FDA Coffers Fill With Funds, But No Money For Reagan-Udall Or Lab Closures
This article is reprinted from the January 7, 2008 issue of "The Pink Sheet"
FDA enters 2008 with the financial wherewithal to go full speed ahead in hiring and establishing the safety programs authorized by the FDA Amendments Act, following President Bush's signing of an omnibus fiscal 2008 appropriations package on Dec. 26.
The measure, which provides appropriations for most of the federal government, gives FDA $2.2 billion to spend in the accounting year that began Oct. 1, 2007. This includes $459,412,000 in prescription drug user fees, a significant jump from the $305 million baseline figure from fiscal 2007.
One of the new efforts authorized by FDAAA - the Reagan-Udall Foundation - will not be receiving federal funds. The law bars transfer of FDA money to the private/public partnership that is designed to modernize medical product development and identify unmet scientific needs.
House Appropriations Agriculture Subcommittee Chairwoman Rosa DeLauro, D-Conn., has urged that the $500,000 to $1.25 million authorized for the foundation be withheld until FDA sets policies to safeguard against undue industry influence (1"The Pink Sheet" Nov. 5, 2007, In Brief).
Most of the money for Reagan-Udall is to come from the private sector, so the withdrawal of federal funds may have a mostly symbolic impact.
As in the House-passed Agriculture/FDA Appropriations bill, the omnibus spending package bars FDA expenditure of funds to close or consolidate any of its 13 field laboratories or 20 district offices that were functioning as of Jan. 1, 2007, or to consolidate inspection or compliance functions.
National Treasury Employees Union President Colleen Kelley applauded the ban, citing the importance of the testing labs for ensuring drug and food safety. Following sharp criticism from Congress, FDA already had delayed its plans to close facilities and reorganize the Office of Regulatory Affairs (2"The Pink Sheet" Aug. 27, 2007, p. 26).
The union, which represents about 5,200 FDA employees, is willing to meet with FDA to develop a plan to strengthen safety efforts and is working to increase funding for the agency, Kelley said.
The bill also suspends the FDA's new user fee program for the review of direct-to-consumer advertisements.
In addition to the specific limits on spending, the legislation also seeks to curb FDA's flexibility in general. In an explanation of the appropriations package, the House and Senate Appropriations Committees question FDA's increasing use of a "central account" to pay for activities without any information submitted to Congress on how the money is spent.
Although there is some value in the account, which is managed by the Office of the Commissioner, the committees point out that the account held about $125 million in fiscal 2006, a 32 percent increase from FY 2003. Calling the "lack of accountability unacceptable," the panels direct FDA to begin providing spending information for the account beginning in fiscal 2009.
The committees' explanation also encourages FDA to develop a system to review unapproved drugs that have been in clinical use for the past 25 years and are prescribed by doctors.
The law calls for at least $41.9 million to be spent by the Office of Generic Drugs, an increase of $6 million above FY 2007. The committees direct FDA to increase spending for drug safety by $21 million; for the Critical Path Initiative by $7.5 million; and for the Office of Women's Health by $1 million.
All reports and studies requested in the House and Senate Appropriations Committee reports on their respective bills must be provided within 60 days (3"The Pink Sheet" July 23, 2007, p. 14).
Comparative effectiveness of medical therapies is addressed by the committees in a discussion of appropriations for the Department of Health and Human Services. The Agency for Healthcare Research and Quality is encouraged to investigate the feasibility of developing a computer model for predicting the effects of health care policy alternatives. AHRQ should work with a consortium of university partners to develop an open-source, no-cost license model to predict costs and health impacts, the panels suggest.
HHS also is directed to maintain "deemed status" coverage under Medicare for federally-funded or reviewed clinical trials. CMS has been considering whether to end automatic Medicare coverage for clinical trials that are exempt from the FDA investigational new drug process (4"The Pink Sheet" April 23, 2007, p. 27).
- Cathy Dombrowski
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