Rosa DeLauro

Ms. DeLAURO

Ms. DeLAURO. Mr. Speaker, it is with great pride that I rise today to join all of those who have gathered in congratulating the National Organization of Italian American Women as they celebrate their 25th Anniversary. This is a very special milestone for this outstanding organization. Twenty-five years ago, a small group of Italian American women gathered in the Upper West Side apartment of Aileen Riotto Sirey. That meeting and their desire to assist other Italian American women and develop a nationwide network of women sharing a common ancestry sparked the formation of the National Organization of Italian American Women. Through their commitment to this effort, NOIAW members have developed a very successful scholarship and mentoring program and also offer a variety of educational and social programs. Today, NOIAW has a strong membership and is well-known as a resource for other Italian American women pursuing their own educational and professional aspirations. Throughout our nation's history, Italian Americans have played a pivotal role in the success and progress of America. The myriad of invaluable contributions that those of Italian ancestry have made to this nation are immeasurable. Musicians, artists, doctors. lawyers, politicians, teachers, activists, and more--the credits of Italian Americans can be found in professional and civic services across America. As an annual celebration of pride in their ethnic heritage, NOIAW recognizes the achievements of today's outstanding Italian Americans. As they mark their 25th Anniversary, NOIAW will also honor three inspiring individuals who have each distinguished themselves in their respective careers. Lisa Caputo Nowak is an astronaut and Commander in the U.S. Navy and will become the first Italian American woman in space with the launch of STS-21 to the International Space Station in the near future. Patricia de Stacy Harrison is the current Assistant Secretary, Bureau of Educational and Cultural Affairs. Prior to her appointment, she founded and managed a top public relations firm and has also served as the Co-Chair of the Republican National Committee. NOIAW's Special Recognition Award will be presented to Antonio Giordano, M.D., Ph.D., Director of the Sbarro Institute for Cancer Research and Molecular Medicine. Dr. Giordano is internationally renowned for his research in cell cycle, gene therapy, and the genetics of cancer. The accomplishments of these individuals and their outstanding contributions to our nation will certainly stand as an inspiration for generations to come. In sharing and celebrating our ethnic heritage, NOIAW has built a strong network of women and supporters who are ensuring that future generations can achieve their dreams. Their mission to support, mentor, and encourage the professional and personal success of other Italian American women is making a real difference in the lives of thousands of women throughout the country. It is with great pride that I stand today and extend my sincere congratulations to the National Organization of Italian American Women on their 25th Anniversary. In just a short time they have already touched the lives of so many, and I send my very best wishes to the Board and its membership for many more years of success!

Ms. DeLAURO

Ms. DeLAURO. Mr. Chairman, I yield 5 minutes to the gentleman from Wisconsin (Mr. Obey), the ranking member of our committee.

Ms. DeLAURO. Madam Chairman, I yield 5 minutes to the gentleman from New York (Mr. Hinchey), a member of the subcommittee.

Ms. DeLAURO. Madam Chairman, I yield 2\1/4\ minutes to the gentleman from Illinois (Mr. Emanuel).

Ms. DeLAURO. Mr. Chairman, I yield 5 minutes to the gentlewoman from Ohio (Ms. Kaptur).

Ms. DeLAURO. Mr. Chairman, I yield myself 2 minutes. Let me just say that I want to make it clear that what we tried to do with regard to the Food and Drug Administration was to call attention to the series of crises that, in fact, have been rampant over the last several months, whether it is Vioxx or whether it is Bextra or whether it is the post-marketing studies that were to occur that never did occur or the slighting, I believe, of our committee in not coming forward and having the director come before our committee. What we tried to do is to create a balance, and that is to provide additional funding for the Office of Drug Safety to look at direct-to- consumer advertising in order to try to protect the public and to provide additional funding to create some more infrastructure. I, too, believe that we should have made in order the amendments offered by the gentleman from New York (Mr. Hinchey). Really what should be happening is FDA should be coming to the Congress for authority in order to be able to change the labeling that, in fact, ultimately protects the public interest and that we ought to have the opportunity and they ought to come and demand from us authority in order to do post-marketing surveys about the risks of some of the products that are on the market. They should be coming to us. Instead, we want to provide that authority but are not allowed to be able to do that. I think that it was a mistake for us not to do that, but I think we need to continue this effort about trying to provide the agency which has the regulatory power over the pharmaceutical industry to develop some spine in order to be able to protect the public interest.

Ms. DeLAURO. Mr. Chairman, I offer an amendment.

Ms. DeLAURO. Mr. Chairman, it would seem to me that the regular order of the House would be to allow legislation that in fact meets the definition or the goal of the mission that we have been entrusted with. I wish that the Committee on Rules would have made this amendment in order because it is so critical to public safety. I concur with my colleague when he says if it is not made in order, then we have to concede the point of order. But what we are conceding is the life and death of American people, and that is not the regular order.

Ms. DeLAURO. Mr. Chairman, I wish to speak on the point of order. Mr. Chairman, I want to echo my colleagues' comments, because I think that we have an obligation. In my opening comments, I said that I believed that this bill is about what the House of Representatives and Members who are part of this effort have been asked to do, and we have been asked to protect the public interest on a whole variety of measures, and, in this case, we are talking about life and death.

Ms. DeLAURO. Mr. Chairman, I thank the gentleman for accepting the amendment.

Ms. DeLAURO. Mr. Chairman, I yield myself such time as I may consume. I thank the gentleman for his statement. I am pleased to join him for the first time in my capacity as ranking member of the agriculture appropriations subcommittee. It has been a pleasure working with the gentleman from Texas and his staff to put together the 2006 agriculture appropriations bill and with the gentleman from California (Mr. Lewis) and the gentleman from Wisconsin (Mr. Obey) as we worked in full committee to get here today. I, too, would like to say thank you to the staff of the subcommittee: to Martha Foley; to my own personal staff, to Karen Wilcox, Ashley Turton and Becky Salay; the majority office, Martin Delgado, Maureen Holohan, Leslie Barrack, Tom O'Brien, Jami Burgess. I really again say thank you for your expertise and for your patience. Let me also compliment the chairman on doing the very best with limited resources in this bill. Unfortunately, we know that the budget situation means that the funding allocation for this subcommittee was simply not sufficient to meet all the needs of rural America and our Nation's farmers. When I chose to sit on this subcommittee 9 years ago, I did so because I believed that the issues overseen by this subcommittee are core responsibilities of the Federal Government. This is the only subcommittee where farm policy, rural development and conservation, nutrition programs, food safety, drug regulations, and public health all come together. Although some might be surprised to learn, I have nearly 400 farms in my district ranging from dairy farms to horticulture and aquaculture, to orchards and vegetable cultivation. In fact, the first experiment station in the United States still does cutting-edge research in New Haven. Another area that I have spent time on is determining how we can best secure our food supply, something in which every American has a stake. My duties as cochair and founder of the bipartisan Food Safety Caucus have informed my understanding of the importance of the responsibilities of USDA and FDA alike, giving me the opportunity to visit slaughter plants and feed lots as well as fruit and vegetable farms across the country. I see food safety as a public health issue. I look forward to finding ways that can mutually benefit the health of our people, our farms, and our food supply. In addition, urban areas like New Haven rely on feeding programs for women, infants and children, for schools, for seniors, and for some of the disabled living on the edge of poverty. Yesterday was National Hunger Awareness Day, and our subcommittee is certainly aware that the President's budget predicted an increase in the use of food stamps in 2006. Unfortunately, this bill does not provide enough funding to maintain current participation in the Commodity Supplemental Food Program. At least 45,000 participants, the overwhelming majority of older Americans, will have to be dropped from this program unless there are more funds provided. Ensuring that these programs are funded is, in my opinion, among the very serious moral obligations of government. It is my belief that the bill before us today is more than a list of programs and funding levels. It is statement of values, of principles and priorities, a moral document so that when we discuss the bill and how it allocates $16.8 billion for USDA, I believe we must think of it in those terms. We should remember that the farm programs and the international trade promotion and advocacy that help our farmers across the country and sell our products have profound implications on our Nation's overall economy and our quality of life, that research programs at USDA are critical to our efforts to protect our agricultural plant and animal products, our environment, and our public health. Unfortunately, in some of these area this bill falls short. I believe that the President's budget failed to meet the needs of rural America, decimating rural development programs. This bill makes headway in reversing cuts made by the President. However, I am concerned that funding for water and waste grants, for example, remains below the level of last year's House bill and well below the 2004 bill. Rural America faces serious economic development challenges: affordable housing, clean drinking water, sewerage systems, access to remote educational and medical resources. I am afraid that this funding shortfall will lead to long-term deficiencies in rural infrastructure. Of course, this bill covers the funding of one of the most important agencies in our entire government, the Food and Drug Administration within the Department of Health and Human Services. FDA oversees some of the most critical products that our citizens rely on every single day. The vast majority are processed and fresh foods, except for meat, poultry, and egg products; our prescription and over-the-counter drugs; medical devices; our blood supply. This agency had many problems over the last year, from the recalls of Bextra and Vioxx to hearings in which its drug safety scientists have been at odds with the senior management of FDA. It is troubling, very troubling, that the FDA's acting commissioner was not permitted to come before our subcommittee to testify this year, and that failure made it difficult for the committee to make informed decisions. I thank the chairman for accepting the amendment that I offered in subcommittee to withhold 5 percent of the funds from the Food and Drug Administration's central offices until the head of the agency testifies regarding their budget request. This will not affect food or drug safety. It will only affect FDA's administrative offices. But I am sure that it will serve to get the administration's and the leadership of FDA's attention. On that same topic, I thank the chairman for working with me to include funding to double the annual funding for review and direct-to- consumer ads by FDA, as well as another $5 million for drug safety at the FDA. In 2001, the drug industry spent $2.7 billion on direct-to-consumer advertising, but the FDA office charged with ensuring that those ads are accurate was funded at less than $1 million, $884,000 to be precise. Doubling that amount is a small start toward remedying the inequitable advantage, and the $5 million will be devoted to the most critical aspects of drug safety. I find it unfortunate the bill includes a 1-year limitation on implementation of the country of origin labeling for meat and meat products. Country of origin labeling would give people the information they need to make an informed choice to protect the safety of their families. Thirty-five other countries that we trade with, including Canada, Mexico, members of the European Union, already have a country of origin labeling system in place. I believe it is a mistake to not move forward on implementing country of origin labeling. On International Food Aid, the subcommittee bill restores $222 million of funds under Public Law 480 that the administration sought to move to USAID, and I thank the chairman for preventing that move. However, we remain well below the funding level the past few years for that critical aid program. This law not only benefits those in dire need around the world, many of whom are starving to death, it benefits our farmers and our maritime shippers by utilizing our farm products and sources of transportation, and I hope that we can bring that funding level up before this bill becomes law. I am pleased that the President's proposals to change formula funding for agriculture research institutions and to alter the funding stream for the Food and Safety Inspection Service through user fees were not included in the bill. I also appreciate the chairman's working with the Democratic members of the subcommittee to begin to fund last year's Specialty Crop Competitiveness Act to enhance specialty crops such as fruits, vegetables, tree nuts, dried fruits, and nursery crops in this bill and for the Farmers Market Promotion Program, a function that can expand the farmer-consumer relationship in many areas of our country. The programs funded through this bill directly impact the everyday lives of every American, from public health and FDA to rural development, infrastructure maintenance, environmental conservation and preservation, to nutrition assistance at home and abroad. Failure to adequately invest in these programs will have serious long-term consequences for our Nation. Again, I have enjoyed working with the chairman and his staff, and I believe that we can take pride in the progress we have made in significantly improving the bill over the proposals that we did receive from the President. Mr. Chairman, I yield 2 minutes to the gentleman from California (Mr. Farr).

Ms. DeLAURO. Mr. Chairman, I thank the gentleman for yielding me this time. I rise to speak on the Hinchey amendment to require that the FDA stop waiving conflict of interest revelations by their advisors and to start to make an affirmative search for scientists who can give unconflicted advice to this critically important agency. Unfortunately, there is abundant evidence that scientists are being invited onto and accepted onto these committees, even when they tell the FDA that they have a conflict. They are permitted to serve, regardless of conflict. This must stop. Other agencies, such as the NIH, have regularly found unconflicted, fully qualified professional advisors so that the agency can receive the best, unbiased advice possible. I am mindful that there may be scientists whose expertise deserves to be presented to an advisory committee, and nothing in this amendment, as I understand it, precludes these individuals from being asked to testify before a committee. When enacted, this amendment will also start to contribute to and rebuild the credibility of the actions of FDA. We cannot have even the aura of influence by the pharmaceutical industry or other regulated industries when it comes to the FDA. Surely, in a country that is renowned for its scientific and medical expertise, I think we have 125 medical schools in the United States, that it is possible to find scientists without conflicts of interest to advise the FDA and to protect the public health. I urge support for the Hinchey amendment.

Ms. DeLAURO. Mr. Chairman, I yield back the balance of my time.

Ms. DeLAURO. Madam Chairman, I would ask the chairman if he has any additional speakers.

Ms. DeLAURO. Mr. Chairman, I reserve the balance of my time.

Ms. DeLAURO. Mr. Chairman, I reserve the balance of my time.

Ms. DeLAURO. Mr. Chairman, I thank the gentleman for yielding me this time. I hear a lot of talk about voluntary, but we have no mandatory right to recall tainted products. We have voluntary labeling of drugs, which can hurt people. We have voluntary marketing studies after a drug has been brought to market. When are we going to do something that makes sure that we are protecting people's interests? Country-of-origin labeling is about providing people the information they need to make an informed choice to protect the safety of their families. Thirty-five other countries that we trade with, including Canada, Mexico, members of the European Union, have country-of-origin labeling. Seven out of ten people say they are willing to pay more to know where their food is coming from. Food imports are increasing. The number of inspections of imported meat is actually decreasing. Consumers have a right to know, given the fact that we continue to have major recalls of meat products. This year we have had over 30 recalls. This effort is about being able to trace back contaminated product in the event of a recall. Knowing the source of an outbreak is a critical part of the process so that we can quickly take action to prevent people from getting sick. It is critically important considering the 76 million sicknesses, 5,000 deaths that occur every year from food-borne illness. Some say that if we halt the implementation of the country-of-origin labeling for meat, it will allow more time to consider the impact on the food industry. Congress has given the USDA more than 2 years to design a program that is fair to all parties including industry and consumers. Country-of-origin labeling will not violate trade agreements, lead to retaliation. It will not bankrupt the food industry. It simply says to consumers they will know where their food comes from. We owe the American people that. I urge my colleagues to support the Rehberg-Hooley amendment.

Ms. DeLAURO. Mr. Chairman, I yield 2 minutes to the gentleman from Arkansas (Mr. Berry).

Ms. DeLAURO. Madam Chairman, I move to strike the requisite number of words. Madam Chairman, I rise in support of this amendment. Unfortunately, plant diseases are continuously emerging; and they can threaten not only our agriculture but our environment and our public health. I think that in Connecticut, for instance, I will talk about sudden oak death, which has been identified recently. We are looking at potentially massive deforestation, and we are working hard at the New Haven Experiment Station to cooperate on research on the plant disease before our forests of Connecticut are heavily impacted. We all know the results of massive deforestation: Bad for our land conservation, bad for our environment, and it contributes to the lowering of, the actual lowering of our air quality. Mr. Chairman, I urge a ``yes'' vote on this amendment.

Mr. DeLAURO

Mr. DeLAURO. Madam Chairman, I yield back the remainder of my time.

Ms. DeLAURO

Ms. DeLAURO. Mr. Chairman, let me just ask a point of inquiry here. As I understand it, this amendment is for a year's duration?

Ms. DeLAURO. I yield to the gentleman from New York.

Ms. DeLAURO

Ms. DeLAURO. Mr. Chairman, I move to strike the last word. Mr. Chairman, I rise in strong support of the gentleman from Michigan's (Mr. Stupak) amendment to provide whistleblower protection to FDA employees. We have talked a lot today about scientific and management problems at the FDA, about whether their scientific advisory committees have been corrupted by pharmaceutical company influence, about how we can be sure that FDA has the tools that it needs to do its job to protect the health of the American people. Yet I might just quote to you the White House Chief of Staff, Andrew Card, who said, ``The agency is doing a spectacular job,'' and should ``continue to do the job they do.'' Unfortunately, we know that the FDA has not always lived up to its responsibilities; and rather than encouraging employees to speak out and engage in scientific debate, the FDA has worked hard to silence employees who believe that a drug on the market is harmful to the health of the American people. Dr. David Graham, as my colleague pointed out, is just one example of how things have gone wrong at the FDA. After 20 years of service, when Dr. Graham testified before the Senate Finance Committee at the request of the committee chairman in November of 2004, in response to a question, he listed, as has been stated, five drugs he believed to pose serious health risks. His concerns turned out to be warranted. One of the drugs he mentioned, Vioxx, has since been removed from the market, following reports that it causes heart attack and stroke, and others on the list have been shown to have equally serious and sometimes deadly side effects. FDA employees did all they could to stop Dr. Graham from testifying. A statement by the head of the agency, Dr. Crawford, was e-mailed to the reporters quoting something that Graham said in an internal e-mail. After the hearing, Dr. Graham himself said, ``Senior management at the FDA did everything in their power to intimidate me prior to my testimony.'' FDA employees went out of their way to slander Dr. Graham. The director of the Center of Drug Safety, Dr. Steven Galson, contacted the editor of the Lancet to suggest that Dr. Graham manipulated a study which was about to be published. The Government Accountability Project has reported that FDA managers posed as whistleblowers to attack his credibility. Fortunately, they were foolish enough to call from government phones so that the source of the calls was easy to trace and the trail ended at the FDA. FDA has since said that they are working to improve the handling of differences of opinion and that it acknowledged the right of employees to raise concerns to oversight groups. In that case, they should welcome the passage of this amendment to give its employees whistleblower attention. Mr. Chairman, the Food and Drug Administration is charged with such an important responsibility. It ensures that medications that Americans take every day are safe. It should be simple; it should be done without influence, by industry or anyone else. Unfortunately, that is not always the case; and when things go wrong, we depend on scientists at the agency to alert the American public that they may be putting their health in serious jeopardy with a certain medication. This amendment simply says that we will ensure that they can do that without fear of reprisal. I urge my colleagues to support the amendment. Point of Order

Ms. DeLAURO

Ms. DeLAURO. Mr. Speaker, by direction of the Democratic Caucus, I offer a privileged resolution (H. Res. 307) and ask for its immediate consideration.

Ms. DeLAURO

Ms. DeLAURO. Mr. Speaker, I thank the gentleman from Massachusetts for yielding me time and for all the effort and attention the committee has paid to this important bill on agriculture and the Food and Drug Administration. I just might say to the gentleman from Massachusetts, I, too, want to applaud his passion and his diligence and vigilance on the issue of hunger and how it affects our children and families in the United States and internationally. I thank him for leading the way for us. I also want to compliment the gentleman from Texas (Chairman Bonilla) on working under very difficult circumstances to deliver this bill on the floor and for working across the aisle. His staff, the gentleman from Wisconsin's (Mr. Obey) staff and mine have worked diligently to get us here today, and I thank all of them for their service and for their patience. This bill, unfortunately, falls short in filling the needs in rural America and in fully protecting our public health. While I believe that the gentleman from Texas (Mr. Bonilla) has done his best with a difficult allocation, regrettably there are shortfalls. We have barely maintained the same funding level as last year, $16.8 billion, in discretionary funds; and we all know that there are increased benefit costs and salary increases that need to be accounted for in that number. A stable number does not mean a stable agriculture and food and drug effort by our government. The chairman had to make up for a huge gap in the administration's proposal when it included an unauthorized user fee of $139 million in the budget. Finding that amount of money to keep our extremely important food safety efforts for meat and poultry operating was not an easy task. It certainly forced the chairman to leave other needs unmet at USDA. In addition, Mr. Speaker, the bill still does not include enough funding to cover the food security needs of the elderly under the Commodity Supplemental Food program. There are hundreds of millions more pending requests for building and repairing water and sewer systems and for conserving our precious soil and water resources. The Commodity Supplemental Food program operating in 32 States and providing surplus food commodities to seniors and to families of young children who no longer qualify for any other help, but who have hungry young ones to feed, is predicted to have to stop feeding at least 45,000 people with the current level of funding in this account. At the same time, USDA resources are essential so that our agricultural base is not harmed by outbreaks of diseases such as soybean rust or bovine spongiform encephalopathy, BSE or mad cow. United States agriculture is not isolated, and we need to remain vigilant and steady in our support of scientific research institutions in our prevention efforts and in our strategic planning and coordination for these types of challenges to our food supply and our health. In the natural resources area, the bill is $52 million below last year. Water and waste grants, so critical to public health and economic growth for our rural communities, are funded below 2004. The agriculture community has so many important needs, from commodity support to export promotion, from building new community facilities in rural areas to conserving farm land, and by combating animal and plant diseases and protecting human health, by enforcing our food safety laws and maintaining basic nutrition for our citizens. Rural areas are not always places with high tax bases and young working people. Rather, we know 90 percent of the country's poorest counties are in rural America, and these counties have a poverty rate that is a disturbing 14.2 percent. If we want these areas to begin to prosper again, we have to help them with infrastructure and community-building. Some forget that another important public health agency is also funded in this bill, the Food and Drug Administration within the Department of Health and Human Services. Again, the chairman has done a good job in trying to find funding for this budget for the Food and Drug Administration. This year, the subcommittee was deprived of the opportunity to hear from the Acting Commissioner of FDA due to what we understand was intervention from the administration. This meant that we had to work on their portion of the bill without being able to ask questions that we would ordinarily have used to learn about their current operations. Nevertheless, with the gentleman from Texas' (Mr. Bonilla) help, we have started down a road to building some additional resources for drug safety and the possibility of more effective oversight of postmarket prescription drugs, by increasing the resources of the office that performs direct-to-consumer advertising claims reviews. FDA is an agency that has demonstrated itself to be in crisis over the last year. We had an influenza outbreak predicted, but we were surprised to learn that another government's regulatory system had found the flu vaccine supply on which we were counting to be flawed. Drugs like Vioxx and Bextra that scientists at FDA knew were causing illness and death were permitted to remain on the market and be advertized well beyond the point that they should have been voluntarily withdrawn or forced off the market. Companies that had promised to perform postmarket studies in return for early introduction of their products failed miserably in keeping their promises without penalty. However, I am pleased that the subcommittee took action on this matter by fencing off 5 percent of the appropriation to the leadership offices of FDA until the head of the agency testifies before our subcommittee. This is a very important provision to maintain in this bill until we get some answers. I am also pleased that the subcommittee adopted an amendment addressing the reimportation of FDA-approved prescription drugs from FDA-approved facilities from Canada and other developed countries so that our people can buy them at affordable prices. This House has expressed its will on this issue over and over again, most recently with a letter signed by a bipartisan majority of the House to the Speaker, and we want to be able to keep this provision in the bill through conference. I thank the gentleman from Texas (Chairman Bonilla) for his willingness to work across the aisle to replace many of the cuts sent up by the President. We know that we cannot meet all the actual needs that are out in the country; but this bill is a valiant effort, given the budget parameters. I know there will be several amendments offered today, especially on behalf of enhanced civil rights and solutions to regional or specific problems. I believe that debate will be a healthy one, and I look forward to it. I thank the gentleman for yielding me the time.