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Date Posted: 23:05:42 02/08/04 Sun
Author: Dolf
Subject: Drug firms oppose reimportation
In reply to: Don 's message, "U.S. FDA turns up heat in battle over Canada drugs" on 12:23:34 02/04/04 Wed

Drug firms oppose reimportation

Jeff Trewhitt, a spokesman for the Pharmaceutical Manufacturers of America, visited The Free Press on Friday and spoke with City Editor Joe Spear about a variety of issues regarding prescription drugs.

Q. What is wrong with Americans buying cheaper-priced prescription drugs from Canada?

A.There are two major problems. The Food and Drug Administration has been warning consistently about the safety risks of imported medicine for years. It's not a partisan thing. They have been warning both through the Clinton administration and Bush administrations. Two federal secretaries of Health and Human Services from both sides of the political aisle have declined to certify the safety of imported medicines. ...

Q. As you know, some people dispute this, that Canadian drugs are unsafe. Our Congressman Gil Gutknecht, our governor, as you know, said: Where are the dead Canadians? How do you respond to that?

A.Well, there aren't any dead bodies. But there are a lot of disappointed patients who were defrauded, who paid for a treatment and did not get the treatment. ...

Q. As I understand Congressman Gutknecht's legislation, he is actually advocating the FDA can just go ahead and approve, go to these places in Canada and approve them and then you know you're getting it from an FDA- Seller. What's wrong with that?

A. Well, because there are better, safer alternatives to imported medicine. First of all, we need better coverage in this country ... Congress needs to address that problem. They have started to address that problem by passing the new Medicare law ...

In the meantime, until there is full and better coverage and until we have a fully implemented Medicare law by the spring in 2006, we strongly recommend that patients who are having difficulty getting their medicines actively explore the many different patient assistance programs in the country sponsored by our companies.

All Pharma member companies have patient assistance programs. Those programs last year provided free medicine to about 6.2 million people, and the companies have signaled that if necessary, there's room for more ...

Another viable option is the fact that as part of competitive marketing, our companies provide free samples for a wide range of medicines for hundreds of thousands of doctors all over the country and those free samples are worth about $12 billion a year, so there are a lot of free samples ... and those free samples are generally given to patients who are having difficulty. ...

Q. They certainly couldn't get free samples for an extended period of time, could they?

A. These are stopgap measures, just as importation is a stopgap measure. It's not a good stopgap measure, but it's a stopgap measure. And you're right, a patient probably could not get a free sample, indefinitely. ...

One other alternative, and this is very important to note, that many studies have been conducted ... in towns and cities all over the country and those studies show the same thing ... You can go into any given town and city and look at the retail pharmacies and you're going to find wide price disparities ... among retail pharmacies in the same town. ... Sometimes the price difference is 50 to 100 percent.

Q. Does your organization believe the price increases for prescription drugs are too high?

A.The pharmaceutical inflation rate has been cut by more than half over the last 15 years. The average (annual) pharmaceutical price increase throughout the 1980s was about 10 percent. The pharmaceutical inflation rate in 2002 was 4 percent. ...

There's a reason for that. It may be tough on the companies, but it's good news for patients. ... the pharmaceutical marketplace in the U.S. is undergoing a shift from the more expensive one-on-one doctor to patient fee for service to the different types of managed health care plans.

The different types of private health plans today make up 60 percent of the market and they are continuing to grow. And they are demanding and getting increasingly generous price discounts ... (of) between 20 and 40 percent. ...

If they can get into a health plan, if they can afford the co-pay and the premium, many times they are brought down to the Canadian cost level.

Q. I'm glad you brought up the bargaining power of insurance companies and health plans. As I understand it, the pharmaceutical industry opposed allowing the federal government to negotiate discounts through the Medicare bill that was recently passed. Why would they be opposed to that?

A. Because you're going to get the best discounts by using the private health plans to negotiate with the companies. ...

Q.You mentioned private-sector solutions. Isn't importing drugs from Canada a private sector solution?

A. Here's the problem with it. There's not only the safety concern, there also is the fact that what you have in Canada is a very strict price control system. ...

Those artificially low prices in Canada don't take into account the fact that the average cost of researching and developing a new drug has increased from $231 million about 20 years ago to more than $800 million per product today. ...

Q. As you probably heard also, Congressman Gutknecht has criticized the system we have because it puts all the cost of developing new medicines on Americans, whereas everybody else is getting a free ride.

A. Congressman Gutknecht may be very surprised to hear this, but we completely agree with him on that. ...

Q. So why not cut off Canada?

A. I don't have a definitive answer because I don't work for a company and because of the federal anti-trust law I can't get into their pricing strategies.

But what I have heard - this is what I've heard, this is not what I know directly ... - I have heard, and I read this in a number of places, that the Canadian government has sort of this kind of implied threat, a consistent threat, that if companies don't go along with the nationalized system and the strict price controls ... then they might consider compulsory licensing of the patent, meaning in other words, they'll ignore the brand name company and ignore the brand name company's patent and go to a copycat company and have the copycat company make the drug for less.

Q. It sounds like a threat that has worked for Canadians though.

A.Well, but here's what it's done to the Canadian pharmaceutical industry. It's killed it. ...

Q. Well, they don't need an industry because they get subsidized prices from ours.

A. But if we have imported medicines ... from Canada with the artificially low prices, it has the effect of importing somebody's else's failed price controls and we can't afford that in this country. And the reason why we can't afford it in this country is because we are the most innovative pharmaceutical industry.

Q. Would re-importing from Canada really hurt the business of pharmaceutical companies? I hear it's a very small market. The amount of drugs that come over would be minuscule.

A. I have a colleague in Washington who's tearing her hair out right now because she is monitoring the different states that have importation proposals and she's looking at 25-30 state proposals right now.

And they all have differing approaches. ... So you're talking about if this happens, and the potential of a patchwork quilt ... which makes it difficult for the FDA to monitor and regulate and at that point you potentially open the floodgate for imported medicines.

And at that point there could be a threat to innovation. ...

Going back to a key point you made: American consumers should not be subsidizing patients in other countries who are getting artificially low prices. And we have suggested to the U.S. government that that practice, that allowing patients in other countries to have the benefit of price controls, should be put on the table in bilateral trade talks because they should be paying their fair share.

Q. We talked about the dangers of ordering drugs over the Internet. Minnesota has recently set up a system that allows consumers to do this. Is it dangerous?

A. To be honest with you, I don't know enough about the Minnesota system. Now we'll be hypothetical because I don't know enough about it. If you are talking about a licensed Internet pharmacy with physicians heavily involved in the process, there may well be less of a danger.

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  • Net drugstores thrive -- Jensen, 22:39:25 02/10/04 Tue
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