FDA, NIH, NSF Get Increases in House Spending Plan; Debate Moves to Senate
The U.S. House of Representatives approved a $463.5 billion spending package on Jan. 31 to fund key government departments and agencies through the rest of the fiscal year.  The measure allocates $28.9 billion to the National Institutes of Health.  This is an increase of $619.5 million to support 500 additional research project grants, 1,500 first time investigators and expand funding for “high risk high impact” research.  The National Science Foundation will receive an additional $335 million, totaling $4.7 billion for FY 2007, for innovation programs to increase the nation’s global competitiveness.  The Food and Drug Administration is funded at $1.9 billion, an increase of $127 million over FY 2006.  The measure will allow for a $47 million increase at the Center for Drug Evaluation and Research, a $30 million increase at the Center for Biologics Evaluation and Research, and $8 million increase at the Center for Devices and Radiological Health.  The debate now moves to the Senate where it is unclear whether members will be able to reach a final agreement.  If they cannot, a short term continuing resolution would be necessary to avoid a government shutdown Feb. 15.

Follow-on Biologics Debate Gaining Traction in Congress
House Democratic leadership has opened debate on how to approach follow-on biologics.  Government Reform Chairman Henry Waxman (D-Los Angeles) has argued that enabling the production of cheaper versions of expensive biotech drugs could save government enough money to pay for the State Children’s Health Insurance Program when its funding expires.  And he has suggested connecting a follow-on biologics measure to the Prescription Drug User Fee Act (PDUFA), which funds a major share of FDA operations.  The issue is complicated and controversial.  CHI is focused on educating members of Congress and staff on the particular characteristics of genetically-engineered drugs, including the processes for determining their safety and efficacy, and the unique intellectual property and patent issues they raise.  The next generation of biotech products will require many billions in high-risk investment.  If lawmakers’ enthusiasm for saving money by encouraging follow-on biologics discourages this investment, patients will suffer the consequences.

FDA and Senators Address Drug Safety
Last week, in a response to a 2006 Institute of Medicine report on drug safety,  FDA outlined a comprehensive plan to bolster the agency’s safety programs, including improved communication and operations as well as pre-market testing, post-market surveillance and risk management.  Meanwhile, two pertinent pieces of legislation have been introduced in the Senate.   Health, Education, Labor and Pensions Committee Chairman Ted Kennedy (D-Mass.) and Ranking Member Michael Enzi (R-Wyo.) re-introduced the “Enhancing Drug Safety and Innovation Act,” and Senators Charles Grassley (R-Iowa) and Christopher Dodd (D-Conn.) re-introduced the “Food and Drug Administration Safety Act.”  CHI is concerned that portions of these proposals may adversely affect the approval of new technologies by placing overly stringent regulations and burdens on industry and the FDA.  The issue is expected to come to the forefront in the early spring when Congress takes up PDUFA, which some legislators view as a vehicle for drug safety legislation.

California Delegation Committee Assignments
Below is a list of California Delegation members who hold assignments in committees that have jurisdiction over issues of interest to the life sciences community.  The party affiliation and district number for each committee member is in parentheses after the name.