Floor Statements

I ask unanimous consent that not withstanding the provisions of rule XXII, when the Senate completes its action on S. 1082, it proceed to executive session to consider Calendar No. 104, Debra Ann Livingston to be U.S. circuit judge; that there be 3 hours for debate equally divided between the chairman and the ranking member of the Judiciary Committee or their designees; that upon the use or yielding back of time the Senate, without any intervening action, vote on the nomination; that the motion to reconsider be laid on the table, the President be immediately notified of the Senate's action, and the Senate then return to legislative session.

Mr. President, I ask unanimous consent that the Senate proceed to the immediate consideration of H. Con. Res. 124, just received from the House and at the desk.

Mr. President, I ask unanimous consent that the concurrent resolution be agreed to and the motion to reconsider be laid on the table, without intervening action or debate.

Mr. President, I ask unanimous consent that when the Senate completes its business today, it stand adjourned until 9:30 a.m. tomorrow, Wednesday, May 9; that on Wednesday, following the prayer and pledge, the morning hour be deemed expired, and the time for the two leaders be reserved for their use later in the day; that there then be a period for morning business of 60 minutes with Senators permitted to speak therein for up to 10 minutes each, with the first half controlled by the Republicans and the final portion controlled by the majority; that at the close of morning business, the Senate resume consideration of S. 1082, as provided for under the previous order; provided further that the cloture vote on the motion to proceed to H.R. 1495 not occur before Thursday, May 10.

Mr. President, if there is no further business to come before the Senate today, I now ask unanimous consent the Senate stand adjourned under the previous order.

Today, we are likely to wrap up consideration of legislation that modifies the rules governing the FDA, an agency that oversees all of the medical products we use and most of the food we eat. FDA came into being about a century ago because Americans were being sold medicines that caused injury, that caused birth defects, that even caused death; and Americans were consuming food products that too often were not safe. Those kinds of medicines were being sold as cures, but they didn't cure anything.

FDA's first responsibility--first responsibility--is to safeguard the health of American consumers. But because the products under FDA's authority account for 25 cents out of every dollar U.S. consumers spend, there is a pull on the agency that has nothing to do with patient safety and everything to do with drugs, both brand name and generic, and medical device industry profits.

I remember a few years ago, when I served as ranking member of the Commerce Committee's Health Subcommittee in the House of Representatives, a representative from FDA started his testimony to us in front of that subcommittee by showing us a chart that tracked the U.S. drug industry's global market share.

As I told that representative, FDA is not the marketing arm of the drug industry. It is the patient safety arm of the Federal Government, to guarantee safe products for Americans who consume medicine, food, and the like.

But FDA's drug industry dog and pony show is emblematic of the key problem this bill is designed to address. FDA has strayed from its public health mission, and this legislation will help to get us back on track.

S. 1082 requires FDA and drugmakers to work together to assure the safety

of medicines before and after a new drug is approved for marketing. It gives FDA more authority to prevent misleading drug ads and limit patient exposure to drug risks that may still be emerging.

S. 1082 is intended to realign FDA's actions with its public safety mission. While there are aspects of the bill that I wish were stronger, I believe S. 1082 will improve patient safety and ultimately the bill will save lives.

Chairman Kennedy and Ranking Member Enzi, their staff members, and Ellie Dehoney on my staff, literally worked night and day on this legislation. Other Senators have been there right along with them working to incorporate other key consumer health and safety provisions into this bill.

As a result, this legislation will not only help us prevent drug safety crises, it will help prevent the exploitation of the ``citizen petition'' process, which delays access to lower priced medicines.

Prescription drug affordability is a patient safety issue. What medicines cost determines who can afford them and who must forego them. That is a patient safety issue.

Thanks to the hard work of Senators Hatch and Stabenow, among others, this bill also responds to the problem of antibiotic resistance. It takes steps to spur innovation and reduce costs in that market.

Thanks to the hard work of Senators Dodd, Clinton, and others, this bill will help ensure children receive the right medicine at the right dosage and that they can benefit from medical devices tailored to their special needs.

S. 1082 is an important bill, and it will be a better bill if this body passes the Dorgan amendment to enable the safe importation of prescription drugs and rejects Senator Cochran's amendment to prevent safe reimportation.

Consumers are importing prescription drugs today. Seniors in Ohio are taking bus trips to Canada to buy their prescriptions in Windsor. It is happening in border States throughout our country because our country pays the highest prices in the world for prescription drugs.

Our Government isn't doing anything about that. Too many members of Congress--House and Senate--are, frankly, too involved and too influenced by big drug companies. So American consumers are now taking matters into their own hands. American consumers are importing prescription drugs today. We can help them do it safely or we can turn our backs and simply wish them well. This Senate, and the House, for too many years, along with this President, have turned our backs and wished them well.

It is time for something different. Let's help our citizens import prescription drugs safely. Vote for Senator Dorgan's drug safety initiative and vote against Senator Cochran's poison pill.

I yield the floor, and I suggest the absence of a quorum and ask unanimous consent that the time be charged equally to both sides.

Madam President, I have a few comments on this afternoon's proceedings. I was disappointed, as I know many in the Chamber were, in the passage of the Cochran amendment and what that means to the price of prescription drugs.

An awful lot of us believed--those of us running for election last fall, those of us who were just observers of the American political scene--understand that the drug industry has had way too much influence in the Senate and the House and particularly the White House in the last many years.

Many of us talked about reimportation of prescription drugs, particularly from Canada. Many of us--I know the Presiding Officer has done this. I have, from my Northeastern Ohio Congressional District before I was elected to the Senate last fall, taken busloads of senior citizens to Canada to buy less expensive but identical--same drugs, same dosage, same packaging, same manufacturing,--drugs in Canadian drugstores.

We all thought that it made no sense for Americans to leave our country to buy drugs, often made in the United States, but certainly drugs that are safe as those at a drugstore in Elyria, Ashtabula or Toledo or Dayton.

Many of us were disappointed at the passage of the Cochran amendment,

which is what the drug companies wanted, and what again stands in the way of direct reimportation so that American seniors and other Americans could get less expensive drugs. There is simply no reason the Canadian drugs--that our drugs should cost two, three, four times what people pay for the same drug, same manufacturer, same dosage, the same packaging in Canada.

I am intrigued by Senator Dorgan's idea of country-of-origin labeling on prescription drugs. We know, for example, that a doctor prescribes Lipitor, and the patient buys Lipitor; that these actual drugs were manufactured--that medicine was manufactured in Ireland. We do not seem to think there is anything wrong with that. So it makes sense to me to put on country-of-origin labeling because then Americans would see that these drugs, whether they are made in Ireland, whether they are made in Canada, whether they are made in Germany, whether they are made in the UK, whether they are made in the United States, that because of the FDA we know those drugs are safe in our country. We know they are safe if they are coming from Britain or Ireland or Canada.

I am intrigued by Senator Dorgan's idea. I also, for a moment, wanted to speak on the amendment that the Presiding Officer has led the charge on with Senator Thune and with Senator Lott and myself, on the citizen petition issue. That, I understand, is in the managers' amendment. I am hopeful that will become part of this bill as it moves through the process.

We know of abuse of the citizen petition process. We know that while, of course, we want to protect peoples' rights in this country to petition their Government always, we also note the drug companies have gamed that system, turned that system to their advantage and used that petition process to block the generics getting on the market.

We know the drug companies will do darn near anything to get their way, to keep their prices higher. It is the most profitable industry in the country--return on investment, return on sales, return on equity-- for almost a generation, almost every year except for when the oil industry does slightly better than the pharmaceutical industry. We know they will try almost anything.

But Senator Stabenow's work on this issue and this amendment will draw a balance so that citizen petition rights are protected, that consumers are protected, which will mean generics are earlier to market, safe generics, identical generics that will mean lower prices for our consumers.

I am hopeful we can get this bill in better shape than it has been. I appreciate particularly the efforts of Senator Dorgan on reimportation.

I appreciate his leadership on this matter and want to work with him to ensure that we exercise appropriate oversight over FDA and hold the agency, and in this case, the Office of Generic Drugs, accountable for its decisions. I also appreciate working with him and other members of the HELP Committee on the issue of antimicrobial resistance. So my question is, isn't this a public health crisis that requires immediate action?

I ask unanimous consent that there now be a period of morning business with Senators permitted to speak for up to 10 minutes each.

Mr. President, I ask unanimous consent that at 11:50 tomorrow, the Senate proceed to executive

session to consider Executive Calendar No. 84, the nomination of Frederick J. Kapala to be a U.S. district judge, there be 20 minutes of debate equally divided between the chairman and ranking member of the Judiciary Committee or their designees, and at the conclusion or yielding back of time, the Senate vote without any intervening action on the nomination; that the motion to reconsider be laid on the table, the President be immediately notified of the Senate's action, and the Senate then return to legislative session.

I ask unanimous consent that S. 1138 be star printed with the changes at the desk.

I ask unanimous consent that the Senate proceed to the immediate consideration of S. Res. 189 submitted earlier today.

I ask unanimous consent that the resolution be agreed to, the preamble agreed to, the motion to reconsider be laid upon the table, and that any statements relating thereto be printed in the Record.

I ask unanimous consent that the Senate now proceed to the consideration of S. Res. 190 which was submitted earlier today.

I ask unanimous consent that the resolution be agreed to, the preamble be agreed to, and the motion to reconsider be laid upon the table.

I understand that S. 1312, introduced earlier today by Senator DeMint and others, is at the desk, and I ask for its first reading.

I now ask for its second reading and object to my own request.

Mr. President, I ask unanimous consent that when the Senate completes its business today, it stand adjourned until 10 a.m., Tuesday, May 8; that on Tuesday, following the prayer and pledge, the Journal of proceedings be approved to date, the morning hour be deemed expired, and the time for the two leaders reserved for their use later in the day; that there then be a period of morning business for 60 minutes, with Senators permitted to speak therein for up to 10 minutes each, with the first half under the control of the majority and the second half under the control of the Republicans; that at the close of morning business, the Senate resume consideration of S. 1082; that on Tuesday, following the vote on the judicial nomination, the Senate stand in recess until 2:15 p.m., in order to accommodate the regular party conference meetings; that all time during any recess, adjournment, and period of morning business count postcloture, and that any time used in morning business by any Member be charged against their hour postcloture; provided further that Members have until 10:30 a.m. Tuesday to file any second-degree amendments, notwithstanding rule

If there is no further business to come before the Senate today, I ask unanimous consent that the Senate stand adjourned under the previous order, following the remarks of the Senator from Alabama.

Mr. President, I appreciate very much Senator Durbin's words on Darfur and how he continues to keep that issue in front of the American public, and how important it is that the assistant majority leader do that.

I rise to speak on behalf of the Dorgan amendment, the reimportation amendment, which will mean major cost savings to Americans when they buy prescription drugs. Several times over the last decade as a Member of the House of Representatives from a district in northeast Ohio, including Lorraine, Akron, and Medina, I took busloads of senior citizens to Windsor, Ontario to buy prescription drugs--a rather peculiar thing perhaps for a Federal official to do, to take people to another country to buy a consumer good. But what all of us know in this Chamber and most of the American people who have paid attention to this and understand, is that the same drug, the same dosage, the same manufacturer, often the same packaging--that those prescription drugs cost one-half, one-third, and sometimes as little as one-fourth in Canada what they cost in the United States. So we would take busloads of mostly seniors across I90 on the turnpike, up through Toledo, into Windsor, Ontario to buy prescription drugs and save seniors several hundred dollars, sometimes several thousand dollars a trip for each of them.

The opponents of the Dorgan amendment, the opponents of reimportation, for years--and when I was in the House they used these same arguments--have continued to use the issue of safety, as if the drugs you buy at Hunter's Pharmacy in Windsor, Ontario are any less safe than the drugs you buy 3 miles away across the bridge in Detroit, MI, or 50 miles down the road or 60 miles down the road in Toledo, OH. The fact is that issue is a smokescreen. We know that drugs sold in Canada often are drugs that are made in the United States. Lipitor is a drug made in Ireland. It is sent to Canada or it is sent to Steubenville, OH. It is the same drug, the same packaging, the same dosage, the same manufacturer, and it is every bit as safe in Steubenville, OH, as it is in Windsor, Canada, or just as safe in Windsor as it is in Steubenville.

Let me talk for a moment about the whole issue of the safety of these drugs. Importation, I believe, as Senator Dorgan does and as do so many in this Chamber, as do I believe 62 Senators who voted for cloture, importation is safe for drugs and for other sensitive commodities. In the year 2000, for example, the Pentagon imported Anthrax vaccine from Canada for U.S. troops. There was no question as to whether it was safe. Of course it was safe, and it mattered, and it protected our troops. The U.S. imports guns and explosive chemicals, uranium, food, pacemakers, heart valves, and other medical devices safely. Again, we are able to make sure these drugs are safe.

If the Federal Government can put a man on the Moon, they can certainly ensure the safety of imported prescription drugs. The Federal Government that says it can build a nationwide missile shield with thousands of precisely coordinated weapons and sensors can ensure the safety of imported prescription drugs. The Federal Government that says it can develop hydrogen-powered cars within 15 years can

surely ensure the safety of imported prescription drugs. A Federal Government that says it can safely ship and store thousands of tons of nuclear waste can surely ensure the safety of imported prescription drugs.

What is the real safety issue? The real safety issue is not whether a consumer from Ohio, from Ashtabula, driving up to Canada, driving through Erie, PA, into Buffalo and across the river into Ontario, can't buy the same safe drug with the same safe drug regimen in Ontario as that consumer does in Ashtabula. The issue about drug safety is that, frankly, unaffordable drug prices are what compromise the safety of these drugs.

Let me give a couple of examples. The drug companies' pricing policies compromise the health and safety of U.S. patients in this way: A study completed last year found that seniors who can't pay what the drug companies demand fill fewer of their prescriptions. That means the doctor is telling the patient that the patient should take this drug the doctor prescribed and the patient is not fully filling the prescription, so the patient is compromising his or her safety. Another study found that thousands of seniors with serious health problems reported they skipped doses to make prescriptions last longer. My wife last year was in a Shaker Heights drugstore--a generally affluent suburb west of Cleveland--and standing in line behind a patient who was trying to negotiate the price with the pharmacist. The patient asked if there was any way she could get the drug less expensively. The pharmacist said: This is the only price I am able to charge. The elderly woman said: How about if I just skip today and take the drug every other day, and the pharmacist said: You can't do that. It would compromise your health. The lady said: How about if I cut the pill in half and take a half a pill every day, and the pharmacist cautioned against that. When she walked away, my wife said: Does that happen often? The pharmacist said that happens every day, all day.

A 2001 study determined that patients were choosing less effective alternative medicines instead--pill-splitting, for instance. Patients will sometimes buy doses larger than appropriate for their condition in order to save money, and then divide the pills with a knife. That kind of pill-splitting is on the rise. Some health insurers actually require their enrollees to do it. The VA encourages it. Florida's Medicaid Program requires its beneficiaries to split their antidepressant medication that way. This controversial practice raises important safety concerns, all because of cost. It is why Medicaid, why the VA, and why health insurers require their enrollees to do it. The American Medical Association, the American Pharmaceutical Association, the American Society of Consultant Pharmacists, all oppose this pill- splitting.

The Miami Herald last year reported that a recent study of 11 commonly split tablets found that eight of them, after splitting, no longer met industry guidelines.

A spokesman for the drugmaker Pfizer told the Washington Post:

We don't recommend it for patients. Splitting can lead

patients to receive too much or too little medicine.

All of this happens because of the pricing of prescription drugs.

So when the opponents of the Dorgan amendment say we can't guarantee the safety of these prescriptions we get from Canada, that Drug Mart or CVS might buy wholesale from Canada, that these can't be guaranteed safe--they can be guaranteed safe just as well as CVS or Drug Mart going to an American wholesaler the FDA has approved. The real safety issues are when patients cannot afford the high cost of these drugs and either don't fill the prescription or take the drug every other day or cut the pill in half so their prescription lasts twice as long for the same costs. Those are the real problems.

Only the Dorgan amendment will save money. When you think about what has happened with drug costs in this country, the Alliance for Retired Americans issued a comparison this year of United States and Canadian retail prices for 20 popular medicines. Compared to Canadian citizens, United States customers pay 20 percent more, for instance, for their high blood pressure medicine Norvasc, 60 percent more for their cholesterol medicine Pravachol, 100 percent more, twice as much, for the heartburn drug Prilosec, 200 percent more, 3 times as much, for the heart medicine Toprol XL, and 750 percent more for the breast cancer medicine Tamoxifen--750 percent more.

Many of these drugs were developed by U.S. taxpayers through National Institutes of Health grants. Yet the drug companies thank American taxpayers for doing all this research by charging Americans 750 percent more for Tamoxifen that will save the lives of women who have breast cancer, and by charging 3 times more for heart medicine, and by charging 3 times more for another drug or 60 percent more for cholesterol medicine. The fact is, again, that safety is compromised because of the high price of these drugs.

In 2001, U.S. consumers filled 24 million prescriptions for the arthritis medicine Celebrex and another 23 million prescriptions for the arthritis medicine Vioxx. Using the ARA price differential of about $41 for Celebrex and $46 for Vioxx, U.S. consumers spent almost $1 billion more for Celebrex in 2001 than Canadian consumers, and over $1 billion more for Vioxx than did Canadian consumers.

No wonder so much is at stake in the Dorgan amendment. It saves consumers billions--$50 billion is I think the number he used on the floor yesterday--$50 billion. This saves American consumers billions of dollars. That means individual seniors out of pocket, it means insurance companies, it means taxpayers, it means the VA, it means all of us would save significant amounts of money. But we know what is at stake because the drug companies are going to make that much more money as a result.

That is what this is all about. It is all about drug companies protecting their profits, increasing their profits. We all know the drug industry--and this amendment is not against the drug industry. It is for consumers. It is for taxpayers. It is for small businesses. It is for insurers. It is for the payers, people who are paying for these expensive drugs. But we know that in this institution, in the Senate and down the hall in the House of Representatives, it is all about drug company lobbyists, hundreds and hundreds and hundreds of drug company lobbyists fighting to keep their profits, to expand their profits. It is an industry that over the last 20 years has been the most profitable industry in America, year in and year out, exceeded only a couple of years by the oil industry. But typically, in a normal year, the drug industry's return on investment, return on equity, return on sales is far and away the most profitable industry in this country.

The U.S. market accounted for 60 cents of every dollar in revenue for the 10 biggest drugmakers. The 10 biggest drugmakers in 2001, for instance, their revenue was $217 billion more than the gross domestic product of Austria. They had profits of $37 billion--more than the Government spent on VA health care, more than the entire budget that year for the U.S. Department of Housing and Urban Development; profit margins of over 18 percent, 3 times the average of other Fortune 500 companies. These companies charge too much. They get much of their research done by the U.S. Government, and then they are charging these kinds of prices, which compromises the safety of seniors who struggle to pay for these prescriptions that their doctors have ordered.

In addition, when you think about what these skyrocketing drug prices mean--health care overall, and especially skyrocketing drug prices-- just for American families, not just for seniors but for taxpayers and for small businesses--prescription drug costs increased almost 19 percent in 2002. Medicaid prescription drug costs increased a similar amount in 2001. Private health insurance premiums grew 15 percent and are projected to grow another 14 percent this year. Small employers saw HMO premiums increase 25 percent. This is consistently, 25 percent, 15 percent, 10 percent, year to year to year. What that means is because of the high cost of drugs, it is not just compromising the safety of our seniors, it is also hurting our small businesses. It also means that in too many cases, American companies simply have difficulty internationally competing with other countries, because they want to take care of their

own employees and provide prescription drug coverage for them.

The Dorgan amendment makes sense for small business. It makes sense for taxpayers. It makes sense especially for seniors who are taking these prescription drugs. Pure and simple, it makes sense for our country. If we care about the safety of seniors and the safety of drugs, don't buy the argument that these drugs are contaminated or adulterated or not safe. The fact is we know the drugs that are sold in pharmacies in Canada or Great Britain or by pharmacists in those countries or pharmacies in Japan or Israel and Germany are safe. They have a regimen like FDA to protect the safety of their drugs. The issue here is whose side are you on? Are you on the side of seniors, on the side of taxpayers, on the side of small business, or are you going to side with the drug companies? It is pretty clear where people line up in this institution.

I ask my colleagues in the Senate to support the Dorgan amendment when it comes to a vote next week.

Mr. President, I yield the floor, and I suggest the absence of a quorum.