Judd Gregg will reportedly be appointed as Sec. of Commerce today.
Here a few data points on pharmaceutical issues.
Gregg was once a supporter of parallel trade. But his tone of these issues had changed quite a bit, as illustrated by some of the passages quoted below. Judd was an opponent of having Medicare negotiate drug prices, and he voted against the expansion of SCHIP. In the past, Gregg has expressed some reservations against direct to consumer advertising by pharmaceutical companies.
SCHIP
July 31, 2007. “Under the cloak of trying to address the issue of health care for children, we are seeing an explosion in cost, the purpose of which is not necessarily to cover children who need coverage because many of the children who are going to be covered here are already covered under private plans, but the purpose is actually to dramatically expand the role of government in the area of limited health care in this country, and it is openly acknowledged as being an effort to move down the road toward universal health care.”
Senator Gregg Comments on Senate Passage of SCHIP Reauthorization Conference Report
September 28, 2007
“I regretfully cannot support the way this program is being used to expand the size of government, advance a national healthcare system, and pass the cost along to hard-working Americans.”
Medicare Part D price negotiations
Gregg voted against the pharmaceutical benefit program under Medicare Part D, and he voted against requiring price negotiations for Medicare Part D reimbursements.
Vote number 2007-132 requiring negotiated Rx prices for Medicare part D on Apr 18, 2007 regarding bill S.3 & H.R.4 Medicare Prescription Drug Price Negotiation Act, Results: Cloture vote rejected, 55-42 (3/5ths required) Cloture rejected. Senator Gregg voted against requiring price negotiations for Medicare Part D.
Parallel trade
http://www-935.ibm.com/services/us/imc/pdf/ge510-3611-03.pdf
In June 2004, U.S. New Hampshire Senator Judd Gregg (R) introduced the latest in a series of bills to allow prescription drugs from Canada and other countries into the American market. Earlier bills have fallen by the wayside, not least because the FDA fears that drug reimportation could greatly increase the risk that consumers will be exposed to counterfeit drugs or products that have been contaminated. But Congress is now reported to be seriously considering such a move, and the Bush administration has set up a task force to investigate how drugs can be reimported safely.
http://en.wikisource.org/wiki/Floor_Statement_of_Senator_Judd_Gregg_on_the_FDA_Reauthorization_Bill_And_Prescription_Drug_Reimportation
Floor Statement of Senator Judd Gregg on the FDA Reauthorization Bill And Prescription Drug Reimportation
May 2, 2007
The average pharmaceutical product in this country takes 12 years and $800 million to bring to the market. Think about that: 12 years and $800 million before you can produce a product Americans can take. That is a pharmaceutical product. If you are getting in the biologics area, which is a much more complicated area, it takes even longer. It is even more complex, and in many instances it is even more expensive.
It is these products that are changing the life expectancy of people and making the quality of life of people so much better. We have basically gone from a medical regime in this Nation where invasive action was always the first call, was always the first event, where you basically went under the surgical knife, to a regime where you are given pharmaceuticals or biologics to try to address a very serious illness. It is a huge step, an exponential step in the direction of better health care and a better lifestyle for Americans and for the world.
Where are these products developed? Well, they are developed here in the United States. Why are they developed here in the United States? Why are almost all the major pharmaceutical breakthroughs and all the biologic breakthroughs coming in the United States? Because we have a market system which allows people to take the risks to develop those products.
We do not fix prices, as they do in Canada or in England, at a rate that is so low that nobody would be willing to invest in developing that product because the return on that investment is too low. We allow people who make the investment, who take the risk, who put the 12 years in, who invest $800 million, to get a reasonable return on their investment and on their effort. As a result, we have the explosion in advances in technology, in medical technology, in biologics, and in pharmaceuticals.
It is a result of the fact that people who want to take that risk, and who have the ability to pursue that type of opportunity to make life better for people by creating these pharmaceutical products and these biologic products, have the capacity to get resources to do it. It is called capital markets.
Now, capital does not flow for goodwill. People do not invest in things because it makes them feel good, in most instances. People invest where they are going to get the best return on the dollars they invest, or a reasonable return on the dollars they invest. So we have to maintain an atmosphere in this country where people are willing to put money–cash, capital resources–into the investment and research and development of pharmaceutical and biological and device products.
But if you listen to the other side of the aisle, almost every proposal they come forward with seems to be of the view that these products are grown in some wheatfield in North Dakota, that they do not take any effort, that they do not require any capital, they do not require any expertise, research, or time. All they require is to be price fixed, to be limited in their ability to be distributed relative to the price that is charged.
Time and again, the other side of the aisle has come forward with proposals which basically undermine the incentive for capital to flow into these research areas. Believe me, if capital is disincentivized from going into these areas because they do not get a reasonable return, they will go somewhere else–they will go into developing software, into gaming, into whatever it is that happens to give them a reasonable return, into investing in some other country’s activities in some area.
Capital does not flow out of goodwill into pharmaceutical production, into biologic production, into device production. It flows into those accounts because they expect a reasonable return.
Now, sure, the countries of Canada, England, and the European common market, to some degree, are living off of the fact that we give people a reasonable return on our pharmaceuticals and biologics in this country. That is absolutely true, and it is reasonably disgraceful. In fact, in Canada, they threaten to take people’s patents away if they don’t–they basically capture American patents if they don’t sell these drugs at a price which nobody would have invested in them in the first place to produce them were the price fixed at that level. But that is their policy.
Now, we could subscribe to that policy, which is what the other side of the aisle wants us to do. They proposed it in Medicare negotiations, they proposed it now and passed it here in the child drug review. They proposed it in this reimportation, and they proposed it in the negotiated language relative to Medicare, and in biologic generics. In all of these areas they are basically saying: Well, drugs must appear in the marketplace. We don’t have to be concerned with the fact of getting capital into the investment exercise. We don’t have to be concerned with the fact that it takes years and years to research these products and hundreds of millions of dollars to bring them to the market, they just appear. We can basically, for lack of a better term, kill the goose that is laying the drug or the biologic or the pharmaceutical or the device that is saving people and not worry about it.
Well, that is not true. If you were to follow all of the proposals from the other side of the aisle, or even a significant amount of them, we would see investment in this area start to dry up. We would see a contraction of the production of pharmaceuticals that save lives, of biologics that save lives, of devices that save lives. We would see fewer and fewer of those coming to the American people and to the world because people wouldn’t invest in that activity any longer, or the investments would be significantly curtailed because money would flow in other directions.
This concept of the marketplace totally escapes the other side of the aisle. This concept that drugs have to actually have some flow of capital behind them to be produced because it takes so long to get them to the market, and it takes so much money to actually research them–and that is especially true in biologics and equally true in devices. It totally escapes the other side of the aisle. Their idea is, we have a good line, we have a motherhood statement, let’s let people go buy the drugs somewhere else at a price that is fixed at which nobody would have ever produced the drug in the first place if that was the price. Let’s negotiate so we have a regime of price setting at the Federal level, which basically eliminates the capacity for that drug to be competitive.
Let’s create a biologic generic which basically wipes out the capacity of the true biologic to actually come to the market and be successful. Let’s create an atmosphere where testing on children of the drugs will basically not have a fiscal return which will make it worthwhile to test them on children. Let’s do all of those things in the name of the motherhood language of getting a better price for drugs for Americans, ignoring the fact that what you are actually going to end up doing is dramatically limiting the number of drugs coming to the market for Americans, and therefore significantly impacting the quality of life of Americans and our ability to advance the dramatic and revolutionary activity that we are seeing in bringing biologics to the marketplace, which are basically curing and have the potential to cure diseases which have been extraordinarily threatening to the American population for so long.
It makes no sense, if you look at the substance of the issue, what they are proposing. It is totally inconsistent. They are saying they are doing this to help people. What they are actually ending up doing is harming not only the people of today who won’t be able to get the drugs because they won’t be produced but people in the future because the drugs won’t be brought to the market. There is a blindness to the fact that market forces are at work. I guess it is just a function of the fact that you want to get out a good press release, so you are going to send it out. Of course, anybody who takes the position I just outlined is immediately demagogued, and the pejorative tool of the drug industry is thrown out there.
Well, I am hardly that, since I was one of the few people in this Chamber who actually aggressively opposed and tried to stop the Medicare Part D Program, which was the biggest windfall the drug industry ever got and which was voted for by many of my colleagues on the other side of the aisle and which ended up putting an $8 trillion bill which is unpaid for onto our children’s future.
More importantly, the reason I take the position I take is because I believe very strongly that America should not give up its lead in one of the industries where it is at the cutting edge and where it is producing jobs and where it is producing the intellectual capital that is going to keep us a vibrant, strong economy. In addition, we should not give up an industry or undermine an industry and geniuses and creative individuals who are producing products which are saving lives and are giving people a better livelihood. So I am not going to sign on to these various jingoistic proposals which are brought to the floor for the purposes of putting out good press releases about how I did this or that for motherhood at the expense of undermining the quality of care for future generations by basically limiting dramatically the ability of people to get capital who want to be creative, who want to invest, and who want to do research in the area of producing biologic products, pharmaceutical products, and medical devices.
That is why I take the position I take, to say nothing of the fact that if you start haphazardly importing products from the Internet and from countries such as Canada, as strong as Canada is, without any FDA oversight or approval of those products, you are going to harm a lot of people at the end of the day. A lot of people are going to be hurt, and some people are going to die as a result of buying products which have not gone through FDA approval and which are not subject to FDA oversight because they are bought from a pharmacy or a provider in Canada, and that product may have come out of India or it may have come out of Afghanistan. It may have come out of Pakistan. It may be adulterated, and it may kill. The same can be said by a factor of 10 relative to purchasing on Internet pharmacies.
So there are some big issues at play. There are big issues at play relative to the future of the health of Americans on the issue of importation, on the issue of negotiation and Medicare, on the issue of biologic generics, and on the issue of making sure that children are adequately tested relative to the application of drugs which are brought to the market. There are big issues relative to safety and big issues relative to whether this country remains on the cutting edge of producing products that help people and give them a better lifestyle with a biological, pharmaceutical, or medical device. We shouldn’t just pass these proposals willy-nilly for the sake of putting out a nice press release. Mr. President, I yield the floor.
http://rfidlawblog.mckennalong.com
May 15, 2007 US Senate Passes Amendment That Bypasses RFID on Pharmaceuticals
Last week, the US Senate passed legislation that reauthorized the federal user fees on pharmaceuticals that help fund the FDA. Buried in the legislation was a provision — posted earlier on this blog site — authored by Senator Judd Gregg of New Hampshire, that would require Internet pharmacies selling to US citizens to use tracking technology to minimize the risk of counterfeiting.