Follow-on Biologics Legislation Introduced in House and Senate
Legislation introduced last Wednesday, Feb. 14, would create a pathway at the Food and Drug Administration (FDA) for the approval of follow-on versions of biologic drugs.  CHI has been focused on educating members of the California delegation on the complex nature of biologics products, and the potential safety concerns and unique intellectual property and patent issues that are a part of this complicated debate.  CHI has joined with others over concern for a fast-track approach to the legislation, as being discussed by policymakers looking for potential cost savings to be directed towards other government programs.  H.R. 1038, the Access to Life-Saving Medicine Act, was re-introduced by Rep. Henry Waxman (D-Los Angeles) in the House, while New York Senators Hillary Clinton and Chuck Schumer sponsored companion legislation, S. 623, in the Senate. 

President Bush Signs Government Spending Measure
On Thursday, Feb. 15, President Bush signed legislation allocating funding for the federal government through Sept. 20, 2007.  The measure, H.J. Res. 20, passed the House on Jan. 31 and was approved by the Senate (both California Senators supported) on Feb. 14.  CHI submitted a letter to Senators Feinstein and Boxer urging their support for funding increases for agencies that fund and regulate medical innovation.  Under the law, the National Institutes of Health (NIH) will receive $28.9 billion, an increase of $619.5 million, to support additional grants and research projects.  The Food and Drug Administration (FDA) also received $1.9 billion, a moderate increase of $127 million, allowing additional resources to be allocated to the Centers of Drug and Biologics Evaluation and Research (CDER and CBER).

House Hearing Reopens Discussions on Patent Reform
The House Judiciary Subcommittee on Courts, the Internet and Intellectual Property held a hearing on Thursday, Feb. 15, titled “American Innovation at Risk: The Case for Patent Reform.”  The hearing marks the beginning of a new round of congressional activity on the issue that carries over from last year.  In the 109th Congress, various pieces of legislation were introduced in an attempt to overhaul the current patent system.  Consensus between the high-tech and biomedical industries on various provisions was never reached and in the end no legislation was approved.  Legislators in both chambers have announced their intention to consider legislation again this year, although it remains unclear if it will be in one package or through smaller less comprehensive bills.  CHI continues to work with pertinent congressional offices to discuss various provisions, such as apportionment of damages and a post-grant review “second window,” that could weaken the intellectual property standards that are the foundation of biomedical research and development.

Congress Adjourns for Presidents' Day Recess
On Friday, Feb. 16, legislators in the House and Senate left Washington as Congress adjourned for the Presidents' Day District Work Period.  During the recess period there will be no congressional hearings or other activities in Washington until lawmakers return on Monday, Feb. 26.