Print BCTV: Biotech's Voice -- Rep. Eshoo's biotech agenda, America HEALS Act,compassionate use

Biotech's Voice

Transcript of BioCentury This Week TV Episode 189

 

GUESTS

Representative Anna G. Eshoo (D-CA)

 

PRODUCTS, COMPANIES, INSTITUTIONS AND PEOPLE MENTIONED

 

Mr. Shaun McCutcheon

Former Senator Ted Kennedy (D-MA)

Senator Richard Durbin (D-IL)

Rep. Steny Hoyer (D-MD)

Rep. Nancy Pelosi (D-CA)

Rep. Henry Waxman (D-CA)

Rep. Frank Pallone (D-NJ)

 

Google Inc.

23andMe, Inc.

Netflix, Inc.

Stanford University

Citizens United

 

Supreme Court of the United States

Health and Human Services

National Institutes of Health

Food & Drug Administration

Department of Defense

Veterans Administration

 

Human Genome Project

Zohydro ER hydrocodone bitartrate, Zogenix, Inc.

 

HOST

Steve Usdin, Senior Editor

 

SEGMENT 1

 

STEVE USDIN: Representative Anna Eshoo's district is the epicenter of the San Francisco Bay Area biotech industry. She's been a leading voice in Congress on issues involving biomedical progress since 1993. Now, she's trying to increase her influence in Washington.

 

Representative Eshoo is in a tight race to replace Henry Waxman as ranking member of the Energy and Commerce Committee, which has jurisdiction over FDA, Medicare, the Patent Office, and many other agencies that are critical to biomedicine. Today, we'll hear her life sciences agenda. I'm Steve Usdin. Welcome to BioCentury This Week.

 

NARRATOR: Connecting patients, scientists, innovators, and policymakers to the future of medicine, BioCentury This Week.

 

STEVE USDIN: Anna Eshoo represents Silicon Valley in Washington. Her district is home to Stanford University, Google, Netflix, and venture capital's famed Sand Hill Road. It's also at the center of the Bay area's biotech hub.

 

And so is Eshoo. In 2010 she fought and won a battle against leading Democrats including President Obama and Representative Henry Waxman to give biotech drugs 12 years of protection against competition from biosimilars. Eshoo's accomplishments include laws fostering research on drugs for children, funding bio-terror countermeasures, and prioritizing NIH research on pancreatic and other recalcitrant cancers. First elected in 1992, Eshoo won her last election by 40% and is expected to be reelected in November. Eshoo's chances in another election are less certain. She's running to replace the retiring Waxman as ranking member of the Energy and Commerce Committee. Her opponent, Frank Pallone, has more seniority. The rivalry has split Democrats.

 

Speaker Nancy Pelosi backs Eshoo while Democratic Whip Steny Hoyer supports Pallone.

 

From the House Recording Studio on Capitol Hill, I'm pleased to be joined by Representative Anna Eshoo, Representative Eshoo, thank you for sitting with us today.

 

ANNA ESHOO: Delighted, thank you.

 

STEVE USDIN: I wanted to start by asking you what's at the top of your agenda for life sciences with the Energy and Commerce Committee?

 

ANNA ESHOO: Well, first of all, I think that the listening public should have a deep appreciation for what the Energy and Commerce Committee actually does. It is the committee of the future. Its jurisdictions are very broad.

 

And they, actually, whether people realize it or not, those jurisdictions walk into their lives every single day. I'm very concerned that even though the United States of America has been the leader in the world on this very important research that the federal government funds. And it takes place throughout the university systems, our universities.

 

In my case, in my congressional district, it's Stanford University that we continue to cut back on those investments. Now, what happens as a result of this? You go into the labs. You see a lot of people with white coats.

 

And if the grants are not funded, they take those white coats off. They have to leave. They're forced to leave.

 

And - and the research that they have already done through the National Institutes of Health -- through NIH -- that's all scrapped. And so in many ways, we've eaten our seed corn already. So the bill that I'm carrying in the House and which has been introduced in the Senate by the Assistant Majority Leader Dick Durbin is to do the following -- and it is to set up a trust fund that would have funding in it, consistent funding, which is what you need for research.

 

It can't be stop/start. And that trust fund would be adjusted to inflation plus 5% every year for -- the bill covers 10 years -- for a decade. And we both think that this is essential for the people of our country and for our collective future. It's bold.

 

It's important. If we don't do it we are not only going to lose our standing in the world, but the American people will lose. Because we are dependent upon that advanced research to make the breakthroughs.

 

STEVE USDIN: It's bold. It's also expensive. It's about $150 billion.

 

ANNA ESHOO: Well, it was expensive to raise my children as well. For their healthcare, for their education. And I think that those are some of the best things that I did for them. So I think that the American people have a huge appreciation of this issue.

 

I think it's a matter of bringing the Congress up to understand that this is an investment that really must be made. I have a fear of what will happen if we don't. And we are on the decline now.

 

We see other countries making investments. Europe has to put forward a five-year plan. The Asian countries are continuing to add more and more. We are doing less and less. In fact, what we're doing today, our investments, are equal to 1965. I would say shame on us.

 

STEVE USDIN: Well, and what I want to talk to you about when we get back is how you get that consensus and where the money might come for that. We'll be right back.

 

ANNA ESHOO: Mr. Chairman, I rise today to support the Pandemic All-Hazards Preparedness Act reauthorization. This is legislation that I wrote together with congressman Mike Rogers.

 

NARRATOR: You're watching BioCentury This Week.

 

SEGMENT 2

 

STEVE USDIN: We're back with Representative Anna Eshoo. Representative Eshoo, we were talking about this idea of funding NIH and creating a trust fund of something like $150 billion. Very quickly, I wanted to ask you what you think the prospects are for actually getting that money, and then to move on to some other issues.

 

ANNA ESHOO: First of all, I think that this is a bold plan. And I think that it needs to be, I might add that. And that's why the bill is written the way it is. Everyone always asks how you're going to pay for something. That becomes the first question. I think the first question is, test the political will of the people inside the institution. I think that there is an eloquent case to be made for this consistent funding for NIH, for CDC, part of DOD, because there is research that takes place there, as well as the VA. If you develop the political will, then you will find the money.

 

STEVE USDIN: So I want to shift over to some other issues.

 

ANNA ESHOO: Certainly.

 

STEVE USDIN: One of the things that we've talked about on this show recently is about compassionate access, the idea that there are patients who feel like more needs to be done to get access to investigational, experimental drugs. Is that something you think that Congress could play a role in?

 

ANNA ESHOO: Well, of course we can. It depends again on the political will in the case. I'm very familiar with this subject area. Because over my years of service in the Congress, there have been many members of Congress that have contacted me because of the biotechnology companies that are in my congressional district, and their need for this exception for a special drug that has great promise to it, but it is still in a clinical trial. The FDA usually will sign off on it, but there is hesitation on the part of the companies.

 

STEVE USDIN: Exactly. Do you think more needs to be done to give them some kind of incentives or some kind of freedom to do that?

 

ANNA ESHOO: I think if the goal is to help people that are actually desperate, because in many of these cases they are in advanced stages of an illness and want to try anything. Remember, these are drugs that are still in a clinical trial. I think that companies are somewhat reluctant. They hold back. They pull back for legitimate reasons. Is it going to despoil the clinical trial that they're in when it comes to the FDA? That's one question.

 

Another question that arises is, what if it doesn't work? Can the company be sued? And so, in my view, I think it would be worthwhile examining a safe harbor provision in this, so that there will be more of a willingness of companies to do it. Now, I've been successful on behalf of those that have asked for my assistance. But it's very delicate, because the drug has not been approved yet, even though it does have promise and there's desperation on the part of the families and there is something that's hopeful, and yet it hasn't been approved yet. So I think that off the top of my head that perhaps a safe harbor provision could be examined and that could help the situation.

 

STEVE USDIN: I want to ask you when we come back about whether there's some ideas that you have for advancing pediatric drug development beyond what you've already done. Be right back.

 

SEGMENT 3

 

STEVE USDIN: We're discussing Representative Anna Eshoo's life sciences agenda. Representative Eshoo, you played a big part in legislation that facilitated the development of labeling, of studying drugs and what the proper doses are for children. I'm wondering whether you've got ideas to go beyond that for things that might stimulate the development of new drugs for kids, especially, for example, with cancer.

 

REP. ANNA ESHOO: Well, I'm glad that you asked, because in the first case that you just mentioned, pediatricians told me that when they would prescribe a prescription drug for children, the pediatricians, that they would advise the parents to cut the pills up, because there really was not any dosage prescription for a pediatric care. And so that's why I introduced the bill. It did become law. In fact, the 500th drug was just approved for labeling.

 

So we've come a long way in partnering with the pharmaceutical industry, pediatric applications. But there's always more to be done. You can be celebrating something that is working well, and there are still needs.

 

I think that kind of the secret sauce in that legislation was to motivate, but also reward. We knew we had to go through the pharmaceutical industry for this. But we also, in structuring the bill, understood that there needed to be some rewards along the way, because this is not an application for hundreds of millions of people. It's a smaller population.

 

And so I think that that same kind of partnership, as we move to the next chapter and the chapter after that, is to replicate that in the legislation. Because you have to be partners. I mean, this is both public and private.

 

STEVE USDIN: And I want to move to another area that you really were a leader on which is biosimilars.

 

REP. ANNA ESHOO: Yes.

 

STEVE USDIN: And you pushed very hard for that. It's been four years since legislation was passed allowing biosimilars. There hasn't been a biosimilar approved in the United States. And as far as anyone knows publicly, there hasn't been even an application for one. Are you surprised by that, and do you think that more needs to be done to implement the law?

 

REP. ANNA ESHOO: Well, four years -- I can't believe that it's been four years, but it has been four years since that legislation became law. That's a long time for something not to even have the beginnings of implementation. This is for the American people. This is for the patient, consumer, so that we know what came with the generic prescription drugs.

 

STEVE USDIN: A tremendous decrease in cost, increase in access, yes.

 

REP. ANNA ESHOO: A tremendous decrease. And so this is the same thing, but for biologic. So --

 

STEVE USDIN: So why do you think it hasn't taken off?

 

REP. ANNA ESHOO: I don't know. I can't tell you why it hasn't moved along. I just wrote to the FDA commissioner, Hamburg, going over the entire area, and asking questions, and essentially why naming and interchangeability have not -- they've done some studies, but they have not come out with a scientific pathway forward. So that what the law actually calls for isn't on its way into people's lives.

 

STEVE USDIN: So it's a little arcane, but we've talked about it on the show before. There's a big dispute about how biosimilars should be named. Basically, should there be distinct names for biosimilars, or should they have the same what's called non-proprietary name as the original biologic. Where do you stand on that?

 

REP. ANNA ESHOO: Well, I think that we need to see what comes forward from the FDA. I'm a legislator. I'm not someone that works inside of an agency. What I want to see is the law working, because these biologics or biosimilars are, again, an enormous opportunity for people that are sick. And it is an exciting area. It's where science has moved to. And there are people that will benefit from this.

 

And unless and until this implementation begins and there's a smooth pathway, no one has access to it, nor can they afford what's out there right now, which was the reason why Senator Kennedy and I built the case, did the legislation, and why it is the law today.

 

STEVE USDIN: Since you were first elected to Congress in 1992, and up until very recently, you hadn't formed a Political Action Committee. Now you've formed a Political Action Committee. And not surprisingly, the main contributors to it are some of the industries that are in your district, and the ones that are going to be regulated by the Energy and Commerce Committee. I'm wondering why you made the decision to do it, and what think about people who are kind of skeptical, that kind of feeds a kind of cynicism about Washington.

 

REP. ANNA ESHOO: Well, there's a reason why I opened a Political Action Committee. As you've said, I've never had one in 22 years, but I did announce my candidacy to be the lead Democrat of the Energy and Commerce Committee. There is an opening there, because of Henry Waxman announcing that he's retiring from the Congress after 40 years of extraordinary service to the American people, and the people of his district. So by necessity, really, I opened the PAC to help other members, to help bring in new members. And so that's why I did. And --

 

STEVE USDIN: And what would you say to people who basically have a kind of skepticism, whenever they see members of Congress who have PACs and who are getting contributions from industries that their committees are regulating?

 

REP. ANNA ESHOO: Well, it's very important to note that there are many, many individuals that contribute as well. So this is not just for businesses. This is for individuals, and there are limits of what they can contribute.

 

I will never defend the political money system in our country. It's not defensible. It simply isn't defensible. And I think that Citizens United and what the Supreme Court did with that decision -- I think it's one of the worst decisions that any court in the history of our country has made.

 

And now with McCutcheon on top of it, it is just the tsunami of money that will wash over the system. This PAC has limits. I mean, people cannot give unlimited amounts. And everyone knows who's contributing. So there is transparency.

 

But the overall system, is it defensible? I don't think so. I know that my constituents don't like it. I was part of an amicus brief to the Supreme Court on the case, and I think a dream come true in this country would be that we have public financing, and everything else would go away.

 

STEVE USDIN: Well, thanks. We'll wrap up a little bit more with Representative Eshoo in just a moment.

 

REP. ANNA ESHOO: Biologics, the biotechnology industry today in producing biologics has infinity -- that's how long they have -- forevermore. We are bringing this down to straight 12 years.

 

SEGMENT 4

 

STEVE USDIN: We're wrapping up with Representative Anna Eshoo. Representative Eshoo, one of the issues going forward with personalized medicine is direct-to-consumer genomics. And there was a case recently where FDA stopped a company, 23andMe, from making health claims about people's genetic information.

 

And there are various reasons for it, but one of them was that they felt that certain kinds of claims should have to go through people's physicians, or certain kinds of information should go to people's physicians, rather than directly to individuals themselves. So there's a lot of controversy about that. What do you think about it?

 

ANNA ESHOO: Well, first of all, in terms of broadening the lens, I think it's very important that we move toward and really have standards to personalized medicine. And the Human Genome Project, everything that has come out of that, really speaks to it. Each one of us has our own set of determinants. And so targeting the uniqueness of what each human being has really is what personalized medicine is all about.

 

So I think that the Congress needs to think very broadly about that entire field, what it means, bring about some standards that would give direction to the key agencies that have jurisdiction. I'm very familiar with 23andMe. I'm very proud that they are a constituent company, and I know the owner. And so questions were raised about, I think, the efficacy of the kits and all of that. Now, I think --

 

STEVE USDIN:  Yeah. So I'm not going to ask you to comment specifically about them. But the broader issue basically is, should people be able to get -- individuals be able to get information, including potentially medically-actionable information about their own genome? Or are there circumstances where that information should be only available through a trusted intermediary like a physician?

 

ANNA ESHOO: Well, I think that in the one model, it's now called trusted because it's with a physician. The other model is a new one, and so it's innovative, and it's out-of-the-box thinking. And agencies, you know, like the FDA, may not be as skilled to understand what the rules of the road should be. That's why I'm saying it's the Congress that needs to, with the scientists, I think, very importantly, come together.

 

STEVE USDIN: There have been calls recently when members of Congress haven't liked some approval decisions that the FDA has made about Zohydro or about women's reproductive health issues. And they've called for the HHS Secretary on some occasions to overrule the FDA, or they've introduced legislation to try to roll back an FDA decision. What's your view? What should Congress, what should the political process's role be about specific drug approvals like that?

 

ANNA ESHOO: Well, I think that what I'm experiencing at my committee is, first of all, there are so many members that really reject science. Now, science is evidence-based. And so I think that that foundation is so important to respect before you get something else. Now, there is a tendency for individuals to go to bat for a company that's in their congressional district, regardless of what the facts or the science are, and that's not healthy.

 

Now, I understand advocacy. I've advocated. Obviously, I've spent my life advocating for the things that I believe in and where their manifestations are. But I think if you only advocate on behalf of someone because of its commercial value, that you're forgetting a very important aspect in what we do, and that is to protect the public interest. So you have to be able to combine all those things.

 

On the other hand, there are members of Congress that say, we're not going to be disease-specific. Just let the agencies make up their minds about what they're going to pursue and what cures they're going to pursue, and we're not going to get into whether it's going to be Alzheimer's or prostate cancer. I don't agree with that either. So I think that you really have to be very judicious in making these decisions. And commercial value certainly is one, but it's not the only one. It's not the only one.

 

STEVE USDIN: So I want to ask you about one other thing. You talked about things having to be science-based and the importance of science. Well, one of the things that is happening actually, and your district is a hotbed of it and it's happening all across America, is people rejecting science. And one way that they're rejecting science is --

 

ANNA ESHOO: No, my district does not reject science. It's based upon it.

 

STEVE USDIN: So in one aspect, which is the anti-vaccine movement. And there have been outbreaks of pertussis, measles, other vaccine-treatable diseases across America, but especially in California. And I'm wondering, do you think that the federal government needs to do more, basically, to persuade people, or require them to vaccinate their children?

 

ANNA ESHOO: Well I think it's very important to address the challenges and the questions that people will raise about something, and why they are suspicious of a particular vaccine, you know, allegedly bringing on other conditions, and that it might not be safe. In their view, it's dangerous. The way to counter that, to address it, is with more science. And not just saying so, but with the science that brings about the evidence.

 

I remember when I was first elected to Congress, there was a movement about fluoride in the water supply. And there would be a whole group of people that would kind of follow me around to all of my town hall meetings saying that this causes brain damage. So it's science that needs to answer that, not political science, evidence-based science.

 

STEVE USDIN: Thank you, Representative Eshoo. That's this week's show. Have a thought about today's show? Remember, you can tweet about it using the hashtag #BioCenturyTV. I'm Steve Usdin. I'll see you next week.

 

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