WEBVTT - Biden’s Drug-Pricing Expansion Plan, Part 2 0:00:12.160 --> 0:00:14.560 Hello to our listeners, and welcome to the Votes and 0:00:14.680 --> 0:00:17.880 Verdicts podcast, hosted by the policy and litigation team at 0:00:17.880 --> 0:00:22.840 Bloomberg Intelligence, the investment research platform of Bloomberg LP. Our 0:00:22.920 --> 0:00:27.000 podcast series examines the intersection of business policy and law. 0:00:27.480 --> 0:00:30.040 I'm one of your hosts for today, Tishwalker. I'm an 0:00:30.080 --> 0:00:35.000 analyst with Bloomberg Intelligence covering patent pharma litigation, and. 0:00:35.040 --> 0:00:39.240 I'm dwain Right, a senior healthcare policy analyst at Bloomberg Intelligence. 0:00:40.840 --> 0:00:43.800 On today's episode, Duayne and I are revisiting the Biden 0:00:43.840 --> 0:00:47.520 Administration's proposal to update martian rights under the BIDOL Act 0:00:47.560 --> 0:00:50.440 to include a specification that price can be a factor 0:00:50.479 --> 0:00:53.320 in determining that a drug is not accessible to the public. 0:00:54.120 --> 0:00:56.480 You'll recall that Duayene and I discussed this topic on 0:00:56.520 --> 0:01:00.000 our January eighteenth episode with doctor Aaron Kesselheim of Harvard 0:01:00.240 --> 0:01:02.640 Medical School, who is very much in favor of the 0:01:02.680 --> 0:01:06.480 administration's proposal, and as we noted on that episode, we 0:01:06.560 --> 0:01:09.039 see this effort by President Biden as part of a 0:01:09.040 --> 0:01:12.679 broader conversation on drug pricing ahead of the November elections, 0:01:13.200 --> 0:01:16.080 setting up a contrast with the likely challenger Trump, who 0:01:16.120 --> 0:01:18.800 sought to prohibit the exercise of marching rights on the 0:01:18.800 --> 0:01:21.840 basis of price alone. To help us round out our 0:01:21.880 --> 0:01:25.120 discussion on this topic, we've invited Joe Allen, who was 0:01:25.160 --> 0:01:28.679 the lead staffer for Indiana Senator birch By when the 0:01:28.680 --> 0:01:31.920 by Doll Act was enacted back in nineteen eighty. Joe 0:01:31.959 --> 0:01:35.000 is now the executive director of the Bidel Coalition, which 0:01:35.040 --> 0:01:38.600 seeks to preserve the underlying framework of the law. Joe 0:01:38.680 --> 0:01:41.000 will talk with Dwayne and I about his work as 0:01:41.000 --> 0:01:44.919 a staffer developing the legislation and how his efforts now 0:01:45.200 --> 0:01:48.640 and his efforts now leading the coalition. Joe, Welcome to 0:01:48.680 --> 0:01:51.080 the Votes and Verdicts podcast, and thank you so much 0:01:51.120 --> 0:01:52.639 for joining Dwayne and I today. 0:01:54.080 --> 0:01:55.840 Well, thank you very much for inviting me. I'm really 0:01:55.840 --> 0:01:57.120 looking forward to our conversation. 0:01:57.480 --> 0:02:01.040 Well, Joe, can you tell us about your background, starting 0:02:01.120 --> 0:02:04.880 with your work on the US Senate Judiciary Committee for 0:02:05.160 --> 0:02:09.880 Senator By, which ultimately led to passage of the Bidule Act. 0:02:11.560 --> 0:02:15.400 Sure, I was actually a very junior staffer. Actually, Senator 0:02:15.400 --> 0:02:17.440 By inherited me. I actually worked for a Senator named 0:02:17.520 --> 0:02:20.520 John Tunney on Judiciary Committee. You ever saw the movie 0:02:20.720 --> 0:02:23.359 The Candidate with Robert Redford and Dustin Hoffman. It's about 0:02:23.480 --> 0:02:27.240 Senator Tunney, and after he lost, Senator By inherited me. 0:02:27.639 --> 0:02:29.400 I was, like I said, I was a junior member. 0:02:29.400 --> 0:02:34.079 I was basically a research assistant, and they were very 0:02:34.080 --> 0:02:35.840 gracious they took me on. I think probably because I 0:02:35.880 --> 0:02:40.040 was cheap, but anyway, I was doing some work for 0:02:40.080 --> 0:02:45.440 Senator Bye and actually got him into another topic which 0:02:45.480 --> 0:02:49.320 was unrelated to the Senate Judiciary Committee on making alcohol 0:02:49.400 --> 0:02:51.480 fuel out of corn, which was a big deal in 0:02:51.520 --> 0:02:55.000 the seventies because we had a gas embargo and Senator 0:02:55.000 --> 0:02:57.840 By got excited about it. But I was on Judiciary Committee, 0:02:57.840 --> 0:03:00.320 so another staffer took it away from me once the 0:03:00.320 --> 0:03:03.880 Senator got interested. So my general counsel nels Ackerson knew 0:03:03.919 --> 0:03:06.320 I was pretty crushed, and he said one day, Hey, 0:03:06.320 --> 0:03:08.760 we've got Purdue coming by to talk about some patent thing. 0:03:08.800 --> 0:03:10.400 Would you like to sit in And I said sure. 0:03:11.080 --> 0:03:13.160 We had no idea what Purdue was going to talk about, 0:03:13.600 --> 0:03:16.040 but they mentioned that they were having They made it 0:03:16.080 --> 0:03:19.320 a mentioned with Department of Energy funding and under current 0:03:19.520 --> 0:03:21.800 policies in place, then it was going to be taken 0:03:21.840 --> 0:03:25.240 away from them and never utilized. So we thought, well, 0:03:25.240 --> 0:03:27.120 that didn't make any sense, and they actually had with 0:03:27.200 --> 0:03:30.560 them the General Council from that institute National Institutes of Health, 0:03:31.040 --> 0:03:33.600 who said, this is a big problem across the government. 0:03:34.120 --> 0:03:37.880 So long story short, my General counsel asked me to 0:03:37.880 --> 0:03:38.480 look into it. 0:03:38.520 --> 0:03:40.200 I did, and we. 0:03:40.120 --> 0:03:43.240 Also found out that Senator Dole, who was a Senator 0:03:43.280 --> 0:03:47.240 birch By was a liberal Democrat. Senator Bob Dole was 0:03:47.280 --> 0:03:50.080 a conservative Republican. They didn't agree on hardly anything. It 0:03:50.640 --> 0:03:53.040 would be sort of like today if Ted Cruz and 0:03:53.080 --> 0:03:56.960 Elizabeth Warren suddenly joined forces on something. But we found 0:03:57.000 --> 0:04:00.280 out that Dole was interested in the same issue, said well, 0:04:00.320 --> 0:04:04.119 let's work together. It'll be bipartisan. And about a month 0:04:04.200 --> 0:04:08.040 later we were invited to make My general counsel was 0:04:08.040 --> 0:04:10.120 invited to make a talk to the universities and he 0:04:10.200 --> 0:04:12.560 hurt us back, so he asked me if I would go. 0:04:12.800 --> 0:04:15.880 So I'd never spoke, never spoken in public before. I 0:04:15.920 --> 0:04:18.640 was going down to talk to a group of university 0:04:18.920 --> 0:04:22.120 technology transfer people who knew more about this than I did. 0:04:22.200 --> 0:04:25.120 But anyway, it turned out that actually I wound up 0:04:25.160 --> 0:04:27.839 taking over the issue. So it was serendipity, and I 0:04:27.839 --> 0:04:30.520 guess it's best. But I've been actually working on this 0:04:30.560 --> 0:04:31.080 ever since. 0:04:32.160 --> 0:04:37.960 So that's great history. And we'll dig into the mechanics 0:04:37.960 --> 0:04:41.920 of the Bidual Act, specifically the marching provisions in a second, 0:04:42.000 --> 0:04:45.719 but can you fill us in now? Fast forward to 0:04:46.160 --> 0:04:51.320 twenty twenty four. You're the executive director of the Bidal Coalition. 0:04:52.200 --> 0:04:54.599 What's the goal and the function of this group. 0:04:56.160 --> 0:04:58.560 Well, that's also a story of serendipity. 0:04:59.360 --> 0:05:03.440 In nineteen we were coming up on the fortieth anniversary 0:05:03.440 --> 0:05:05.640 of by Dole. Bid Dole was passed in nineteen eighty 0:05:05.720 --> 0:05:10.600 and twenty twenty would be the fortieth anniversary. So somebody 0:05:10.600 --> 0:05:12.960 called me. Hans Souer from Bio called me and said, 0:05:12.960 --> 0:05:15.360 you know, we had to do something to actually recognize 0:05:15.360 --> 0:05:18.240 the fortieth anniversary. And I said, yeah, that I was 0:05:18.279 --> 0:05:21.640 actually doing doing some consulting then, and I said, well, 0:05:21.640 --> 0:05:23.520 that makes sense, because you know, we got to really 0:05:23.520 --> 0:05:27.679 celebrate what Bidole has done. Because the by Dole Act 0:05:27.839 --> 0:05:31.400 didn't create any new bureaucracy, didn't create any new funding. 0:05:31.440 --> 0:05:32.560 So it's kind of invisible. 0:05:32.600 --> 0:05:34.479 It's like the little train that could sort of working 0:05:34.480 --> 0:05:37.040 here in the background, and it doesn't really get much recognition. 0:05:37.680 --> 0:05:40.560 So we said let's put something together. And you know, 0:05:40.600 --> 0:05:44.039 we talked to some other university people, some industry folks, 0:05:44.080 --> 0:05:45.680 and we were just going to do a program at 0:05:45.680 --> 0:05:49.880 the National Press Club. Well, a thing called COVID happened 0:05:49.960 --> 0:05:52.440 after in the end of twenty nineteen, so it turned 0:05:52.480 --> 0:05:55.640 out we couldn't do our press event. We wound up 0:05:55.640 --> 0:06:01.279 doing a webinar and it actually went very well, and 0:06:01.279 --> 0:06:03.599 we started actually doing some events throughout the year because 0:06:03.640 --> 0:06:05.320 by Dole has been under attack and a lot of 0:06:05.360 --> 0:06:07.720 people don't know the history, which we'll talk about today. 0:06:08.320 --> 0:06:12.360 So again another long story short. You know, we actually 0:06:12.400 --> 0:06:15.680 started putting out the real history of by Dole, how 0:06:15.680 --> 0:06:18.000 the law was passed, what it does, et cetera, et cetera, 0:06:18.080 --> 0:06:22.640 trying to counter some of the misrepresentations, and that went 0:06:22.720 --> 0:06:25.360 so well that people said, well, you know, we got 0:06:25.360 --> 0:06:28.800 to keep the same going. So actually last year we 0:06:28.800 --> 0:06:30.840 actually turned it into a five oh one c four. 0:06:30.960 --> 0:06:32.880 Before that was kind of like a club. You know, 0:06:32.920 --> 0:06:35.720 we basically had no real budget. We were just kind 0:06:35.760 --> 0:06:38.680 of going along from from month to month, but the 0:06:38.720 --> 0:06:42.279 issues kept coming up. So actually it is now a 0:06:42.320 --> 0:06:46.279 real organization. We have members across the spectrum industry, members 0:06:46.400 --> 0:06:51.800 university members, venture capitalists associations, and the purpose of the 0:06:52.000 --> 0:06:55.000 of the coalition is is pretty simple. We tried to 0:06:55.040 --> 0:06:57.720 explain the history of by Doll, what it's done, and 0:06:57.760 --> 0:07:00.520 why it's important to make sure it works as intended. 0:07:02.360 --> 0:07:05.360 And so you mentioned that BI Dol is under attack, 0:07:05.440 --> 0:07:07.520 and we'll talk about that a little more in some 0:07:07.560 --> 0:07:10.880 of our later questions. But what's your general experience been 0:07:11.120 --> 0:07:14.000 in how the act has functioned over the last forty 0:07:14.080 --> 0:07:15.400 years since it's been passed. 0:07:16.880 --> 0:07:19.840 Well, you know, by Doll was an experiment because before 0:07:19.920 --> 0:07:22.960 by Doll, going back to World War Two, the government's 0:07:23.000 --> 0:07:26.160 policy was that if the government funded any research, an 0:07:26.240 --> 0:07:29.160 invention was made, the government would take that invention away 0:07:29.160 --> 0:07:31.840 from whoever created it, take it to Washington, and make 0:07:31.880 --> 0:07:34.840 it available basically that anybody wanted it, which was it 0:07:34.880 --> 0:07:37.440 was kind of like a Marshall Plan of technology. And 0:07:37.480 --> 0:07:40.520 that seems really laudable because again, in nineteen forty five, 0:07:41.040 --> 0:07:43.960 the United States is one of the few economies still standing. 0:07:44.000 --> 0:07:48.160 Europe was devastated, Japan and China were devastated, and so 0:07:48.280 --> 0:07:49.880 that seemed like a nice thing to do. But what 0:07:50.000 --> 0:07:53.440 happened was in the seventies, Japan and Germany got back 0:07:53.480 --> 0:07:57.920 on their feet and they started taking taking technologies away 0:07:57.920 --> 0:08:02.360 from US steel, automotives, electronics, c And so the time 0:08:02.400 --> 0:08:05.120 we started by Dole, the American economy was really in 0:08:05.160 --> 0:08:08.080 a tail spin. So that's one of the reasons we started. 0:08:08.240 --> 0:08:10.160 You know, it was an experiment. We said, it doesn't 0:08:10.160 --> 0:08:12.239 make any sense for the government to take things away 0:08:12.280 --> 0:08:15.520 and they're not being commercialized. We need to make sure 0:08:15.520 --> 0:08:18.240 that we reverse at and give people incentives to actually 0:08:18.280 --> 0:08:20.880 step in and turn these into real products, which takes 0:08:20.880 --> 0:08:24.600 a lot of industry investment. But I think the best 0:08:24.760 --> 0:08:26.920 thing I've seen that actually shows how it's worked is 0:08:27.480 --> 0:08:31.040 the Economist Technology Quarterly, which is not even a US publication, 0:08:31.200 --> 0:08:34.120 said the bi Dole Act is probably the most inspired 0:08:34.160 --> 0:08:37.800 piece of legislation over the past half century. More than anything, 0:08:37.840 --> 0:08:42.360 it helped reverse America's precipitous slide into industrial irrelevance. So 0:08:42.559 --> 0:08:45.719 it's the basis for public private sector partnerships, and that's 0:08:45.760 --> 0:08:47.520 a big deal. That's one of the reasons we've actually 0:08:47.559 --> 0:08:51.480 reasserted our technology leadership. Really starting with the passage of 0:08:51.480 --> 0:08:54.560 Bidole in nineteen eighty that we were in danger of losing. 0:08:54.600 --> 0:08:57.400 So I think it's been a tremendous success, but like 0:08:57.440 --> 0:08:59.719 I said, it doesn't have any bureaucracy, it doesn't have 0:08:59.720 --> 0:09:03.240 any cheerleaders, and so a lot of people that don't 0:09:03.360 --> 0:09:04.880 like that policy, they want to go back to the 0:09:04.920 --> 0:09:07.520 pre by Dole policy of the government, you know, basically 0:09:07.679 --> 0:09:10.120 micromanaging things and giving things away serve and we can 0:09:10.200 --> 0:09:14.240 use them. Have created an alternative history, and that's one 0:09:14.240 --> 0:09:15.760 of the reasons that we want to make sure that 0:09:15.840 --> 0:09:21.200 we're going back and really explaining what bi Doll does, 0:09:21.640 --> 0:09:25.240 how fundamental it is to the US economy, and how 0:09:25.280 --> 0:09:26.959 important is to keep that going. 0:09:27.000 --> 0:09:27.120 You know. 0:09:27.200 --> 0:09:29.640 Now, particularly we're being challenged by China, which is actually 0:09:29.640 --> 0:09:31.680 adopted by Doll to compete against. 0:09:31.360 --> 0:09:34.360 Us, and you know, so one of the things that 0:09:34.360 --> 0:09:37.559 by Doll did though, was sort of preserve the ability 0:09:37.600 --> 0:09:42.120 for the government to go in and recapture, let's say, 0:09:42.160 --> 0:09:45.000 recapture an invention. And so maybe we can set the 0:09:45.000 --> 0:09:47.400 stage a little bit for our listeners here. I mean, 0:09:47.400 --> 0:09:50.160 we talked about this on our last podcast, but can 0:09:50.160 --> 0:09:52.400 you remind us sort of what are the laws four 0:09:52.480 --> 0:09:55.240 key pillars that would open the door for the government 0:09:55.320 --> 0:09:58.559 to come back in and exercise what we call march 0:09:58.600 --> 0:10:01.880 in rights under the bi Dola Sure. 0:10:02.440 --> 0:10:05.080 Basically I mentioned before that even before by Dole, the 0:10:05.120 --> 0:10:08.400 government would take inventions away and take them to Washington 0:10:08.440 --> 0:10:10.520 and they would sit there. Well, it soon became a 0:10:10.640 --> 0:10:13.800 parent that that really was not working because the government's 0:10:13.800 --> 0:10:17.319 funding early stage inventions, you know, things like out out 0:10:17.320 --> 0:10:20.280 of basic research or mission research, neither one of which 0:10:20.320 --> 0:10:23.360 is leading to a commercial product. So when the government 0:10:23.440 --> 0:10:25.959 has when a patent comes out of government funding, it's 0:10:26.000 --> 0:10:29.040 more like an idea than a product. And what happened 0:10:29.120 --> 0:10:32.720 was before by Dole, the Cumptroller General found there were 0:10:32.720 --> 0:10:35.480 twenty eight thousand inventions sitting on the shelf in Washington 0:10:35.559 --> 0:10:39.280 basically being unused. So even as far back as the 0:10:39.640 --> 0:10:44.000 as nineteen fifties and the Truman administration, the government recognized, hey, 0:10:44.559 --> 0:10:46.240 you know, there might be cases where we need to 0:10:46.320 --> 0:10:49.960 let the inventing organization own the technology so they can 0:10:50.000 --> 0:10:53.040 commercialize it. And even when they did that, they said, 0:10:53.040 --> 0:10:54.960 but we want to make sure you're really making a 0:10:54.960 --> 0:10:57.400 good faith effort to turn it into a product. So 0:10:57.520 --> 0:11:00.680 if you're not, even if we wave you the rights, 0:11:01.160 --> 0:11:03.080 if you're not turning into a product, the government can 0:11:03.120 --> 0:11:06.120 march in and either take the invention back or license 0:11:06.160 --> 0:11:09.600 it to somebody else. And so President Kennedy expanded on 0:11:09.679 --> 0:11:12.840 that actually made it easier for people to get their 0:11:12.840 --> 0:11:16.200 petitions granted, and President Nixon did the same thing. So 0:11:16.400 --> 0:11:19.200 marching rights precede by Dole. But the purpose has always 0:11:19.240 --> 0:11:21.880 been to make sure that good faith efforts are being 0:11:21.920 --> 0:11:25.480 made to turn a federally funded invention into a useful product. 0:11:26.120 --> 0:11:28.120 So when we passed by Dole, we build on that, 0:11:28.160 --> 0:11:30.520 and in fact, we took some of the same language 0:11:30.600 --> 0:11:34.720 going back to the Kennedy administration and the Nixon administration 0:11:35.800 --> 0:11:38.319 into the by Dole Act. Now, the other thing I 0:11:38.360 --> 0:11:42.600 should mention is By Dole, as I said, changed forty 0:11:42.679 --> 0:11:43.720 years of government. 0:11:43.360 --> 0:11:44.960 Policy so overnight. 0:11:45.080 --> 0:11:48.800 Literally under by Dole, what we said was that a 0:11:48.920 --> 0:11:51.720 university or a small company making an intervention with government 0:11:51.760 --> 0:11:55.000 funding can own it, they can license it for commercialization. 0:11:55.760 --> 0:11:57.800 The university has to give a preference for a small 0:11:57.840 --> 0:11:59.840 company and people that make it. In the United States, 0:12:00.559 --> 0:12:03.400 but before by Dole, most universities had never managed a 0:12:03.440 --> 0:12:06.760 technology before. So we have four march in triggers. As 0:12:06.800 --> 0:12:10.119 you mentioned, the first one only applies to the university, 0:12:10.160 --> 0:12:13.760 to the patent owner, and under Bidole, it's typically a university, 0:12:13.920 --> 0:12:16.400 and it says that you need to make sure that 0:12:16.440 --> 0:12:21.080 the technology has been made into it is being turned 0:12:21.080 --> 0:12:24.559 into a product. In other words, it's practical application. It's 0:12:24.600 --> 0:12:27.880 being made something useful, and we define that is making 0:12:27.880 --> 0:12:30.560 sure it's available to the public on reasonable terms. And 0:12:30.559 --> 0:12:33.360 that's really what the debates centered on. Well, what we 0:12:33.480 --> 0:12:35.719 meant by that, and what's clear by reading the statute 0:12:35.760 --> 0:12:39.040 was we didn't want the university putting crazy terms in 0:12:39.120 --> 0:12:42.080 the license agreement, like for example, you have to hire 0:12:42.160 --> 0:12:45.480 the chancellor's daughter is a CEO, where you have to build. 0:12:45.280 --> 0:12:46.600 Us a new football stadium. 0:12:47.040 --> 0:12:49.440 We also wanted to make sure universities were actually putting 0:12:49.960 --> 0:12:52.000 terms in there where they're monitoring it to make sure 0:12:52.040 --> 0:12:54.200 a company is turning us into a product. Because one 0:12:54.200 --> 0:12:57.040 of the fears before, one of the criticisms of by 0:12:57.080 --> 0:13:00.679 Dole was well, what of the giant company licenses technology 0:13:00.679 --> 0:13:04.040 from some university to suppress it because maybe it competes 0:13:04.080 --> 0:13:06.880 with an existing product. So we want to make sure 0:13:06.920 --> 0:13:09.760 that the universities had milestones in their agreements to make 0:13:09.760 --> 0:13:11.600 sure it's being turned into a product. So that's the 0:13:11.640 --> 0:13:15.599 first first trigger. A practical application again the burdens on 0:13:15.640 --> 0:13:19.120 the university to make sure you're licensing unto reasonable terms 0:13:19.520 --> 0:13:23.680 and also that you're monitoring commercialization. The second one was 0:13:23.720 --> 0:13:26.360 to make sure that the product can meet public health 0:13:26.360 --> 0:13:28.640 and safety needs. In other words, you're producing. 0:13:28.400 --> 0:13:28.760 Enough of it. 0:13:28.760 --> 0:13:30.960 If you have a COVID pandemic or something like that, 0:13:31.080 --> 0:13:34.000 you know, make sure that there's enough quantity going out. 0:13:34.440 --> 0:13:37.160 The same thing for meeting the needs of government regulations. 0:13:37.679 --> 0:13:40.240 And as I mentioned before, Bia DOLE gives a preference 0:13:40.280 --> 0:13:42.320 in licensing to people that will make the product in 0:13:42.360 --> 0:13:46.040 the United States. So if somebody reneges on their agreement 0:13:46.240 --> 0:13:48.920 and you're making the product in Bolivia as opposed to 0:13:49.320 --> 0:13:52.839 New York, and the government finds out, it can march 0:13:52.880 --> 0:13:55.840 in and it can force the university to either license 0:13:55.880 --> 0:13:58.520 other people or the government can do it itself. And 0:13:58.559 --> 0:14:00.400 the other thing I should say is when my Dole 0:14:00.520 --> 0:14:04.160 uses the phrase reasonable terms issues twice in the statute, 0:14:04.200 --> 0:14:07.200 both referring to the terms of a license. So if 0:14:07.280 --> 0:14:10.960 the university refuses, if the government marches in and says 0:14:10.960 --> 0:14:13.560 you have to license another person, the losses has to 0:14:13.559 --> 0:14:14.920 be done on reasonable terms. 0:14:14.960 --> 0:14:15.600 In other words, you. 0:14:15.600 --> 0:14:17.360 Can't have your nose out a joint and make it 0:14:17.360 --> 0:14:20.480 impossible for the next person to commercialize it. So that's 0:14:20.520 --> 0:14:24.840 what marching rights do, and by Dole was passed in 0:14:24.920 --> 0:14:27.160 nineteen eighty. Marching Rights was, by the way, not a 0:14:27.200 --> 0:14:30.120 big contention of the by Dole. We can talk about 0:14:30.520 --> 0:14:33.000 the debate of her by Doole. Marching rights was not 0:14:33.080 --> 0:14:36.360 an issue. People understood that, and for twenty years there 0:14:36.400 --> 0:14:39.040 was no there was no debate about it. But then 0:14:39.080 --> 0:14:42.000 what happened was I should also mention there were people 0:14:42.040 --> 0:14:46.280 that didn't like by Dole, and it was criticized on 0:14:46.320 --> 0:14:49.080 two bases. One of which was she had people like 0:14:49.200 --> 0:14:52.640 Ralph Naders Group Public Citizen and Admiral Ricover who liked 0:14:52.640 --> 0:14:55.760 the old policies that the government would take inventions away 0:14:56.640 --> 0:14:59.960 and put them in the public domain. The second debate was, 0:15:00.080 --> 0:15:02.760 and the more serious attack, was that by Dole only 0:15:02.800 --> 0:15:07.080 applied to universities and small companies, and a lot of 0:15:07.120 --> 0:15:09.240 people said, well, we should put big business in there, 0:15:09.280 --> 0:15:11.400 and we didn't do that because we said the promise 0:15:11.600 --> 0:15:16.080 is really more focused on universities than small companies. So anyway, 0:15:16.160 --> 0:15:18.840 twenty years after by Dole passed, we were sitting around 0:15:18.880 --> 0:15:22.040 mining our own business. A couple of law professors put 0:15:22.040 --> 0:15:25.400 out this article claiming they'd found a secret meaning in 0:15:25.440 --> 0:15:28.080 by Dole. You know, again, we don't leave you don't 0:15:28.120 --> 0:15:31.800 leave secret meanings in a statue like the da Vinci Code. 0:15:32.320 --> 0:15:34.320 Don't you don't write bills like the da Vinci Code. 0:15:34.360 --> 0:15:37.040 We have like secret meanings in there. So I when 0:15:37.080 --> 0:15:40.360 I actually got a copy of the article, I actually 0:15:40.520 --> 0:15:42.760 I was actually running a thing called the National Technology 0:15:42.760 --> 0:15:45.560 Transfer Center, which is funded by Congress to help people 0:15:45.600 --> 0:15:49.160 commercialize technologies. And at first I was stunned because I 0:15:49.280 --> 0:15:51.880 actually put together the hearings on by Doll. I wrote 0:15:51.880 --> 0:15:55.280 the Senate Judiciary Committee report, I staffed it through the Congress, 0:15:55.280 --> 0:15:58.200 and I actually oversaw the Department of Commerce. So I'm 0:15:58.240 --> 0:16:00.720 reading this paper and it has in there, you know, 0:16:00.760 --> 0:16:03.400 alleging to be the debate over by Dole, all about 0:16:03.520 --> 0:16:07.240 marching rights. And I don't recognize what they're talking about. 0:16:07.680 --> 0:16:09.800 So I look at the footnotes and I found that 0:16:09.840 --> 0:16:13.000 what they've done is the legislative history of the bill 0:16:13.320 --> 0:16:17.560 is the debate on that bill, you know, the committee 0:16:17.600 --> 0:16:20.480 report on that bill. What these people had done is 0:16:20.520 --> 0:16:23.840 they'd gone back and look at other committee debates over 0:16:23.920 --> 0:16:26.960 patent policy. There were bills before by Dole or people 0:16:27.000 --> 0:16:31.000 that didn't like by Dole, So it was actually I 0:16:31.040 --> 0:16:32.640 actually laughed once I realized what they did. 0:16:32.640 --> 0:16:34.200 I said, well, no one's going to believe this. 0:16:34.280 --> 0:16:36.200 I mean, you know, I guess anything can get through 0:16:37.240 --> 0:16:43.000 an academic publication. But then they then the two authors 0:16:43.040 --> 0:16:45.680 got a wrote an op ed in the Washington Post 0:16:45.800 --> 0:16:48.760 called paying Twice for the Same drugs, And what it 0:16:48.800 --> 0:16:52.000 was alleging was that the government could march in and 0:16:52.080 --> 0:16:56.120 force force university as to license another person if somebody 0:16:56.120 --> 0:17:00.000 thought that a product wasn't reasonably priced. Now, there's nothing 0:17:00.080 --> 0:17:03.080 in the statute about that. There's no definition of reasonable pricing. 0:17:03.760 --> 0:17:06.320 So I hadn't worked for birch Buy for twenty years, 0:17:06.640 --> 0:17:07.480 and I actually. 0:17:07.160 --> 0:17:08.320 Called him up on the telephone. 0:17:08.359 --> 0:17:11.280 We didn't really have PCs back then, in the ancient days, 0:17:11.840 --> 0:17:13.560 and I got him on the phone he was at 0:17:13.560 --> 0:17:16.119 a law firm and explained what was going on. I said, Senator, 0:17:16.200 --> 0:17:18.159 this is really serious now, because this is in the 0:17:18.240 --> 0:17:22.720 Washington Post and this completely misrepresents how your law works, 0:17:22.760 --> 0:17:25.760 and it actually undermines it. Because one of the bases 0:17:25.840 --> 0:17:30.160 of by Dole was we decentralized technology management from Washington 0:17:30.200 --> 0:17:33.760 to the people creating the technology. There's a few things 0:17:33.800 --> 0:17:36.400 government can do, but basically they get out of the way. Well, 0:17:36.440 --> 0:17:40.000 this was an attempt to reinsert Washington micromanagement, in other words, 0:17:40.000 --> 0:17:41.880 to turn the whole bill on its head, because now 0:17:42.040 --> 0:17:45.399 government can decide whether a product is reasonably priced or not. 0:17:46.160 --> 0:17:48.880 And so after I talked to Senator Buy, he said, 0:17:48.960 --> 0:17:52.080 let me call Bob Bob Dole, and so they immediately 0:17:52.119 --> 0:17:53.760 wrote a rebuttal. 0:17:53.480 --> 0:17:54.520 To the Washington Post. 0:17:55.240 --> 0:17:58.399 Now, when you're writing, when you're writing an article in 0:17:58.440 --> 0:18:02.159 the newspaper, there's an ed which is longer. They wouldn't 0:18:02.160 --> 0:18:03.600 give us an op ed. They would only give us 0:18:03.600 --> 0:18:06.840 a letter to the editor. So Buy and Dole wrote 0:18:06.840 --> 0:18:09.439 a rebuttle back saying that's not how the law works. 0:18:10.119 --> 0:18:15.719 And anyway, nevertheless, after that, the people that that uh, 0:18:16.200 --> 0:18:19.960 the Ralph naderfolks, started filing a series of petitions to 0:18:20.040 --> 0:18:23.800 the government alleging that the law allows the government to 0:18:23.840 --> 0:18:26.120 march in if a price was if a product isn't 0:18:26.160 --> 0:18:31.200 reasonably priced. And you know, it started its start of 0:18:31.240 --> 0:18:33.640 the whole thing which is which is existing to today. 0:18:33.880 --> 0:18:36.120 We can get into a little a little bit later. 0:18:36.240 --> 0:18:39.879 But that's that's really how we got into this debate again. 0:18:40.040 --> 0:18:43.000 It wasn't a fight. We saw it again for twenty years, 0:18:43.000 --> 0:18:45.440 the law work as intended, and all of a sudden 0:18:45.480 --> 0:18:48.080 you had people come up with a you know, a 0:18:48.119 --> 0:18:51.399 manufactured alternative history to buy Dole. So one of the 0:18:51.400 --> 0:18:53.680 things we've done in the Bi Dole Coalition to counter 0:18:53.760 --> 0:18:57.000 that is we put the original documents on our website. 0:18:57.000 --> 0:18:59.640 We have a thing called a virtual library, a digital library, 0:19:00.200 --> 0:19:03.160 so you can actually read the real history of Baidol 0:19:03.280 --> 0:19:07.120 and you'll see there's nothing in the statute about reasonable pricing. 0:19:07.760 --> 0:19:11.800 So that's a helpful history which I was not aware of. 0:19:12.000 --> 0:19:16.400 So I appreciate that. And I think when I reflect 0:19:17.720 --> 0:19:22.000 on your comments and our previous podcast, I think there 0:19:22.160 --> 0:19:27.240 is a bit of an insinuation that, well, Joe, you 0:19:28.520 --> 0:19:31.879 worked for the Senator, you were part of this effort 0:19:32.280 --> 0:19:37.280 to put this bill into law. Now you're kind of 0:19:37.560 --> 0:19:41.600 a hired gun of sorts. So of course your attitude 0:19:41.680 --> 0:19:46.440 or your views changed, and the legislative history shows that 0:19:46.840 --> 0:19:50.680 price was always meant to be part of this discussion. 0:19:50.880 --> 0:19:54.520 Seems like you're saying, no, it was never part of 0:19:54.520 --> 0:19:57.199 the discussion. Hence all that we've done is part of 0:19:57.200 --> 0:19:59.960 the coalition. But can you just expand on that a bit. 0:20:01.320 --> 0:20:03.679 I'm really happy to because you said it very nicely. 0:20:03.720 --> 0:20:06.399 It's actually worse than that. They've actually attacked the integrity 0:20:06.400 --> 0:20:09.719 of birch Buy and Bob Dole, who can't defend themselves. So, 0:20:10.480 --> 0:20:14.280 as I mentioned before, Senator By and Dole immediately responded 0:20:14.280 --> 0:20:16.840 to the Washington Post saying price is not a factor 0:20:16.880 --> 0:20:21.000 in by Dole, and they started filing marching petitions shortly 0:20:21.040 --> 0:20:24.840 after that, basically on this false premise that by Dole 0:20:24.880 --> 0:20:27.200 allows people to mark the acause the government to march 0:20:27.240 --> 0:20:30.920 in if a product isn't reasonably priced. So there's only 0:20:30.960 --> 0:20:36.240 been one public meeting in twenty years on marching petitions, 0:20:36.560 --> 0:20:38.600 and that was held by the National Suits of Health 0:20:39.080 --> 0:20:42.320 on the on the first one on price control. And 0:20:42.640 --> 0:20:44.199 they didn't call it a hearing, they called it a 0:20:44.240 --> 0:20:47.800 meeting because under the marching rights, the way it works is, 0:20:47.840 --> 0:20:50.280 first of all, somebody files a petition like they did, 0:20:50.760 --> 0:20:52.960 the agency looks at it and says, okay, do you 0:20:53.000 --> 0:20:55.240 meet one of the four triggers we talked about earlier. 0:20:55.280 --> 0:20:57.960 If you didn't meet the four triggers, it's dismissed. If 0:20:58.000 --> 0:20:59.960 you do meet the four triggers, it starts a whole 0:21:00.119 --> 0:21:03.160 series of administrative hearings and you can actually appeal to 0:21:02.760 --> 0:21:06.040 the Court of Claims. But what NIH did was when 0:21:06.080 --> 0:21:09.119