THIS SEARCH     THIS DOCUMENT     THIS CR ISSUE     GO TO
Next Hit        Forward           Next Document     New CR Search
Prev Hit        Back              Prev Document     HomePage
Hit List        Best Sections     Daily Digest      Help
                Doc Contents      

AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS ACT, 2001--Continued -- (Senate - July 20, 2000)

Unfortunately, this five year downward trend was reversed in 1999. The approval time rose to 18.6 months. This was in a year when the number of products approved actually fell from 225 drugs to 186 drugs. So the time per completed review grew for the first time in 5 years and it is now growing at

[Page: S7330]  GPO's PDF
a time when many important drug products will be coming off patent.

   We cannot afford to let this continue.

   The data on the monthly averages rending applications are also troublesome. Under the law, FDA has 180 days to act on a generic drug application.

   Let's look at what is happening with the number of generic drug applications that are overdue--that is at FDA for more than 6 months. In 1995 the monthly average of backlogged generic drug applications was 46 applications.

   This number increased to 59 in 1996.

   It jumped to 109 in 1997.

   In 1998, it rose to 127 overdue applications.

   And last year, the average monthly number of overdue generic applications rose again to 147 overdue applications.

   So the number of overdue generic drug applications has grown by more than 300 percent since 1995.

   Clearly, this trend needs to be reversed.

   It seems obvious to me that we want FDA to have sufficient resources to efficiently evaluate generic drug applications. The funds the Hatch- Durbin amendment provides would be sufficient to fund about 20 full-time equivalents (or ``FTEs'') in the Office of Generic Drugs.

   Given the fact that so many important medications are about to lose their patent status, it is imperative that FDA has the necessary skilled personnel and computer equipment to do the job of assuring the American public that generic drug products come on the market as soon as possible.

   We need to make sure that FDA's Office of Generic Drugs has sufficient resources to conduct timely reviews of generic drug applications. That's what this amendment accomplishes, and that is why Senator DURBIN and I have joined together in a bi-partisan manner to work to see that the promise of more affordable generic drug products reach the American public.

   Mr. President, this is an important amendment. I am pleased that the managers are willing to put it into the bill. I think it is something that will benefit everybody in this country. Hopefully, we can resolve some of these conflicts with regard to generic drugs and help bring the price of drugs down, as the Hatch- Waxman bill has done for the last 16 years.

   I yield the floor.

   The PRESIDING OFFICER. The Senator from Illinois.

   Mr. DURBIN. Mr. President, I join my colleague, the Senator from Utah, Mr. HATCH< /b>, in offering this amendment for consideration by the Senate.

   This is an amendment which will provide $2 million more for the processing of approvals of generic drugs.

   We are all familiar with the issue of prescription drug prices. We certainly understand that Congress should do as much as possible to help reduce the high cost of these prescription drugs, particularly for the elderly and disabled.

   One of the things we are doing with this bipartisan amendment is providing more money to the Food and Drug Administration for generic drug approvals. The high prices of drugs can be significantly reduced by putting more generic drugs on the market. Generic drugs typically enter the market 25 to 30 percent below the cost of brand name drugs and within 2 years are 60 to 70 percent cheaper than brand name drugs. Increasing the development of safe and effective generic drugs, is good for American consumers.

   Key to increasing access to such drugs, is making sure that the approval process is as efficient as possible. This chart illustrates the number of applications pending more than 180 days before the Food and Drug Administration for generic drugs. As we can see, the numbers have continued to increase. This is because the numbers that the Food and Drug Administration is being asked to approve has increased over the past few years.

   In fact, the median approval time for generics has steadily decreased from 19.6 months in 1997 to a little over 18 months in 1998 and 17.3 months in 1999. But under the present budget, according to the Food and Drug Administration, they are estimated to go up again in 2000 and 2001, and we are going to see a slowdown in the approval of generics.

   Senator HATCH< /b> and I have offered this amendment to provide $2 million to the Office of Generic Drugs. It is on top of the increase which the bill already puts in place of $1.2 million. This money will allow them to hire the professional people to approve the drugs, to put the computers and technology in place so that they can move forward with new ways to assess the drugs on a more timely basis, and to make certain that these drugs are available for American consumers as quickly as possible.

   Very soon some of the blockbuster patent drugs are going to come off patent. Let me give some examples: Mevacor for high cholesterol, Vasotec and Zestril for high blood pressure, Glucophage for diabetics, Accutane for cystic acne, Lovenox to prevent blood clotting and Prilosec for those with stomach acid, heartburn or ulcers. These brand name drugs have sales of billions of dollars. Prilosec alone has sales of over $2.8 billion annually. Together, these drugs represented over $8 billion in sales in 1997. This year, their sales are certainly far more than this.

   If we want to make certain these drugs move from brand name to generic so consumers across America can afford them, then the investment in the Food and Drug Administration which Senator HATCH< /b> and I propose is money well spent. I am happy to join Senator HATCH< /b> in this effort. I hope the Senate will approve this amendment and make it part of this appropriation bill.

   The PRESIDING OFFICER. The Senator from Minnesota.

   Mr. WELLSTONE. Mr. President, may I ask exactly how we are proceeding here?

   Mr. REID. Mr. President, I think what the manager of the bill wanted to do was to have the Harkin amendment disposed of at this stage.

   Mr. COCHRAN. Mr. President, if the Senator will yield, the pending business is the Cochran amendment to the Harkin amendment. It would be helpful, just as a coherent way of proceeding with the bill, if we would proceed in regular order.

   Mr. REID. Senator HARKIN is here.

   Mr. COCHRAN. It is my hope we could proceed to dispose of that amendment.

   Mr. REID. Momentarily, we should.

   Mr. COCHRAN. As I suggested earlier, if the Senator will yield further, it would suit me if we adopted both the Cochran amendment and the Harkin amendment on a voice vote to try to resolve the issue in conference with the House. I made that suggestion earlier.

   Mr. REID. I suggested that to Senator HARKIN and when I spoke to him earlier today, he was not willing to do that.

   Mr. WELLSTONE. Mr. President, I ask both Senators, the Senator from Mississippi or the Senator from Nevada, after we make a decision as to how we will proceed with the Harkin amendment and the Cochran amendment, am I in order next or do we go to an amendment on the other side? Just so I know whether I should need to be here. I am trying to move things forward.

   The PRESIDING OFFICER (Mr. L. CHAFEE). The Senator from Mississippi is recognized.

   Mr. COCHRAN. Mr. President, I appreciate that spirit of cooperation very much. I hope we can move on and complete action on the bill sometime this afternoon. To do that, we are going to have to act on the amendments we have that are going to be offered. It doesn't matter, in my view, who goes next. I don't really care. I am anxious that we proceed and move along and make good progress on the bill. Some Senators have already indicated that the list of amendments we have in order to be offered to the bill will not all be offered. That is good news. We have had some Senators suggest that they are willing to forgo offering their amendments.

   Mr. REID. Mr. President, if I may reclaim the floor, the two leaders have instructed the managers of the bill, as I understand it, that they want to finish this bill today. Is that the manager's understanding?

   Mr. COCHRAN. It is.

   Mr. WELLSTONE. Mr. President, I ask unanimous consent that as soon as we make a decision on the Harkin amendment, I be allowed to offer an amendment.

   Mr. REID. I think there is already a unanimous consent agreement that following the amendment by the majority, the Senator from Minnesota will be next in line.

[Page: S7331]  GPO's PDF

   Mr. WELLSTONE. I thank the Senator.

   Mr. REID. Mr. President, I suggest the absence of a quorum.

   The PRESIDING OFFICER. The clerk will call the roll.

   The assistant legislative clerk proceeded to call the roll.

   Mr. HARKIN. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

   The PRESIDING OFFICER. Without objection, it is so ordered.

   AMENDMENT NO. 3938

   Mr. HARKIN. Mr. President, parliamentary inquiry. What is the regular order right now?

   The PRESIDING OFFICER. The pending question is on the Cochran amendment.

   Mr. HARKIN. Thank you.

   Mr. President, let's go back to where we were a few hours ago when I first offered an amendment this morning. That amendment would state clearly that the Department of Agriculture--the Secretary of Agriculture--had the authority to set standards for pathogen reduction in meat and poultry inspection. Again, the amendment was carefully drafted not to set the standard. That should not be our business.

   The reason for the amendment was precipitated by a court case in Texas in May in which a Federal district court judge found that the Department of Agriculture--the Secretary of Agriculture--lacked the statutory authority to set and enforce pathogen reductions in meat and poultry inspection.

   When the Department established its new inspection rules in 1996, the USDA adopted a new food safety system based on hazard analysis, critical control points, and pathogen reduction standards, otherwise known now as HACCP. The system was designed to protect human health by reducing the levels of bacteria contamination in meat and poultry products. It has been in existence now for 4 years.

   What then happened was we had this plant in Texas, Supreme Beef. Three times they were warned by the inspectors that they were not meeting the salmonella reduction standards. Three times they failed. It is not that they weren't warned adequately; they were. On the third time when they failed it, the USDA did the only thing they could do under the authority they have, and that was to withdraw inspection from the plant, and, in effect, by withdrawing inspection from the plant, the plant had to shut down.

   The plant hired attorneys and took the case to district court and got an injunction. They got an injunction against the USDA so that they could keep operating, and they did. Then the judge decided, after a hearing, that the USDA lacked the legislative and statutory authority to both implement the rule and to enforce it. That is why we are here today with this amendment.

   We have worked long and hard on this. This is not something new. During the 1980s and 1990s, both the House and the Senate Agriculture Committees had numerous hearings. The Department of Agriculture, under both Republican and Democratic Presidents, had numerous field hearings and rulemaking procedures. They eventually came up with this new program that blended the old inspection program with new flexibility for industry and new standards for pathogen reduction.

   Why was this necessary? Because we have bigger plants now, faster assembly lines, meat and poultry go through the system faster; and we also found increases, according to the Centers for Disease Control, in a number of foodborne illnesses that we had not seen before in our country. So we wanted to have a system whereby we could assure consumers of the highest level of confidence that once that meat left the slaughterhouse, once it left the processor, it would be as safe as possible.

   Here again are CDC's statistics on foodborne illness. I had this chart this morning. It indicates that there are 76 million illnesses every year because of foodborne pathogens, 325,000 hospitalizations, and 5,000 deaths.

   Now, since we established the rule in 1996, salmonella rates in ground beef have dropped 43 percent for small plants and 23 percent for large plants.

   Since these performance standards were issued in 1996, we have had this big drop in salmonella in ground beef. The standard is working. But now a district court has said USDA lacks the statutory authority to enforce that standard. That was why I offered my amendment this morning. Not to set a standard but only to say USDA has the statutory authority to enforce a standard once it has been set. Adoption of my amendment doesn't mean that a packing plant or a processing plant couldn't still go to court and say: Your rule is arbitrary or it is onerous or it is inapplicable. But we never got to that in the Supreme Beef case. The Court just said they lacked the authority to set the rule.

   So they have thrown overboard years and years of work by the Senate Committee on Agriculture, the House Committee on Agriculture, and the Department of Agriculture under both Republicans and Democrats, and Republican and Democratic Secretaries of Agriculture to make progress in improving food safety.

   This morning, I tried to give statutory authority to the Secretary of Agriculture because without authority to enforce food safety standards, consumers are left exposed in this country. All we are trying to do is give them that authority.

   There was a motion to table the amendment made by the Senator from Mississippi. The motion to table lost on a tie vote. The Senator from Mississippi then put a second-degree amendment on my amendment. We were taking a look at it trying to figure out exactly what it did. It only changes a few words in my amendment. My amendment says at the end, standards ``established by the Secretary''--not our standard but standards set by the Secretary. The amendment by the Senator from Mississippi strikes that ``established by the Secretary'' and says ``promulgated with the advice of the National Advisory Committee on Microbiological Criteria for Foods.'' The key part of his amendment is ``and that are shown to be adulterated.''

   What do those words mean?

   First of all, when they say ``promulgated with the advice of the National Advisory Committee on Microbiological Criteria for Foods,'' the committee was were there when they first came up with the standards. They had input on the standards when they were established in 1996. There may be debate about the extent of consultation, but they were consulted. But the key words of the amendment by the Senator from Mississippi are these: ``that are shown to be adulterated.''

   What does that mean? If the amendment of the Senator from Mississippi is adopted, it will mean that the Department of Agriculture will have to go all the way back and again go through rulemaking to develop new performance standards. We, under the amendment of the Senator from Mississippi, are codifying a standard.

   The Senator from Mississippi, this morning, was saying the amendment that I offered was codifying the standard. I challenged him to show where that was so. It is not so. We do not codify a standard. Yet the amendment of the Senator from Mississippi codifies a standard. What is that standard shown to be? Adulteration; that is the standard.

   What does that mean? It means that USDA now can't just go into a plant and test for pathogen reduction and for salmonella and say they are not meeting the standard on salmonella--that they are failing to reduce pathogens. They now have to show that the meat is adulterated. That is what we have been doing for 70 years. A USDA inspector in a plant has had that authority for all of my lifetime, and for all of the lifetime of the Presiding Officer. They have the authority to go into a plant and withdraw inspection on the basis of adulteration. That is the old standard.

   The Senator from Mississippi would turn the clock back to where we were before 1996. No longer will we be able to say to

   parents: Your kids can have school lunches and not worry about pathogens because we have a pathogen reduction standard that is being enforced. No, we will have a gaping hole there because USDA will now have to show that the food is adulterated. It will have to show that the plant is unsanitary. That is what we tried to get beyond in 1996.

   The key part of the amendment by the Senator from Mississippi is that it codifies the adulteration standard as the essential element of pathogen reduction standards. Yet the Senator

[Page: S7332]  GPO's PDF
from Mississippi went after this Senator, just this morning, claiming that I was trying to codify a standard, which I wasn't. The judge in the Supreme Beef case said that for the USDA to take action, it had to show adulteration. That was the key part of the case. The judge said under the statutory law that exists, the only way the USDA can shut down an inspection line is if they show that it is adulterated--not that they didn't meet a salmonella reduction standard, not that they had pathogens in their food. They have to show that it is adulterated, that there are unsanitary conditions in the plant.

   Based on that holding, the judge said the USDA lacked the authority to enforce the existing salmonella standards. This amendment takes the holding in the Supreme Beef case, and makes it the law of the land. It makes the standard ``adulteration''. This amendment would make it the law of the land--not just in Texas but all over the country. Why would we want to do that? If we have to go back to ``promulgate with the advice,'' we will be another 2, 3, or 4 years waiting for pathogen reduction standards.

   What do we tell our consumers in the meantime? There is no standard. We go right back to where we were before. What do we tell the 325,000 Americans hospitalized every year because of foodborne illnesses? What do we tell the parents of kids eating school lunches? This amendment by the Senator from Mississippi would throw all of our meat inspection into a huge morass. It would basically say we are back now where we were 30 years--poke and sniff and have to prove that it is adulterated, or have to prove it is unsanitary.

   What does that mean? Salmonella can enter meat, for example, anywhere. It can enter it in the livestock yards, slaughterhouses, transportation, processing facilities. The point is not to lay blame on anyone. It is not to have the processor say: Our plant is clean, it is sanitary, and if there is salmonella there, we are not to blame, go blame somebody else.


THIS SEARCH     THIS DOCUMENT     THIS CR ISSUE     GO TO
Next Hit        Forward           Next Document     New CR Search
Prev Hit        Back              Prev Document     HomePage
Hit List        Best Sections     Daily Digest      Help
                Doc Contents