2007-11-01

FY 2008 Funding for NIH Still in Question

With fiscal year (FY) 2008 having begun on October 1 and funding levels for the year still not approved and finalized, Congress passed a continuing resolution (CR) to continue funding the federal government and various federal programs at FY 2007 levels while completing work on FY 2008 funding bills. When this issue of The Hematologist went to print, Congressional leaders had established mid-November as their target date for adjournment for the year and to finalize FY 2008 funding levels.

The House and Senate Appropriations Committees’ proposed FY 2008 NIH funding essentially represents a cut for NIH, because the small increases it provides do not keep pace with the projected 3.7 percent increase in biomedical inflation. The House version of the FY 2008 Labor-HHS spending bill provides a net increase of $549 million (1.9 percent) over FY 2007 for NIH. Meanwhile, the net increase proposed by the Senate for the NIH budget in its draft bill is $799 million (2.8 percent) over FY 2007.

Though the full House ultimately passed its version of the funding bill, timing for consideration by the full Senate remained in question as this issue of The Hematologist went to print, though congressional leaders sought to complete all outstanding work on FY 2008 funding bills by mid-November. It is likely that the Labor-HHS funding bill will be combined with additional funding bills into an “omnibus” bill.

ASH encourages all members to visit the ASH Advocacy Center to help influence the budget process and find the most up-to-date information about NIH funding and ASH’s advocacy efforts.

Congress Delays Tamper-Proof Rx Pad Regulation

Physicians and pharmacies will have an extra six months to implement a Medicaid requirement that prescriptions be written on tamper-resistant paper for pharmacies to receive reimbursement. New legislation passed at the end of September resolved the problem that the original tamper-proof mandate implementation date of October 1, 2007, did not provide enough time for states to acquire the pads. The extension means that pharmacies will be able to avoid having to forgo reimbursement or turn away patients.

Congress Approves FDA Authorization Bill

Both the House and Senate approved a comprehensive legislative package to reauthorize drug industry user fees, provide greater incentives for pediatric drug testing, and require reporting of clinical trial results. The final legislation (H.R. 3580) reflects a compromise between House and Senate bills to reauthorize various programs at the U.S. Food and Drug Administration (FDA). The measure reauthorizes through FY 2012 the Prescription Drug User Fee Amendments (PDUFA) and the Medical Device User Fee Amendments (MDUFA), and includes a number of provisions intended to improve drug safety. Also included in the bill is a provision expanding the ClinicalTrials.gov data bank at the Library of Medicine to include registry information for clinical trials of all drugs, biologics, and devices, as well as results for clinical trials of approved products.

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