While Congress had hoped to complete all spending bills by October, that goal now seems unlikely. Senate Majority Leader Harry Reid (D-NV) laid out an agenda that, while ambitious, included plans to act on a Fiscal Year (FY) 2008 continuing resolution to keep the government operating during the beginning of the 2008 fiscal year. It now seems likely that many FY 2008 domestic spending bills will be finalized by both chambers in the form of a large omnibus bill before being sent to the President. It is not clear when the spending bill will be completed. The full Senate schedule is likely to keep the Senate in session at least through mid-November with a strong possibility of continuing after Thanksgiving.

The House approved its version of the FY 2008 Labor, Health and Human Services and Education appropriations bill on July 19. It contains a 1.9% increase above FY 2007 to the overall NIH budget (after $300 million is transferred from the budget to the Global HIV/AIDS Fund). In late June, the Senate Appropriations Committee approved a bill with an overall increase of 2.8% above FY 2007, and the bill is now awaiting consideration by the full Senate.

FY 2008 Food and Drug Administration (FDA) appropriation levels also need to be reconciled. The agriculture subcommittees in both the House and Senate have passed bills that include increased funding for the FDA. The House subcommittee version contains an increase of $158M over FY 2007, while the Senate subcommittee version contains a boost of $186M.

As the spending measures proceed to conference committee, it is important that the biomedical community take action and encourage increased funding for these vital agencies.

The President has threatened to veto the spending bills because they are in excess of his proposed FY 2008 budget.

The reauthorization of the Prescription Drug User Fee Act (PDUFA) is expected to occur before its expiration on September 30. In a letter sent prior to the August congressional recess to FDA commissioner Andrew C. von Eschenbach, Senator Edward Kennedy, Majority Leader Harry Reid, Speaker Nancy Pelosi and Congressman John Dingell stated:

"The American public deserves a strong and effective FDA, which only its highly qualified employees can provide. You and each of the dedicated employees of the FDA should have every confidence that Congress will reauthorize these important public health programs in early September."

The PDUFA program allows the FDA to collect vital funds from product sponsors to offset the cost of application review. It is a part of an omnibus FDA bill that includes reform to the U.S. drug safety system, reauthorization of a similar user fee program for medical devices, as well as the reauthorization of programs that provide incentives for research on product use in pediatric populations.

Both chambers have passed versions of the FDA reauthorization bill and negotiations have been underway to resolve the differences between the two. The major differences between the House and Senate versions include enhancements to clinical trial registries, amounts of applicable financial penalties to non-compliant companies, and the management of potential conflicts of interest on FDA advisory committees.

August 10, 2007
The Boston Globe

IN "TRANSPARENCY, strength at the FDA" (Op-ed, Aug. 1), Susan F. Wood and David Michaels ask whether the drug safety legislation in Congress will "make a difference." As heads of organizations dedicated to cancer research, we believe the answer is an emphatic yes. The simple reason is that the legislation already includes almost all that Wood and Michaels call for: increased authority, staff, and budget for post-market monitoring of drugs; disclosure of clinical trial results; and modernization of the Food and Drug Administration's IT system.

They say the FDA is rushing dangerous products to the marketplace, and suggest that a slower, more cautious FDA is needed.

The debate should not be about how long it takes the FDA to review a new drug application. The true measure of the agency's success should be its ability to bring better science, modern information systems, and new technology to the drug review and monitoring process, thereby strengthening an already robust system.

We want an FDA that eliminates roadblocks and bureaucracy so that patients with serious conditions, such as cancer, gain access to new treatments in a timely way. The Kennedy-Enzi bill takes significant steps forward and should be passed and sent to the president.

ELLEN V. SIGAL
Chairwoman, Friends of Cancer Research
Washington

Dr. EDWARD J. BENZ JR.
President, Dana-Farber Cancer Institute
Boston

Symposia

Friends works with world class cancer research institutes to host public symposia all around the country. These events bring together policymakers, researchers, patients, and health care providers to discuss and learn from one another about the amazing opportunities on the horizon in cancer research and the ways we can work together to accelerate innovation in cancer prevention, detection, and treatment.

We welcome you to join us for one of our upcoming events.

For more information, contact Heather Chaney at hchaney@focr.org.

The following appeared in the news within the past month.

"Americans Without Health Benefits Rose to 47 Million"
Bloomberg, August 28, 2007

"GOP Candidates: Ramp Up Cancer Fight"
New York Times, August 28, 2007

"Candidates pledge to fight cancer"
Des Moines Register, August 27, 2007

"FDA blamed for dip in new drugs"
CNNMoney.com, August 16, 2007