Statement of Congressman John D. Dingell, Chairman
Committee on Energy and Commerce

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS HEARING ENTITLED
"THE ADEQUACY OF FDA EFFORTS TO ASSURE THE SAFETY OF THE DRUG SUPPLY"

February 13, 2007

Mr. Chairman, thank you for conducting this oversight investigation and holding the first hearing of this Congress on drug safety and the Food and Drug Administration (FDA). This Subcommittee has a long history of FDA oversight and, by and large, it is a fine organization where many good people do much good work for the American people.

Unfortunately, from time to time this Committee has had to expose problems at that Agency. It seems every so often the FDA loses its way, sometimes because of the work of scoundrels, sometimes because of poor management. But sometimes it is because of a more serious breakdown in the policies and procedures that are critical to assure the safety of the food, drugs, blood, and medical devices that are essential to the health of the American people.

Today’s hearing will deal with just such a fundamental breakdown in policies and procedures for evaluating the safety of drugs. It is clear from the work that Chairman Stupak has already performed, which will be the subject of today’s hearing, that the FDA is badly broken. I expect that before we finish this investigation, which is just getting underway, we will discover whether the problems we have found are due to the work of scoundrels, irrational penny-pinching, or because the doors to the FDA “hen house” have been thrown open to foxes. It may be a combination of all three.

What we do know from our friend Senator Grassley, to whom I extend a very warm welcome, is that this Administration appears to be engaged in hiding wrongdoing at the FDA. We see this at other Federal agencies as well. Yet today we will hear a warning from Senator Grassley that during its investigation this Subcommittee will be confronted by obfuscation and delay by an Agency that tries to hide all of its poor decision-making behind a specious veil of Executive Privilege.

Those with the ear of the Secretary and the Commissioner of the FDA may erroneously believe that Committees of competent jurisdiction can be denied documents and interviews to obtain information Congress must have to fulfill its constitutional obligations. There are those who may be counseling the Secretary and Commissioner that Congress may not interview or call to testify Department of Health and Human Services (HHS) and FDA employees under any circumstances. There may even be those who are tempted to think that it is permissible to deliberately mislead us.

I promise those in charge of HHS and any other department that chooses to deny this Committee the information and access to bring proper and needed oversight, as is our responsibility, that they will not succeed. There is an easy way to be investigated and there is a hard way and the hard way is not necessarily better.

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(Contact: Jodi Seth, 202-225-5735)