By Lisa Seachrist
WASHINGTON - Just a week after the House overwhelmingly passed proposals permitting the reimportation of FDA-approved prescription drugs for personal use from countries with lower drug prices, the Senate followed suit with a measure that would allow wholesalers and pharmacists to reimport the drugs.
Like some of the House provisions, the Senate plan is attached to the appropriations legislation for the Agriculture Department. The Senate measure, sponsored by Sen. Jim Jeffords (R-Vt.), would permit 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.
"Our amendment will allow pharmacists and wholesalers to import safe, U.S.-made, FDA-approved lower-cost prescription drugs from other countries," Jeffords said on the Senate floor last Wednesday. "We maintain the gold standard of safety in this country, but hope to rein in the platinum standard we have for prices."
The Senate proposal differs substantially from the House proposals that are designed to permit the reimportation of such drugs by individuals for personal use only. The proposals attached to the agriculture appropriations legislation include a measure to forbid the FDA's enforcement authority over drugs reimported for personal use, and forbid FDA from using appropriated funds to interfere with the importation of drugs. (See BioWorld Today, July 17, 2000, p. 1.)
The pharmaceutical and biotechnology industries have opposed such measures in full-page newspaper ads in the Washington area. In addition, former FDA Commissioner David Kessler and current Commissioner Jane Henney are on record opposing reimportation because of the safety risk posed by counterfeit drugs.
"I asked FDA for technical assistance on this bill and addressed each safety concern that the agency raised," Jeffords said. "I also point out that this amendment specifically authorizes FDA to incorporate any other safeguard that is believes is necessary to ensure the protection of the public health of patients in the United States. This amendment is about free trade."
In addition to accepting Jeffords' amendment, the Senate also passed a measure proposed by Thad Cochran (R-Miss.) to permit the reimportation to become effective only if the secretary of the Department of Health and Human Services certifies the proposal poses no risk to public health and results in the significant reduction in the cost of prescription drugs.
"There is a great deal of attention being focused on this highly controversial issue," Cochran said. "All the states along the northern tier that border on Canada have a great interest in this. It has become a hot-button political subject for debate in senatorial campaigns and, I guess, all the congressional elections and the presidential campaign. So this is a big political item here we are called upon to understand, to sort through, and then to make sure we legislate in a fashion that serves the public interest - not somebody's private political interest."
Even though the House and Senate proposals are different, they both are attached to the agricultural appropriations, making it more likely some form of reimportation will pass.
"Basically, what we have here is because Congress is unable to enact any program to enhance seniors' access to prescription drugs, they are trying to reimport drugs," Chuck Ludlam, vice president for government relations at the Biotechnology Industry Organization (BIO), said. "Because Congress abhors a vacuum, they've voted on a series of poorly crafted and irresponsible amendments that pretty clearly attack FDA's authority to protect consumers from harm caused by the reimportation of counterfeit drugs."
Congressional Caucus Providing Biotech Education
Sixty-five members of the House of Representatives kicked off the revival of the Congressional Biotechnology Caucus last Thursday. The congressmen's group is dedicated to fostering a greater understanding of the issues facing biotechnology.
The newly revived group will focus both on agricultural and pharmaceutical biotechnology, although the initial focus of the group will be agricultural. Reps. Robert Ehrlich (R-Md.), Cal Dooley (R-Calif.), Tom Ewing (R-Ill.) and Lois Capps (D-Calif.) co-chair the caucus and announced its agenda.
The Biotechnology Caucus will serve as a clearinghouse for the exchange of information regarding the safety and potential of biotechnology to enhance agricultural and pharmaceutical products. In addition, it will serve as a credible source for information from the scientific and academic community, major farm and commodity groups, food industry representatives, consumer groups, and technology providers. The caucus also will provide a forum to educate members of Congress and their staffs about the regulatory framework, research on the utility and benefits of genetically enhanced products, and international trade and regulatory issues. Finally, the group will alert members about legislative and regulatory activity affecting the biotechnology industry.
"The newest advances in biotechnology are critical to making American goods and farm products more competitive in the global marketplace," Dooley, a fourth-generation farmer, said in a statement. "By allowing growers to increase yields and produce higher-quality crops, biotechnology will help provide greater economic opportunities for families in the Central Valley. At a time when the success of the Human Genome Project has demonstrated that biotechnology provides endless opportunities to improve the quality of life, the caucus' efforts will help promote biotech's success and dispel the myths surrounding its use."
Michael Phillips, executive director for food and agriculture at BIO, said, "We've been very supportive of the reinvigoration of the caucus. What we are after is having a bipartisan clearinghouse for information exchange. This is a bipartisan effort."
Medical Biotech Benefits More Than 250 Million
In a survey of its member companies, BIO has determined more than 250 million people worldwide have benefited from biotech drugs and vaccines.
The survey was based on the approximate number of people who have been helped directly by currently marketed drugs and vaccines developed through cellular or molecular processes.
BIO President Carl Feldbaum said in a statement, "The magnitude of this number only represents the tip of the iceberg since the biotechnology industry currently has 350 medicines in late-stage (Phase II and III) clinical trials."