Rx Drugs

FDA and Health Canada clashed on whether Canadian Internet pharmacies are selling unsafe prescription drugs in the United States, just days after the two parties signed a memorandum of understanding (MOU) aimed at tackling potential safety problems stemming from cross-border drug sales, FDA and Canadian sources say.

House Democrats, worried that the Republican majority would renege on its promise to allow members three full calendar days to inspect the Medicare conference report before its consideration, issued a letter to the House Rules Committee demanding more time to inspect the bill.

FDA and Health Canada signed a memorandum of understanding this week to share information on pharmacies that export prescription drugs to either nation. The MOU will allow the two countries to share information on quality defects or product recalls and regulations or policies regarding drugs. The MOU also covers sharing information about post marketing surveillance of drugs.

House Democratic leaders, with the backing of allied seniors groups and labor unions, are whipping up opposition to the Medicare prescription drug bill, seeking to minimize defections by conservative Democrats working to discredit the bill's endorsement by AARP.

Democrats and their allies are focusing on the premium support demonstration, arguing that competition between private plans and traditional Medicare will lead to the privatization of the government program.

Lawmakers of both parties and even HHS Secretary Tommy Thompson courted the House Blue Dog coalition Tuesday (Nov. 18) to support the Medicare bill, signaling the GOP's need for bipartisan backing as support from House conservative Republicans weakens.

Nine members of the moderate-to-conservative House Democratic group crossed party lines to secure passage of the House bill in June as the only members to defy the minority leadership. The coalition's potential for cross-over votes that could mitigate conservative GOP defections make it very valuable as a final vote draws nearer.

The House passed a motion Tuesday (Nov. 18) urging lawmakers charged with reconciling the House and Senate versions of the FDA fiscal year 2004 appropriations bill to include language that would prohibit FDA from spending money to stop drug reimportation from Canada. The House version of the bill already includes such language, but the Senate version does not.

An influential House conservative this week came out against the Medicare conference report and urged fellow Republicans to vote down a bill that lacks comprehensive market reforms and a means to contain the program's growing costs.

Rep. Pat Toomey (R-PA), who in September led an effort by 13 conservative Republicans to push for fiscally conservative provisions in the bill, said in a Nov. 18 statement that the conference report "falls short of needed reforms."

GlaxoSmithKline is using federal law to defend itself against the Minnesota attorney general's charges that the firm violated state antitrust law by blocking sales to Canadian pharmacies selling drugs to U.S. consumers. Under federal law, importing drugs from Canada is illegal and a drug company can take steps to stop illegal sales of its products, according to GSK. Federal law pre-empts the attorney general's action, the company adds.

In a politically momentous move, AARP has officially declared its support for the tentative Medicare agreement hammered out by conferees, simultaneously handing proponents of the legislation much-needed leverage and reversing its recent track record of non-committal stances on Medicare legislation. The endorsement, however, has drawn both criticism and praise from opposing sides of the aisles.