From: Strambler, Karen
Sent: Tuesday, June 01, 2004 2:08 PM
To: Dockets, FDA
Subject: FW: reimport testimony?
Please post to docket no. 2004N-0115.
-----Original Message-----
From: Rael, Mary
Sent: Tuesday, June 01, 2004 1:08 PM
To: Strambler, Karen
Subject: FW: reimport testimony

-----Original Message-----
From: Ed Fulginiti []
Sent: Tuesday, June 01, 2004 12:56 PM
Subject: reimport testimony



Mary, thanks for your help with this! Here, below, is the testimony from 60 Plus.






Ed Fulginiti
Communications Director
60 Plus Association





 Comments from Jim Martin

President, 60 Plus Association

Regarding: Drug Reimportation


May 28, 2004


 My name is Jim Martin and I'm the President of the 60 Plus Association, a national, 11-year-old nonpartisan seniors group headquartered in Arlington, VA.


Regarding drug reimportation, I recall the old adage, 'buyer beware'. In the short run, drug reimportation looks like 'good medicine' for senior citizens via immediate lower prices. But unfortunately, in the long term, reimportation will prove to be 'hazardous to your health' for one simple reason: foreign countries such as Canada will stop their supplies from being shipped back into the US because it will cause a drastic shortage in their own country.


So Canada would have to either raise prices or curtail the sale of drugs back into the US.


It all comes down to research and development. In the U.S., drug firms spend about $800 million dollars on average to bring a blockbuster drug to market. Higher prices are charged accordingly to recoup that investment. When the drug manufacturer has recouped most of that profit, they then sell their bulk quantities overseas.


60 Plus is one of the fastest growing seniors groups in the country. 60 Plus can now call on support from nearly 4.5 million citizen lobbyists to mail letters to Congress.  60 Plus publishes a newsletter, SENIOR VOICE, and a SCORECARD, bestowing a GUARDIAN OF SENIORS' RIGHTS award on lawmakers in both parties who vote "pro-senior."  60 Plus has been called "an increasingly influential lobbying group for the elderly...".


60 Plus counts among its core issues, the permanent repeal of the so-called "death" tax, working to reform Social Security and Medicare for future generations and enhancing ways to provide seniors on fixed incomes with prescription drug coverage.


60 Plus strongly opposes any amendment or bill, which would allow the reimportation of prescription drugs. As we've stated the past few years whenever such legislation was considered, reimportation of prescription drugs is a problem waiting to happen. It would pose a serious threat to the safety and health of the American consumer and fail to solve the problem of affordable access to prescription drugs. Frankly, it's little more than an open door for terrorists and ought to be vigorously opposed by any senator who cares about America's senior citizens.


Department of Health and Human Services Secretary Tommy Thompson and his predecessor, Donna Shalala, and every living former Food and Drug Administration commissioner since 1969 - Democrats and Republicans alike - have all publicly stated their opposition to the importation of prescription drugs. They know that reimported pharmaceuticals could well introduce foreign counterfeits into the American distribution system. Also, that proper storage and handling of legitimate pharmaceuticals would not be able to be guaranteed by U.S. law once drugs made here in the States' left our boundaries, eventually to return to our country after Canadian price-fixing schemes were applied.


60 Plus has been and remains on record opposing such legislation. Drug reimportation is bad medicine. It's hazardous to your health.


60 Plus says finding a fix for affordable drug prices should be done from within, not from without. We strongly support fair pricing for seniors for all prescription drugs, but not at the risk of their health and safety.


Here's what must be considered:


*Fake drug contents.

*Mislabeled drug bottles and packages.

*Mishandled shipments of drug supplies.


Who's to say your Procrit is truly Procrit? Who's to say your little purple pill is as purple as it ought to be? Who's to say what you're inhaling is actually what's printed on the label? Talk about an accident waiting to happen!


60 Plus knows that the cost for prescription drugs is a major budgetary consideration for millions of Americans, in particular, those on fixed incomes. But we believe working to solve the burden of these drug costs ought to be taken up by the United States, in the United States, for the United States. Not from Canada.


Our country rightfully boasts the safest drugs and the safest drug supply links in the world. Let's keep it that way.


To reiterate, I'll end where I began: The 60 Plus Association strongly opposes any amendment or bill, which would allow the reimportation of prescription drugs.


I thank you for your time and consideration.