Rx DRUG COSTS: Former FDA Head Supports Reimport Bill
Former FDA Commissioner David Kessler has lent his support to the Senate-passed bill that would make it easier for pharmacists and wholesalers to reimport lower priced, U.S.-made prescription drugs shipped to other countries. The Wall Street Journal reports that Kessler, currently dean of the Yale University School of Medicine, has lent "conditional support" to the bill, saying that "with sufficient safety controls and adequate funding for FDA enforcement," reimported drugs would not pose greater health risks to American consumers (Lueck, 9/20). In a letter released by lawmakers yesterday, Kessler stressed the need for regulations that would guarantee that imported pharmaceuticals are "both authentic and unadulterated products" and provide "an important safety net for consumers." Senate Health, Labor, Education and Pensions Committee Chair James Jeffords (R-Vt.), the amendment's sponsor, said: "The savings (to consumers) will be in billions of dollars. The costs will be in the low millions. This is a deal we can't afford not to take" (Rovner, CongressDaily, 9/19). Lawmakers also released a letter from HHS Secretary Donna Shalala expressing similar support, provided Congress allots $23 million in the first year to the FDA to implement and oversee the project. Shalala objected to a House version of the bill, which lacked the "consumer safeguards" of the Senate measure. The two amendments are attached to the House and Senate versions of the FY 2001 agriculture spending bill, which is now in conference.
Drug Empire Strikes Back
Pharmaceutical companies opposed to the legislation have released letters from 11 former FDA commissioners, including Kessler, objecting to the import initiative. The drug companies argue that allowing imports of pharmaceuticals poses a "huge safety risk" to consumers by "potentially exposing them to counterfeit and substandard drugs." In addition, the companies argue, government regulation of the operation would be costly to taxpayers. But the Wall Street Journal reports that the Kessler letter cited by the industry was written in June 1999 and refers to a different bill, which Kessler claimed "would allow unapproved or damaged drugs to be imported" (9/20). Rep. Bernard Sanders (I-Vt.) released a report yesterday revealing that seven of the 11 former FDA commissioners opposing the measure "have strong financial ties" to the pharmaceutical industry, with four of the seven currently employed by drug firms. "The pharmaceutical industry is having a seizure here trying to figure out how to defeat what we have done here in the Senate," Sen. Byron Dorgan (D-N.D.) concluded (CongressDaily, 9/19).