House To Vote Today on Rx Reimport Measures as Thompson Expresses Safety Concerns

The Bush administration said Tuesday that the FDA "cannot guarantee the safety" of reimported prescription drugs, "dealing a second blow" to a law first passed last year but never implemented, the AP/Arizona Republic reports (AP/Arizona Republic, 7/11). Under the law, pharmacists and wholesalers could import from abroad pharmaceuticals that meet U.S. safety standards ( Kaiser Daily Health Policy Report, 11/15/00). However, HHS Secretary Tommy Thompson said that the law could "fill U.S. shelves" with counterfeit or contaminated drugs, pointing out that the FDA cannot "sufficiently monitor" medicines after they leave the United States (AP/Arizona Republic, 7/11). In a July 9 letter to Sen. Jim Jeffords (I-Vt.), a key supporter of the law, Thompson said, "I do not believe we should sacrifice public safety for uncertain and speculative cost savings" (Fulton, CongressDaily/AM, 7/11). Jeffords, "disappointed" with the decision, said that he would "return to the drawing board." Thompson's announcement reaffirms a decision made last December by former HHS Secretary Donna Shalala, who refused to implement the law over safety concerns (AP/Arizona Republic, 7/11). Still, Rep. Bernie Sanders (I-Vt.) pointed out that the FDA helped to draft the legislation and "questioned why" Thompson opposes the law when President Bush said during his presidential campaign that he would support the measure. "Secretary Thompson's statement is essentially a regurgitation of the pharmaceutical industry line," Sanders said.

House, Industry Action
Meanwhile, in the House today, lawmakers plan to vote on two prescription drug reimportation amendments to the FY 2002 agriculture appropriations bill. One amendment, sponsored by Sanders, would prevent the FDA from enforcing a ban on the drug reimportation law passed last year. Under a separate amendment, sponsored by Rep. Gil Gutknecht (R-Minn.), the FDA would be prevented from enforcing restrictions on consumers who import prescription drugs into the United States for "personal use" (CongressDaily/AM, 7/11). In recent weeks, the pharmaceutical industry has "launched an intensive lobbying campaign to derail" the amendments, the Wall Street Journal reports. Steve Jennings, a pharmaceutical lobbyist, said, "This is a war -- nothing less," adding that the provisions would "expose people to counterfeit, ineffective and dangerous" drugs. Although the industry lost the debate last year, they appeared "better prepared" this year, winning support from a number of lawmakers, including Rep. Peter Deutsch (D-Fla.), who supported the drug reimportation bill passed last year (Lueck, Wall Street Journal, 7/11). Rep. John Dingell (D-Mich.), who helped to draft last year's drug reimportation legislation, also opposes the proposed amendments (CongressDaily/AM, 7/11). However, according to Sanders, the provisions would allow consumers to "stand up" an industry that has reaped "exorbitant profits" (Wall Street Journal, 7/11). The House today will also vote on an amendment sponsored by Rep. Sherrod Brown (D-Ohio) that would allow the FDA to spend $1 million to enforce drug patent laws (CongressDaily/AM, 7/11).