Congress

Senate health committee chair Edward Kennedy (D-MA) is circulating a new draft of his biogenerics legislation that is more favorable to generic drug makers and insurance companies than earlier discussion drafts by lowering the standard for substituting follow-on biologics for brand biopharmaceuticals.

Kennedy previously had circulated at least two drafts. One outlined specific market exclusivity, the other, which came later, left the exclusivity period blank.

The Senate Republican sponsor of drug safety legislation is working with Senate health committee GOP members on a new version of the bill's key provision -- its post-market risk management measure -- and the compromise may be included in the bill or as a GOP amendment on the floor, a source says.

Senate Finance Committee Chair Max Baucus (D-MT) is crafting a bill to inject more transparency into the Medicaid 1115 waiver process, Inside CMS has learned. A GOP aide said the committee's top Republican, Sen. Charles Grassley (IA), "shares an interest" in revamping the process.

Sen. Orrin Hatch (R-UT) wants to introduce next week stand-alone biogenerics legislation requiring clinical trials for follow-on biologics and giving brand biopharmaceuticals market protections similar to those in Europe -- and is hinting at user fees. Hatch said Wednesday (April 25) he would like to introduce the bill before an omnibus FDA reform/user fee bill hits the Senate floor, but a Hatch staffer said several health committee members would vote against the FDA bill were it amended with biogenerics.

Senate Finance Committee Chair Max Baucus (D-MT) has indicated that future war supplemental bills will remain the vehicle for an SCHIP shortfall fix if the White House follows through on its pledge to veto the initial version of the bill next week over issues unrelated to the children's health insurance language.

House appropriators last week blasted a provision of the 2008 White House budget proposal that would eliminate funding for a health program targeting urban-dwelling Native Americans, indicating they will push legislation to prevent the cuts if necessary.

Under the president's proposal, the Urban Indian Health Program (UIHP), which will receive nearly $33 million in fiscal 2007, would get no federal funding in fiscal 2008.

An aide to Sen. Charles Grassley (IA) said Tuesday the Finance Committee's top GOP member does not support a compromise provision included in the emergency war supplemental bill that would delay by one year CMS' controversial rule cutting back state Medicaid payments. The comments came a day after Sen. Richard Durbin (D-IL), who was pushing for a two-year delay, said he struck a one-year compromise with Grassley, who had advocated a six-month postponement.

Editors' Note: The original online version of this story said Sen. Charles Grassley was part of the deal reached with conferees, based on information Inside CMS received from Sen. Richard Durbin. Durbin later clarified that he had merely suggested to Baucus that Grassley be a part of the negotiation process and had actually never personally met with the Iowa senator or his staff. Grassley aides confirm he was not involved in the compromise, and still objects to the amendment (see related story).

House and Senate leaders will meet Monday (April 23) to hash out differences surrounding their emergency 2007 spending bills -- including approximately $750 million to plug SCHIP deficits this year -- but observers are already looking further ahead, as a promised presidential veto leaves in question how Democrats will move the legislation before states are forced to dip into Medicaid or cut kids' coverage.