Statements on Introduced Bills and Joint Resolutions - S. 2328

STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

By Mr. DORGAN (for himself, Ms. SNOWE, Mr. KENNEDY, Mr. MCCAIN, Mr. DASCHLE, Mr. LOTT, Ms. STABENOW, Mr. CHAFEE, Mr. JOHNSON, Mr. PRYOR, and Mr. FEINGOLD.

S. 2328. A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes; to the Committee on Health, Education, Labor, and Pensions.

Mr. KENNEDY. Mr. President, I am pleased today to join my colleagues Senator DORGAN, Senator SNOWE, Senator MCCAIN, Senator DASCHLE, Senator LOTT, Senator CHAFEE and others in introducing legislation to allow the importation of safe prescription drugs from Canada, the European Union, Australia, New Zealand and Japan.

This issue is about fairness for middle class Americans who are struggling to afford costly prescription drugs. Americans understand fairness, and they know it's wrong that Americans pay far too much for prescription drugs-more than Canadians, more than the British, more than in any other country in the world. That's not right. Prescription drugs mean the difference between sickness and health-even life and death-for millions of average Americans. It's not fair that drug companies overcharge middle class families and patients have to do without the drugs they need.

We're here to say that help is on the way.

Our legislation will legalize safe imports of U.S.-approved drugs manufactured in U.S.-approved plants. It is a creative new approach to meeting the needs of our middle class families. We know it will be opposed by the drug companies, who are determined to continue to reap windfall profits at the expense of American patients. It will be opposed by the Bush Administration, which is determined to protect the pharmaceutical industry and its powerful campaign contributors. But it will be welcomed by someone else-by every family in every community in America who needs to fill a prescription.

Every pharmaceutical company in the world wants its drugs approved for sale in the United States. We're the largest market on Earth. A decision by the Food and Drug Administration that a drug is safe and effective is the gold standard for the world. But once that drug is approved for use in the United States, the drug manufacturer applies a greedy double standard. What's fair about a system that forces American patients to pay sixty percent more than the British pay or the Swiss pay for an FDA-approved drug manufactured to FDA standards? What's fair when, on average, Americans pay two-thirds more than Canadians? What's fair when Americans pay 80 percent more than Germans and twice as much as Italians?

This legislation will end that indefensible disparity, by enabling U.S. consumers to buy FDA-approved drugs at the same fair prices as they are sold abroad.

The drug companies and the Bush Administration claim that imported drugs threaten the health of American consumers because of the possibility of counterfeiting or adulteration. Under this bill, that argument can't pass the laugh test.

One-quarter of the drugs that Americans use today are already legally imported into the United States. The American people have no idea how large a percentage of the pills they take are out-sourced-produced for U.S. drug-makers in plants overseas, where wages are cheaper. The catch is that the law allows that. Drugs can be legally imported by the drug companies themselves, who then sell them at the high U.S. price.

If drug companies can import drugs at high prices, why can't patients import them at fair prices?

Our legislation sets up iron-clad safety procedures to guarantee that every drug imported legally into the United States is the same FDA-approved drug that was originally manufactured in an FDA-approved plant-whether the drug is manufactured abroad and shipped to the U.S., or whether it is manufactured in the United States, shipped abroad and then imported back into the United States.

Under our bill, the FDA is given new legal authority and resources to enforce the law. In fact, under this legislation, the procedures to prevent counterfeiting or adulteration of drugs shipped into the United States are actually stronger than the protections against counterfeiting of drugs manufactured for the domestic market.

Our legislation also includes strict rules to close the loopholes that drug companies may use to evade the law. Violations will be considered unfair trade practices under the Clayton Act, and violators will be subject to triple damages.

No doubt, in the months ahead, as the election approaches and the political pressure builds, drug companies and their allies in the Bush Administration and Congress will offer an alternative program. They'll call it an importation bill, but consumers beware. Counterfeit drugs have no place in American medicine cabinets, and counterfeit proposals to reduce drug prices have no place in Congress.

Year in and year out, drug companies profits are the highest of any industry in the United States. Year in and year out, patients are denied the life-saving drugs they need because those astronomical profits are obtained by equally astronomical prices-prices that drug companies can't charge anywhere else in the world because no other country in the world would tolerate such high prices. It's time to end the shameful price-gouging here at home. It's time for basic fairness. It's time to pass this bill, and I urge my colleagues in the Senate to support it.