Copyright ©2009 by Federal News Service, Inc., Ste. 500, 1000 Vermont Ave, Washington, DC 20005 USA. Federal News Service is a private firm not affiliated with the federal government. No portion of this transcript may be copied, sold or retransmitted without the written authority of Federal News Service, Inc. Copyright is not claimed as to any part of the original work prepared by a United States government officer or employee as a part of that person's official duties. For information on subscribing to the FNS Internet Service at www.fednews.com, please email Carina Nyberg at firstname.lastname@example.org or call 1-202-216-2706.
SEN. DORGAN: Well, I'm pleased to be joined by my colleagues in a bipartisan effort to reintroduce what we call the Pharmaceutical Market Access and Drug Safety Act with Senator Snowe, Senator McCain, Senator Stabenow, Senator Kennedy, Senator Grassley. It truly is bipartisan. We have 25 original cosponsors as we put this bill in.
It is an identical piece of legislation to a bill that we had introduced in the previous Congress, but it -- what it does is it allows the American people to have access to lower-cost prescription drugs, identical drugs, FDA-approved, produced in FDA-inspected plants. The difference is that the American people pay the highest prices in the world for prescription drugs while people in other countries pay a much lower price. We want to bring opportunities to the American people to pay that lower price, which we believe would force a repricing of that drug in our country.
Just a couple of observations.
This is one of the most popular drugs in our country, the most widely prescribed drug, Lipitor, 20-milligram tablets. You will see that I have, in fact, two bottles here. The only difference is in -- is in color: one is red, one is blue. But this Lipitor is made in the same place -- in Ireland -- and then sent to many countries. This one was sent to Canada, this one sent to the U.S. The only difference is the U.S. consumer gets to pay more than twice as much for the identical pill put in the same bottle. That's unfair, we believe. Zocor, you'll see -- again, I'm using Canada as an example -- twice the price for Zocor.
And then I'll put up a copy of a January 23rd story in The New York Times, "More Americans skipping necessary prescriptions, survey finds. One in seven Americans under 65 went without prescribed medicines in 2007, as drug costs spiraled upwards," and so on. We know the effect of these increased drug prices. We know the effect of having the American consumer paying the highest prices in the world. We believe it's unfair.
And I have a list of where prescription drugs are made. We are told by some, "Well, we can't reimport or import because it's unsafe." The fact is, most of these drugs or many of these drugs are made in other countries and imported by the manufacturer.
We have significant safety precautions in this bill. This bill is very important in terms of safety. It will prohibit counterfeiting -- counterfeit drugs coming into this country, with substantial additional opportunities for the FDA to be involved in that. We have pedigrees on drugs that are produced. This has significant safety provisions attached to it.
Simply, it is this: we allow licensed pharmacists and wholesalers in the United States to acquire FDA-approved drugs that are sold in other countries, bring them here, and pass those savings along to the American consumers. In addition, with respect to Canada, we allow consumers to bring in a quantity of those drugs.
My colleagues and I have worked on this for a long while. I'll make one final observation. I think there's a tailwind here this year that didn't exist previously. The new president was a cosponsor last year and is a supporter, as evidenced in his budget this year. Chief of staff at the White House was a cosponsor in the U.S. House on this subject. Senator McCain, of course, has been a cosponsor last year and this year. And we introduced this with 25 original cosponsors.
We believe that this time we will have the opportunity to get this through the United States Congress and lower prescription drug costs for the American people. We estimate about $50 billion of savings in the 10-year period.
Let me call on a cosponsor -- the original cosponsor that I've worked with -- Olympia Snowe.
SEN. SNOWE: Byron, thank you. Well, thank you, Senator Dorgan.
And I'm just delighted to be able to join you once again in introducing this legislation -- along, of course, with our stalwart allies, Senator McCain and Senator Stabenow. In fact, I remember, when Senator McCain was chairing the Commerce Committee, of which I'm a member, he held some of the first hearings on this question when Senator Dorgan initiated this proposition I think almost a decade ago. So I want to commend Senator Dorgan for his long-standing leadership, as well.
We hope that the House and the Senate can proceed almost in tandem to fulfill this obligation that I think that we have on behalf of the American people to address this unmet need. There is no question that we can get it done this year. And there's no question about the fact that it's -- this is an issue that's been elevated to an extraordinary degree, given the perilous economic times in which we find ourselves, and Americans are facing escalating health care costs without question. We have addressed the safety issue in this legislation from every facet. Now it's up to those who have opposed this legislation in the past to explain to their constituents why they would stand in the way of offering lower prescription drug prices to their constituents and to American consumers.
It is absolutely unconscionable, as Senator Dorgan indicated, that Americans are finding themselves in a position of rationing their medications that have been prescribed by their physicians. In fact, in the state of Maine this last week, there was another story about Maine's shrinking health care system that talked about a registered nurse who lost her job, and therefore lost her health insurance, has had to face the frightening prospect of rationing her medication and dosages with respect to her cholesterol. That's regrettable. But again, it is underscoring the stark reality so many Americans are facing because of the skyrocketing increases in health care.
The fact is, we have introduced this legislation I think five years ago. I think Senator Dorgan introduced it as an amendment 10 years ago. We have had 10 separate hearings on this question to address every dimension of any of the issues that have been raised with respect to it.
Had that bill become law by now, many Americans would have had access to lower drug prices that are already available in other industrialized nations. It's indisputable that Americans are paying 35 (percent) to 55 percent more than consumers in other countries. When it comes to brand names, it is two and three times the rate of inflation.
So we are voicing and echoing the views of seven out of 10 Americans when it comes to lifting the ban on this prohibition (sic). President Obama obviously has supported it and indicated that last week, because he recognizes the rising cost of health care clearly is imperiling the safety of Americans during these very difficult economic times.
We've set up a drug safety regime for the first time. We give the FDA resources for inspections because so many of the medications are manufactured in foreign plants that are not inspected. Many Americans think, when seeing those medications, that they are actually ones that are made here in the United States, but obviously not. So we've set up a regime with pedigrees and anti-counterfeiting technology, tracking the chain of custody, and regulating, overseeing, verifying and monitoring the handling of the medications throughout the process entirely. So we just don't say we certify the safety, we set up expanded for that safety regime, which is critically important.
And we have, you know, had so many medications or ingredients of medications manifest in foreign plants. And there are very few inspections that take place in those foreign plants; in fact, it could be as much as 20 years in between inspections, if at all. And 40 percent of ingredients are manufactured in China and in India.
And therefore, we happen to believe that we should require that there are inspections of these facilities. There will be inspections of every facility and approval by the FDA for every facility that -- where we import these medications because we think that that is the appropriate approach to take when it comes to this critical legislation. Global outsourcing -- you know, the production of pharmaceuticals to a lower-cost country -- means that FDA should be required to inspect every facility.
Finally, when it comes to a -- you know, the unmet need and not -- Americans not being able to meet the -- you know, the prescription drug need has only grown exponentially since 2003. In fact, in 2007, one in three Americans who are uninsured are in a position of not being able to fill their prescription. And that is obviously only going to grow by the numbers, given the dimensions of the unemployment problem and the loss of health insurance that so many millions of Americans are facing currently in this environment. I think it gives you a dimension of the depth and breadth of the problem.
Final analysis, it's injecting competition into the marketplace that will only benefit American consumers. Thank you.
SEN. DORGAN: Senator McCain.
SEN. MCCAIN: Please, go ahead, Deb.
SEN. STABENOW: Oh, no, go ahead. Go ahead.
SEN. MCCAIN: Please. Please.
SEN. STABENOW: Well -- (chuckles) -- thank you very much.
SEN. MCCAIN: I'm sorry.
SEN. STABENOW: No, no, no.
Well, it's my pleasure to be here with Senator Dorgan, Senator Snowe and Senator McCain on a piece of legislation that I've worked on, as well, in the House and in the Senate. It's been over 10 years ago, over a decade, that I first began taking bus trips from Michigan into Canada. For us, this is a real sore point, when you can look across the Detroit River, and when you can go five minutes on a bridge or in a tunnel and be able to be in Canada and see the dramatic differences in the prices -- very same drugs; and in many cases, as my colleagues have said, those that are already being manufactured in other countries, brought into the United States, sold in other countries at a much smaller -- at a lower price.
I just wanted to share one of thousands of stories of people I've talked to in Michigan. But I talked to a gentleman named Joe, who's a 40-year-old father with heart disease. His family says, despite the heart condition, that he's doing well, enjoys working, but his medicine is $4,800 a month -- $4,800 a month -- and his insurance is capped at $10,000 a year. So after two months, that $4,800 needs to come out of his pocket. And if he goes to Canada, the family has determined that they could save $2,000 a month. So for him, it's $20,000 a year difference if we were to pass this legislation. That's a huge amount of money for him and for his family.
We know the lower cost, the prices -- Senator Dorgan has talked about that as well. What -- what we're interested in is making sure that licensed pharmacists can do business -- just like any other business would be able to choose between American products or be able to do business with someone in another country if they met the safety rules and regulations and so on, we want pharmacists to be able to bring into this country the lowest-priced medicine so people can get the best price. Frankly, this is not like buying a pair of shoes or buying some other commodity. When you can't get your medicine, it literally is life-threatening.
So this is a very serious issue for people. And we can make a dramatic difference by passing this legislation. This legislation in concept has been supported by a very diverse group of organizations, from AARP to the Alliance for Retired Americans, Families USA -- and the Cato Institute, because it's bringing competition to the marketplace.
And as Senator Snowe said and described so well all of the safety provisions. We have addressed any concerns. And in fact, I would argue that this makes the process safer than it is today for Americans, and that's very, very important.
We're talking about Americans not only who have a high drug bill -- like Joe who I spoke about earlier -- but people who fall in the, quote, "doughnut hole," that -- that gap in coverage under Medicare now, people with disabilities and seniors as well.
So this is important to do. We've all been working on this for a long time. And the good news is that we have a president who supports this. It's in his budget. We have a new secretary of Health and Human Services, Secretary Sebelius, who as a governor joined a multi- state drug importation program. So we know that she supports this as well. And we know that this is the moment where we're going to be able to make a real difference for Americans to be able to get life- saving medicine.
SEN. DORGAN: Senator McCain.
SEN. MCCAIN: I'd like to be very brief, except to say thanks to Senator Dorgan, who represents prairie populism in its finest sense. He continues to work and advocate for -- advocate for all of our citizens, particularly average Americans. And I thank him for his tenacity in this issue and on this issue. And maybe our time has come.
Senator Snowe, whose independence is respected on both sides of the aisle and also all over America.
And -- and Senator Stabenow, who represents a state who is having tremendous economic difficulties, and I appreciate her long-time advocacy.
Two quick points.
One, the -- the response that will be immediate from the pharmaceutical companies -- "Well, it compromises safety standards" -- Senator Dorgan has described it does not. It does not. We would not be proposing legislation that would in any way endanger the health of any of our citizens.
Second is the costs. We've just seen recent data -- I saw it today, again -- the cost of a health insurance premium has almost doubled since the year 2000, almost doubled. The problem with health care in America today is it's not affordable. The cost of pharmaceuticals is a major part, a major aspect of the cost of insurance premiums for average Americans. We've got to bring costs -- health-care costs under control by allowing the kind of competition that reimportation of pharmaceuticals will allow, we'll contribute to the -- to the challenge that lies ahead of us.
SEN. DORGAN: Thank you, John.
Q How does this bill -- what would this bill do that a different law doesn't do already? We have -- I think twice Congress passed a law saying we can -- as long as the HHS secretary would certify them safe and it would save money, that you can go ahead and do it. And Sebelius, as you said, supports it. So why do we need the legislation?
SEN. DORGAN: Well, currently, there -- for example, a licensed pharmacist in this country or a wholesaler is not allowed to reimport prescription drugs. There's a law that prevents it. Our legislation repeals that law, puts in place substantial safety considerations and -- and new provisions calling for development of pedigrees for drug lots and so on. So we think it's very important that this legislation be enacted, we believe that we've got a better chance to do it this time than we've ever had, and we've described the savings.
Let me just, if I might -- I think one of my colleagues put it in the context of a person. I was at a farm in North Dakota sitting on hay bales with a bunch of folks in that neighborhood talking about farm policy, and there was an old guy there in his 80s. And he said, "My wife has been fighting cancer for three years, breast cancer." And he said, "She's supposed to take Tamoxifen, but we don't have very much money. So we drive to Canada once every couple of months to get Tamoxifen because it costs 80 percent less."
Now, think of that and spread that over thousands and millions of families and people about the over-charge for prescription drugs in our country. We're trying to change that.
SEN. STABENOW: If I might just -- to comment as well -- and by the way, when Senator Dorgan mentions Tamoxifen, we have many, many people going from Michigan over there, women with breast cancer. It is -- one of the largest savings is in this critical breast-cancer drug.
But to emphasize the difference in terms of why we need this versus what we have today, an individual is allowed to be able to bring back up to a 90-day supply across the border now. But you have to actually go to Canada and go through a bunch of hoops to be able to make that happen, but your pharmacist cannot bring those to your local drugstore.
Also, I had a call from a major university in Michigan with a medical school. They wanted to do business with a Canadian pharmacy or enterprise to be able to lower their cost to the medical school, to be able to do business like they would do with any other kind of commodity. Couldn't do it.
So what we're talking about is the ability to bring in medicine into this country at a lower price; and to allow people who are registered, licensed pharmacists, those that are in the business of making sure there's a supply chain and it's safe, to be able to do that.
SEN. MCCAIN: When Senator Stabenow was referring to Joe, I thought she was talking about Joe the Plumber. But -- (laughter).
SEN. STABENOW: You know, when I said that, I worried about that, too, John. (Laughs, laughter.)
SEN. MCCAIN: He's got troubles.
Q Are you expecting this would be included in a broader health care reform, or this to move as a separate piece of legislation -- (off mike)?
SEN. MCCAIN: What's that?
SEN. DORGAN: We don't know at this point. The strategy for moving it is something we will develop, but it has 25 original cosponsors. We will get many more, in my judgment. And one way or another, whether it's a standalone piece of legislation or part of a broader health-care reform, we intend to move this.
Q How will this bill fit in -- work with somebody who already had drug coverage and who's paying a $10 copay or something? How will it save that individual money?
SEN. SNOWE: Depends on what their -- you know, just that they may be able to -- to benefit with even a lower price because of the competition involved in bringing in a lower-price drug from another country. So it adds competition to the -- the drug sales here in the United States.
I mean, it is interesting to note, you know, even with, you know, generic drugs and manufacturer-assisted, you know, drug programs, it still hasn't brought down the cost of drugs in this country. I mean, that's, you know, indicated by -- in all the drug prices and -- and the rising costs associated with them. So it hasn't benefited to any great degree.
That's why you need the competition that leads from bringing in those drugs from other countries. So that's what it could do. It could -- you know, they could go out and maybe purchase the drug even cheaper. It would be available at a lower price than even what they would get through their insurance premium --
SEN. DORGAN: Can I make one additional comment here? Europe has done this for a couple of decades in something called parallel trading. If you're in Germany and want to buy a prescription drug from Spain, no problem. France, want to buy a prescription drug in Italy? No problem. They have parallel trading, and there has not ever been a circumstance in Europe where there's been a safety issue. If they can do this in Europe, we too in this country can certainly allow the American consumers, through our pharmacists and wholesalers, to access lower-cost drugs.
Thank you very much.
Q How detailed have your conversations been with the Obama administration? Have they just signaled that this --
SEN. SNOWE: Well, he was -- as a former colleague, he was a cosponsor of this legislation. But also -- I haven't had specific conversations with the administration, but last week he announced his support for, you know, a safe importation drug bill, absolutely.
SEN. DORGAN: He and his chief of staff cosponsored this identical bill. And we're going to the -- some of us are going to the White House tomorrow for a health-care forum, and I expect that this will come up.
But I -- you would expect a president that signed up as a member of the Senate for this identical bill to support it, as he's already done in this budget message.
Thank you very much.
SEN. SNOWE: Thank you.
SEN. STABENOW: Thank you.