NIH Spending Package Caught in Larger Funding Debate
House and Senate negotiators approved a spending package on Nov. 1, that would fund the National Institutes of Health (NIH) at $29.8 billion for FY 2008, a 3.1 percent increase over last year, and a boost above both House and Senate-passed versions.  CHI, in conjunction with other life sciences groups, sent a letter to influential House legislators on Oct. 22, advocating funding for the agency equal to or above the Senate level.  Despite the unexpected increase in NIH funding, the Labor, Health and Human Services (HHS) spending package faces an uncertain future because Republicans oppose its being combined with other spending measures. In addition, the president promises to veto the Labor HHS package because spending levels are higher than he requested.  For more information please contact David Burt, CHI legislative director (858.551.6677 or burt@chi.org).

CHI Pushes for Extension of the R&D Tax Credit
As Congress winds down legislative activities for the fiscal year, CHI continues to advocate congressional action to strengthen and extend the federal research and development (R&D) tax credit, which expires Dec. 31, 2007.  The credit provides companies with an important incentive to commit to future, high-risk, high-dollar investments in R&D that fuel medical innovation and economic growth.  On Oct. 22, CHI and 34 member companies signed a broad coalition letter to House and Senate leadership urging congressional action on the credit before Congress adjourns.  Last Thursday, the House Ways and Means Committee passed a tax extenders package on a party-line vote that would extend the R&D credit through Dec. 31, 2008.  The legislation is expected to come to the House floor this week.  For more information please contact David Burt, CHI legislative director (858.551.6677 or burt@chi.org).

Committee Will not Move Follow-On Biologics Bill This Year
Members of the House Energy and Commerce Health Subcommittee concluded last week that they do not have enough time this year to create and pass legislation that would allow the U.S. Food and Drug Administration (FDA) to approve follow-on versions of biologic drugs.  The Health, Education, Labor and Pensions (HELP) Committee in the Senate approved language earlier this year, but the measure was never taken up in the House.  CHI continues to work with members of the California delegation in the House to encourage an approach to follow-on products that includes appropriate measures to ensure patient safety, incentives for the creators of innovative first-in-line medical products, and reasonable intellectual property protections.

Pricing Transparency Legislation Introduced in the Senate
Over the past two months, Senator Charles Grassley (R-IA) has introduced two pieces of legislation of concern to CHI and its membership.  S. 2221, the “Transparency in Medical Device Pricing Act of 2007,” would require manufacturers of implantable medical devices to file quarterly reports with the Secretary of HHS outlining their sales price data.  Under the legislation, manufacturers would be subject to civil monetary penalties from $10,000 to $100,000 for failure to report or misrepresentations of price data.  Senator Grassley also introduced S. 2029, the “Physician Payments Sunshine Act of 2007,” legislation that would require drug, device and biologics manufacturers with annual gross revenues that exceed $100,000,000 to disclose the amount they give to doctors through payments, gifts, honoraria, travel and other means.  Penalties for noncompliance would range from $10,000 to $100,000 per violation.  CHI is in the process of gathering more information on these bills.  If you have questions or comments, please contact Todd Gillenwater, CHI vice president-public policy (202.974.6313 or gillenwater@chi.org).