Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News
While details differ, Romney, Gingrich, Santorum, and Paul all want to slice FDA and NIH’s budget.
While news accounts typically reduce elections to horse races, this year’s Republican presidential campaign threatens to live up to that metaphor all the way to the GOP convention in Tampa, FL. Republican voters have been treated to an ongoing debate largely focused on the economy, foreign policy, and social issues alongside attacks on President Barack Obama’s policies.
With President Obama releasing his budget proposal on January 13, over the coming weeks, candidates will no doubt pick at the details. While FDA’s budgetary authority would inch up only 0.4% to $2.517 billion, adding in industry user fees boosts total spending 17%. CDC’s discretionary budget authority would shrink by 11.6% to $5.068 billion, but after nondiscretionary spending is factored in, total funding rises by 0.4% to $11.236 billion.
The president froze NIH funding at $30.702 billion in discretionary budget authority and $30.86 billion in overall program level funding. Those are both 0.2% below FY 2011 levels. Among agencies linked to the biopharma sector, NSF saw the most favorable boost, getting a 4.8% increase to its budget authority to reach $7.373 billion.
All the GOP candidates have voiced opinions on these agencies that have been a resounding “no” to spending increases. As they present their take on the president’s proposal, the fact that it is an election year will likely mean the tough decisions get postponed until after a presidential winner emerges. While biopharma has seen less attention than tax cuts, immigration, or even Gingrich’s call for a new moon shot, the candidates have nonetheless sought to stand out on a variety of issues affecting the industry.
Former Massachusetts governor Mitt Romney said he will “immediately cut nonsecurity discretionary spending by 5%” under his Believe in America economic plan. That would shrink NIH’s budget from FY 2012’s $31.6 billion to $30.02 billion. FDA’s budget would drop from $2.497 billion to $2.372 billion.
As governor, Romney created a state-funded, quasi-independent agency charged with advancing biopharma in Massachusetts, with $10 million in authorized funding. The responsibilities of the Massachusetts Life Sciences Center (MLSC) grew under Romney’s Democratic successor and current Governor, Deval Patrick, to a $1 billion program called Life Sciences Initiative.
As governor, Romney banned research using human embryonic stem cells (hESCs) that were derived from embryos created solely for research. Patrick’s administration lifted the restrictions in 2007.
The restrictions marked an about face for Romney, who shifted right with his 2008 Republican presidential campaign in mind. While in 2007, he advocated against using federal funds for hESC research, he also told CBS News: “if a parent decides they would want to donate one of those embryos for purposes of research, in my view, that’s acceptable. It should not be made against the law.”
That comment appears to contradict Romney’s claim that he changed his mind from a supporter to an opponent of hESC research after a 2004 meeting with Harvard University researcher Douglas Melton, Ph.D. According to Romney, Dr. Melton several times used the word “killing” to describe what happens to two-week old embryos involved in hESC research; Dr. Melton has repeatedly denied using the word “killing.”
Newt Gingrich, speaker of the House of Representatives from 1995–98, has promised to create “a new 21st Century FDA” that would overhaul the agency into “a fair and competent regulatory regime that emphasizes both consumer safety and ensures that life-saving breakthrough products get from our labs to our pharmacies and homes as efficiently as possible.
“Unfortunately, the FDA falls well short of this expectation, and its stagnant bureaucracy has only gotten worse in recent years,” Gingrich said, citing the approval of just 21 new drugs in FY 2010. FDA insists its performance is improving since it approved 35 new drugs in FY 2011. The new FDA, said Gingrich, would prioritize drug reviews for brain disorders including Alzheimer disease, autism, mental illness, and Parkinson disease, priorities that presumably would be exercised as well by NIH in awarding research grants.
In a February 11, 2011 interview with The Hill, Gingrich joined former FDA commissioner Andrew C. von Eschenbach and Wayne Oliver, a vp at the Gingrich-founded think tank Center for Health Transformation, in dismissing NIH’s new National Center for Advancing Translational Sciences as “well intentioned” but “doomed to fail.” However, Gingrich opposed Republican efforts in FY 2011 to cut NIH’s budget by $1.6 billion; the agency that year saw 1%, or $330 million, less funding than the previous year.
Gingrich has drawn fire from some conservatives opposed to abortion rights, after telling ABC News in an interview published December 2, 2011, that he considered human life to begin at implantation: “I think that if you take a position when a woman has a fertilized egg and that’s been successfully implanted that now you’re dealing with life, because otherwise you’re going to open up an extraordinary range of very difficult questions.”
A day later, Gingrich insisted that “human life begins at conception” and declared to ABC: “I oppose federal funding of any research that destroys a human embryo because we are also dealing here with human life.” Gingrich said he wouldn’t rule out hESC research, adding, “if you can get embryonic stem cells for example from placental blood, if you can get it in ways that do not involve the loss of a life, that’s a perfectly legitimate avenue of approach.”
Pennsylvania’s junior senator from 1995 until 2006, Rick Santorum has long opposed hESC research. In 2006 with the Senate in Republican hands, Santorum introduced S.2754, the Alternative Pluripotent Stem Cell Therapies Enhancement Act. The measure required NIH to fund peer-reviewed research into developing isolation and production techniques for pluripotent stem cells, without deriving them from human embryos, as well as issue guidelines within 90 days to outline and prioritize such research. While the Senate passed the bill 100–0, the measure died in the GOP-controlled House despite a 273–154 vote in favor, since a two-thirds vote was required.
A year earlier, Santorum co-sponsored the Stem Cell Therapeutic and Research Act, signed into law by then-president George W. Bush. That measure requires HHS to contract with qualified cord blood stem cell banks to assist in collecting and maintaining 150,000 new units of high-quality cord blood for transplantation.
Five years earlier, Santorum supported the “Responsible Stem Cell Research Act,” also aimed against hESC research. The measure, which didn’t pass the Senate, would have authorized a 50% increase in stem cell research spending to $275 million but focused research on adult stem cells. The bill also called for creating an adult stem cell donor bank.
“I fervently believe that fertilization produces a new member of the human species. To use a human being, even a newly conceived one, as a commodity is never morally acceptable,” Santorum said in 2001.
Sartorum has traditionally supported greater NIH spending. He joined with senators in both parties to double NIH’s 1998 budget over five years, to $27.2 billion in FY 2003, and supported budget hikes in later years.
Santorum would be hard-pressed to maintain that record if elected, having committed to cutting $5 trillion of federal spending within five years. Upon taking office, Santorum has promised to lower federal nondefense discretionary spending to FY 2008 levels. That would take NIH down to $29.3 billion, a 7% decrease from FY ’12. Discretionary funding for FDA would fall to $2.369 billion from the $2.497 billion approved for 2012, a 5.1% drop.
Texas Rep. Ron Paul is promising to cut federal spending by $1 trillion in his first year, shrink the annual deficit his first two years in office, and replace it with a $13 billion surplus by FY 2015 and $19 billion by FY 2016.
Paul would not eliminate HHS but has proposed that five other cabinet agencies—Energy, Housing and Urban Development, Commerce, Interior, and Education—would have to brace for significant cuts. Paul would cut 40% from FDA’s FY 2006 budget of just under $1.88 billion. The resulting $1.128 billion would mark a 55% reduction from the current budget.
He previously suggested that FDA should be abolished: “The FDA just serves the drug companies. They also prevent drugs from coming on the market until 10, 15 years later than other countries have it. So, yes, government just gets in the way on so many of those things,” Paul said last year on The Diane Rehm Show, on NPR radio station WAMU.
He would reduce NIH by 20% from its FY 2006 budget of just under $28.533 billion, down to $22.826 billion, or 28% below current fiscal year. Paul has also committed to a 20% cut from the FY 2006 level for CDC of $5.826 billion. That agency’s budget would fall from the current $6.1 billion to $4.66 billion, down 23.6%.
In Congress, Paul introduced the Cures Can Be Found Act of 2009, a bill that allowed tax credits for donations to stem cell research or storage facilities and donations of umbilical cord blood. Credits would have been awarded only for donations to facilities that do not engage in hESC research. The bill died in a Democratic-controlled House.
The Republican nominee will face in President Obama an incumbent who has embraced biopharma on key issues, from raising NIH spending through his $814 billion stimulus measure, to lifting hESC research restrictions, to signing a healthcare overhaul requiring FDA to prepare a path for biosimilar drugs. The GOP candidate can counter by tying Democrat Obama to FDA red tape, increased federal spending, and tax policies that have driven U.S. biopharma jobs overseas. The argument, of course, will be settled on Election Day.
Alex Philippidis is senior news editor at Genetic Engineering & Biotechnology News.