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CONFERENCE REPORT ON H.R. 4461, AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS ACT, 2001 -- (House of Representatives - October 11, 2000)

The Administration is disappointed that the prescription drug reimportation provision in this bill will fail to achieve its goal of providing needed relief from the high costs of prescription drugs. The majority leadership chose to end bipartisan negotiations and instead produced a provision in the conference report that leaves numerous loopholes that will render this provision meaningless. Specifically, it allows drug manufacturers to deny importers access to the Food and Drug Administration (FDA)-approved labeling required for reimportation so that any and all drug companies could--and probably would--block reimportation of their medications. Second, a ``sunset'' was added that ends the importation system five years after it goes into effect. This will limit private and public sector interest in investing in this system. Third, the conference language permits the drug industry to use contracts or agreements to provide financial disincentives for foreign distributors to reimport to U.S. importers. Finally, despite the Administration's repeated requests, the conference requires FDA to pay for the costs associated with this provision from within resources needed to perform its other important public

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health activities. It is wrong that U.S. citizens pay the highest prices in the world for medications, leaving many with no other option than to go abroad to obtain affordable prescription drugs. But it is also wrong to provide false hope that this provision will work to address this problem. Moreover, Congress has thus far failed to pass a meaningful Medicare prescription drug benefit that will not only provide price discounts but will insure seniors and people with disabilities against the catastrophic costs of medications.

   On the ``Trade Sanctions Reform and Export Enhancement Act of 2000,'' which is included in the conference report, there are two major concerns to the Administration. First, the restrictions on the ability of the President to initiate new sanctions and maintain old ones are overly stringent. This effectively disarms the President's ability to conduct foreign policy while providing potential targets of U.S. actions with the time to take countermeasures. Second, the provisions of the bill affecting travel to Cuba would significantly set back our people-to-people exchanges that are in the interest of opening up Cuban society. They also would preclude travel by technicians and others needed to conduct normal business by the U.S. Interests Section in Havana, as well as travel for humanitarian purposes.

   With respect to the provision, ``Continued Dumping and Subsidy Offset Act of 2000,'' the Administration agrees with the findings that state that unfair trade laws have as their purpose the restoration of conditions of fair trade. However, that is the purpose of the anti-dumping and counter-vailing duties themselves, which accomplish that purpose. By raising the price of imports they shield domestic producers from import competition and allow domestic manufacturers to raise prices, increase production, and improve revenues. Consequently, distribution of the tariffs themselves to producers is not necessary to the restoration of conditions of fair trade. In addition, there are significant concerns regarding administrative feasibility and consistency with our trade policy objectives, including the potential for trading partners to adopt similar mechanisms. Such concerns were raised and examined with regard to a similar proposal considered during passage of the Uruguay Round Agreements Act. That proposal was ultimately rejected.

   In addition, the Administration believes the provision removing the authority of USDA's Undersecretary for Natural Resources and the Environment has no justification, will interfere with the agency's ability to manage itself effectively, and sets a highly undesirable precedent.

   The Administration is also disappointed that the bill prohibits the Secretary of Agriculture from designating any part of a USDA research lab in Ft. Reno, Oklahoma, as surplus land, thereby preventing any consideration of returning land to the Cheyenne-Arapaho tribe. The Secretary should retain his authority to effectively manage USDA property and consider its alternative uses.

   Ms. KAPTUR. Mr. Speaker, I yield 2 minutes to the gentlewoman from California (Ms. WATERS), the ranking member of the Subcommittee on Domestic and International Monetary Policy of the Committee on Banking and Financial Services, who is so very passionate and committed and intelligent.

   Ms. WATERS. Mr. Speaker, I rise to oppose this conference report because it includes language that is against the will of this body.

   Mr. Speaker, there is a United States embargo against Cuba. The blockade serves no real purpose but to satisfy the Florida anti-Fidel Castro Cubans who wish to direct the will of this House.

   The people of Cuba need food and medicine. The children are in desperate need of these supplies that we could easily sell to Cuba.

   

[Time: 16:15]

   The United States Chamber of Commerce has been to Cuba, the Farm Bureau has been to Cuba, and many members of the agriculture caucus of this body have been down to Cuba, and they are all desirous of lifting this embargo, at least to be able to sell food and medicine.

   However, some Members of this House are captives of those Cubans in Florida who have not only tried everything that they can to keep this embargo intact but they have also influenced certain Members of this body to get involved with placing further travel restrictions in this bill.

   We have done very well with travel to Cuba. Many Americans go there. We have academic exchange. We have cultural exchange. And it is working very well.

   If people are desirous of seeing Cuba, the Cuba that they think it should be, it is only because there is people-to-people contact. But having codified these travel restrictions, we have now placed this in jeopardy.

   Well, this meager, little attempt to sell to Cuba without having any financial infrastructure to do so, no credit from the United States financial institutions or government, is not going to work. We are undermining the very efforts of those who would like to sell agricultural products and food and medicine to Cuba.

   I would ask for a no vote. This is a wrong-headed policy.

   Mr. SKEEN. Mr. Speaker, I yield 3 minutes to the gentlewoman from Missouri (Mrs. EMERSON).

   Mrs. EMERSON. Mr. Speaker, I want to address the issue that the gentlewoman from Ohio (Ms. KAPTUR) spoke about and say I brought this up earlier.

   Yesterday the Supreme Court refused to grant certiorari to Smith Kline Beecham on an appeal because they were concerned that FDA was allowing a generic drug company to copy their labels. The Supreme Court would not take the issue.

   Basically, I will read the judge's ruling. It says, ``We hold that Hatch -Waxman amendments to the existing Food, Drug and Cosmetic Act require generic drug sellers to use labeling that may infringe the copyright in the label of the pioneer drug. We further hold that, as a result, copyright liability cannot attach to Watson's use of Smith Kline's label.''

   Therefore, allowing the copying of the label. And in the language that we have in the legislation, there is broad enough language giving the Secretary and the FDA the discretion to require this.

   Mr. GUTKNECHT. Mr. Speaker, will the gentlewoman yield?

   Mrs. EMERSON. I yield to the gentleman from Minnesota.

   Mr. GUTKNECHT. Mr. Speaker, I thank the gentlewoman for yielding.

   Mr. Speaker, I have been listening to some of this debate today about importation and reimportation. I would like to talk for a minute about how I got involved in this debate. It was because our own Food and Drug Administration has been and even to this day is sending out threatening letters to senior citizens who try to save a few bucks on prescription drugs. That is how I got into this debate.

   Now, some people are saying, well, it does not go far enough; and some people are saying it goes too far. I am reminded of what Winston Churchill said the day after the invasion at Normandy. He said, ``This is not the end. This is not even the beginning of the end. This is simply the end of the beginning.''

   This debate on opening up the market and creating more competition for prescription drugs is not over. This is the beginning.

   But, at least, for the first time in 8 years, the Congress is sending a clear message that the threatening letters to seniors for trying to save a few bucks on prescription drugs is going to end. And if it does not end, by the grace of the voters in my district, I will be back and I will be working with people from all sides of the aisle.

   I do not like some of the restrictions that were put on in the conference committee. But I know this, we have made more progress in the last 3 weeks on this issue than this administration has made in 8 years. And I think it is good progress, and I think we are going to see prescription drug prices coming down.

   Let me just show my colleagues this chart again. Look at what people pay in the United States compared to the rest of the world.

   Why are we sending threatening letters to seniors?

   This bill may not be perfect, but it is a giant step in the right direction. I congratulate the gentlewoman from Missouri and those of my colleagues who had the courage to stand by and fight for this issue because I think, in the years to come, we are going to see prescription drug prices in the United States come down dramatically.

   I would hope we will do this on a bipartisan basis. I do not think saving money for seniors is a partisan issue.

   Ms. KAPTUR. Mr. Speaker, I yield 1 minute to the very distinguished gentleman from Maine (Mr. BALDACCI).

   Mr. BALDACCI. Mr. Speaker, I thank the gentlewoman for yielding me the time.

   First of all, let me just say there is a lot of good things in this bill for agriculture. I commend the gentleman from New Mexico (Chairman SKEEN) and the gentlewoman from Ohio (Ms. KAPTUR) for their hard work in the committee.

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   Second of all, I would like to say that the reimportation issue that we have worked on is not a long-term solution to the problem but it certainly moves forward. It is not perfect but it certainly is going to enhance the ability of Americans and Maineards to be accessing low-cost, affordable prescription medicine.

   Now, maybe there is a better way to do it. Maybe there is an easier way to do it. And that probably is by being able to amend Medicare to be able to have this part of the program universally offered. But that is not the issue we have before us. Our seniors need relief.

   I want to commend the gentlewoman for working together on this issue, recognizing that there have been differences and it is not a perfect piece of legislation. But I do think it is going to go a long way. We have 325,000 seniors in Maine that do not have access to low-cost, affordable prescription medicine or insurance. This will afford the State an opportunity to negotiate to be able to have access to this pricing so we can do better for its seniors, and that is something that we should be supporting.

   Ms. KAPTUR. Mr. Speaker, I yield myself 15 seconds only to say that the reason, I say to the gentleman from Minnesota (Mr. GUTKNECHT) that we do not have prescription drug legislation is because this Congress did not pass it. And this is our only chance, and, unfortunately, a flawed bill is being presented as the only option that a few people here negotiated on their own, not in a bipartisan way.

   Mr. SKEEN. Mr. Speaker, I yield 1 minute to the gentleman from Iowa (Mr. GANSKE).

   Mr. GANSKE. Mr. Speaker, I am going to vote for this bill. But I think before we be too self-congratulatory, we should be modest, particularly in regards to the provisions on the Cuba agricultural trade issue and on the reimportation issue. There are many areas in both of those provisions that we should strengthen. And we will be back next year I predict and we are going to strengthen those.

   I consider this a small step forward on both of those. And so, I am going to vote for the bill. But just one of the provisions on the reimportation says that first an importer must get the drug tested and then get the manufacturer to supply the paperwork to the pharmacist.

   What will happen then? The manufacturers will know every pharmacist that is reimporting drugs. Maybe the next time that pharmacist needs to have a drug from that pharmaceutical company they will find that the pharmaceutical company does not have enough drugs to provide them.

   These are the types of things that we should have debated more fully and had some amendments on. But I do think the bill should move forward and I will vote for it, and I encourage a yes vote from all of our colleagues.

   Ms. KAPTUR. Mr. Speaker, I yield 2 minutes to the gentlewoman from Texas (Ms. JACKSON-LEE) a very outspoken Member and a very able Member.

   Ms. JACKSON-LEE of Texas. Mr. Speaker, first let me thank the gentlewoman from Ohio (Ms. KAPTUR) for her persistence and consistent work dealing with agriculture in the United States. And I thank the chairman of the committee.

   I am from Texas. And there is a lot of agricultural business and work in Texas. There are also a lot of issues dealing with the needs of hungry people in the agriculture bill.

   But it disturbs me greatly and I have expressed my consternation and opposition in voting against the previous question how we would ignore the thousands of seniors in my congressional district who are already aware that they cannot finance food and rent and prescription drugs, and then to ignore a bipartisan effort on the question of drug reimportation seems to be the height of hypocrisy.

   This bill claims to have a drug reimportation provision, but it allows drug companies and their intermediaries to price discriminate against U.S. pharmacies and importers. It sunsets the legislation so we cannot even put in a reasonable infrastructure to encourage our pharmaceuticals and others to engage in this program. It allows drug manufacturers to block the importation of drugs through labeling because it does not allow the use of FDA-approved labeling. And we have gotten our consumers very label conscious.

   And so, this is a death knell for the legislation. And it does not guarantee American consumers access to the best world market price because it restricts the countries eligible for importation even though the FDA agrees that safety standards for imported drugs are high enough to allow access to the entire world market.

   Our neighbor in Texas, of which many of my constituents go to, Mexico, has been excluded, one of the largest countries in the southern hemisphere where thousands of seniors are already busing themselves to get cheaper drugs.

   This is a poor statement on a crisis in America. It is a tragedy that we be so hypocritical. I am sorry we have used the agricultural vehicle for such a legislative initiative. I hope, Mr. Speaker, we can fix this problem.

   Mr. Speaker, I rise to offer mixed sentiments regarding the consideration of the conference report for our Nation's Agriculture appropriations. First and foremost this legislative effort represents our plans for our Nation's food source for the next year, but this bill is much more because it touches prescription drug reimportation into the United States.

   The measure appropriates $78.5 billion--$3.0 billion (4 percent more than the House bill, 4 percent more than the Senate measure and 2 percent more than requested by the administration. The agreement includes $3.6 billion in emergency funding to aid farmers hurt by disasters and low commodity prices; the House bill had provided only $115 million in emergency aid to apple and potato growers, while the Senate measure had $2 billion in disaster relief.

   Over 75 percent ($59.8 billion) of the total budget authority provided by the agreement in FY 2001 is mandatory spending for entitlement programs, including $20.1 billion for the food stamp program. The remainder ($18.7 billion) is for discretionary programs. The discretionary spending in the bill is $4.7 billion more than the FY 2000 appropriation and $3.2 billion more than the administration's request.

   As has been the case with the last couple of agriculture appropriations bills, this year's measure broke with a tradition of easy passage and has been complicated by various issues. At the top of the list of things stalling the measure has been a proposal to relax trade sanctions against food and medicine sales to Cuba and other so-called rogue nations. In addition, proposals to ease Food and Drug Administration (FDA) rules for importing drugs and address rising prescription drug prices slowed the measure's progress dramatically. Finally, settling on emergency funding levels to aid farmers recovering from disasters and struggling with low commodity prices also proved difficult. Negotiators developed compromise language on each of these contentious issues during conference action.

   This bill also makes an historic step toward removing the last vestiges of the cold-war era by instituting conditions for trade with Cuba. The agreement lifts current economic sanctions to allow shipments of food and medicine to Cuba among other nations. In the case of Cuba, the measure bars public and private United States financing of Cuban agricultural purchases. It also codifies restrictions (currently implemented by executive order) on Americans traveling to Cuba. This is an unfortunate result and this Congress should work to change this stifling action that will impair efforts to help the Cuban people.

   The agreement purports to allow pharmacies and wholesalers to buy American-made prescription drugs abroad and reimport them into the United States. Unfortunately there is a loophole in this legislation, which may allow drug manufacturers to continue charging higher prices for medicine to our Nation's elderly who so desperately need relief. Under this legislation the drug companies will be allowed to continue to market the same drugs that Americans have to pay higher prices for under different names in Mexico and Canada. Further, there is language in this bill, which will allow drug companies to restrict the marketing of these drugs under their cheaper names back here in the United States. Once again the American public is being told that Congress is responding to the problem of the high cost of prescription drugs in this country, but yet again there is a loophole for the consumer to fall through. This Congress should not abdicate its responsibility to offer financial relief to the millions of elderly Americans who have to choose each month between paying their bills, purchasing food, paying rent, or buying vital medicine.


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