Prescription Drug User Fee Amendments of 2007
Floor Speech
PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 -- (Senate - May 07, 2007)
BREAK IN TRANSCRIPT
Mr. GRASSLEY. Madam President, we have three critical votes ahead of us this afternoon. These votes mean that today is the day we show the American people whether we can really pass drug importation or whether we are just giving it lip service and nothing else. The Dorgan amendment is the moment American consumers have been waiting for and today is the day.
As I said last week, the Dorgan amendment is the result of a collaborative effort by myself with Senator Dorgan and with Senator Snowe and Senator Kennedy to finally make drug importation legal in this country.
This is the golden opportunity this year to get it done.
Now we have heard here on the floor the concerns that some have with drug importation and drug safety. Let me tell you that this is something I take seriously. Everyone who knows me knows that I care deeply about the safety of drugs, and I would not be standing here today urging support for the Dorgan amendment if I didn't think it had the right stuff on drug safety. And it does.
The fact is that the unsafe situation is what we have today.
Today, consumers are ordering drugs over the Internet from who knows where, and the FDA does not have the resources to do much of anything about it.
The fact is that legislation to legalize importation would not only help to lower the cost of prescription drugs for all Americans but also should shut down rogue Internet pharmacies selling unsafe drugs.
The Dorgan amendment would improve drug safety, not threaten it. And it would open up trade to lower cost drugs.
We see news accounts on a regular basis describing Americans who log on to the Internet to purchase drugs from Canada and elsewhere.
In 2004, my staff were briefed about an investigation by the Permanent Subcommittee on Investigations for the Senate Government Affairs Committee.
The Permanent Subcommittee on Investigations conducted an investigation into current drug importation. They found that about 40,000 parcels containing prescription drugs come through the JFK mail facility every single day of the year--40,000 packages each day.
Now, the JFK airport houses the largest International Mail Branch in the United States, but even then it is the tip of the iceberg.
Each day of the year 30,000 packages of drugs enter the United States through Miami, and 20,000 enter through Chicago. That's 50,000 more packages each day.
What is worse, about 28 percent of the drugs coming in are controlled substances.
These are addictive drugs that require close physician supervision.
While most people are ordering their prescriptions from Canada, they are also ordering prescriptions from Brazil, India, Pakistan, the Netherlands, Spain, Portugal, Mexico and Romania.
Although the Federal Food, Drug, and Cosmetic Act prohibits the importation of unapproved, misbranded, or adulterated drugs into the United States, the fact is that thousands of counterfeit and unregulated drugs are seeping through our borders. This is what is happening today.
John Taylor, Associate Commissioner of Regulatory Affairs for the Food and Drug Administration, FDA, in his testimony before the House Committee on Energy and Commerce in June 2003 stated that, ``the growing volume of unapproved imported drugs, which often are generated from sales via the Internet, presents a formidable enforcement challenge.''
Despite the hard work of both the FDA and BCBP to control our borders, the importation of illegal drugs has become an unenforceable problem. That is because today, the FDA does not have the authority or the resources to do much about it. The Dorgan amendment would change that.
The basic approach to assuring the drugs are safe in the Dorgan amendment which I coauthored with him--is to give FDA the ability to verify the drug pedigree back to the manufacturer, require FDA to inspect frequently, and require fees to give FDA the resources to do this.
For imports by individuals from Canada, the bill requires the exporters in Canada to register with FDA and to post a bond that they will lose if they send unsafe drugs. Frequent inspections by FDA ensure compliance.
For commercial imports, American wholesalers and pharmacists must register with FDA and are subject to criminal penalties if they import unsafe drugs. Again, frequent inspections by FDA ensure compliance.
The bill requires manufacturers to inform FDA whether foreign drugs meet FDA standards, and if they don't, the manufacturers have to give FDA the information necessary to evaluate the safety of the drug. If a foreign drug is manufactured in a plant the FDA has not inspected, FDA can inspect it.
The bottom line is the legislation gives the FDA the authority and resources it needs to implement safely the drug importation program set up under this bill.
The fact is that the unsafe situation is what we have today: 40,000 drug packages coming in every day in New York, 30,000 drug packages coming in every day in Miami, and 20,000 drug packages coming in every day in Chicago. That is 90,000 packages with drugs coming in from other countries every single day.
We are already saying yes to drug importation every day that we allow this unregulated and unsafe situation to exist. We say yes to it 90,000 times a day.
What we need to do and what the Dorgan amendment would accomplish is giving the FDA the resources to clean up this mess.
The Dorgan amendment gives the FDA the resources and authority to
crack down on the unsafe and unregulated importation of drugs. That is what we need. That is one of the key reasons I have been working with Senator Dorgan and Senator Snowe and Senator Kennedy on this legislation. One of our key aims is to improve drug safety.
I have been doing a lot of work in the area of drug safety, as my colleagues know, and I felt that I should talk about why the Dorgan amendment is important for improving drug safety.
A vote against the Dorgan amendment is a vote in favor of the unsafe situation we have today.
I must also say that a vote for the Cochran amendment is a vote to kill the Dorgan amendment. So a vote in favor of the Cochran amendment is a vote in favor of doing nothing. It is a vote for keeping the unsafe situation we have today.
Congress must act now on legislation that will not only shut down rogue Internet pharmacies selling unsafe drugs to consumers but will also lower the cost of prescription drugs.
Legalizing the importation of prescription drugs through a highly regulated system overseen by FDA will stem the tide of unregulated pharmaceuticals coming into the United States and create a safe and effective system for obtaining low-cost prescription drugs.
The bill before us is the vehicle this year to get it done. The bill we are debating is a must-pass FDA bill. The Senate should send a strong message that we are committed to finally getting it done this year.
And that is what we are working together to do today.
Making it legal for Americans to import their prescription drugs is a top priority at the grassroots. It needs to be a top priority here in Washington.
I have long advocated allowing American consumers access to safe drugs from other countries. I have always considered it a free-trade issue.
Imports create competition and keep domestic industry more responsive to consumers.
In the United States, we import everything consumers want. So that should be the case on prescription drugs.
We need to do it legally and safely. We need to give the FDA the authority and resources to do it. That is what the Dorgan amendment would do.
Consumers in the United States pay far more for prescription drugs than those in other counties.
If Americans could legally and safely access prescription drugs outside the United States, then drug companies will be forced to reevaluate their pricing strategies. They would no longer be able to gouge American consumers by making them pay more than their fair share of the high cost of research and development.
Now, 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 the Dorgan amendment, prescription drug companies will be forced to compete and establish fair prices here in America.
Now some don't want this to happen. And I want to reiterate that there is an attempt to kill drug importation as has been done many times before in this Chamber. I am referring to an amendment by my good friend from Mississippi, Senator Cochran. His amendment would require a certification about health and safety. That amendment is designed to kill drug importation once again. It is a clever amendment but it is a poison pill.
Our effort develops an effective and safe system that gives Americans access to lower prices. This amendment requires that all imported drugs be approved by the FDA. The amendment sets a stringent set of safety requirements that must be met before Americans can import drugs from that country. And there are stiff penalties for violating the safety requirements.
Don't be fooled by the Cochran amendment. Voting for the Cochran amendment is a vote to kill drug importation.
With the Dorgan amendment, we are working to get the job done.
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.
Americans are waiting. We must make sure they have access to affordable prescription drugs.
I urge my colleagues to vote against the Cochran amendment and in favor of the Dorgan amendment.
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