June 14,2006

Grassley Comments at the Department of Health and Human Services Regarding Access to Information About the FDA and The Antibiotic Drug Ketek

Remarks of U.S. Sen. Chuck Grassley of Iowa
at the U.S. Department of Health and Human Services
Wednesday, June 14, 2006

Finance Committee staff investigators have been looking into the fraud that took place
when the antibiotic drug Ketek was studied for safety and efficacy. This drug is on the market
for adults despite all the questions about it. It’s being studied in babies as young as six months

I came here today because I’ve been asking for a meeting with a special agent for the
Food and Drug Administration and documents related to that agent’s work on Ketek.
I’m fed up with resistance from the bureaucracy. It’s been one excuse after another.

Practices and policies have changed from one day to the next. Files available one day become
“confidential” overnight. A line agent isn’t allowed to tell his story, even though line agents
have been made available in other cases. The agency says its employees will not be prohibited
from cooperating with Congress, then instructs its employees not to cooperate with Congress.

The agency won’t provide a background briefing on past regulatory decisions.

None of the excuses for withholding information come anywhere near the importance of
getting to the truth. Based on the run around that’s gone on, I smell a cover up.

I came here today out of frustration, and after exhausting many other avenues, including
formal letters of request, countless staff phone calls, a personal call from me to Secretary Leavitt
and personal letters to Secretary Leavitt. I’ve only come in person to a federal agency one other
time, when I went to the Pentagon in 1983. So I wish I didn’t have to make this trip.

The FDA and the Department of Health and Human Services, in consultation with the
Justice Department, are dug in. Sadly, that position will not help those taking Ketek now and the
children already enrolled in the clinical trial.

Therefore, I’ve instructed my staff to look at a possible Finance Committee hearing. It’s
time to get all this out on the table and in the light of day. I’m committed to getting to the bottom
on the questions and fulfilling my Constitutional responsibility to oversee the executive branch of
government. Public safety and government accountability are at stake.