Certify FDA Drug Safety And Savings

Statement By 60 Plus Association President Jim Martin

Arlington, VA – “Senator Byron Dorgan’s (D-ND) amendment allowing cheap drug imports is a terrible idea and 60 Plus urges a NO vote. The Dorgan amendment poses a clear and present danger for senior citizens seeking access to less expensive and sorely needed drugs. Instead, it will open even wider the counterfeit floodgates to allow dangerously diluted medicines that Congressional hearings have already revealed many were not fit for human consumption. It’s a bad idea.

Instead, the Senate should vote YES on Senator Thad Cochran’s (R-MS) amendment that would restore language requiring any Health and Human Services Secretary to be able to certify drug safety and cost savings.

The Cochran provision, which Dorgan’s amendment does not contain, has been overwhelmingly supported in the past, twice by unanimous votes in the Senate, 96-0 and 99-0. What part of “unanimous” doesn’t Mr. Dorgan understand?

What senior citizens and all U.S. consumers certainly do not need is a drug supply chain tainted with counterfeit medicines, but this is the direction we’re headed if the Dorgan amendment is passed by the Senate, a measure the President has vowed to veto.

Drug re-importation has consistently faltered in the U.S. Congress because the law requires health officials to certify that imported drugs are safe and that the program would save money. But HHS heads under both Presidents’ Clinton and Bush have failed to provide such certification. As a matter of fact, no HHS Secretary — Democrat or Republican — has been able to demonstrate that importation is safe or will lead to cost savings. Mr. Clinton’s HHS Secretary, Donna Shalala, concluded it was ‘impossible…to demonstrate that it [importation] is safe and cost effective.’ And Secretary Tommy Thompson, under President Bush, determined that he could not ‘sacrifice public safety for uncertain and speculative cost savings.’ Wise decisions both.

The Dorgan bill would permit importation and distribution of drugs that are not FDA approved. 60 Plus says NO. The Dorgan bill would allow the importation of drugs that are not

bioequivalent to any U.S. drugs. 60 Plus says NO.

The Dorgan bill would expand importation automatically from Canada to the current members of the European Union, Australia, New Zealand, Japan and Switzerland after one year — regardless of whether there are any safety problems identified during the first year and regardless of whether FDA believes it can or can’t administer the program safely from these other countries. 60 Plus says NO.

And the Dorgan bill would allow for transshipment through any of the countries in the legislation into the U.S. 60 Plus says NO.

It is inconceivable that the U.S. Senate would seriously consider deregulating the importation of potentially adulterated prescription medications without any safeguard, consumer information or oversight mechanism for basic consumer safety.

The 60 Plus Association feels very strongly about this matter. We plan to key vote this legislation for our 110th Congressional Scorecard because we believe the 4.5 million seniors we call upon for support agree with us that supporting the Dorgan amendment is wrong, wrong, wrong. 60 Plus believes allowing any drug importation must — MUST — be safety certified by the Secretary of HHS or Commissioner of the FDA.

We urge all U.S. Senators to oppose Senator Dorgan’s amendment and support Senator Cochran’s amendment that would restore language requiring that the HHS Secretary must be able to certify drug safety and cost effectiveness.”

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