Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2007

Date: May 23, 2006
Location: Washington, DC


AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS ACT, 2007 -- (House of Representatives - May 23, 2006)

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Ms. DeLAURO. Mr. Chairman, I yield myself such time as I may consume.

Mr. Chairman, let me first thank you and Mr. Obey, as well as Chairman Lewis, all of whom I have been pleased to work with on this bill. In particular it is a pleasure to join the chairman again as we bring to the floor our second and final agriculture appropriations bill together. As before, this has been a good process, one in which we have made substantial progress on many issues.

As I have said before, I want to take a moment to recognize that this is not only the last time this bill will be considered on the House floor under Mr. Bonilla's management, but also his last year of service on our subcommittee. He has served as chairman with distinction and carried out his responsibilities to this subcommittee with a real sense of determination and focus. So I thank you, and it has been a pleasure to work with you.

This is always an important bill, from public health and the FDA, to rural development and food safety, to environmental conservation and nutrition assistance, to investing in renewable sources of energy.

The mission of the Agriculture Appropriations Subcommittee is, at its core, about improving people's lives; and I think the subcommittee has produced a bill overall that we can be proud of.

There are several areas in particular that have been improved from the President's request. For one, the bill includes increased funding for the Commodity Supplemental Food Program and the Specialty Crops Program on which so many of our farmers rely. The bill restores the section 515 Housing Program and included $25 million for a National Fresh Fruit and Vegetable Program.

In addition, we have turned aside several misguided proposals by the administration not included in this bill, including proposals that would have changed funding for the Agriculture Research Institutions and capped WIC administrative funds.

We also made some progress during the markup. I appreciate the chairman's willingness to increase funding for the Office of Generic Drugs, bringing that up to $5 million. This will help to reduce the backlog of generic drug applications and in turn contribute to reducing the price of prescription drugs.

I was pleased that the committee accepted an amendment that I offered to give the FDA the authority to mandate post-market drug studies when needed. With 65 percent of the post-market studies pending, it is clear that the system FDA has in place is broken and must be fixed. As such, giving FDA the authority to mandate post-market drug studies and authorizing the agency to begin proceedings that would move a drug from the market, should the drug company refuse to carry out its responsibility, is a critical part of the drug safety process.

I was also pleased that this subcommittee accepted language preventing the implementation of a final rule by USDA to allow processed chicken products from China to enter the United States. We all know China has massive problems with avian influenza in its chicken population. Only hours after the Food Safety and Inspection Service announced it would allow the imports from China, claiming these products would be safe because they will be fully processed and cooked, a Tennessee firm announced the recall of more than 20,000 pounds of breaded chicken due to possible undercooking. Stopping that process from going forward was a good decision.

I do think that there are some areas where the bill falls short. While I know we cannot do everything we want to in this bill, I believe that many Members will be disappointed to see that, for instance, we could not fund a pilot program to look at the impact of eliminating the Reduced Price Meal Program that requires children from low-income working families to pay 40 cents per lunch and 30 cents per breakfast. If a family qualifies for free WIC benefits, they should qualify for free school meals as well. I wish we had found the money to make that pilot program happen, even if only as a pilot program.

I am also disappointed that we failed to substantially increase the funding for the McGovern-Dole International Food Program which is funded in this bill at $100 million, an increase of a mere $1 million over last year's bill and the budget request. This program fights child hunger in the world's poorest countries, while expanding educational opportunities for children; and it has a proven track record. It should have been a priority in this bill.

Lastly, we missed a golden opportunity with this bill to jump-start the country's energy independence efforts by seriously and aggressively funding the many programs in this bill that deal with renewable energy. I offered an amendment that was defeated on a roll call vote of 24-36 to our commitment to renewable energy and rural development by $500 million. It is time to be bold about energy independence; and this bill is an appropriate place to start doing that, which is why I intend to offer this amendment again before the full House.

I look forward to debating this bill today, Mr. Chairman, and I want to say thank you to you and your staff as well as staff on our side of the aisle for working so hard to put together the bill before us. As I have said throughout the process, barring any unexpected developments, it is my intention to support this bill.

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Ms. DeLAURO. Mr. Chairman, I move to strike the last word.

Mr. Chairman, I won't take all of my time, I just want to lend my support to this amendment as a State in which we are seeing increasing efforts in terms of organic farming, and having visited those efforts, myself and understanding the concerns that they have in making these kinds of transitions with the kinds of movement of the American public that is moving in this direction.

I just wanted to associate myself with the words of my colleagues and support the amendment.

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Ms. DeLAURO. Mr. Chairman, I move to strike the last word.

Mr. Chairman, I rise in support of the gentleman's amendment because I, too, am very, very concerned that the USDA is deciding or may decide to lower the number of BSE tests that are performed annually. I spent some time in this area.

Since the enhanced testing program began, the Inspector General of the USDA has raised series concerns about the current enhanced surveillance program. We have raised concerns with the USDA agencies in hearings and in private conversations.

Let me just give you just a little bit of information. For example, 2004, the IG reported serious problems with the testing program, including sampling was not random, and APHIS had not exercised the authority it had to collect the samples. Geographic representation in the testing was not assured. Cattle with central nervous system symptoms were not always tested. Because of interagency confusion, a process for getting samples of animals that die on the farm, those who are at the highest risk, was not in place.

More recently, the IG found that senior APHIS officials blocked the recommendations of scientists at the National Veterinary Services Laboratory in Ames, Iowa, for additional BSE testing on a sample that had tested positive initially several times.

Faced with the conflicting results, the scientists recommended additional testing to resolve the discrepancy. APHIS headquarter officials concluded no further testing was necessary, because testing protocols were followed. In the end, it was the IG who decided the additional testing should take place. It was done by AIS and the British lab at Weybridge who both found that the sample tested positively for BSE.

The IG also made shocking findings about the quality assurance and the BSE testing program at the NVSL, the National Veterinary Service Laboratory, such as the lack of adequate controls and procedures to ensure the quality or capability of the BSE testing program, the failure to implement an adequate quality assurance program for its own laboratory testing procedures, or to obtain internationally recognized accreditation for its BSE testing program.

Those are our concerns. That is what I was trying to lay out here, and flaws in the program, the existing program. It does not make sense to return to a lower level of BSE testing. I support the amendment.

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Ms. DeLAURO. Mr. Chairman, I regret that my friend has moved to strike this language, particularly given the GAO's recent findings.

The FDA needs the authority to mandate post-marketing drug studies when needed, and indeed, the General Accountability Office has issued a very harsh report of the post-market studies saying, and I quote, FDA lacks clear and effective processes for making decisions about and providing management oversight of post-market safety issues. They further say that, to improve the decision-making process for post-market drug safety, Congress should consider expanding FDA's authority to require drug sponsors to conduct post-market studies, such as clinical trials or observational studies, as needed, to collect additional data on drug safety issues.

The FDA is under increasing pressure to approve new drugs quickly. Some of us have been concerned by the implication of the approval process. Since 2000, ten drugs have been withdrawn for safety reasons by their manufacturers, all voluntarily. As far back as 1996, when the inspector general at HHS looked into the matter, it found that the FDA lacked an appropriate system for monitoring or tracking the status of the post-market----

The CHAIRMAN. The gentlewoman would confine her remarks to the substance of the point of order.

Ms. DeLAURO. Mr. Chairman, no one is accusing FDA of willful negligence. There can be innocent reasons why this study is not done, but the fact is the FDA needs to have authority in order to assure that we are not putting lives at risk with unsafe drugs that are not fully tested.

This language would ensure that they have the authority. Prescription drugs are the foundation of modern medical treatment. The public's interest is being preserved by having the FDA have this authority.

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