CONGRESS PRESSES FDA ON INVESTIGATIONS

WASHINGTON -- The criminal-investigations wing of the Food and Drug
Administration is in hot water with Democrats and Republicans in both
the Senate and the House.

The Office of Criminal Investigations, or OCI, has operated largely
autonomously in recent years, emphasizing a crackdown on illegal
abuse of drugs such as Oxycontin. Its budget doubled to $42.8 million
from fiscal 2000 to fiscal 2009, even as FDA officials were conceding
that funds for assuring the quality of imported drugs weren't
adequate. Monday, the Bush administration announced it would ask
Congress for an extra $275 million to beef up FDA inspections.

In May, Rep. Joe Barton of Texas, the ranking Republican on the House
Energy and Commerce Committee, demanded information from OCI that
would explain why its arrests and convictions in fiscal 2006 were 20%
lower than in fiscal 2000, according to numbers on the agency's Web
site. During the same period, the number of investigators jumped
nearly 50%. The FDA says unpublished statistics for this year show
arrests moving upward. Sen. Chuck Grassley of Iowa has asked the
Government Accountability Office, or GAO, to review whether OCI
dropped some cases because of direction from other FDA officials.

Sen. Grassley's request follows questions raised by Democrats on the
House Energy and Commerce Committee in February during a hearing on
Ketek, the antibiotic made by Sanofi-Aventis SA. OCI agents testified
about their unsuccessful efforts to initiate a task force on Ketek
that would have looked at whether Sanofi's executives knew that an
outside contractor had used fraudulent data in a clinical trial of
the drug. Rep. Bart Stupak (D., Mich.), who leads the Ketek
investigation in the House, wrote in a release that "OCI management
did not follow through on the line agents' work, and recommendations
to expand fraud investigations were ignored." The company says it
acted in good faith and didn't know the clinical-trial data were
fake. An outside researcher went to federal prison. FDA officials say
they acted appropriately. In November, a year after Mr. Grassley
began an investigation into Ketek, the FDA sent a warning letter to
Sanofi about its lax oversight of that study.

Mr. Grassley has already cut into OCI's autonomy. For nearly a
decade, OCI worked under a little-known memorandum of agreement that
gave OCI precedence over the Inspector General's office at Health and
Human Services Department in conducting internal-affairs cases. That
authority was withdrawn at the end of 2007 after Mr. Grassley
complained that OCI selectively investigated FDA whistleblowers.

The FDA will cooperate with any GAO review, said Julie Zawisza, an
FDA spokeswoman.

Mr. Barton is concerned that OCI may be too focused on abuse of drugs
such as Oxycontin or ingredients for methamphetamine, where the FDA
agency's efforts may duplicate those of the Drug Enforcement
Administration, FBI and local police, a spokeswoman for Mr. Barton
says. Mr. Barton wants the OCI to say how many cases it started on
its own, she said.

OCI's longtime director, former Secret Service agent Terry
Vermillion, has hired many former police officers, FBI and Secret
Service agents. Mr. Vermillion hasn't been made available for
interviews. He came under fire from Democrats and Republicans last
year when news reports revealed that large bonuses pushed his
take-home pay for 2006 to $198,000, more than that of a member of
Congress or a Supreme Court justice.

Margaret Glavin, the FDA associate counsel for regulatory affairs,
said OCI's drug-abuse cases are "very much a part of our mission."
She disputed Mr. Barton's concerns about the drop in productivity,
saying unpublished numbers for fiscal 2007 are "trending upward,"
with 501 arrests and 350 convictions.

Carl Nielsen, a former OCI official, said, "You can generate a case
by merely being part of a task force," he said, adding that cases
translated into overtime, which drove the justification for constant
increases in the budget. Mr. Barton has asked for information on
OCI's overtime and a breakdown of cases involving outside agencies.
In an earlier interview, FDA officials said they don't break down OCI
cases by outside-agency participation.