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Public Statements

Food and Drug Administration Safety and Innovation Act

Floor Speech

Location: Washington, DC


Mr. McCAIN. Mr. President, this is not a new issue. This has been before this body on several occasions. I want to assure my colleagues that if the lobbyists for the pharmaceutical companies in this town are able to block this, we will be revisiting this issue. This is an issue of fundamental fairness and decency and giving Americans the opportunity to have access to very important medication that in many cases is lifesaving. It has been blocked by one of the most powerful lobbies in Washington, that of the pharmaceutical companies.

For years, along with many other Senators and the current occupant of the White House--the President of the United States, when he was a U.S. Senator, supported this amendment. I would love to see the administration weigh in and take the same position that then-Senator Obama took on this issue of basic and fundamental decency and fairness to people who are badly in need of medicine to, in many cases, literally save their lives.

Industry opponents of the comprehensive importation proposals have found various ways to confuse the issue, raise red herrings about safety, or cut secret deals to block passage of reasonable and widely supported prescription drug importation programs.

Let me give an example--this recently came up--of the activities of the pharmaceutical companies in the formulation of ObamaCare. ``GOP probe uncovers deal between Obama and drug companies,'' by Philip Klein, the senior editorial writer of the Washington Examiner.

Three years ago, President Obama cut a secret deal with pharmaceutical company lobbyists to secure the industry's support for his national health care law. Despite Obama's promises during his campaign to run a transparent administration, the deal has been shrouded in mystery ever since. But internal emails obtained by House Republicans now provide evidence that a deal was struck and GOP investigators are promising to release more details in the coming weeks.

What the hell?'' White House Deputy Chief of Staff Jim Messina, who is now Obama's campaign manager, complained to a lobbyist for the Pharmaceutical Research and Manufacturers of America (PhRMA) in January 15, 2010 email. ``This wasn't part of our deal.''

This reference to ``our deal'' came two months before the final passage of Obamacare in an email with the subject line, ``FW: TAUZIN EMAIL.''

At the time Billy Tauzin was president and CEO of PhRMA--

And I might add, one of the highest paid lobbyists in history, millions of dollars--

the e-mail was uncovered as a part of Obama's closed-door health care negotiations that was launched by the House Energy and Commerce Committee oversight panel:

``In the coming weeks the Committee intends to show what the White House agreed to do as part of its deal with the pharmaceutical industry and how the full details of this agreement were kept from both the public and the House of Representatives,'' the committee's Republican members wrote in a memo today.

On June 20, 2009, Obama released a terse 296-word statement announcing a deal between pharmaceutical companies and the Senate that didn't mention any involvement by the White House.

``The investigation has determined that the White House, primarily through Office of Health Reform Director Nancy Ann DeParle and Messina, with involvement from Chief of Staff Rahm Emmanuel, was actively engaged in these negotiations while the role of Congress was limited,'' the committee members wrote. For example, three days before the June 20th statement, the head of PhRMA--

That is Mr. Tauzin--

promised Messina, ``we will deliver a final yes to you by morning.''

Meanwhile, Ms. DeParle all but confirmed that half of the Legislative Branch was shut out in an e-mail to a PhRMA representative: ``I think we should have included the House in the discussions, but maybe we never would have gotten anywhere if we had.''

What went on in the formulation of ObamaCare is still one of the worst, sleaziest exercises I have seen in my many years here, and this involvement by the pharmaceutical companies was probably the most egregious. All this amendment does is allow U.S. consumers who need more affordable prescription drug options to either go without their medications or pay higher prices than they could get from legitimate Canadian pharmacies. But that is not a reason. It is not a reason for us to stop fighting for those in the United States who need more affordable prescription medications.

There are Americans in this country today who cannot afford their medications. They have a choice between eating or taking their prescription drugs. Meanwhile, there is a way for them to get much cheaper drugs, and this amendment does that.

We will hear from the pharmaceutical company supporters in the Senate who will talk about safety and how Canadians don't have the same standards we do. Really? Do we really believe the Canadian regulations and oversight are any better or worse than the United States? To ensure that U.S. patients have at least one option, this amendment takes a very narrow approach to safe importation by focusing on legitimate Canadian pharmacies.

Under this amendment the Secretary of Health and Human Services will certify ``approved Canadian pharmacies'' based on certain safety and quality criteria. To ensure that patients are not exposed to unsafe medications ``approved Canadian pharmacies'' can only sell drugs to U.S. customers that are the same as U.S. approved drugs. To protect U.S. patients against rouge distributors, a list of approved Canadian pharmacies must be published by the Secretary of Health and Human Services so Americans know which Canadian pharmacies are legitimate.

The cost of health care, including prescription drugs, continues to increase. However, there is nothing in the underlying FDA bill that will bring down the cost of prescription drugs. I wonder if the bill should be enacted when it doesn't do anything to address costs. The quality of pharmaceuticals in this country is outstanding, and I recognize that. But don't we all know how expensive it is?

For example, don't we know that in the United States of America, Nexium, 20-milligram, 30 tabs, is $195.99. The Canadian brand is $108.55, and Canadian generic is $69. For Plavix, the U.S. brand is $195; the Canadian brand, $132.

I am sure many Americans whose health coverage does not include these very expensive pharmaceuticals would be eager to take advantage of the same quality brand of prescription drugs that are available at these pharmacies in Canada.

As we all know, unemployment remains over 8 percent, and millions of families have mothers and fathers who remain unemployed or underemployed and have no health insurance coverage. But the unemployed and uninsured still have health conditions, and they need medications. Millions continue to search for more affordable ways to get their needed prescription drugs.

Unfortunately, in my State many of my fellow citizens who cannot afford it go to Mexico to get drugs, and I cannot guarantee what they purchase there will always be what it is purported to be. That is not a criticism of my friends south of the border. But the fact is in Canada they have the same kind of process we do. Despite there being no official program to import medications from Canada, approximately 1 million U.S. consumers use their own money to safely get their medications from legitimate Canadian pharmacies.

In Arizona, over 20,000 patients purchase their medications safely from Canadian pharmacies. In Florida over 85,000 patients purchase their medications safely from Canadian pharmacies. A recent study from Roger Bate, an AEI scholar, confirms that in drugs dispensed from legitimate Canadian pharmacies there was no failure of authenticity between drug samples obtained online from U.S. pharmacies compared to the same drug from Canadian pharmacies. Within the verified pharmacies U.S. prices on average were 52.5 percent higher than Canadian pharmacy prices. In other words, the drugs from Canadian pharmacy sites are the same dosage, form, and potency as drugs in the United States, only much less expensive.

The drugs are the same as I mentioned. This amendment doesn't authorize insurance companies, huge pharmacy chains, or drug wholesalers to import massive quantities into the U.S. system. This is about safely allowing uninsured, unemployed, and the underemployed to individually import these drugs they need.

So, please, somebody explain to me how we tell the struggling family who needs their medications that they cannot use their own money to get the same drug from legitimate Canadian pharmacies where the costs can be more than 50 percent lower than U.S. prices. It is not about the alarms of safety because this amendment requires the Secretary of Health and Human Services to promulgate

regulations permitting individuals to safely import medications from Canada, and the following safety criteria must be met for a patient to import drugs from FDA-approved Canadian pharmacies: The prescribed drug must be dispensed by a licensed Canadian pharmacist; the prescribed drug must be for personal use in quantities that don't exceed a 90-day supply; the prescribed drug must be dispensed in accordance with a valid prescription issued by a physician licensed to practice in the United States; the imported drug must have ``the same active ingredient or ingredients, route of administration, dosage form, and strength as a prescription drug approved by the Secretary.''

The amendment recognizes that approved Canadian pharmacies meeting safety criteria can and should provide needed alternatives to U.S. patients using their own money to affordably obtain their medications. The Secretary is required to publish on the FDA Web site a list of ``approved Canadian pharmacies'' that meet the following stringent criteria: The pharmacy has been in existence for 5 years prior to enactment of the program and has a purpose other than to participate in the U.S.-Canadian safe drug importation program; the pharmacy operates in accordance with provincial pharmacy rules and regulations; the pharmacy complies with all inspection and data reporting procedures; the pharmacy agrees that labs approved by the Secretary shall be used to conduct product testing to determine the safety and efficacy of sample pharmaceutical products; the pharmacy does not resell products from online pharmacies located outside Canada to consumers in the United States.

Safe drug importation is a bipartisan issue. People in all of our States are still struggling with family budgets, and the Senate cannot do anything to give patients more choices about where they can get their needed drugs because the drug industry opposes allowing individual Americans to use their own money to safely get the same drugs from Canada, and it doesn't make sense.

Just a word about the types of medications that are eligible. I have been asked by colleagues whether biologic medicines can be part of the program. The answer is not unless they can be safely imported under the provisions of the amendment and regulations issued by the Secretary.

The amendment doesn't discriminate against the type of conditions or medicines that patients should be able to safely import under this program. Not all biologics are the same. Some biologic medicines are available in capsules; others are injectable medications that require refrigeration. Some injectables don't require refrigeration and are shipped to patients throughout the United States every day.

I don't believe U.S. patients should be necessarily prevented from saving money on biologics. If a biologic medicine cannot meet the various safety provisions in the amendment, it should not be eligible. If it can meet the requirements of the amendment, then a biologic can be available to U.S. patients.

If the past is a prologue, then obviously this amendment will go down. Then after this amendment is rejected, I hope none of my colleagues have any curiosity about the way the American people feel about us; about the incredible, inordinate, illegitimate, outrageous influence of the pharmaceutical companies in America over the average American citizen. American citizens should be able to purchase pharmaceuticals from an approved pharmacy in Canada that many times is saving them half the money.

I am sure the distinguished chairman, my friend from Iowa, knows how many families do not have prescription drug coverage who are making a choice today between eating and medicine. What are we going to do? We are going to turn down this commonsense amendment.

Congratulations ahead of time to the corrupt pharmaceutical companies and their influence in the United States Senate and Capitol.


Mr. McCAIN. Mr. President, this amendment is a simple one. It creates a safe individual drug importation program only from approved Canadian pharmacies, overseen by the Secretary of Health and Human Services.

In a normal world, this would probably require a voice vote. But what we are about to see is the incredible influence of the special interests, particularly PhRMA, here in Washington, where people who cannot afford it will have to make a choice between eating and medicine. They will not be allowed to purchase a medication at less than half the price, many times, than they will in American pharmacies in Canada.

So what you are about to see is the reason for the cynicism the American people have about the way we do business in Washington. PhRMA--one of the most powerful lobbies in Washington--will exert its influence again at the expense of average low-income Americans who will, again, have to choose between medication and eating.


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