|2004N-0115 - Prescription Drug Importation; Public Meeting|
|FDA Comment Number :||EC57|
|Submitter :||Mrs. Mary Mahoney||Date & Time:||06/03/2004 04:06:28|
|Organization :||United Seniors Association|
| May 28, 2004
Members of the Task Force on Drug Importation
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
Dear Task Force Members:
I appreciate the opportunity to address such a critical issue as drug importation. We are deeply concerned about Congress considering the possibility of allowing Americans to buy more medicines from foreign sources. Due to the significant safety risks posed, we believe that importation is not a solution to the problem of access and affordability to medicines.
Why is importation illegal? The answer is safety. Several Secretaries of the Department of Health and Human Services (both Republicans and Democrats) have determined that HHS could not implement the importation of drugs because the safety of American consumers could not be ensured. Formidable evidence suggests that importation will open our borders to counterfeiters and unscrupulous individuals, putting patient health and safety at risk from fraudulently manufactured and unsafe drugs.
Congress has recently tightened restrictions on certain foods and other imported goods. It is counterproductive for Congress to now consider easing importation restrictions, which would place our nation's medication supply at greater risk. Both the precedent and the need exist for oversight and protection for these products. Despite the remarkable efforts of the many agencies and individuals responsible for American national security, allowing this importation offers a realistic and unnecessary threat.
The U.S. Food and Drug Administration (FDA) has the job of overseeing and regulating pharmacies, drug wholesalers, and manufacturers operating inside U.S. borders whether those drugs are being sold to U.S. citizens or not. The FDA does not assure the quality of imported drugs and the increased strain of monitoring and approving all of the drugs coming into the U.S. illegally will prevent adequate and effective protection of American citizens.
Safe medicines and patient protection must be our first priorities not only for seniors, their children, and their grandchildren but, for all Americans.
Mary P. Mahoney
| Vice President of Government Relations
United Seniors Association/USA Nest * 3900 Jermantown Road, Suite 450
Fairfax, Virginia 22030* www.usanext.org