Grassley - Sentinel on the Hill Gets Runaround at the FDA

[Guest guest]

SSRI-Research@

Thu, 22 Jun 2006 12:12:16 -0400

[sSRI-Research] Grassley - Sentinel on the Hill Gets

Runaround at the FDA

 

 

 

 

Sentinel on the Hill Gets Runaround at the FDA

 

by U.S. Sen. Chuck Grassley

 

Americans place their trust in government. As Iowa's senior U.S.

Senator, I work to make sure the federal government earns the public's

trust.

 

As a U.S. Senator, part of my job includes making laws that govern the

country.

 

Of equal or arguably greater importance, part of my Constitutional

responsibility includes oversight authority to help ensure the laws are

faithfully executed.

 

For more than 25 years, I have served as a sentinel on Capitol Hill to

keep all branches of the federal government accessible and accountable

to the American people.

 

That includes my legislative victory to make Congress live under the

same workplace laws it applies to Main Street. Enacted in 1995, the

Congressional Accountability Act forces members of Congress to

understand how the laws we pass impact employers and workers across the

country.

 

As a senior member of the Judiciary Committee, I also work to make the

federal judiciary more accessible, accountable and understandable to the

taxpaying public. That includes my long-standing efforts to allow

cameras into federal courts and to put a permanent watchdog in place

with an inspector general for the judicial branch of government.

 

As for my oversight work of the executive branch, I've ruffled more than

a few feathers along the way. Once I sink my teeth into an issue, the

object of my inquiry discovers my bite is as fierce as my bark. Just ask

the FBI, IRS, HHS, FDA, USDA, and the Departments of Energy, Justice,

Homeland Security and Defense to name a few.

 

As a freshman senator in the early 1980s, I got the run-around from

Pentagon officials when I started connecting the dots that would reveal

scandalous financial mismanagement at the U.S. Defense Department.

 

When higher-ups refused to allow me to question a budget analyst about

his report exposing flagrant disregard for the defense budget and tax

dollars, I hopped in my orange Chevette and drove to the Pentagon to

track him down myself.

 

Although I used unconventional means to exercise my oversight authority,

it helped save tax dollars in the end. That's because the same budget

analyst who was not allowed to brief me one-on-one was later forced to

testify at a congressional hearing about the budget-busting defense

program. That gave me the arsenal necessary to freeze spending on

unaccountable defense spending in the mid-1980s.

 

For the last two years, botched safety processes at the Food and Drug

Administration have led me to set my sights on patient safety. I want to

make sure consumers can trust what's in their medicine cabinets. I am

not trying to tie up the important system that regulates and approves

life-saving drugs and innovative medical devices for the marketplace.

Rather, I am insisting on accountability.

 

My concerns began when the drug safety agency tried to suppress

information about the dangers of antidepressants when used by children

and teenagers. Since then, I have introduced legislation to improve

independent post-market surveillance by the FDA and to require

information about clinical trials be publicly available.

 

Sunshine is the best disinfectant to pull questionable activities out of

the shadows of obscurity. Nothing gets the ball rolling in Washington

faster than front-page news and roiled public opinion.

 

Two years ago I called a congressional hearing to probe the FDA's

handling of the withdrawn painkiller Vioxx. It might be time to round up

another oversight hearing after the runaround I got recently at the FDA.

 

The FDA refused to allow me to question an internal investigator who is

leading an inquiry into alleged fraud involved with clinical trials for

the antibiotic Ketek. The FDA approved Ketek for the marketplace using

falsified clinical data. Now the drug is linked to adverse effects,

including abnormal liver function.

 

So for only the second time in 23 years, I resurrected in June my

unconventional means to fulfill my Constitutional oversight

responsibilities. I appeared at the FDA's doorstep.

 

But agency officials refused to let the FDA investigator talk to me.

 

Bureaucratic stonewalling won't deter this U.S. Senator. I won't rest

until the light of day exposes what ought to be available for public

consumption. It all boils down to keeping the government accountable to

the people and strengthening the public trust in government.*