By Kim Coghill
WASHINGTON - The Biotechnology Industry Organization (BIO) issued a statement urging President Bill Clinton to delete the drug reimportation section from the Agriculture Appropriations bill, which was overwhelmingly approved by both the House and Senate.
In a prepared statement, BIO president Carl Feldbaum said, "Congress focused on a stop-gap, election-year 'solution' to the prescription drug issue. But the reimportation approach will harm the FDA and could put the health of seniors at risk."
The bill is expected to be signed by Clinton within the next 10 days. It directs the FDA to implement a regulatory program to monitor United States borders and test reimported drugs for safety and counterfeiting.
The House provisions 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 to U.S.-manufactured drugs or drugs produced in FDA-inspected facilities. (See BioWorld Today, July 26, 2000; July 17, 2000; Oct. 11, 2000; and Oct. 13, 2000.)
Although the measure excludes biologics, biotechnology sources fear their products will be added sometime down the road. Rep. Marion Berry (D-Ark.), a strong supporter of the measure, said in an earlier interview that his intention is to add biologics.
Both Berry and Jeffords said their votes are an effort to protect the American public from soaring prescription drug prices.
In his floor statement last Friday, Jeffords said, "The American people are fed up with the situation that exists today where Americans pay far more for FDA-approved, American-made prescription drugs than patients in any other country in the world.
"I am not here to demonize the drug industry. It's true that these companies are making some miraculous breakthroughs and improving the lives of many Americans," Jeffords said. "But why must Americans have to shoulder seemingly the entire burden of paying for research, development and a healthy return to shareholders?"
But Rep. John Dingell (D-Mich.) said passage of the measure is no guarantee that more drugs will be available at an affordable price.
In his address to the House, Dingell said, "This bill is riddled with numerous loopholes that will allow manufacturers to label or produce their products in a form that makes them either impossible or cost-prohibitive to reimport. The notion that this bill will create an abundance of cheap, properly labeled and properly repackaged drugs, easily available to reimporters is simply false."