By Kim Coghill
WASHINGTON - Reports on Capitol Hill that Congress and the White House are close to a deal that would allow reimportation of FDA-approved drugs has prompted quick response from biotechnology industry insiders.
In a letter mailed to Congress Friday, Biotechnology Industry Organization (BIO) president Carl Feldbaum urged members to reject amendments to the Agriculture Appropriations bill or any other legislation that would undermine the FDA's patient protection powers and resources regarding imported prescription drugs.
"This is not a good bill," Feldbaum told BioWorld Today. "I believe this is a political fig leaf to cover the need to do real Medicare reform."
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; and July 17, 2000, p. 1.)
Representatives of the Pharmaceutical Research and Manufacturers of America (PHRMA) would not comment beyond a prepared statement attributed to Alan Holmer, president. "This was a bad idea before and it's still a bad idea," according to the statement.
Although the proposals exclude biologics, BIO is concerned that Congress is focused on stopgap, election-year "solutions" that will harm the FDA, put the health of seniors at risk and undermine incentives for biomedical research.
Language in the House version says the FDA may not use any appropriated funds to interfere with the importation of drugs that have been approved for use within the U.S. and were manufactured in an FDA-approved facility in the U.S., Canada or Mexico. The House amendments were introduced by Reps. Tom Crowley (D-N.Y.) and Tom Coburn (R-Okla.).
Feldbaum said the proposal "cuts back on the ability of the FDA to protect the safety of patients."
In the letter he states, "We support full funding of the FDA so that it can provide professional services to protect patients. This is why we oppose the pending proposals. This is not a vote on prescription drugs prices; it's a vote on FDA regulatory powers to protect patients."
Others in the biotechnology and pharmaceutical industry oppose the measures for a number of reasons, including the threat of counterfeit drugs.
But in an earlier interview with BioWorld Today, Jeffords said the FDA was asked for technical assistance and addressed all safety concerns. He said the amendment is about free trade and lower-priced drugs.
"That's double-talk," Feldbaum said of the senator's comments. "This is actually importing price controls from other countries.
"This overall sets a bad precedent," he said. "We are against this bill in any form."
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 significant reduction in the cost of prescription drugs.
However, in his letter to Congress, Feldbaum wrote, "Any measure that imports the Mexican, Canadian or other government drug price controls undermines incentives for biomedical research to develop the next generation of drugs. The biotechnology industry is dedicated to bringing breakthrough products to market, but this is an industry that could not exist under policies like those we find abroad."