked

him to delete much of it, he said: " What they asked me to do was gut the report,

and I refused to do it. " The FDA's Dr. Throckmorton said he believes

Breckenridge was asked by FDA to extend its work, at no cost, which would have

" given us an opportunity to talk about those misunderstandings, those

inaccuracies. "

FDA contracting practices, as well as the agency's handling of drug safety, are

already the focus of congressional investigations. Senate Finance Committee

Chairman Max Baucus, a Montana Democrat, and ranking Republican Grassley

of Iowa have sent a letter to the FDA about the computer-system issue. Mr.

Baucus said the report raises " troubling questions, " and Mr. Grassley said the

report is evidence of a " broken-down process " at the agency. In the House Energy

and Commerce Committee, Democrats Dingell and Bart Stupak, both of

Michigan, are also examining FDA contracting.

According to the Breckenridge report, the agency by June 2004 was considering

moving forward with a package of off-the-shelf software. That potentially could

have allowed AERS II to be up and running in 2005, at a one-time cost that had

been projected at about $4.5 million, according to the report.

But, the report says, an official in the drug center's information-technology

office in June 2004 advocated a different approach: a system that could track

adverse events from all products regulated by the agency, such as medical

devices, rather than just drugs. Later, the report says, the

information-technology office commissioned further analysis, including

assessments of what a new adverse-event tracking system would need, with some

work done by contractors.

The need for the new analysis was questioned by officials who worked in drug

safety at the FDA, who argued they " could not wait two more years...to repeat

the process they had just completed, " according to the report. That analysis was

nonetheless carried out. The Breckenridge report contends it " did not add any

value " and helped delay a new system.

The FDA's Dr. Throckmorton said the agency is already moving to address issues

related to its safety culture. Yesterday, the agency formally unveiled its plan

to publicize emerging safety issues on its Web site.

As for the delay of AERS II, Dr. Throckmorton said, " based on what I know, those

timelines were caused by the complexity of it, the need to get it right, and the

need to consider integration into a larger system, " rather than by strategic or

management errors. He added that the integrated approach was endorsed at high

levels of the FDA. Generally, analyzing goals is " absolutely essential " in

developing a good system, he said, adding that the FDA " considered " the earlier

off-the-shelf software package and " rejected it. "

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