It's widely understood that high prescription drug costs in the United States are too high, but what is behind the high prices and how could Congress and the administration take on drug pricing in the current environment? The Commonwealth Fund recently convened three experts to address these questions in an informational briefing for members of the press. The invited experts, Bill Corr, senior advisor at Waxman Strategies and former Department of Health and Human Services deputy secretary, Charles Phelps, an economist and member of the National Academy of Medicines Committee on Ensuring Patient Access to Affordable Drug Therapies, and the honorable Henry Waxman, former chairman and ranking member of the U.S. House of Representatives Energy and Commerce committee, presented their insights into proposed federal policies related to prescription drug costs and answered participants’ questions. Among the solutions addressed were drug-cost provisions in the Bipartisan Budget Act of 2018, which Congress passed in early February and in the president's budget blueprint.
Stream an audio recording of the briefing below, or read the full transcript below.
- Prescription Drug Prices Teleconference Recording
SHAWN BISHOP: Good afternoon and thank you for joining this teleconference on high prescription drug costs in the US and what Congress and the administration can do about it. I'm Shawn Bishop of the Commonwealth Fund and I will be moderating this discussion. I'm joined by three experts who will provide their insights into federal policy developments related to prescription drug costs: Bill Corr, senior advisor at Waxman Strategies and former HHS deputy secretary, Charles Phelps, economist and member of the National Academy of Medicines Committee on Ensuring Patient Access to Affordable Drug Therapies, honorable Henry Waxman, former chairman and ranking member of the US House of Representatives Energy and Commerce committee and sponsor of major laws related to prescription drug innovation and pricing in the US.
Congress included three provisions in the Bipartisan Budget Act of 2018 and President Trump included somewhere in the order of 16 provisions in his fiscal year 2019 budget blueprint that addressed pharmaceutical costs. Most of us have a general sense of what these provisions are, but it would be helpful to have more detail on what they do or might do.
Bill, let's begin with that. Could you explain the pharmaceutical provisions that Congress included in the Budget Act and that President Trump proposed in his budget? What are they and how far do they go in lowering prices?
BILL CORR: Thank you Shawn and thanks to the Commonwealth Fund for hosting today's teleconference. We're experiencing historic increases in prescription drug prices and prescription drug spending. As we discussed in the Waxman Strategies report published with the Commonwealth Fund last summer, and as discussed in the National Academy's report last fall, these price and spending increases are the result of a multifaceted set of problems that are driving higher prescription drug prices.
There are a wide range of policy actions that are needed to tackle these problems. President Trump has repeatedly advised the country that he intends to significantly reduce drug prices. Last Thursday he said his new Secretary of Health and Human Services was, quote, "really setting the world on fire with your lowering of prescription drug prices."
So let's briefly consider the reaction actions Congress and the administration are taking and what impact they will have. In early February Congress passed the Bipartisan Budget Act of 2018 which included three provisions that address prescription drug costs. First and likely the least understood is a provision that changes how the Medicaid program reimburses for drugs that have undergone minor changes from the original version of the drug, sometimes referred to as new formulation drugs. The provision requires these drugs to pay higher rebate if their annual price increases are above inflation. It may sound small, but it saves six and a half billion dollars over ten years.
Second. Congress agreed to close the Medicare part D coverage gap or doughnut hole a year earlier by increasing the manufacturer discount from 50 to 70 percent. The coverage gap discount program requires manufacturers of brand name drugs and biologics to provide a discount to beneficiaries in the doughnut hole. These discounts count towards a beneficiaries out of pocket costs, allowing effective beneficiaries to reach the threshold for catastrophic coverage as if they were still paying 100 percent of the costs of the drugs in question. This change saves Medicare money and protects millions of older Americans from high drug costs.
Third. Congress also extended the same coverage gap discount program to include biosimilars making these alternatives to biologics more affordable for patients.
Shortly after the Bipartisan Budget Act was passed the Trump administration released their 2019 budget blueprint. As Shawn mentioned, this budget blueprint includes 16 policy proposals to address drug costs. And I would like to try to categorize those for you in three general buckets.
First there are two Medicaid proposals. The first would address brand name drugs being misclassified as generic drugs for Medicaid reimbursement. The result is the brand name drug pays a smaller rebate to Medicaid. The other is a five state demonstration to allow states to negotiate drug prices. Today states can form purchasing compacts with other states to gain greater leverage in their negotiation. However, federal law limits state authority to exclude a drug from coverage in the program. Under this demonstration, the administration would allow state compacts to exclude drugs from the formularies to gain leverage in negotiations with manufacturers. This proposal could lower prescription drug prices for Medicaid, but it should be balanced with appropriate access to the treatments patients need. This proposal would be implemented through legislation, or it could also be piloted through the Center for Medicare and Medicaid Innovations Authority.
Second, there is an FDA -- second category is there is an FDA proposal related to the 180 day market exclusivity period provided under the Hatch Waxman Act. That act provides for a generic drug approval system that ensures safe, therapeutically equivalent generic drugs are available at lower prices when patents and other market exclusivities terminate.
As an incentive for generic manufacturers who challenge invalid brand name drug patents, the law provides for the 180 day exclusivity period for the first generic approved before a second generic can be approved. The budget proposal would rescind the exclusivity granted to a generic drug manufacturer that has an application deficiency that is delaying the generic drug's entry to the market. It is unclear what this particular proposal is intended to address because a more effective policy would be to end the exclusivity of 180 days if the first generic manufacturer delays going on the market as a result of a settlement agreement with a brand name manufacturer, the so called Pay For Delay settlement.
The third category and the remaining proposals are all related to drug spending in Medicare which occurs in both parts B and D. Some of the proposals such as setting an inflation limit on price increases for part B drugs could directly mitigate significant price increases if implemented in a way that penalized the manufacturer for increasing the price. Many of the other proposals are designed to reduce patient cost sharing, such as eliminating cost sharing for generic drugs for dual eligible beneficiary. The devil is in the details with most of these proposals and we are continuing to wait on the documents that provide that information to conduct further analysis.
In summary, some of the president's budget proposals would have the important impact of reducing Medicare patient costs for prescription drugs and others could alleviate growth in government spending for drugs in Medicare and Medicaid. These are worthwhile actions to take, but we must also recognize that they have limited impact on drug pricing. And the overall impact on federal spending is also limited.
The president's budget proposal is scored to save about 5.7 billion dollars over ten years. The bottom line is that different, more effective policies that are targeted on the drivers of high drug prices are required to lower prescription drug prices and make prescription drugs more affordable. Hopefully the provisions I've described in the budget act and in the 2019 budget and President Trump's predictions will encourage further conversations about those more effective policies. They include proposals like increasing competition in the pharmaceutical industry and distribution system, eliminating anti-competitive behaviors by the industry that block or delay competition, and testing new models for reimbursements that incentivize values and outcomes.
Shawn, I think that's an initial general summary and we can then go into more detail if our listeners would like.
SHAWN BISHOP: Thank you Bill. Chuck, I know you're on the line here. Could you also jump in and share your perspective on the pharmaceutical provisions in the president's budget? What, if anything, should policy makers consider beyond both the Budget Act and the president's budget in your view, and why?
CHARLES PHELPS: Thank you Shawn. I'll be speaking primarily to summarize the report from the National Academies of Science, Engineering, Medicine, "Making Medicines Affordable, A National Imperative." I was a member of that committee along with 17 other experts from widely spread across the fields of pharmaceutical policy and manufacturing.
What we'll find is that the recommendations that the National Academy report specify a much wider set of activities to really control drug pricing than are presented in the Bipartisan Budget Act and the president's budget statement. There are some things that came out of those that were in the National Academy report which I'll highlight briefly. But let me just summarize the areas where the National Academy report felt that important actions needed to be taken and a broad package to control this problem.
The first is to accelerate market entry of generics and biosimilars to enhance competition. This includes specific recommendations to prevent the Pay For Delay that Bill Corr was just speaking about and also the preclude with vigorous antitrust enforcement, anti-competitive mergers. We would also seek to minimize evergreening, which is patent extensions that keep coming along to increase the market exclusivity period without really significantly altering the drug that's available to patients, just extends the time of market exclusivity and high prices.
The Academy also recommends seeking reciprocal drug approval arrangements with trusted nations around the world so we could, in essence, accept their agreement that a drug was safe and effective and allow it into the market before FDA approval has necessarily been granted here. The FDA back log on approving generic entrants is also important. They've done important work to reduce that back log, but as more and more generics come onto the market the back log persists. The European back log is two drugs. It counts in the hundreds in the United States. So we recommended funding in the FDA to eliminate and completely remove these back logs on approving generic competitive entrants in the future.
So there's a whole raft of things relating to generic entry. None of those address the question about prices of drugs that are still in the exclusivity period from patents. And the Academy report recommended on this primarily focusing on these drugs that the government consolidate and apply its purchasing power and formulary design strengthening to directly negotiate with drug manufacturers for lower prices. In effect Medicare CMS would become the bargaining agent, and states would be, on our proposal, empowered to opt in to this bargaining agreement if they wished, but it would greatly strengthen the bargaining power versus the current situation.
As a bit of background, I will say we did not recommend drug price controls on the initial Academy Report. This is a less intrusive negotiation process. And compared to the pricing of other services in Medicare, parts A for hospitals and part B for physician services, this is actually less intrusive, both parts A and B the government directly sets prices without negotiation. So this is, in effect, a more flexible process than the Medicare system does for entirely for almost everything else in health care.
The third set of recommendations that the Academy proposed is to assure transparency in financial flows all through the supply chain. There are several statements in the president's budget, for example, talking about discounts being passed on. Our report finds that you just can't get data to tell what's going on now on that question. When discounts are given we don't know how big they are or we don't know where they stick within the distribution chain. And so the Academy report recommends full transparency to allow understanding of exactly what happens to these discounts as they move through, where profits are sticking and where they're being passed onto lower prices to consumers.
A fourth recommendation area deals with the direct-to-consumer advertising of the industry. The American Medical Association has called for a ban of this practice and the United States is only one of two nations in the world that allow direct-to-consumer advertising ubiquitous on television and other media. Our report recommends removing the tax deductibility of these expenses and seeking an industry code of conduct that would continue to promote public health benefits of these ads without capturing -- you know, trying to avoid the adverse effects that they now have on costs and spending.
Another fifth recommendation we made to put a cap on out of pocket spending in part D. This is directly done in the president's budget, almost exactly the same as the Academy report suggests. Another area of concern for the Academy is the orphan drug program, which Congress when Waxman was essential in helping to bring to market has been very effective in getting drugs to market for diseases that have relatively small populations that might benefit.
There are a number of loopholes that have emerged in the Orphan Drug Act where there've been situations where blockbuster drugs that have more than a billion dollars a year in annual revenue have been eligible for and continue to receive blockbuster -- I'm sorry, [UNINTEL] receive orphan drug benefits. So we proposed limitations on how many times and when pharmaceutical companies can get the benefits of the Orphan Drug Act, so that it continues to function in its very important fashion.
There are several other recommendations that I won't dive into, but those are the ones that I believe are most important. Now let me close with a little bit of context in relation to this. One of the things that's happened in the United States is there's been a very rapid and large growth in prescription drug insurance coverage over the last three or four decades. Want Orphan Drug Act and the Hatch Waxman Act, and to the original Bayh Dole Act developed drugs more passed in the first half of 1980s, 35 percent of prescription drug costs were covered by insurance. That number is now 87 percent according to CMS data. And in a sense, market pressure to control prices has evaporated. So the importance of doing something now on drugs is directly related to the growth in health insurance coverage for prescription drugs. And we believe -- I certainly strongly believe that trying to deal with this just by fixing the out of pocket cost is not going to solve the underlying problem of the cost at the front end of the system. The higher coverage of insurance simply erodes market forces and invites higher prices. And we're bearing the consequences of that now. I'll conclude my remarks with that and be open for questions when we get to that.
SHAWN BISHOP: Thank you Chuck. That's very helpful. And we can-- one of the challenges that we have based on your comments and Bill's comments is that there's a lot of moving parts here. And I think Bill, as you said, a lot of challenges related to the multidimensional nature of problems that need to be addressed. But I'd really like to turn to Congressman Waxman and get your perspective here because you, as you know and we all know, you were a major leader in setting up our current framework for prescription drug pricing in the US. What do you think of the president's package and what are the opportunities for moving all or parts of it over the next three years?
And really what we're trying to get to is, in your view, what will it take to get more action from Congress to lower drug prices given that we have so many things that we need to address? How are we going to get this done?
HENRY WAXMAN: Thank you very much Shawn and Commonwealth for hosting this conference on the high drug costs and prices. And it's particularly with a focus on what the president is proposing. Congress will respond to these proposals the way they always do. They'll take some of them, tweak some of them, and it will be Congress's proposals in the final day.
The proposals that have already passed in the Balanced Budget Act are important ones. And many of these proposals that are now being put forth and the president's suggested -- suggestions for the budget are ideas that have been around for some time. Some of them were even proposed by President Obama with some tweaks on them. So I'm sure Congress will look at these proposals and decide what they want to adopt.
But we're not short on ideas of how to tackle high prescription drug pricing. Bill and Charles discussed several promising proposals that could lower prescription drug prices and make sure patients have access to affordable life saving treatments. Many of the proposals in the National Academy of Science, Engineering and Medicine report were also discussed in the report my team published this summer with the Commonwealth Fund.
There are several good policy approaches, but it will be up to Congress and the Trump administration to decide what problems of high prescription drug pricing they're willing to take on. And this will not be easy. The politics will likely get in the way of the policy. But it can be done if members of Congress have the will.
As you can tell there's no silver bullet to address the issues of prescription drug pricing. In this Congress that will start with figuring out what problems there can be bipartisan support to take action. When I think back to the time when Warren Hatch and I worked to pass it in the 1980s, legislation to create incentives for R & D for new drugs, a generic drug market and also incentives for manufacturers to invest treatments for orphan diseases, those efforts were successful because they were bipartisan and the proposals were well thought out before we-- and we took consideration of the various interests. It took us several years of conversations and debate, but we didn't give up and we were able to build the momentum to pass legislation that focused on striking a balance between competition and incentives.
For a while we found that balance. However, I think that the rising prices of drugs is a result of losing that balance. And there is an opportunity to restore that balance in the Congress today. Our design has run its course and we are in a situation where fundamental changes are needed to balance the incentives and price competition that Senator Hatch and I worked hard to find in the 1980s.
We saw a few small positive steps with the Bipartisan Budget Deal that included closing the Medicare part D doughnut hole a year early, extending the manufacturer discounts to biosimilars and fixing the issues with Medicaid new formulation drugs that allowed excessive price increases.
But keep focused on the fact that while the president's budget also included several proposals that could lower patient costs and reduce federal spending for prescription drugs, it had very few proposals that tackle drug pricing. That's not to say that his proposals aren't without merit and won't help a lot of people, but if we're talking about high drug prices there is very little being proposed to deal with that problem. Complexity of the issues lend themselves to starting with an understanding and agreement of the various problems and what's driving these high prices. And that was the approach that we did when we developed our report. We thought there ought to be a consideration not of just a bunch of ideas and suggestions, because we certainly are not short on ideas of how to tackle high prescription drug pricing. But we need to find where there's a possible consensus on a bipartisan basis to deal with those drivers of costs, where Democrats and Republicans can work together.
And even in a divided Congress, progress can be made. But it has to start with a discussion among the policy makers with a few simple questions. What are the problems and drivers we're willing to take on? And what are we willing to do about these problems?
The media plays an important role in contributing to that conversation by helping people understand these complex and complicated drivers of high drug pricing and that's why I'm pleased that we have this opportunity to talk directly to the media.
There are some immediate items that are right for addressing and could result in incremental fixes that would increase price competition. There are many members of Congress who agree there are problems, and I hope they continue discussing how to find solutions. But I do want to give a couple examples where I think Congress should be ready to act. Brand name manufacturers tactics to delay generic competition using the risk evaluation and mitigation strategies and limited distribution networks, is-- as the Creates Act, and Congress could move on that proposal. They could look it over and see what objections there are to it. But I don't see why there ought to be any objection to making sure that those who want to make a generic copy of a drug can't get the information to be able to make that copy of the drug. Congress could reaffirm FDA's authority to ensure access to samples that would be available when approving a RAMS [?] or approving a new drug application. Generic manufacturers should not have to go to court to get access to the brand drug. That was in the Creates proposal, but there are other ways to address that issue.
Brand name manufacturers should not be allowed to misuse citizens' petition to delay and approvals. In addition to the work FDA is currently doing, Congress could ensure there's no delay as a result of filing of citizens' petitions unless there's a safety issue or other unexpected concerns. FDA can complete the biosimilar pathway including finalizing rules around interchangeability of biologics and biosimilars to encourage more manufacturers to enter the market.
And federal agencies could engage in proactive market monitoring. There's also an opportunity to increase FDA authority and resources to monitor the drug marketplace to identify and address anticompetitive behaviors and gaming by manufacturers. Some of these could be done by Congress, some could be done by FDA alone, some could be done together. But these solutions should not be the end of the work. There are several major areas that also need to be addressed. For example, the role of the federal government in purchasing drugs for the various federal health programs including Medicare, VA and DOD, or address the length of patent and exclusivities protections so that the incentives to develop new drugs are balanced with the need to increase price competition. That's the balance we need. That's the balance we try to achieve in the Hatch Waxman Act. We need to look at those proposals after the experience of several decades and to realize that balance needs to be restored. So I'm pleased to be a part of this discussion and to join in the answering of questions that may come up.
SHAWN BISHOP: Thank you Congressman Waxman for your comments and taking us through your experience. Bill and Chuck, before I open up the lines or we ask the line to be open, do you want to add any additional comments? Or should we -- I understand no from Bill.
BILL CORR: No, I think we're ready to move on.
SHAWN BISHOP: You're good? Chuck, do you want to add anything before we open up the line?
CHARLES PHELPS: Just briefly to emphasize my complete agreement with what Congressman Waxman just said about needing to rethink this balance. This is the key to policy, the policy issues in this area. When the extension of 25 years of exclusivity was granted in legislation in the 1980s that was a really good balance at that point.
As I mentioned earlier, the wide, strong increase in insurance coverage for this has tipped the balance far away from where it needs to be now in my personal judgment. And so I strongly endorse what Congressman Waxman just said in his concluding remarks.
SHAWN BISHOP: Thank you Chuck. I think that now we're happy to take your questions. And if the operator can open up the line we would appreciate that.
OPERATOR: And at this time, if you'd like to ask a question please press *1 on your touch-tone phone. You may remove your question at any time by pressing the # key. Once again, *1 on your touch-tone phone. We'll pause a few moments to allow questions to queue.
We'll take today's first question from Cathy Kelly with Information Week. Please go ahead, your line is open.
CATHY KELLY: Thank you. It's actually Informa. Pharmaceutical manufacturers have been very crucial of the provision in the budget law that increases the discount in the doughnut hole to 70 percent, and have said that they want that repealed. I just wondered what your prediction was about whether they would be successful in repealing it or perhaps revising it?
SHAWN BISHOP: Who wants to take that? Anybody want to jump in on that? Congressman?
HENRY WAXMAN: Well, I think they'll put that issue on the table because it's of concern to pharma. But I think that Congress is going to have to look at all the issues with regard to the Medicare doughnut hole and make sure that what we're trying to do is get people through that doughnut hole without having to pay an extraordinary amount of money.
So obviously if we lowered spending that doesn't mean we're lowering the prices. And we ought to see what the Congress does when they look at all the issues with regard to the Medicare doughnut hole.
SHAWN BISHOP: Anybody else to add in? Bill? Chuck? The only thing I would -- I would just add to that that obviously that would favor, I think Bill you had mentioned, you know, these -- that's where the saver provision in the Budget Act. And so rescinding that would require expenditures. So that's going to be a hurdle if they revisit this. Obviously it would be, at least, taking away something that beneficiaries theoretically would have been given if the law were to be able to go forward. So that's another consideration. So I think there's a hurdle there for sure because it was both -- it's going to cost money to undo it and, two, it's in a sense it's taking something away from beneficiaries that they otherwise would get. So let's turn it back over to the operator to see if we have more questions.
OPERATOR: And as a reminder it is *1 to ask questions. We'll go next to Robert King with the Washington Examiner. Please go ahead.
ROBERT KING: Hi, thanks for taking my question. I wanted to focus on a point made about minimizing evergreen. Would it take an administrative action to do that or does that have to be done through legislation in Congress.
SHAWN BISHOP: Thank you. Bill, can you -- Chuck? Would you like to jump in?
CHARLES PHELPS: Briefly I think the answer is probably both. The evergreen in question is extremely complex. It's one word that encompasses dozens of behaviors. So my guess is that some could be done with administrative action, others may require legislation to clarify authority. I'll just leave my comments at all.
SHAWN BISHOP: Bill, want to jump in?
BILL CORR: I think Chuck is exactly right. The patent office, you know, works initially with the pharmaceutical companies as they submit additional applications. And we've got to be very cognizant in that process that novelty doesn't necessarily mean that a drug is different clinically. And so there are some complicated questions, but it's very important that we get to the bottom of evergreen because the original compromise between patent extensions and generic drug approvals in the early 1980s assumed that you would have one patent life extended for some of the time that you were at FDA. And that has changed.
And what evergreening has done is it allowed companies to extend well beyond what was expected in terms of patent protection, to the extent that the additional patents are not significant improvements in the product itself and the way that it would affect people clinically. We need to reexamine that.
Also part of the patent process that is under challenge from the pharmaceutical industry is the internal review that the Patent And Trademark Office provides when there are questions about additional patents that have been issued. And that issue is before the Supreme Court. I know that the Senate Judiciary Committee has been very interested in assuring that the Patent Office review inter partes review, as they call it, is continued and if successful it's a much quicker way to determine whether patents are valid and assure that we get to the competition side of this equation in a timely fashion.
HENRY WAXMAN: Let me just add if I might that a lot of the proposals that we've been hearing about are proposals to bring about competition sooner, get the generic drugs reviewed and out on the market so that competition can lower the price. But the balance is also not to make sure that the patents and the exclusivities keep this monopoly in the hands of a drug manufacturer without competition. A lot of the ideas that people have should be looked at in terms of the balance, get the competition going sooner, but make sure that the incentive to produce new breakthrough drugs is adequate, but not over extended beyond what anybody ever imagined through games that are played either to stop generic competitor or to hold onto a patent when the time is up and competition will be needed.
SHAWN BISHOP: Great.
CHARLES PHELPS: One more quick comment from Chuck here. Just it's important we think about competition in the broad sense. There's now very solid evidence showing that sometimes only one or two generic entrants is insufficient to get the market price down to a good competitive level. And there's continued price decreases with third and fourth and sometimes fifth entrants in the same market. So it's important to have processes that assure we have multiple competitors in these markets in some occasions.
SHAWN BISHOP: All right, thanks Chuck, thank you all. And I would just add of that, is that what I'm hearing is that there's action to be taken on both sides of the equation, so to speak. Can we encourage more participants in the market and can we make sure that the innovators have a fair amount of time to market their products. So we have a lot to do on both sides. And what I'm hearing from Congressman Waxman is that we need to look at both sides. We have issues and problems on both sides that could rebalance the innovation with the competition.
Let's go back to our operator to see if we have more questions.
OPERATOR: Certainly. And as a reminder it is *1 for questions. We'll go next to Linda Johnson with the Associated Press, please go ahead.
LINDA JOHNSON: Hi. Given the power of the pharma lobby, does anybody think that Trump is actually going to make good on his pledges to reduce high drug prices? And I'm not talking about the competitive things and nibbling around the edges that you've been discussing, I'm talking about allowing reimportation or some kind of price controls so that people here are not paying four times what things cost in Europe and elsewhere.
HENRY WAXMAN: I think that there's --
LINDA JOHNSON: Is this Representative Waxman?
HENRY WAXMAN: This is Henry Waxman -- no appetite to move to price controls. I think we need to look at the existing system or we want to give incentives for development of new drugs, and then to have competition lower prices. Chuck is right when he mentions that it's not just one generic, but often many generics that actually lower the price of drugs. I think that the president has given us an opportunity to look at this issue and to put it at a high priority.
I remember when president George H W Bush after many years of stalemate on the Clean Air Act said he wanted a Clean Air Act. And said that he was ready for Congress to act. I think we ought to look at President Trump's statements as an invitation for members of Congress to take on the issue where they can develop a bipartisan consensus to act. That may not mean, and most likely will not mean anything on price controls or a silver bullet as some people think they might have it, but to look at the various drivers of cost and to figure out ways to deal with it, just as we know that we're ready to do what we can on the Creates Act, there are other areas where I think we're I think we're ripe for action and we need Congress to sit down and focus on the issue, not just who's for this and who's for that, but what can they do.
There's no members of Congress, Democrat or Republican, that hasn't heard from constituents or-- angry at the price-- high price of drugs, which are making these drugs unaffordable. And we know from our own budget we're paying more and more for drugs, and that's an increasing cost for federal health programs and it's certainly a great burden on the private insurance system as well. There are ways to propose less of an impact on people, and many of the president's proposals do that. But I think we've got to start tackling the high price of drugs itself.
SHAWN BISHOP: Chuck or Bill?
LINDA JOHNSON: Which is what I've asked about. And it doesn't sound like you see anybody actually going to do that. I mean you said we need bipartisan agreement of Congress. How is that going to happen?
HENRY WAXMAN: Well, I -- I was in Congress for many, many years with Democratic and Republican presidents, Democratic and Republican control of the House and the Senate. And I think it's a mistake to think that Congress can not act. Even when you have different parties in control we need to focus on what are the drivers of [UNINTEL]. There's no Democratic or Republican drivers, there's questions of what can we do and we ought to look at some of the ideas, kick them around, see what Congress is willing to do, and then work beyond that as we can try to develop a consensus which will have bipartisan support.
Hatch Waxman Act was bipartisan in its nature. Senator Hatch is a conservative Republican. Henry Waxman is a liberal Democrat. The Orphan Drug Act was passed overwhelmingly on a bipartisan basis. And even the Clean Air Act, which is probably something that couldn't pass if it were put on the House or Senate floor today, was overwhelmingly adopted on a bipartisan vote of the Congress, Democrats and Republicans standing up and putting their imprimatur on a law that I think has done a great deal of good. And I think Congress can do it again.
SHAWN BISHOP: Anybody else? I think one of the things that if I were to-- what I'm hearing is that, you know, what we need to focus on as you said Congressman Waxman is what are the problems to be solved. And that's the rallying cry, it's really about what are the drivers, what are the problems. I think that's what I'm hearing for the speaker today. And I think what sometimes we tend to do, because as was said here, we have a plethora of solutions. But what's not-- it's not about rallying solutions. Congress will find the solution, find-- if I'm understanding what you're saying Congressman Waxman, they'll find a solution if they sit down and commit to understanding what the problem is. So that's sort of what this conference call is about, is hopefully the media will be able to help people understand what the problems are and commit to a rallying cry around the problems. And that brings Congress to the table, hopefully, to find a solution.
Any more questions? I think we are at the end of our time. I know we could talk for at least another three hours, maybe just on one of the topics that you all brought up. So let me just say thank you all of you, Congressman Waxman, Bill, and Chuck for coming together today to have a very quick conversation. But we hope we'll have more of these. We really appreciate your participation on the phone and if you have any follow up questions we're happy to speak with you off line and we hope to hear from you again on another future conference call. Thank you.