Prescription Drug User Fee Amendments of 2007

Floor Speech

PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 -- (Senate - May 02, 2007)

BREAK IN TRANSCRIPT

AMENDMENT NO. 990

Mr. GRASSLEY. Mr. President, I am a cosponsor of Senator Dorgan's amendment called the Pharmaceutical Market Access and Drug Safety Act. We want to add the provisions on the importation of drugs to this measure. Obviously, I support that effort. That legislation is the result of a collaborative effort by this Senator, Senator Dorgan, Senator Snowe, and Senator Kennedy to finally make drug importation legal in this country. This is one effort which I hope the new Democratic Congress can finally get passed because last time, my own party did not want to see this passed, even though I worked hard to get that done.

Now is the time for us to make this happen. This is a golden opportunity this year to get it done. I think we are well on the way to getting it done.

I have been a longtime proponent of drug importation. In the years 2000, 2002, and 2003, I supported amendments permitting importation of prescription drugs from one country--Canada.

In 2004, Senator Kennedy and I worked together on a bill that would authorize drug importation, but it did not survive the partisan politics of that year.

I then introduced my own drug importation bill in 2004 with the number S. 2307. After introducing my bill, I began working in conjunction with the efforts of Senator Dorgan, Senator Snowe, and Senator Kennedy. So in this provision before us, we combined our efforts so that we could all get behind the same bill and have a better chance of getting it passed. Of course, that is where we are, working together this very minute.

Making it legal for Americans to import their prescription drugs is a top priority at the grassroots level, as it shows up in my 99 town meetings I have every year in each of our 99 counties, and I have been doing that for 26 years. So I think I have a feel for what the grassroots of my State wants Congress to hear.

This is one issue about which I constantly hear, although I am probably hearing it a little bit less now that we have the Part D provisions of the Medicare bill because for people who couldn't afford drugs, who maybe relied on imports or at least drugs from other countries, they are able to get them a little better through the subsidization under the Part D Program. But I still hear about this issue, and that is why I am still working to get it passed. So this needs to be a top priority in Washington as it is at the grassroots of America.

I have long advocated allowing American consumers access to safe drugs from other countries, but I have not looked at this solely or even most importantly as a health issue. I have looked at it more often as a free-trade issue. Imports of any kind coming into our country create competition and keep domestic industry of all segments of our economy more responsive to the consumer, giving the consumer what they want at a price they are willing to pay and a quality they care about.

In the United States, we seem to import anything that the consumer wants to buy in America, but we don't do it for pharmaceuticals. So why not, with this legislation, do for pharmaceuticals what we do for everything else American consumers want to buy? That is what breaking down the barriers to trade is all about. That is where our country has been for 50 years, breaking down barriers to trade around the world. Yet we keep this barrier up. Consumers in the United States then pay far more for prescription drugs than those in other countries.

If Americans could legally and safely access prescription drugs outside the United States, then drug companies would be forced to reevaluate pricing strategies. More competition would have an impact. They would no longer be able to gouge the American consumer by making them pay more than a fair share of the higher costs of research and development, which is a resource we need for research and development, but why should just the American consumers pay for that?

It is true that pharmaceutical companies do not like the idea of opening up America to the global marketplace. They want to keep the United States closed to other markets in order to charge higher prices here. However, with this amendment, prescription drug companies will be forced to be competitive and establish fair prices in America.

The drug companies will try to find, of course, loopholes to protect their bottom line, but I think our amendment is comprehensive enough to keep that action illegal. It would not allow, for instance, manufacturers to discriminate against registered exporters or importers. It would prohibit drug companies from engaging in any activities to restrict, to prohibit, or to delay the importation of a qualifying drug. The amendment would give the Federal Trade Commission the authority to prevent this kind of possible abuse of the system.

I also understand that there will be an attempt to kill this amendment, as it has been, I believe, in the years 2000, 2002, and 2003, by an amendment that would require a certification about health and safety. That amendment is designed to kill the underlying Dorgan amendment. It is a clever amendment and for sure can legitimately be determined to be a poison pill.

Our efforts develop an effective and safe system that gives Americans access to lower prices. This amendment requires that all imported drugs be approved by the Food and Drug Administration. The amendment sets a stringent set of safety requirements that must be met before Americans can import drugs from that country.

The amendment requires all exporting pharmacies and importing wholesalers to be registered with the Food and Drug Administration, as well as being inspected. It gives the authority for the FDA to inspect entire distribution chains of imported drugs, and it sets very stringent penalties for violation of the safety requirements in this bill, including criminal penalties and up to 10 years in prison.

Don't be fooled by the poison pill amendment to which I just referred. Voting for that amendment is a vote to kill drug importation.

With the Dorgan amendment, we are going to get this job done because we need to make sure Americans have even greater, more affordable access to wonder drugs by further opening the doors to competition in the global pharmaceutical industry.

I think Americans have been waiting for this for a long period of time. When a country such as ours allows every other product to come into this country that the consumer wants for the best price and the best quality, there is no reason we should make an exception for pharmaceuticals. We must make sure they have access to these affordable prescription drugs. So I urge my colleagues to support the Dorgan amendment.

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