Gulf of Mexico Energy Security Act of 2006 - Motion to Proceed

GULF OF MEXICO ENERGY SECURITY ACT OF 2006--MOTION TO PROCEED -- (Senate - July 31, 2006)

BREAK IN TRANSCRIPT

Ms. SNOWE. Thank you, Mr. President. I thank my colleague, Senator Dorgan.

I rise today, along with my colleague, Senator Dorgan, to address the amendment before the Senate based on legislation that Senator Dorgan and I introduced regarding drug importation.

First and foremost, I thank my colleague, Senator Dorgan, for his relentless and dedicated leadership on this very important question which we hopefully can address once and for all here in the Senate and in the overall Congress because it certainly is an issue that deserves consideration. But more importantly, it deserves to become law because it is so important to the interests of the American people.

We have been joined on this legislation by a broad coalition of 30 of our colleagues and many of the leaders of the importation effort, along with Senators GRASSLEY, KENNEDY, MCCAIN, and STABENOW unified with us in advancing this bipartisan legislation. Our voice has echoed those 7 out of 10 Americans who have called for the lifting of the ban on prescription drug importation. We have worked together to see that this legislation is considered in the Senate, and we have had 10 related hearings on this very matter in the Senate since 2004.

When we recently considered the Homeland Security appropriations bill, over two-thirds of the Senate responded to the increase in seizures of medications from Canadian pharmacies earlier this year by voting to stop impeding safe access to affordable medications.

Today, we must do more to respond to this issue. We must pass the legislation we have introduced which will ensure Americans have a safe and effective system to provide access to affordable medications. Our constituents are suffering as the cost of health care is rising rapidly in America, and prescription drug costs have led to that increase.

In response to a request of Senator Wyden and myself to track the price of medications most used by seniors, the GAO has repeatedly reported that the cost of these medications has increased at two to three times the rate of inflation as indicated by this chart. In fact, AARP reported recently that the fact is this the highest third-quarter increase in the cost of brand drugs since they began these studies. We can see here two to three times the rate of inflation in the cost of medications.

As a nation, we are growing older, and as we do we use more prescription drugs. At the same time, relentless price increases have made access to lifesaving drugs more and more unaffordable for Americans. The problem of affordability is shared by everyone. If you have prescription drug coverage, rapid price increases drive up your premiums. If you are one of the millions without drug coverage, the situation is far worse. You bear the full cost of the world's highest prices for medications.

Today, even with the new Medicare prescription drug benefit in place, over 46 million Americans are saddled with the burden of exorbitantly priced medications. A drug can be safe and effective, but what good is it if you can't afford to take it? That is why we simply cannot afford to postpone action any longer on this legislation. We have acted before repeatedly in the Senate and in the overall Congress. It has been law since 2000, when Congress last acted to allow importation.

We have also required certification by the Department of Health and Human Services, that the HHS Secretary must certify the safety of importation. Unfortunately, that has been the caveat and a disguise for blocking the importation measure. It has denied access to importation. The Department of Health and Human Services has not taken steps to ensure that we can allow Americans to import drugs safely from other countries--and in particular Canada. While the FDA was unable to point to any single individual harmed by Canadian drugs, they have actually denied importation from Canada. In Europe, in over 30 years of parallel trading of pharmaceuticals, no death or injury has ever been documented because they know it is safe.

While our constituents have found importation offers them access to lifesaving drugs, we have repeatedly heard from FDA how the practice threatens health. Opponents claim importation will cause harm, but they fail to note that the greatest prescription drug threat to the safety of Americans--that is, the inability to take drugs that are prescribed--exacts a toll of thousands of American lives every year. As Dr. Peter Rost--a former Pfizer executive up until a few months ago--who joined Senator Dorgan and I and others in a press conference, observed, ``Holding up a vote on reimportation, stopping good reimportation bills has a high cost, not just in money but in American lives.'' He is a former executive of Pfizer who actually had the courage to make that statement.

Today, thanks to the intensive reporting of health professionals, we are seeing more evidence of the cost of unaffordable medications. In my own State of Maine, one of our physicians reported hospitalizing two patients in a single month--one of them in the intensive care unit with a dangerous heart arrhythmia simply because they could not afford to refill a prescription.

But Americans recognize the value of prescription drugs, and they have turned to affordable sources of these medications so they can preserve and protect their health. Many of my Maine constituents have used Canadian pharmacies and found both savings and safety. But dangers do exist. There are certainly those who would exploit consumers with dangerous or counterfeit medications. It is imperative that we work proactively to ensure that the importation of prescription drugs is safe.

That is why Senator Dorgan and I, along with our colleagues, have comprehensively addressed the various concerns that have been raised over the months and years about drug importation--so that we can get something done. But certifying safety isn't the answer; any measure should actually make it safe. And there are two key issues we must address as we consider importation legislation. First and foremost, is it safe? Second, will the legislation be effective in delivering real savings for consumers? Our legislation which is incorporated in the amendment before us today does both.

Our constituents have taken action to purchase the drugs they could afford--mostly in Canada--and have demonstrated that importation can be safe. In Europe, with over 30 years of parallel trading of pharmaceuticals, no death or injury has ever been documented. They know it is safe.

Dr. Rost, as I said, who was a Pfizer executive up until several months ago, stated from his own firsthand experience in Europe--and I quote:

I think it is outright derogatory to claim that Americans would not be able to handle reimportation of drugs when the rest of the educated world can do this.

And I agree. Under our legislation, Americans will receive imported drugs from 30 countries. In most cases, Americans will purchase imported prescription drugs from their local pharmacy. The pharmacist will receive those drugs from a U.S. wholesaler which imports them. These wholesalers will be registered, inspected, and monitored by the FDA. This higher level of safety is also a first step in establishing a higher standard for the handling of all medications in the United States.

Our legislation also allows individuals to directly order medications from outside the United States when using an FDA registered and approved Canadian pharmacy. Again, just as with wholesalers handling prescription drugs, the FDA will examine, register, and inspect these facilities on a frequent basis. The FDA will assure the highest standards for such essential functions as recording medical history, verifying prescriptions, and tracking shipments. But regardless of whether one purchases imported drugs from the local pharmacist or uses a Canadian pharmacy, we assure that a legitimate prescription and a qualified pharmacist will be vital ingredients in ensuring safety.

Toward that end, we have also worked with Senator Feinstein to incorporate provisions of the Ryan Haight Act to assure that as we provide safety in an importation system we do not ignore the need to assure safety and integrity in domestic internet pharmacies. These provisions will assure that properly licensed pharmacies and pharmacists are behind Web sites offering prescription drugs and that we no longer see prescriptions issued based on a submitted form or a telephone conversation. There must be integrity and a proper professional relationship between medical professionals and patients.

For those who say the consumers could unwittingly purchase an unapproved or suspect drug, our legislation assures that the drug received will always be FDA approved. If any difference exists in a foreign drug, even the most minute, our legislation assures FDA will evaluate the product and determine its acceptability.

We provide a process to assure imported drugs are the same FDA-approved product, and if a minor difference exists, such as a coloring or inactive ingredient is different, and has no effect on the efficacy of the drug, our legislation assures that it will be tested and labeled so that differences are known. So there will not be motivation for a manufacturer to game the system by making a minor change in order to make a product unapproved and thus unimportable.

For those who say that counterfeiting is a threat, our legislation requires the use of anticounterfeiting technologies to protect drugs. The fact is, we can employ technologies like the one now used on the new $20 bill. We can do the same with prescription drugs. Moreover, this bill supports the development of future anticounterfeiting and track-and-trace technologies which we hope will be used to protect all prescription drugs.

For those who say consumers won't know who has handled an imported prescription drug, our bill requires that a chain of custody--a ``pedigree''--be maintained and inspected to help ensure the integrity of the imported prescription drugs. A pedigree for medications was mandated by law, believe it or not, back in 1988--that is correct, in 1988--and we still await its implementation by the FDA. Almost 20 years later, the FDA has yet to implement that requirement to establish a pedigree for medications to ensure that we have a chain of custody so we understand how they have been handled from the initial process of manufacturing.

Some even attempt to alarm Americans about the countries from which we import drugs, citing Latvia, Estonia, and Slovakia, members of the European Union. Another member is Ireland, where Lipitor is made.

I call your attention to this chart on which the European Union and other countries from which we would import is in blue. These countries meet or exceed our standards. In contrast, we have in red many additional countries in which the FDA inspects pharmaceutical manufacturing plants. These include China, India, Bulgaria, Jordan, and others with lower standards.

For those who say importation isn't safe, we show that it will be, and this legislation sets a model of improving safety in the handling of all prescription drugs. The safety has been attested to by none other than the former FDA Commissioner, Dr. David Kessler. He said our legislation `` ..... provides a sound framework for assuring that imported drugs are safe and effective. Most notably, it provides additional resources to the agency to run such a program, oversight by FDA of the chain of custody of imported drugs back to FDA-inspected plants, a mechanism to review imported drugs to ensure that they met FDA's approval standards, and the registration and oversight of importers and exporters to assure that imported drugs meet those standards and are not counterfeit.

Some say the consumers will not see significant savings, but drugs imported under this program will be labeled as imports, and consumers will be able to compare the side-by-side savings. With increasing consumer awareness of foreign prices and competition between importing wholesalers, we are confident of consumer savings.

Let me say in conclusion, I hope the Senate will give due consideration to this legislation. In the final analysis, it incorporates every issue regarding safety concerns, every measure, every standard that could be put in place to ensure we can have safe drug importation and accomplish the ultimate goal, ensuring affordable medications to the American people. They deserve it.

BREAK IN TRANSCRIPT

Ms. SNOWE. Mr. President, I appreciate all of the Senator's leadership on this issue, but would the Senator agree it is so important for our colleagues to recognize the savings that would be realized for our American consumers? Their counterparts in other countries pay 35 to 55 percent less, so this is an enormous savings both in terms of the U.S. Government and the $50 billion the Senator has mentioned, but also more than $6 billion in direct savings to the Federal Government and to the U.S. budget. Not only do we save $50 billion, with $6.1 billion of that in savings to the U.S. budget according to the CBO, but we begin to address the fact that the American consumers are paying $87 billion more than counterparts in other countries.

This is an enormous savings in all respects. Would the Senator not agree this also would advance those savings to American consumers but, as well, to our Government?

Mr. DORGAN. Mr. President, the large bipartisan group of Senators that has worked to put this bill together and endorsed the bill through cosponsorship has done so believing, first of all, that there is no safety issue. These are FDA-approved drugs that would be allowed to be imported, No. 1. And, No. 2, very substantial savings would exist. The Congressional Budget Office has said that it would be $50 billion over 10 years, $5 billion a year. There would be additional savings to the Federal Government itself.

At a time when we are up to our necks in debt, it is very important to do the right thing not only on behalf of the American consumers but also on behalf of our Government's fiscal policy. The right thing is allowing this to be an opportunity to access the identical FDA-approved drugs at the much lower price that they are being sold in virtually every other country of the world.

BREAK IN TRANSCRIPT

http://thomas.loc.gov