By Kim Coghill
WASHINGTON - Sources on Capitol Hill Tuesday said an Agriculture Appropriations bill containing amendments that would permit the reimportation of FDA-approved drugs likely will pass both the House and Senate this week.
The House provisions would allow the reimportation of FDA-approved prescription drugs for personal use from countries with lower drug prices. The Senate measure, sponsored by Sen. Jim Jeffords (R-Vt.), permits pharmacists and wholesalers to purchase FDA-approved drugs from countries where the identical drug is sold for less. The amendment applies only to U.S.-manufactured drugs or drugs produced in FDA-inspected facilities. (See BioWorld Today, July 26, 2000, p. 1; July 17, 2000, p. 1; and Oct. 2, 2000, p. 1.)
Although the proposals exclude biologics, the Biotechnology Industry Organization (BIO) is concerned that Congress is focused on stop-gap, election year "solutions" that will harm the FDA, put the health of seniors at risk and undermine incentives for biomedical research.
A House-Senate conference committee last week adopted the provision, prompting a written statement from Pharmaceutical Research and Manufacturers of America (PHRMA). "We continue to share the public health and safety concerns expressed by 10 former FDA commissioners, both Republicans and Democrats, that repealing landmark consumer protection legislation in order to reimport prescription medicines will increase risks to American consumers without resulting in any significant savings for them.
"Most importantly, this provision does nothing to provide drug coverage for seniors. Congress and the administration need to move forward with a real solution by strengthening Medicare and expanding coverage for those who most need it - seniors and Americans with disabilities."
Carl Feldbaum, president of BIO, said, "This is electoral politics at its worst. I predict this scheme will not be implemented primarily because it puts public health at risk. The FDA does not have and cannot get the resources it needs to make the assurances required under the bill."