April 08,2004

Sen. Grassley Introduces Prescription Drug Reimportation Bill

Senator sponsors bill to ensure safety of and timely access to lower-priced pharmaceuticals

WASHINGTON — Sen. Chuck Grassley today introduced a bill that would make it legal for U.S. consumers to buy safe prescription drugs from Canada.Grassley said his legislation reflects consumer demand for the lower-pricedpharmaceuticals available in Canada and responds to the fact that the U.S. Food and Drug Administration (FDA) has declined to take action that could lead to certification of prescription drugs from Canada.

"Free trade principles argue for allowing importation of drugs from Canada and othercountries as long as those drugs are safe," Grassley said. "The FDA has been unresponsive foryears, and U.S. consumers have been going around the FDA. Congress needs to take action tomake sure that prescription drug imports are both safe and available to U.S. consumers."

The new proposal, which Grassley named the Reliable Entry for Medicines at EverydayDiscounts through Importation with Effective Safeguards Act of 2004, or the REMEDIES Act,would immediately open the door for U.S. consumers to buy prescription drugs from Canadianpharmacies while the FDA gets a new drug importation system up and running. The bill shutsdown rogue operators and requires the FDA to establish a new system within 90 days. The newsystem would allow individuals, pharmacies and drug wholesalers to buy qualified drugs forimport to the United States from foreign exporters who register with the FDA.

To register, a foreign exporter must demonstrate compliance with safety measures, submitto the jurisdiction of U.S. courts and take other steps to verify the safety of its drugs. This bill isthe first reimportation proposal to contain such a major safety certification component. A userfee charged to registered foreign exporters would provide the financing needed for the FDA toregister and oversee foreign drug exporters and ensure the safety of imported drugs."Imports create competition and keep domestic industry more responsive to consumers,"Grassley said. "Americans are tired of waiting for the federal government to address this issue.My bill lights a fire under the FDA and gives it the directive and resources it needs to fulfill itsobligations to U.S. consumers."

The REMEDIES Act includes both a carrot and a stick to keep U.S. drug manufacturersfrom preventing legal importation. In order to claim either the existing advertising expensededuction or be eligible for a new 20 percent increase in the research and development tax credit,a company must certify that it has not taken any action during the taxable year to prevent orcondition the authorized importation of a qualified drug into the United States from a registeredexporter in accordance with the legislation.

Grassley has been a consistent supporter of importing prescription drugs from Canada.The first reimportation vote in the U.S. Senate occurred in July 2000, on an amendment offeredby Sen. Jim Jeffords of Vermont. Grassley supported the Jeffords amendment. Grassley voted asecond time for reimportation of prescription drugs from Canada in July 2002, on an amendmentoffered by Sen. Byron Dorgan of North Dakota. Grassley voted for another Dorgan amendmentwhen it was offered in June 2003. This legislation became part of the Senate bill to add aprescription drug benefit to Medicare, but it was eliminated in the final conference report on thebill.

"This reimportation initiative would provide yet another option for senior citizens whowill enjoy the prescription drug benefits of the new Medicare program," Grassley said."Reimportation will benefit other consumers, as well."

Grassley is chairman of the Senate Finance Committee. The bulk of his legislativeproposal falls within the jurisdiction of the Health, Education, Labor, and Pensions Committee.Grassley said he hopes to have his bill considered as part of the HELP Committee's action thisyear on prescription drug reimportation.

The text of three documents follows here, including 1) FAQs about the REMEDIES Actof 2004, 2) an overview of key elements of the REMEDIES Act of 2004, and 3) Grassley's floorstatement marking introduction of the REMEDIES Act of 2004. A pdf file containing thelegislative language of the bill is available at http://finance.senate.gov.

FAQs about the REMEDIES Act of 2004

Q: What are the goals of the legislation?

A: The legislation has two objectives. First, it would put an immediate end to the unregulatedand unsafe situation with drug imports that exists today. Second, the legislation would providethe Food and Drug Administration (FDA) with the resources and authority to ensure the safety ofimported drugs.

Q: How does the bill work?

A: Current law prohibits the importation of prescription drugs until the Secretary of Health andHuman Services (HHS) certifies that importation can be done safely. Using current resourcesand authority, the FDA has not been able to provide an assurance of safety of imported drugs.The bill immediately halts unsafe importation but permits individuals to obtain prescriptionsfrom Canadian pharmacies on an interim basis while FDA gets the new drug importation systemup and running.

Under the bill, the FDA is required to issue final regulations for the new system within 90 daysof enactment. Under the new importation system, individuals, pharmacies, and drug wholesalerscould purchase qualified drugs for import into the U.S. from foreign exporters that register withthe FDA. To obtain a registration, a foreign exporter must demonstrate compliance with safetymeasures, must submit to jurisdiction of U.S. courts, and take other steps to assure safety ofimported drugs. A user fee charged to registered exporters would provide the financing neededfor FDA to register and oversee foreign drug exporters and ensure the safety of imported drugs.

Q: How will patients get their prescriptions filled at an overseas drug exporter?

A: First of all, consumers that want to have their prescriptions filled at an overseas prescriptiondrug exporter will be able to go to the FDA website and find a list of companies that have passedFDA's requirements to become a registered exporter. Just as for filling a prescription in the U.S.today, the patient must have a valid prescription written by a health care professional licensed ina state to prescribe drugs. The patient will then compare drug prices at the different registeredexporters to find the best price available. To get the prescription filled, the patient will have tocontact that exporter and either mail or fax the prescription to them.

Alternatively, the registered exporter could call the patient's prescriber and get the prescriptionover the phone. This is the same process as mail order pharmacies in the U.S. use today.A pharmacist at the registered exporter would fill the prescription according to the prescriber'sinstructions. The registered exporter may only fill the prescription with brand-name drugs,meaning these are the same drugs as those approved by the FDA and manufactured by the samecompany as approved by the FDA for sale in the U.S.

Individuals can also have a prescription filled that is technically not an FDA-approved drug, butthe drug must have the same active ingredients, dosage form, strength, and route ofadministration as the FDA-approved drug and is made by the same manufacturer as theFDA-approved drug. These drugs are manufactured by the same brand-name manufacturer andare made for sale in the market of the approved country.

The registered exporter is required to verify that the drug can be traced back to the originalmanufacturer and the drug must have been stored and handled properly. The FDA, through itson-site inspectors, will also be verifying that the prescription drugs being dispensed to patientsmeet FDA's criteria.

Once the prescription is filled, the registered exporter will place a label or other markings on thepackage for shipping that identify the shipment as being in compliance with FDA's safetyrequirements and all registration conditions. These markings will be designed by FDA and mayinclude track-and-trace technologies and anti-counterfeiting measures. When the package entersthe U.S., that marking will signify to Customs officials that the product was dispensed from aregistered exporter and can therefore be permitted to enter the country. Packages with drugs thatlack this marking will be seized by Customs and destroyed.

Q: Can the importation of prescription drugs from other countries be expanded?

A: Yes. In the second year of the importation program, HHS would be required to submit areport to Congress on the safety of the program and its impact on trade. Unless Congress acted,the program would be expanded in year three to include importation from the European Union,the European Free Trade Association, Japan, Australia and New Zealand. Other countries thatmeet specific statutory criteria may also be added to the list.

Q: What is the complete list of countries that would be permitted in the third year of the program?

A: There are currently 15 members of the European Union: Austria, Belgium, Denmark, Finland,France, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Spain, Sweden, TheNetherlands, and the United Kingdom. Beginning on May 1, 2004, there will be 10 new memberstates in the European Union: Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania,Malta, Poland, Slovakia, and Slovenia. There are 4 member countries in the European FreeTrade Association: Iceland, Liechtenstein, Norway, and Switzerland.

Q: How much does this program cost?

A: The infrastructure needed to guarantee the safety of the imported prescriptions would befinanced through user fees. User fees would be paid by registered exporters, which could be theoverseas pharmacies or prescription drug wholesalers, for example. The Congressional BudgetOffice has not yet officially scored the bill.

Q: Now that the bill is introduced, what comes next?

A: Because the bill contains tax provisions, it has been referred to the Finance Committee.Senate leadership has expressed an interest in developing legislation this year to allow theimportation of prescription drugs. Because the bulk of the legislation falls within thejurisdiction of the Health, Education, Labor & Pensions (HELP) Committee, it is expected thatHELP will take the lead in reporting any legislation.

Q: How is this bill different than other legislation on importation?

A: While the idea of importation of prescription drugs from foreign countries enjoys broadbipartisan support, the issue of safety continues to remain a major barrier to allowing importationto move forward. Secretaries of HHS from both the Clinton and Bush Administrations havedetermined that safe importation of prescription drugs cannot be guaranteed with the authorityand resources the FDA has today. Many bills presume that importation is safe and that FDA andthe public should not be overly alarmed. However, there is a legitimate concern about unsafepharmaceuticals entering the U.S. every day. Hundreds of thousands of packages enter ourcountry on a daily basis, with little or no ability for the U.S. Customs Service or the FDA toguarantee these drugs are safe and effective. Rather than ignore the safety issue, this billresponds to the concerns raised by FDA and others and creates a way to ensure safe access tolower cost prescriptions.

Q: How does this bill lower the costs of prescription drugs Americans have to pay?

A: United States consumers pay 30 to 300 percent more for their prescriptions drugs than thosein other countries. Drug manufacturers are forced to sell their products at lower prices in othercountries and try to re-coup their profits by making Americans pay higher prices for the sameproducts. This bill recognizes that competition in the global marketplace can work to lowerprescription drug costs. If lower cost pharmaceuticals are made available to Americans, drugcompanies will be forced to re-think their pricing strategy and won't be able to gouge consumersin the United States.

Q: What mechanisms does the bill propose to guarantee safety?

A: The bill would allow importation of qualified drugs only from registered exporters, whoseactions will be held accountable in U.S. federal courts.

Registered exporters must have an FDA-approved compliance plan that demonstrates they aremeeting the safety requirements established in the bill or by FDA. Exporters must permit FDAinspectors to be present onsite on a continuous day-to-day basis and FDA is required to haveassigned inspectors to that exporter. FDA will conduct day-to-day onsite monitoring of theexporter at the place of business for the exporter including any warehouses owned or operated bythe exporter and FDA will have access to inspect the exporters records to ensure compliance.Only where an exporter has demonstrated a track record of compliance will FDA be permitted toperform periodic inspections. The FDA must verify the chain of custody for each qualifying drugfrom the manufacturer of the drug to the exporter.

Only licensed pharmacists at the registered exporter will be allowed to dispense prescriptionswith a valid U.S. prescription from a U.S. physician. Commercial shipments can only bereceived and resold by licensed pharmacists. Unauthorized imports would be treated ascontraband and would be seized and destroyed upon entry without notice. Under the bill, anexporter's registration would automatically be suspended for any attempted entry of non-qualifiedor unsafe drugs and these exporters can be barred from seeking reinstatement in the future. Thebill would allow for importation first from Canada in order to test the safety of the system anddetermine whether additional controls are needed before expansion to additional counties.

Q: How does the bill prevent drug manufacturers from gaming the system?

A: Drug manufacturers that take any action, directly or indirectly, to prevent authorizedimportation will see a loss of their tax deduction for advertising expenses. Drug manufacturersthat do not take action, directly or indirectly, to prevent importation will see a 20 percent increasein their research and development tax credit for that year.

Overview of Key Elements of the REMEDIES Act of 2004

Legalizes reimportation (or importation) of prescription drugs from FDA approved exporters. Tobe approved, registered exporters must agree to meet safety requirements and to permit FDAinspectors on their premises full time to ensure compliance.

Creates a "fast-track" regulatory process for FDA to implement the importation system quickly.Importation of qualified prescription drugs from Canada is immediately legalized while the newimportation system is developed and implemented by FDA.

Under the new system, individuals, pharmacies, and drug wholesalers are permitted to legallyimport prescription drugs from registered foreign exporters:

o Individuals may order drugs from a registered exporter pursuant to a valid prescriptionissued by a U.S. doctor and filled by a pharmacist whose licensing requirements are equivalent tothose required in the U.S. or by a dispensing pharmacist duly licensed by a state.

o Commercial shipments are permitted only to licensed pharmacists for resale directly to consumers and by drug wholesalers who can sell to pharmacies as they do today.Drugs imported to U.S. pharmacies and drug wholesalers must be FDA approved drugs producedin the United States or in FDA inspected manufacturing facilities in other counties. FDA isrequired to provide the proper labeling for drugs for importation.The FDA through its inspectors is responsible for tracing all drugs exported to the US back totheir original manufacturing plant and ensuring that they have been stored and transported safelyfrom that plant.

Individuals may also purchase drugs that are bioequivalent to FDA-approved brand name drugsthat are produced by the same brand-name manufacturer.

o These drugs are drugs not technically approved by the FDA but the foreign governmenthas approved the drug and that drug has the same active ingredient or ingredients as theFDA-approved drug and the same route of administration, dosage form, and strength.

o If a drug manufacturer believes, however, that the non-FDA approved drug is notbioequivalent to the FDA approved drug, then it must submit a petition to the FDA to show that(a) the differences result in a product that is not bioequivalent to the drug approved in the U.S.,and (b) that such differences are due to scientifically and legally valid differences in theregulatory requirements of the U.S. and the country(ies) in which the apparently similar drug ismarketed. The manufacturer is required to pay a user fee sufficient to cover the cost of the FDA'sreview of the petition and supporting documentation.

A User Fee charged to registered exporters provides the financing to provide the resources to FDA to ensure the safety of imported drugs.

o User fees charged to registered exporters would be sufficient to cover all costs including those incurred for inspection and verification within the United States, at the exporter's premises and any other location where the drugs have been stored prior to entry into the U.S.

o The FDA would be required to verify the source and inspect the intermediate handlers of all drugs intended for export into the United States.

o FDA would also be required to determine by a statistically significant sample that the recipients held valid prescriptions (individuals ordering 90-day supply or less) or verify that recipient was a licensed pharmacy that only dispensed drugs to individuals.

The FDA would also be required to supply valid U.S. labeling upon request of the registered exporter and affix or supervise the affixing of seals, markings or tracking technology that would inform border personnel that such imports were lawful to be entered as labeled.

Drugs not permitted for importation include controlled substances and certain other drugs notappropriate for importation because of storage, significant safety concerns, or drugs that are morelikely to be counterfeited.

Provisions to Protect Safety of the Public:

Unauthorized imports would be treated as contraband and would be seized and destroyed uponentry without notice.

For the first two years, importation would be limited to Canada. The Department of Health andHuman Services would submit a report to Congress in the second year, and unless Congresschanged the law, countries from which importation is permitted would be expanded to include,the European Union, the European Free Trade Association, Japan, Australia, and New Zealand.Other countries meeting statutory criteria could also be added to the list by the Secretary.

The legislation continues to prohibit the import or reimport of drugs supplied free or at nominalcost to charitable or humanitarian organizations including the United Nations or a government ofa foreign country.

Requires pedigrees from the manufacturer to the dispensing pharmacist for all prescription drugssold within the U.S. or to an exporter authorized to export drugs into the U.S.

Requires the automatic suspension of an exporter's registration for any attempted entry ofnon-qualified or unsafe drugs with restricted ability to seek re-instatement in the future.

Requires that registered exporters submit to the jurisdiction of the U.S. federal court system andprovides a mechanism for civil actions against the property of persons that import non-qualifieddrugs.

Repeals the provision in the Controlled Substances Act that permits the personal import ofscheduled drugs, which is a significant source of illegal drug trade in the U.S.

Tax Incentives for Manufacturers to Facilitate Reimportation

Incentive To Not Prevent Reimportation: Manufacturers that do not take any action, directly or indirectly, to prevent reimportation receive a 20% increase in R&D tax credit for that year. Penalty For Preventing Reimportation: Manufacturers that take any action, directly or indirectly,to prevent authorized reimportation lose the business expense deduction for advertising expenses.

April 8th Floor Statement of Sen. Grassley on the REMEDIES Act of 2004

Mr. President, I would like to pose a question to the chamber today. What would you call it if Americans were paying up to 300 percent more for the same product as consumers from other countries were paying?

In Iowa, we would call that "highway robbery." Yet, highway robbery is what is happening everyday in this country, and it's happening over prescription drugs. Yes, prescription drugs are being sold at prices that are 30 to 300 percent higher in the United States than in places like Canada or Europe. Here are some examples. The price in Canada of Nexium, which is for heart burn and ulcers, is about 40 percent of the price in the U.S. Nexium would cost about $120 for 2820-milligram capsules if you bought it here in the States. If you order the same Nexium fromCanada, you'd pay about $51. Here's another example. The price in Canada for Vioxx, which isfor arthritis pain, is also about 40 percent of the price in the U.S. If you purchased 3012.5-milligram tablets in Canada, you would pay about $36 and in here in a U.S. pharmacy, youwould pay about $86.

And why is that, Mr. President? The reason is the importation of prescription drugs, those verysame drugs that patients are using in Canada, is illegal in this country. So consumers in othercountries get price breaks from the drug manufacturers and the American public doesn't. Oneway to look at this is that by paying those higher prices, the American public is paying more thanits fair share for the cost of research and development for future new drugs. That is not fair.This means when a new drug comes on the market, the American consumer has paid for theresearch but consumers in other countries benefit from the new therapy.

Now I have supported amendments to permit Canadian drug purchases before. We have hadnumerous votes in this chamber on legalizing importation. We had a vote most recently duringthe Medicare debate. Last year, the House overwhelming passed a drug reimportation bill by avote of 243 to 186. But, in the end, the conference report for the Medicare bill watered down thepossibility of legal importation such that it was meaningless. I was very disappointed about that.I think it was victory by subterfuge for the pharmaceutical industry.

So, I decided, Mr. President, to roll up my sleeves and go to work on drafting my own bill thatwould address the problems surrounding importation. In fact, I was working very closely sincethe beginning of the year with my friend and colleague from Massachusetts, Senator Kennedy.We were working together until three weeks ago to create a bipartisan piece of legislation. Wehad made a lot of progress. We still had some issues to work out but we were very close tohaving a final agreement.

With my leadership on the Finance Committee, and Sen. Kennedy's leadership on the HELPCommittee, let alone his expertise on the Food, Drug, and Cosmetics Act, I figured we had agood shot at getting something done. But those discussions have since evaporated.

Apparently, the Democratic Caucus was concerned that things were moving too quickly or thattoo much momentum was building behind a bipartisan effort. What I do know is that ourbipartisan product was no longer the priority. So I was disappointed about that too. Sen.Kennedy and I work well together. In fact, we're joining forces even now to get the FamilyOpportunity Act to the floor and passed out of the Senate.

So you can understand why I was discouraged that Senator Daschle had determined lowering thecosts of prescription drugs through importation was going to be a partisan issue.

This reminded me of what happened in 2002 with the Medicare prescription drug debate. Theretoo, Senator Daschle became concerned that the Finance Committee, then chaired by my friendSenator Baucus, would report a bipartisan prescription drug benefit for seniors. So, SenatorDaschle bypassed the Finance Committee and took a bill straight to the floor. That is not howyou get legislation passed in the U.S. Senate and everyone around here knows it. And in 2002, itresulted in a very partisan debate on the floor of the Senate over competing Medicare drugbenefit proposals. There were multiple partisan proposals by the Senator from Florida, SenatorGraham, and I had a proposal supported by both Republicans and Democrats. The Democraticcaucus fought our bill, which was dubbed the Tripartisan Bill because one of the key authors wasSenator Jeffords from Vermont, who is an Independent.

And what happened? Well, the Senate did not pass a Medicare drug benefit proposal that year.The debate fell apart in partisan bickering on the floor. That happened because partisan politicshad intervened to prevent a bipartisan compromise. Well, it looks to me that this is what ishappening here. It's funny, when you go to the pharmacist to pick up a prescription, I don't everremember them asking if you are a Republican or Democrat. And when you pay your healthinsurance premiums, I don't think the insurance company looks for an "R" or a "D" by your namebefore they accept your payment.

No, I don't see the importation of prescription drugs as a partisan issue. Being forced to payhigher prescription prices because there is a lack of competition in the global pharmaceuticalindustry is not a partisan issue. That's why I decided to move ahead and introduce a bill. Nowthis bill I am introducing today is, in large degree, the bill that I was working on with SenatorKennedy. I have made a few changes, but this bill is basically what Senator Kennedy and I wereworking on together. I thought what we had was a good proposal and we were so close to havingall the details worked out, I wanted to go ahead and introduce it.

Let me explain what the bill does. Quite simply, it would legalize immediately the importationof prescription drugs from Canada. After two years, consumers would be able to order theirdrugs from other countries too. And it creates practical and safe system to do it. Today, the lawprohibits the importation of prescription drugs until the Secretary of Health and Human Services(HHS) certifies that importation can be done safely. Using current resources and authority, theFDA has not been able to provide an assurance of safety of imported drugs.

So the HHS Secretaries in the Clinton and Bush Administrations have not provided thatcertification of safety so drug importation was not legally permitted. But we all know more andmore people have been getting the prescriptions filled in Canada, which is technically illegaltoday. The FDA and Customs have been looking the other way. The FDA has said that there areserious safety issues with drug importation from other countries. They say this because no publichealth authority is oversee many of the prescriptions coming in from other countries. In fact, theCanadian government has said that is will not take responsibility for assuring the safety of drugsbeing shipped to the U.S. from Canada. They have basically told the U.S. consumer that you areon your own.

Today, importation is not longer limited to organized bus trips across the border to pharmacies inCanada. Instead, it has becoming a booming mail order pharmacy operation with customers allacross the U.S. We see news accounts on a regular basis describing Americans who log on to theInternet to purchase drugs from Canada and elsewhere. The Permanent Subcommittee onInvestigations for the Senate Government Affairs Committee conducted an investigation intodrug importation. They found that about 40,000 parcels containing prescription drugs comethrough the JFK airport every day. The JFK airport houses the largest International Mail Branchin the U.S. From Miami, 30,000 packages of drugs come into the U.S. and 20,000 in Chicagoeach day of the year. About 28 percent of the drugs coming in are controlled substances. Theseare addictive drugs that require close physician supervision. Where are most of these drugscoming from? I was surprised to hear that it was not only Canada, but also from Brazil, India,Pakistan, the Netherlands, Spain, Portugal, Mexico and Romania.

My bill immediately halts unsafe importation from rogue operators but permits individuals toobtain prescriptions from licensed Canadian pharmacies on an interim basis while FDA gets anew drug importation system up and running. The American public is tired of waiting for thefederal government to take action to legalize importation and to assure the safety of importeddrugs. So, under my bill, the FDA is required to issue final regulations for the new drugimportation system within 90 days of enactment. Under the new importation system, individualsand pharmacies could purchase qualified drugs for import into the U.S. from foreign exportersthat register with the FDA. To be registered, a foreign exporter must demonstrate compliancewith safety measures, must submit to jurisdiction of U.S. courts, and take others steps to assuresafety of imported drugs. A user fee charged to registered exporters would provide the financingneeded for FDA to register and oversee foreign drug exporters and ensure the safety of importeddrugs.

Now the drug makers do not want to see their lower priced products from other countries cominginto the U.S. It undermines their profits here and they will want to do everything they can to stopdrug importation. So under my bill, drug makers that take steps to prevent importation of theirproducts from these registered drug importers will lose their tax deduction for their advertisingcosts. Many people are pretty fed up with all those drug ads you see on TV and how they areprobably adding to the cost of prescription drugs. Now I am fully in favor of free speech and I donot in any way want to prohibit companies from running the ads they want to run. But if the drugcompanies are not going to allow U.S. consumers to have access to these lower prices in othercountries then they will lose the tax deduction for the cost of those advertisements.

On the other hand, the drug makers complain that these lower prices take money from researchand development. So, my bill also creates an incentive for the drug companies to allowimportation. Companies that do not prevent importation from the registered exporters will get a20 percent increase in their R&D tax credit. I think that is fair. I have a more detailed summaryof the bill and I ask unanimous consent that this summary and a question and answer documentbe inserted into the record immediately following my statement.

I believe that free-trade principles argue in favor of permitting importation from Canada andperhaps from other developed countries as long as we can implement a system for safeimportation. Today, there is no assurance of safety-no one is watching the store-and products arecoming in from all over the world.

My legislation has two objectives. First, it will put an immediate end to the unregulated andunsafe situation with drug imports that we have today by default. This is key, because thesituation today threatens the safety of our nation's prescription drug supply and puts patients whoobtain these drugs at risk of harm. Second, the legislation will provide FDA with the resourcesand authority to ensure the safety of imported drugs, and importation will only be permitted byregistered exporters who submit to FDA authority.

Now, this bill will get referred to the Finance Committee because it has tax provisions in it. Butthe bulk of the bill falls under the jurisdiction of the HELP Committee and my friend SenatorGregg has announced that he will hold a markup this year on a drug importation bill. I do notintend to assert jurisdiction over this proposal and I believe we should rely upon that regularcommittee process to work. That is how we get legislation passed in the U.S. Senate. Mr.President, I hope my colleagues will look at this bill. I wanted to get these ideas out here fordiscussion. And, I hope some of them will want to cosponsor this bill.

It is time that we got this done and this is the year to get it done. We must not let partisanpolitics get in the way. If we do, there will be a penalty paid at the ballot box in November. TheAmerican consumer is waiting. Let's get the job done. I yield the floor.