Congress

Legislation that would require the government to haggle directly with drug makers for lower prices under the Medicare drug benefit passed the House Friday (Jan. 12) by a count of 255 to 170 with two dozen Republicans crossing party lines to support the measure. There were no Democratic defections. House leaders suggested their next goal is to create a stand-alone Medicare-administered drug plan.

Lawmakers seeking to establish a single food-safety agency need to ensure their efforts do not backfire, leading to fewer inspections of facilities regulated by the U.S. Agriculture Department instead of boosting inspections at FDA-regulated facilities, according to sources following the matter. Much of the debate in the past has been over the difficulty of meshing different cultures at FDA and USDA, but some say the biggest challenge would be ensuring there is enough money and authority to beef up inspections.

The first several days Congress was back in town, members reintroduced, or made their intentions known to reintroduce, bills regarding generic drugs and RU-486.

Sen. Herb Kohl (D-WI) plans to reintroduce two bills from last year meant to stop tactics used by brand-name drug companies to delay generic competition, according to a statement from his office. This month, Kohl gained control of the Senate Appropriations subcommittee with jurisdiction over FDA's budget.

Senate Finance Chair Max Baucus (D-MT) vowed Thursday (Jan. 11) to support legislation that would repeal the controversial non-interference clause of the Medicare drug benefit -- an about-face that could pave the way for congressional passage of a measure allowing direct government negotiations for drug prices under Part D. Baucus offered few details of his plans, however, declining to disclose if he would push to require the administration to pursue such negotiations -- as a much-hyped House bill would -- or merely authorize it to do so.

Consumer advocates think FDA is not doing enough to get trans fat out of processed food so they plan to lobby lawmakers such as Sen. Tom Harkin (D-IA) and Rep. Rosa DeLauro (D-CT) to lean on FDA to ban trans fat from commercial foods or tighten labeling requirements.

The American Public Health Association and the Center for Science in the Public Interest are also asking state and local governments to do more, pointing to New York City and Chicago as good examples of how municipalities can ban trans fat.

The Senate Finance Committee will hold a hearing Jan. 11 to examine the contentious topic of having the government negotiate drug prices under Medicare Part D, the chairman's office announced yesterday (Jan. 4). The move comes in the midst of a whirlwind of activity surrounding Part D negotiations, as Senate Democratic leaders introduced a "sense of the Senate" negotiation bill (S. 3) Thursday, and House Democratic leaders are expected to introduce a more specific negotiation bill (H.R. 4) Friday (Jan.

FDA has sent to the Office of Management and Budget a proposed rule implementing food irradiation requirements from the farm bill Congress passed in 2002. The food irradiation requirements were pushed by Sen. Tom Harkin (D-IA), who this week took the helm of the Appropriations HHS subcommittee. Consumer advocates already are gearing up to challenge a possible move by FDA to allow companies to substitute the word "pasteurized" for "irradiated" on food labels, pointing to technical requirements included in the law.

Just days before Democrats assume power over the 110^th Congress, Republican House committee leaders are asking the incoming leadership not to detour the traditional legislative process in a bid to swiftly pass measures that include forcing HHS to negotiate with drug makers for lower prices under Medicare's year-old prescription drug benefit.