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AUGUST 2007
IN THIS ISSUE
FY 2008 Appropriations
Drug Safety
In Case You Missed It
FOCR Updates
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Welcome to the August 2007 Friends of Cancer Research newsletter. To view the entire edition online, please visit: http://www.focr.org/news/newsletter/recent.htm
FY 2008 APPROPRIATIONS

 

Approps Bills Pass House, Await
Action in Senate


The appropriations process continues as the House and Senate consider the fiscal year (FY) 2008 appropriations bills. In May, Congress passed a budget resolution setting discretionary spending at $953.1 billion. In early June, the House Appropriations Subcommittee on Labor, Health and Human Services, and Education (LHHS) received an allocation of $151.1 billion to divide among its diverse programs, including the National Institutes of Health (NIH) and National Cancer Institute (NCI). Later in June, the full Senate Appropriations Committee passed its $152 billion LHHS spending bill which included a 2.8 percent increase in funding for NIH in FY 2008. The full House has now considered both the LHHS appropriations bill and the Agriculture appropriations bill (which includes funding for the FDA), while the full Senate has yet to take action on either bill.

NIH Appropriations

On July 11, the House Appropriations Committee approved the FY 2008 LHHS appropriations bill. The bill maintained the funding levels previously determined by the LHHS Appropriations Subcommittee, which included a 1.9 percent increase for NIH. (See July's newsletter for more details.) The full House of Representatives passed the measure by a vote of 276-140 on July 19.

In the Senate, the LHHS appropriations bill passed the Senate Appropriations Committee on June 21 and the bill has not progressed since then. The Senate version of the bill contains a 2.8 percent increase for NIH. Congress is in recess from August 6 until September 4, and the Senate is expected to consider the bill when Congress returns to session in September.


However, the future of the appropriations bills remains uncertain. The President has threatened to veto because they exceed his spending cap by $23 billion.


FDA Appropriations

The House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill was approved by a vote of 237-18 on August 2, amid displeasure from Republican members over procedural motions pertaining to the bill. The agriculture appropriations bill, which funds the Food and Drug Administration (FDA), contains $90.7 billion in funding for FY 2008, $18.8 billion of which is reserved for discretionary spending with the remainder going toward mandatory programs such as food stamps and farm subsidies.

The House bill would provide $1.69 billion for the FDA, an amount that is $128.4 million above last year's FDA appropriation and $62 million higher than the President's FY 2008 budget request.

The overall House Agriculture Appropriations bill exceeds the President's budget request by almost $1 billion, therefore it may face a veto threat from the President. Also included in the bill is a contentious provision allowing prescription drug reimportation from foreign countries, a provision that the Administration strongly opposes.

The Senate Agriculture Appropriations Committee passed its version of the funding bill in July. The Senate's request is $58 million above the House request and an 11% increase above the enacted 2007 budget. From this increase, $17 million is proposed to go toward the FDA's Critical Path Initiative to modernize product development and evaluation. The full Senate is expected to consider the bill after the August recess.

 

DRUG SAFETY

 
PDUFA Reauthorization Takes Recess

The reauthorization of the Prescription Drug User Fee Act (PDUFA) has been a focus for the biomedical community due to the critical role the legislation plays in sustaining resources for the Food and Drug Administration (FDA). Several months ago Congress began initial negotiations on potential components of an omnibus FDA bill that included PDUFA with the intention of reauthorizing the legislation for another 5-year period before the August recess. However, just days before adjourning for recess, consideration of PDUFA was put on hold.

Also included in the bill are provisions that would bring enhancements to the nation's drug safety system, reauthorization of the Medical Device User Fee Modernization Act, and reauthorization of two important pediatric research bills.

Without reauthorization, PDUFA is set to expire on September 30, 2007. Bill consideration was initially expected prior to the August congressional recess in order to avoid circulation of Reduction in Force (RIF) notices to FDA employees warning them of the looming deadline and subsequent loss of revenue. (RIF notices are typically sent to agency employees within 60 days of an approaching funding deadline.) However, Congress has pledged to pass the reauthorization to help prevent the issuance of RIF notices. The FDA has also stated its commitment to avoid layoff notices and reportedly will utilize emergency reserve funds to prevent such measures.

Both the House and the Senate have passed versions of the FDA reauthorization bill and negotiations have been underway to resolve the differences for the past several weeks. Due to the large number of other critical issues that required attention prior to the August recess, PDUFA negotiators concluded that in spite of their substantial progress they would prefer not to rush decisions on this critical policy. Senator Michael Enzi (R-WY), ranking member on the Senate Health, Education, Labor, and Pension committee voiced his disappointment that the bill was not completed and the need for bipartisan support: "If we are to answer to the American people, and give FDA the necessary new authorities to better protect the public's health and safety, we should not be politicizing this process."

It is expected that negotiations on the FDA legislation containing PDUFA will resume shortly after Congress reconvenes in September.

IN CASE YOU MISSED IT


The following appeared in the news within the past month.

"Lance hopes to grill presidential candidates"
MSNBC, July 21, 2007

"How to Get Fewer Scientists"
By Gene Sperling, Washington Post, July 24, 2007

"Small, vital gains over cancer"
By Michael V. Seiden, Philadelphia Inquirer, July 27, 2007

"Cancer Regression"
By Richard Miller, Wall Street Journal, August 1, 2007

"Burden of Proof: Cancer Drug Fails, So Maker Tries New Pitch"
By Greeta Anand, Wall Street Journal, August 2, 2007

FOCR UPDATES

 

New Arrivals


Friends of Cancer Research is pleased to announce the addition of a new staff member.

Heidi Buchanan joins Friends as Administrative Assistant. Heidi was most recently a legislative coordinator with Stateside Associates and previously held internships with Senator Edward M. Kennedy and Senator Bernard Sanders.