Subcommittee on Oversight and Investigations Hearing, RE: FDA Foreign Drug Inspection Program: A System at Risk
WASHINGTON, DC,
Nov 1, 2007 -
OPENING STATEMENT:
Thank you, Mr. Chairman. I appreciate you holding this series of hearings because we are finding ourselves again on the brink of one more problem dealing with imports to our country.
This time, the focus is a little bit different, but the storyline is exactly the same as it’s been over and over again all summer. This committee has spent a great deal of time over the past months discussing the safety and security of imported products. And we’ve learned, our federal agencies that are tasked with keeping Americans safe from harmful foods and products, are often using 20th Century tools, or possibly even 19th century tools when dealing with a 21st Century problem. The FDA does not shoulder all of the blame in this situation. As I continue to study the problem, as the committee continues to study the problem, it becomes more and more convincing that a lot people, including people in the United States Congress, actually could not have anticipated the exploding number of imports that we have seen over the past ten years. Quite frankly our laws and regulations were never meant to handle the ever-increasing number of foreign products entering into our ports. This does not absolve us from guilt, it just means that, as the former Speaker of the House Mr. Newt Gingrich so often says, real change requires real change.
Now as a doctor, I think it’s important that we spend some time today discussing medicine and medicines. Medicine is supposed to heal patients, not harm them. Before I took the oath of office to become a member of the United States Congress, I first swore an oath to my profession to first do no harm. Yet, how can we do no harm if we don’t know what’s in the medicines that are coming from what is supposedly a safe and regulated country? It’s been estimated that more than 80 percent of the active ingredients in medicines come from overseas, and about half of that comes from India and China. China, Mr. Chairman. This is the same country that manufactured over 60 percent of all the consumer product safety recalls, including 90 percent of the recalled toys. Like many other Americans, I am now regarding the label “made in China” as “Warning! Consume at your own risk”.
While that 20-40 percent number is disturbing, analysts predict that 80 percent of the active ingredients will come from China and India within the next 15 years. If this is true, then our action here today and in subsequent hearings is critical. We must help and move the Food and Drug Administration into a 21st Century agency that can handle these 21st Century problems. And it’s not just money alone that will solve the problems. We do need real reform. In fact, you can argue we need to go beyond reform, it’s not just changes at the margin, it’s time for real transformation.
Now, in the last Oversight and Investigation hearing on food safety, I discussed the quality control with the witness from Tyson’s chicken, you may remember. He informed the committee that yes, they did find problems with things that were coming into their plant from suppliers in the country where they were operating within China. And when they found those problems, they dealt with them internally, but they didn’t tell anybody else. They’re under no obligation to self-report any problems that they encounter with the shippers, with other manufacturers, with other shippers, or even the federal agency charged with protecting the health and safety of American citizens. Today, I hope that the witnesses will speak to this issue.
Mr. Chairman, before I yield back, I’d be remiss if I didn’t make a couple of observations about the witnesses before us today. Certainly I want to thank Mr. William Hubbard for appearing before us today. Dr. Hubbard has appeared before us in the past, and has inspired at least me to introduce legislation based on testimony that he has given to our committee. So I thank you for being with us today, and I hope you can continue to shed some light upon the solutions that are needed to fulfill the organization’s own mission of building a stronger Food and Drug Administration.
And of course Dr. Von Eschenbach is with us again today and we are grateful he has given his time. Honestly Mr. Chairman, Dr. Von Eschenbach is the head of a major federal agency. His time is extremely valuable and I know you like to keep him in the audience so he can listen to your penetrating and probing questions, but at the same time, he does have other duties to perform. We’ve tasked the FDA with transformation, we’ve tasked the FDA with keeping us safe, and yet as I sit here this is the third Food and Drug Administrator that we’ve had since I came to Congress a very short time ago. He has an agency to get up to speed, to get up to 21st century functioning and he can scarcely perform that arduous task that we have set before him if he spends day after day after day listening to us pontificate from the dais. He can watch us on CSPAN in between the activities that he needs to do at his agency. I think, I hope in the future when Dr. Von Eschenbach is called to testify we will afford him the courtesy of allowing him to go early in the day as opposed to late in the day. I do realize that we do all ask very entertaining and probing questions, but I know Dr. Von Eschenbach has a lot of other things he could be doing. I, for one, certainly appreciate the time that he has given, the courtesy he has shown this committee. He has never complained about this issue, but I find it undignified that the committee would behave in such a way. I do know that the FDA does require additional resources. The same time just this past year, when we reauthorized the Food and Drug Administration, it wasn’t just the reauthorization of PDUFA MDUFA. We made some basic changes to how data is handled with the FDA. This is going to take us to the cusp of the 21st century-type of transformation that we all need. I hope we aren’t a hindrance in that process.
And I’ll yield back the balance of my time.
