Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News

Two “Dear Colleague” letters from Congressional representatives to hike the budget have elicited plenty of support.

This election year wouldn’t appear to offer much hope for real year-over-year growth in the NIH budget, with both sides of the political spectrum attacking sky-high federal spending. President Barack Obama is proposing to keep NIH’s budget flat in FY 2013 at $30.702 billion in discretionary budget authority from Congress and $30.86 billion in overall program level funding.

Yet two bipartisan “Dear Colleague” letters circulating in Congress in recent weeks have drawn many more signatures than most. Their message is that NIH spending should grow well above the current fiscal year’s level. Reps. Brian Bilbray (R-CA) and Edward Markey (D-MA) wrote a letter calling for at least $32 billion, a 4% increase over the current fiscal year. It won the signatures of 153 House members, a better response than dear-colleague missives usually receive.

“That’s more than one-third of the House stating that NIH is such an important program that we need to provide the funds for this important investment,” Jon Retzlaf, managing director of science policy and government affairs at the American Association for Cancer Research (AACR), told GEN. The letter stated: “NIH must be fully funded if we want to discover the next medical breakthroughs in America and not import them from China or India.”

Additionally, a record-high 47 Senators signed a “Dear Colleague” letter by Sens. Robert Casey (D-PA) and Richard Burr (R-NC), probably because that letter avoided advocating a minimum level of NIH funding. The letter urged Senate Appropriations to “maintain a strong commitment to funding” for the agency, and “consider the tremendous benefits of a sustained investment in the NIH.”

“It’s an indication to me that there is still bipartisan support for the program,” noted Jennifer Zeitzer, legislative director for the Federation of American Societies for Experimental Biology (FASEB).

Efforts to Boost Funding

Falling in between the House and Senate was a March 16 letter by 900 stakeholders from the health, education, and labor spheres. While also balking at setting a number, they did call on the House and Senate to “provide the largest possible FY 2013 302(b) allocation”—Washington-speak for funding level—“to the Labor, Health and Human Services, Education, and Related Agencies Appropriations Subcommittee within the discretionary cap established by the Budget Control Act (BCA).”

By seeking BCA caps, the stakeholders sought higher funding than possible under the House budget, which has lower spending caps and was proposed by Budget Committee Chair Rep. Paul Ryan and supported by the chamber’s Republican majority. The Democratic-majority Senate has vowed to use the higher BCA spending caps.

Subcommittee leaders have also heard from 10 Republican House members, led by Reps. Dave Reichert (R-WA) and Jim Gerlach (R-PA), who signed their own letter seeking “continued support for NIH medical research.”

That doesn’t bode well for efforts to reduce the agency’s funding through lower spending caps.

Exactly how much the House and Senate will seek for NIH and the other biopharma regulatory agencies this time around will emerge in coming weeks, as the House and Senate appropriations committees and their subcommittees are expected to begin marking up spending bills. As productive as that work seems, the bills are unlikely to go anywhere until voters cast their ballots in November for the President, the House, and for many, the Senate.

NIH’s Strategy

Yet that political wrangle hasn’t stopped the House and Senate from holding hearings on NIH and the rest of the Labor-HHS-Education piece of the budget. Testifying March 20 before the House Labor-HHS-Education subcommittee and eight days later before its Senate counterpart, NIH director Francis S. Collins, M.D., Ph.D., said President Obama’s flat overall NIH budget would be sufficient in FY 2013. He also sought to justify the 11% increase proposed for his priority project created last year, the National Center for Advancing Translational Sciences (NCATS).

Dr. Collins would like NCATS to see a $64.32 million increase in FY 2013 to $639.033 million. Most of that extra NCATS spending comes from a fivefold increase—from $9.981 million to $49.624 million—for the Cures Acceleration Network (CAN). CAN includes support for the Integrated Microsystems for Drug Screening Initiative, drug rescue and repurposing, target validation, and other programs.

In a statement, House subcommittee chair Rep. Denny Rehberg (R-MT) expressed concerns that the NCATS budget hike was part of an NIH effort to shrink basic research spending below current and historic levels of 55%. “We do not want to wake up in the future to find an NIH director without a stable full of science available for translation because we took our eye off the ball of basic science.”

Rehberg signaled possible cuts to NCATS by stating that its authority was limited to supporting clinical trials and infrastructure activity “in addition to a reasonable but narrower level of authority to take drugs into Phase II clinical trials. Congress did not provide or envision NCATS or NIH to have authority to compete with industry or become a drug developing organization.”

Dr. Collins countered that increased NCATS funding would not come at the expense of basic research, since NIH expects to fund 9,145 new and competing research project grants (RPGs), up 7.7% from FY 2012. However, total RPGs for FY ’13 are projected at 35,888, down 0.2% from FY ’12. RPG funding would also fall 0.2% to $16.463 billion.

“Basic discovery and the development of therapies go hand-in-hand at NIH. The two types of research have and always will exist together in a continuum,” Dr. Collins testified.

Thomas Insel, M.D., NCATS’ acting director, testified at the same hearings that the center’s FY ’13 priorities include developing a chip to produce more accurate and earlier drug safety assessments; rescuing unapproved drugs and repurposing approved drugs, rare disease R&D, and launching the second phase of the Clinical and Translational Science Awards to create networks with shared resources.

“The focus should be on tools and methodologies that will serve to help the biopharma industry as a whole to more efficiently and effectively conduct research and development,” Scott Koenig, M.D., Ph.D., president and CEO of Macrogenics told the House subcommittee, speaking for the Biotechnology Industry Organization. Dr. Koenig is also chairman of Applied Genetic Technologies.

And, raising home-state issues, Rehberg said he “cannot imagine” supporting NIH’s plan to cut the $51 million increase approved just last year for the Institutional Development Awards (IDeA) program. IDeA was created to broaden the geographic distribution of NIH funding for biomedical and behavioral research beyond top-tier biopharma states. Sen. Thad Cochran (R-MS) voiced similar concerns during the Senate hearing about IDeA, which benefits Mississippi, Montana, and 21 other states plus Puerto Rico. The program would be cut back to $225 million, its FY ’11 budget.

Also, the Senate may rewrite another part of NIH’s budget, judging from concerns raised by Senate subcommittee Chair Tom Harkin (D-IA) about a proposed $80 million increase for additional Alzheimer disease research. The money would be transferred from a disease-prevention fund created within HHS as part of Obama’s healthcare overhaul.

Extra Alzheimer disease funding or not, it will be hard for Congress to resist the momentum being generated to ramp up NIH funding for FY 2013, given the desire of members, magnified in an election year, to position themselves against deadly diseases and for ailing constituents, especially seniors and kids.

Rehberg last year proposed a $1 billion increase for the agency, and that set the stage for the virtually flat NIH budget, only 0.2% below FY 2011 funding levels of $30.767 billion in budget authority and $30.926 billion overall. Given Rehberg continues to chair the subcommittee, “in theory, there is still support for NIH over in the House, so when they put together the Labor-Health and Human Services bill, will they be able to spare NIH from any cuts? I don’t know the answer to that question,” Zeitzer said. The result may not be the billion-dollar bonanza Rehberg envisioned last year but should be above the flat-line budget proposed by President Obama in February.

Alex Philippidis is senior news editor at Genetic Engineering & Biotechnology News.

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