Healthy Skepticism Library item: 8705
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Publication type: news
Mathews AW.
Report Blasts FDA's System To Track Drugs
Wall Street Journal 2007 Mar 3A1
http://users1.wsj.com/lmda/do/checkLogin?mg=wsj-users1&url=http%3A%2F%2Fonline.wsj.com%2Farticle%2FSB117288538061625591.html
Full text:
Consultant Says Mission Is Hobbled by Missteps; Agency Disputes Claims
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.” Douglas 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
Charles 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 John 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.”
Write to Anna Wilde Mathews at anna.mathews@wsj.com