BIO: Reimportation Of Prescription Drugs Puts Patients At Risk

WASHINGTON, D.C. (July 18, 2000)- Biotechnology IndustryOrganization (BIO) President Carl B. Feldbaum said BIO supports the FDA’s powers regarding reimportation of drugs from Mexico and Canada and opposes Congressional proposals that would put patients at risk of getting unsafe medicines.

Legislative measures passed by the House of Representatives, Feldbaum said, would prevent the FDA from protecting U.S. patients from spoiled or adulterated medicines from Mexico and Canada. Neither the FDA nor the importer will be able to determine if the drugs were stored, handled and shipped properly after leaving the United States. And it will not be possible to determine if drugs manufactured in other countries have been made correctly or if they have been counterfeited and misbranded.

These reimportation efforts are misguided attempts to controldrug prices in the United States in the name of expanding access to prescription medicines for Medicare beneficiaries, Feldbaum observed. These measures, however, are political quick fixes aimed at attracting votes in this highly charged presidential election year. They may not improve the health of Medicare beneficiaries. In fact, they may put the health of seniors and the disabled at significant risk.

The U.S. House has approved legislation as well as twoamendments to the Agriculture Department Appropriations bill designed to more permit U.S. patients to import prescription drugs from Mexico and Canada. Similar legislative efforts are being made in the Senate.

This approach, however, violates the 1988 Prescription DrugMarketing Act, which was adopted to give the FDA power to protect U.S. citizens against risks of unsafe and ineffective imported medicines.

We support providing Medicare beneficiaries with better accessto prescription drugs, Feldbaum added. The way to achieve this is to provide seniors and the disabled with affordable access to private-sector drug coverage that includes stop-loss provisions. Stop-loss limits out-of-pocket expenses when seniors and the disabled are sickest and their drug bills are the highest.

BIO represents more than 900 biotech companies, academicinstitutions and state biotech centers in all 50 states and in 26 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products.