Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News

Presidental candidates’ responses to query are inadequate and more discussion is essential.

With the U.S. economy stuck in neutral, science issues haven’t been high profile in this year’s presidential campaign. Yet they haven’t been ignored by President Barack Obama and Mitt Romney, judging from what they’ve been saying in recent months—most recently in answers to 14 questions released last week by nonprofit

Those answers—as with many of their speeches and papers—raise almost as many questions as they answer about how Obama and Romney would address key science issues over the next four years. If there are answers, the candidates aren’t saying; representatives for both campaigns did not respond to written questions emailed by GEN.

Take the NIH budget. Obama positions himself as agency-friendly by stating in ScienceDebate what he has said elsewhere—that he is “committed to doubling funding for key research agencies to support scientists and entrepreneurs.”

“You could see scenarios where they would provide increased support for basic research, not just at NIH, but [NSF], the Department of Energy and other agencies, and do that at the expense of other programs,” Dave Moore, senior director, government relations for the Association of American Medical Colleges, told GEN. “That can be done in a tight budget environment, but that obviously means that other programs elsewhere are going to have to be cut.”

Obama made a similar promise in 2008: “Barack Obama supports doubling federal funding for basic research,” his website declared.

Instead, under Obama, NIH’s discretionary budget authority rose exactly 0.77% over four years, from $30.396 billion in the 2009 federal fiscal year, to $30.623 billion in the current FY 2012—down from $30.688 billion in FY 2011 and $31.005 billion in FY 2010. Those figures do not include $10.4 billion spent over three fiscal years through the American Recovery and Reinvestment (“stimulus”) Act.

NIH is unlikely to see much more in the fiscal year beginning October 1. The House Appropriations Committee’s Labor-HHS-Education subcommittee in July approved an NIH budget for FY 2013 identical to this year’s, in an 8–6 party-line vote. A month earlier, the full Senate Appropriations Committee approved an increase of just $100 million (0.3%) in the Labor-HHS-Education portion of its FY ‘13 budget, in a 16–14 party-line vote.

No matter the November winner, NIH’s budget and priorities will be shaped less by the president than by Congress and agency leaders. Last year, Congress approved the National Center for Advancing Translational Sciences (NCATS) proposed by NIH Director Francis S. Collins, M.D., Ph.D., setting aside $574.713 million for FY 2012. For FY’13, Collins seeks a $64.32 million increase, to $639.033 million.

“Between Congress and the director, that is clearly what is driving agency priorities. I think that’s going to continue in the next Congress,” Jennifer Zeitzer, legislative director for the Federation of American Societies for Experimental Biology, told GEN.

Zeitzer noted that Congress, especially the House, is relying on policy stipulations or riders to enforce its priorities. One such rider would require NIH to certify that every grant it awards will impact public health and is of scientific value.

Like Obama, Romney has promised to advance basic research: “As president, I will focus government resources on research programs that advance the development of knowledge, and on technologies with widespread application and potential to serve as the foundation for private sector innovation and commercialization,” the former governor told ScienceDebate.

During the primaries, however, Romney said he would “immediately cut nonsecurity discretionary spending by 5%” through his Believe in America economic plan. It would effectively shrink NIH’s budget to $30.02 billion and FDA’s budget to $2.372 billion from the current $2.497 billion.

Yet those reductions are lower than the across-the-board 7.9% cut faced by NIH, FDA, and all nondefense agencies come January 2, 2013, unless Obama and Congress agree on how to make the $1.2 trillion in budget cuts over 10 years required by last year’s Budget Control Act.

Under Obama, FDA’s discretionary budget grew 13.7% over four years, from $2.196 billion in FY 2009. In July, Obama enacted the fifth authorization of the Prescription Drug User Fee Act (PDUFA V), which raises fees for prescription drugmakers and introduces fees on makers of generic and biologic drugs—in return for commitments to faster FDA drug reviews.

The biopharma industry has long complained about sluggish drug reviews, especially after FDA’s post-Vioxx shift toward more risk-benefit analysis. Romney echoed this theme in his comments to ScienceDebate: “[Obama’s] FDA has slowed the drug development process and inserted requirements that drive up the cost of developing new antibiotics.”

PDUFA V includes incentives toward developing antibiotics, while FDA has trumpeted quicker approvals of new treatments: 30 in 2011, 14 between January and June. But 18 drugs were approved in the first half of 2011, prompting Fitch Ratings to forecast a drug approval decline for July–December 2012 that remains to be seen.


Also unknown is how Obama and Romney will fulfill promises to strengthen the nation’s biosecurity. While the House and Senate have passed similar versions of a new Pandemic and All-Hazards Preparedness Act and Project BioShield Act, reauthorizing an array of federal biodefense programs created after 9/11, they have not ironed out differences.

“The problem with authorizations is that the money has to be delivered. Even if there’s a mandated pot of money established, oftentimes that money is diverted to other sources,” Moore said.

Project BioShield created a Special Reserve Fund to purchase medical countermeasures for the Strategic National Stockpile. Money from that fund was transferred to the U.S. Department of Homeland Security three times between FY 2004 and FY 2009. Also hurting biodefense, Moore added, are years of cuts to CDC’s immunization and public-health preparedness efforts, which will continue under Obama’s proposed FY 2013 budget, accounting for much of a $664 million (11%) reduction in the agency’s budget.

STEM Education

Obama is also touting administration programs advancing science-technology-engineering-math (STEM) education. They include Educate to Innovate, which has attracted more than $750 million in donations and in-kind contributions from companies and foundations; Change the Equation, a network of more than 100 CEOs; and the development of a five-year STEM education strategic plan. In July, the president announced a $1 billion STEM Master Teacher Corps to reward and retain the field’s top educators.

Rather than address STEM directly, Romney instead advocates foundational education reforms such as increasing parental choice, raising standards, and rewarding top teachers. At least Romney cited a policy paper (“A Chance for Every Child”)—unlike Obama, who amazingly missed a chance to promote his administration’s National Bioeconomy Blueprint, which details how it intends to apply biological research innovations toward national challenges.

Also missing from Obama’s answers is his reversal of predecessor George W. Bush’s 2001 order limiting research to 21 human embryonic stem cell (hESC) lines and banning all federal funding for hESC research.

As Massachusetts governor, Romney banned use of hESCs from embryos created solely for research, angering life-science leaders until his successor, current Gov. Deval Patrick, lifted the restrictions in 2007. Romney also created a $10 million state-funded, quasi-independent agency charged with advancing biopharma in Massachusetts. The Massachusetts Life Sciences Center (MLSC) was expanded by Patrick to oversee the state’s $1 billion Life Sciences Initiative.

With polls showing a tight race, neither Romney nor Obama will likely fill in the blanks in science policy, or other issues, until well after the votes are counted and a winner sworn in. That’s all the more reason why science leaders and others must press the candidates for answers well before Election Day.

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