Sens. Schumer and Gregg Hold news Conference on Generic Medicine Bill

Date: June 5, 2003
Issues: Drugs

Sens. Schumer and Gregg Hold news Conference on Generic Medicnie Bill

GREGG:

    Senator Schumer and I are here today, and we're joined also, but not physically, but joined by Senator McCain and Senator Kennedy to announce an agreement on a generic drugs bill which will address some of the major issues which confront the ability of people to purchase drugs at a reasonable cost and in a manner which makes them available in a quick and prompt way.

    This is an issue which we've dealt with as a Congress now for about five years, and we haven't been able to come to an agreement. There's been a lot of different views and a lot of good effort made, but we've never been able to come to a consensus which is bipartisan and involves a lot of different players who are interested in the issue.

    However, with this agreement between myself and Senator Schumer, Senator Kennedy and Senator McCain I think we have made a great stride down the road towards trying to resolve this issue.

    This bill, as it's structured, will do a number of things.

    First, it will make drugs available to folks at a reasonable price. It'll make them available in a prompt and quick way. It will make it a less litigious exercise, and it will continue to encourage innovation.

    It was essentially mean the drugs instead of being in the courtroom will be in the medicine cabinet, and that was our goal.

    And I'm very excited about this initiative. In fact, we will be marking up this bill next week in the health committee. So we're going to put it on the fast track.

    And I'm glad to have the support obviously of the ranking member of the committee and Senator Kennedy in this initiative.

    And I'll turn it over to Senator Schumer.

SCHUMER:

    Well, thank you, Judd. And first, let me thank you for your leadership.

    Judd and I became friends on the basketball court in the House gym.

GREGG:

    We were on the...

    (CROSSTALK)

SCHUMER:

    Yes. When no one else showed up, we got to start, and they usually had us guard each other.

    But in any case, I want to thank Judd for his leadership today and for us coming together. I guess they say that politics can make strange bedfellows. And Judd standing here today with me, and John McCain and Senator Kennedy in absentia, but Judd and I being here today reminds me of the great artists, Vincent Van Gogh and Paul Gauguin, who were arch rivals before coming together to create beautiful art.

    "In general, Vincent and I do not see eye-to-eye especially as regards painting," Gauguin wrote to a friend in 1888. But later that year the two spent nine weeks together in southern France producing works that helped set the stage for what we know today is modern art.

    Well, what Judd and I are working together to achieve today 100 years later may not be art, but the effects might be just as eye- catching. We've achieved a real breakthrough with this agreement because we've met the original goals of the Schumer-McCain bill by modifying it to address the concerns that critics, like Senator Gregg, had from supporting it last year.

    We've really come together. We've met halfway. And as a result, I think we've got a stronger bill poised to roll through the Senate, and it stands a good chance of being able to make it through the House as well.

    As Judd said, the proposal we put together makes it easier for less expensive generic drugs. And it'll significantly reduce costs to senior citizens, but also to younger people who need these drugs, and to the U.S. government, and to companies throughout America that are struggling with the high costs of medical care.

    The U.S. government will save billions of dollars, and that's not chump change; it's real savings. And if there was ever a time we needed those savings, it's now.

    America's economy is hurting, and prescription drugs become a costly necessity for millions of Americans and for this government. State Medicaid programs, businesses, employers, insurers -- we're all struggling to pay for prescription drug coverage. And consumers of all ages are struggling to pay for their prescription drugs. We've all heard the stories.

    This bill does something to reverse that situation: It's free market, pro-consumer, and it doesn't cost the government a penny.

    It's a nice going-away present to Mitch Daniels. It's the kind of bill he would dream of, that is, again, a bill that's free market, pro-consumer and doesn't cost the government a penny. It saves the government money to boot.

    So let me illustrate how this helps the average consumer.

    My office surveyed some of the most commonly prescribed drugs to senior citizens in New York, and we figured out how much they'd save if the generic was available. The savings are astonishing.

    And you can see some of them here in terms of the gap.

    New York City residents pay $1,100 for Celebrex -- that's a very popular and effective arthritis medication. A generic drug would cost New Yorkers about $420 a year.

    The numbers are the same and are similar in New Hampshire or throughout the country. I just did them for my state.

    In Long Island, the average cost of Lipitor -- the popular cholesterol drug, which I am taking -- is $935 a year. A generic version is $365.

    Instead of paying $590 for Norvasc -- the hypertension and angina drug -- people would pay $230 a year for the generic version.

    So for the individual consumer, these prescriptions are almost a dream come true. They show that these drugs can one day be within the reach of working Americans without having to take out a second mortgage.

    Judd has gone over some of the details. They're in the press release. I think we'll forego the details.

    But Judd is exactly right. We've done a bunch of things. We've kept the basic thrust that you can't go for an extra 30-month period and 30-month period and 30-month period. We've made it difficult if not impossible to file frivolous patents and extend the original patent to the drug. But we've done it in a different way, one that reduces litigation so everyone won't be in court arguing.

    And we've done it in a way that says to a drug company: Continue to innovate. We want you to innovate, because we're not going do anything to curb your first set rate of return.

SCHUMER:

    And so that's basically what we do here.

    And we also tell the generic industry: No more games. If you have an exclusivity agreement, you can't use that to prevent the drug from coming on the market.

    So this is not pro-brand-name drug, it's not pro-generic drug; it is pro-consumer. When either industry is doing something they shouldn't, the bill takes it into account, but does it in a way that they won't end up in court all day long.

    So we're proud of this bill. It's going to make a real difference.

    And I know with Judd's leadership as chairman of the committee, we'll get it through the health committee and then make sure we can make it come to law.

    I just want to add a few personal notes.

    Aside from Judd's leadership I want to thank John McCain. He was going to be here. I don't know what happened. Five minutes? Well, we'll hope.

    But John has been my partner in this originally, and he's been a great partner and someone who really cared about this issue, stuck his neck out. And when he saw that Judd and I were putting together a compromise, he helped make it happen in the sense that he said, "You do what we have to do to get this bill done." And I appreciate that.

    I want to thank Ted Kennedy, also who was going to be here today but is very busy. And he, again, when he was chair of the committee, he really made this issue and put it front and center.

    And two other people I want to thank are John Edwards and Sue Collins. Both of them worked real hard to make modifications. John has been lobbying me from day one and working with me to make sure this happens, and both of them deserve a lot of credit as well.

    Let's hope we can make this bill law.

GREGG:

    We'll take any questions.

QUESTION:

    (OFF-MIKE)

GREGG:

    Well, first off, I think that we have a much better bill. I mean, obviously a strong -- it was made last year, and my disagreements went basically to the litigiousness that I thought would come out of the bill and to the chilling effect I was afraid it might have on innovation. But those have all been addressed.

    So I do think we have a much better product to make a case for.

    I'm hopeful, and I think we have -- I can't speak for the White House, but I do think the administration has looked at this and feels fairly positive about it. And hopefully that will be the case.

    As for the House, I would never, never speak for the House of Representatives on any subject. But hopefully if the Senate can put together a good bill, the House will take a long, hard look at it.

    The industry? I think both sides of the industry might have some concerns. Because we didn't try to write an industry bill that was either generic-oriented or brand-name-oriented. We tried to write a bill that would be good for the consumer and would also protect the basic goals of those two industries.

    The brand names wanted to protect their intellectual property and their ability to make money off their intellectual property, and the generics wanted to get onto the playing field quickly and without a lot of gamesmanship -- and we've attempted to that. And so there may be reservations on both sides, but I think we can overcome them because it's a good bill.

QUESTION:

    (OFF-MIKE)

GREGG:

    Well, this does have a price tag of saving somewhere in the $60 billion range, depending on what the administration does relative to their regulation on the 30-month rule. But as it presently stands, it would be scored I think somewhere in that range.

    Will it end up on the Medicare bill? It could, or it could move free-standing, in my opinion. It's going to have a very strong vote coming out of the committee, I think.

SCHUMER:

    One other thing I just want to mention, Julie (ph). I don't think this is a weaker bill. I think in terms of the consumer, in terms of it bringing the prices down, it's every bit as good as the bill that Senator McCain and I did last year. It just takes a different approach, particularly on the enforcement side, saying there are better ways to do it than long litigation.

QUESTION:

    What was Senator Frist's reaction (OFF-MIKE)

GREGG:

    You should probably ask Senator Frisk. But he's been kept apprised of what we're doing. And obviously he is not only the leader, he's the key player on our committee. So we want to make sure Senator Frist is content.

QUESTION:

    Under this legislation, FDA will have to adopt and make changes (OFF-MIKE)

GREGG:

    Well, there has been no regulation issued. And we think that they're functioning under a regulatory straitjacket which doesn't allow them to do as much and be as creative and be as positive as we were.

    So we hope that they'll take a hard look at this and evaluate it before they come to conclusion as to what they've put forward as regulation.

SCHUMER:

    Last year when the FDA came out with its regulation and many of us called them and asked them, "Well, why didn't you do this, this or this," they said much of what we would have to do would have to be statutory, that they didn't have the ability to just write the regulation as best they want.

    And I'm hopeful that the FDA, when they see this, they'll say, "We're supportive of this, and we don't need the regulation." But that'll be up to them.

QUESTION:

    Senator Gregg, if I can something on another topic. This whole question of...

    (CROSSTALK)

GREGG:

    Well, let's just see if there are any other questions on this topic first.

    Yes?

QUESTION:

    If this were added to the Medicare legislation given the (OFF-MIKE) $60 billion in savings, would this essentially free up more private -- or add to the prescription drug benefit in Medicare?

SCHUMER:

    It very well might.

QUESTION:

    I mean, it could be a $60 billion kind of...

    (CROSSTALK)

SCHUMER:

    Well, the $60 billion is everybody's savings. It's not just the government's savings.

QUESTION:

    Would that be specific to Medicare? How would that...

SCHUMER:

    I can't remember, our number for Medicare was about $60 billion?

STAFF:

    Without (OFF-MIKE) drug benefit I think would have been around $20 billion.

SCHUMER:

    $20 billion. So it will clearly free up some money for Medicare if this passes, and for Medicaid, and for other things.

GREGG:

    Makes it much more attractive to the Medicare package, I would think.

QUESTION:

    (OFF-MIKE)

GREGG:

    I think we probably should save that for another event, because that would become the dominant topic of this event if we were to get into it, quite honestly.

    Yes?

QUESTION:

    The Democrats, you know, have been outraged (inaudible) child tax credit was taken out of the tax bill. Now they're citing 250,000 military families that will now no longer get the child tax credit. What's your response to those charges that the Republicans were, you know, are not doing anything for (OFF-MIKE) tax cut.

GREGG:

    See, again, I think that's probably best left to another arena. But I suspect that that's going to be addressed by the majority leader and the chairman fairly quickly.

QUESTION:

    (OFF-MIKE)

GREGG:

    I'll leave that to the majority leader and the chairman at the moment.

QUESTION:

    (OFF-MIKE) and then again in three months say that all patent issues should be resolved. Do you think generics are concerned with (OFF-MIKE) might expire but then they'll still seen liable for treble damages?

SCHUMER:

    Well, first, the generic can start the suit before the patent actually expires. So, in fact, they can start at any time up to -- starting with five years after the drug is on the market.

QUESTION:

    (OFF-MIKE)

SCHUMER:

    After they fill their application.

QUESTION:

    (OFF-MIKE)

SCHUMER:

    Right. Sorry. File their application. So that will cut back on the time rather significantly that is needed there.

    You know, smart generic companies will have most of these issues resolved by the time the patent expires. Now, I mean, could it work out in a couple of instances that it wouldn't? Yes. But overall that doesn't seem to be a problem.

GREGG:

    Last question? Yes?

QUESTION:

    (OFF-MIKE)

GREGG:

    No, that's dropped.

SCHUMER:

    Well, the Orange Book provision -- there is an Orange Book provision in there.

GREGG:

    There is, but it doesn't go to that.

SCHUMER:

    Doesn't talk about that, right.

GREGG:

    It's not the use-it-or-lose-it situation, or list-it-or- lose-it. It basically limits the damages that are available if somebody sues on the issue of whether the patent exists. You can't hide the patents any longer and get treble damages.

    Is that the correct...

    (CROSSTALK)

SCHUMER:

    Yes.

GREGG:

    ...of that?

QUESTION:

    (OFF-MIKE) but only in the context of a counterclaim, and that's what the Federal Trade Commission has recommended in its report last year.

SCHUMER:

    I think if you look at this bill overall, I mean, it deals with a lot of the problems. These were not pro-drug, pro-brand, pro-generic. Just problems. Because this is such a complicated area. And I think we deal with them effectively.

    I am convinced, from my perspective, that this is a better bill. Not just a compromise, but a better bill.

GREGG:

    Thank you very much.

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