REPORT: FDA DRUG SAFETY TOOLS LACKING

Agency Efforts Found Unlikely To Fill Gaps In Long-Term Monitoring

WASHINGTON -- More than a year after the Food and Drug Administration
announced it had strengthened its drug safety system, the agency
still lacks a reliable way to keep track of emerging problems,
congressional investigators conclude in a report to be released Monday.

The Government Accountability Office found that a new Drug Safety
Oversight Board and other FDA initiatives "are unlikely to address
all the gaps" in the agency's system for monitoring the long-term
safety of prescription drugs approved for market.

While the board may help straighten out high-profile cases, the GAO
said, day-to-day oversight of safety issues still is 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 depicted in the report as a
bureaucratic stepchild.

The safety office "serves primarily as a consultant" to the Office of
New Drugs "and does not have any independent decision-making
responsibility," the report said. In some cases, it found, the new
drug bureau has excluded safety officers from presenting their
findings to scientific panels that the FDA relies on for advice.

With eight directors overseeing its safety office in the last 10
years, the FDA "has not effectively overseen post-market drug safety
issues, and as a result, it is unclear how [the agency] can know that
important safety concerns have been addressed and resolved in a
timely manner," the report said.

It is too early to tell whether the report will provide a boost for
stalled legislation to beef up the FDA's safety office and make it an
independent center within the agency. While GAO investigators
outlined a long list of unresolved problems, they credited the FDA
for working to make improvements.

In a statement, the FDA vigorously disputed the finding that its
safety office plays a secondary role.

Two key lawmakers who requested the GAO inquiry were divided in their
reactions.

"The GAO report shows that the drug safety system is not in crisis,
but the FDA's process may need some fine tuning," said Rep. Joe
Barton (R-Texas), chairman of the Energy and Commerce Committee,
which oversees the pharmaceutical industry.

A spokesman said Barton would wait for a National Academy of Sciences
report due this summer before deciding whether to pursue legislation.

Sen. Charles Grassley (R-Iowa), co-author of the FDA reform bill,
said the findings by non-partisan investigators bolstered his
proposal. Grassley held widely publicized hearings into the FDA's
failure to identify the heart risks of the painkiller Vioxx despite
warnings from its safety office.

"At the Vioxx hearing, some said there was a crisis at the FDA and
others said everything is all right," Grassley said. "This report
provides solid evidence that everything is not all right. . . . The
FDA's problems are systemic and cultural, not isolated or easily fixed."

In preparing their report, GAO investigators interviewed FDA
scientists and managers and reviewed documents usually not provided
to the public. Meetings of the drug safety board, for example, are closed.

The FDA's oversight problems begin with spotty data, investigators
found. The agency's Adverse Event Reporting System, which relies on
voluntary reports from doctors, only captures a fraction of bad
reactions to drugs.

In most cases, the agency lacks legal authority to order
manufacturers to conduct follow-up safety studies once a drug is
approved. Grassley's bill would grant the agency such authority.

Drug data should soon be more complete, investigators said, because
FDA has obtained $10million in funding from Congress to tap into
health insurer databases and other sources.

Investigators found that the new drug bureau and the safety office
repeatedly get bogged down in bickering over what the data means.
Such scientific disputes can continue for months, even years.

"Several [safety office] staff characterized this as . . . falling
into a 'black hole' or 'abyss,'" the report said.