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MARCH 2009



Biotech under Barack
 - Jeffrey L Fox, Nature Biotechnology 27, 237 - 244 (2009)

The Obama administration looks to be a welcome shot in the arm for the scientific endeavor, but the current economic crisis is likely to keep several issues of key interest to biotech firmly on the back burner.

Barack Obama came into office with campaign promises of keen interest to the biotech industry, including commitments to overhaul the US healthcare system, to lift restrictions on federal funding for human embryonic stem (hES) cell research and to increase focus and funding for science. But the economic crisis that weighs down the US economy, as well as skirmishes with the US Senate over key Cabinet and top-level appointees, has kept the new administration from dealing with much else during its first weeks in office. The anticipated changes in the healthcare system, if realized, are widely expected to lower the pricing of biological therapeutics by ushering in biogenerics, also known as follow-on biologics, sooner rather than later. Healthcare reforms also might introduce a system for evaluating therapeutic regimens on a cost and comparative-efficacy basis.

"It is heartening to see the Obama administration embrace science as an important input of government and science policy as a driver of the American economy," says Thomas Murray, president of the Hastings Center (Garrison, NY, USA), which focuses on bioethics. "Instead of muzzling or ignoring science, it will sit at the table, along with the appointment of a set of remarkable science advisors."

"Obama is clearly a science buff, and is really, honestly, into knowing the facts, having them laid out, and then making the best choices that can be mustered," says a policy watcher who was close to the transition team but is outside the federal government. "It is a whole different approach compared to the 'How can we spin this information?' approach of the [Bush administration]. Back to 'honest-to-goodness' curiosity, which is, yes, incredibly refreshing."

Thus, there is solid enthusiasm for some of Obama's early choices for key Cabinet posts, including Nobelist Steven Chu, physicist from Lawrence Berkeley Laboratory (Berkeley, CA, USA), for secretary of the Department of Energy (DOE), and former Iowa governor Tom Vilsack for secretary of the US Department of Agriculture (USDA) as well as for high-level science advisors, such as Harold Varmus, also a Nobelist, president of the Memorial Sloan-Kettering Cancer Center (New York) and a former director of the NIH, and Eric Lander, who is founding director of the Broad Institute of the Massachusetts Institute of Technology and Harvard (Cambridge, MA, USA).

"We're jazzed," says an insider at DOE, referring to Energy Secretary Chu. "He's a great pick, and it's a huge boost to think of someone who can speak science to anybody-even to the OMB," he adds, alluding to the federal Office of Management and Budget, whose top officials in recent years have habitually blocked federal research or policy initiatives.

"With this president, a lot of policies are going to change, and a number of them are likely to be exciting for us," says Willy De Greef, secretary general of EuropaBio (Brussels). He points to USDA Secretary Vilsack as but one example of Obama appointments that look positive for biotech. The new USDA secretary "understands what biotech crops can do and has a deep interest in putting agriculture in play, including for energy independence and biofuels," De Greef says. Although no details are available, he adds, Vilsack's attitudes toward and familiarity with biotech-related agriculture issues "are very good for our sector."

The appointment of Vilsack is "nothing but positive for biotechnology," says Val Giddings, a Washington-based industry consultant and former USDA official. "There's not been an ag [USDA] secretary who comes in so familiar with biotech issues and who doesn't have to be briefed for the first time, but is favorably disposed to biotech for farmers. Plus, he respects data and evidence." As for Energy Secretary Chu, Giddings says, "He can't help but advance the [DOE] biotech portfolio. There will be greater openness, and it's nothing but positive."

"On the food side, I expect biotechnology to be a fairly unimportant issue for the next couple of years," says Conko of the Competitive Enterprise Institute. Instead, he and others recognize that conventional safety issues, with the salmonella-laced peanut butter problem the most recent example, will be predominant. One exception directly involving biotech could be a move to reinstate a premarket notification rule for genetically engineered plants, a move that was blocked by Bush but could be brought back by the Obama administration. "There is no reason to think the [Obama] administration would go toward more deregulation, much to my chagrin," he says.

Meanwhile, Conko anticipates a "concerted effort to evaluate how FDA looks at general food safety" amid renewed talk of splitting it into two agencies. "The food people at FDA are really underfunded, and CFSAN [Center for Food Safety and Applied Nutrition] is seen as the ugly stepsister to the medical products side," he says. Experts have debated the possibility of separating those two FDA responsibilities into different entities for more than two decades, and there are plenty of obstacles standing in the way, he adds. "But I expect to see some congressional hearings and internal FDA investigations within the next two years."

Indeed, Representative Rosa DeLauro (D-CT) in February introduced a bill, HR 875, seeking to establish a separate "Food Safety Administration." Here again, despite such signs of renewed interest in separating food from drug and possibly splitting FDA into two agencies, Washington insiders provide plentiful reminders of how complicated and potentially contentious it will be to legislate that move. Even with bipartisan agreement, many congressional committees have partial jurisdiction over FDA programs, ensuring that such a restructuring effort will be a bureaucratic nightmare.

What happens with biofuel development ties in with developments and policies affecting agriculture and, here again, Obama's selection of Tom Vilsack for USDA secretary is drawing praise from biotech analysts. "Agbiotech is regarded as important, but let's have no illusions," says Washington-based consultant Giddings. "The economy and Middle East are first-tier issues, and Vilsack won't get Obama's attention for quite a while. And, even if they [administration officials] could be specific about agbiotech, they wouldn't because they will set it on the shelf and get to it once they deal with other stuff."

In terms of regulatory policies affecting genetically modified crops, little is expected to change anytime soon during the Obama presidency, except perhaps for a greater emphasis on transparency. "It is likely that the Obama administration will be more open than Bush's to a wide range of stakeholders," says Gregory Jaffe, who directs the Biotechnology Project at the Washington-based Center for Science in the Public Interest. More generally, the new administration is more likely to seek additional regulatory authority or even to ask Congress to amend laws in cases where rule-making becomes too much of a stretch for those already on the books. However, he adds, with so many other pressing food-safety issues to face having to do with microbially or chemically contaminated products, "I don't think biotech foods will be high on Obama's agenda."

"Expect more scrutiny of new varieties and more disclosures and transparency about biotechnology in food and agriculture," agrees Mark Mansour, an attorney with Bryan Cave (Washington, DC, USA). He, too, does not anticipate "much change" from recent policies in the near term, except for "some concessions to watchdog groups. But this will take a while, and will be expressed in due course."

One area where agricultural policy might change course is internationally, particularly with Secretary of State Clinton revitalizing international outreach programs, according to Mansour. This could take shape as an "aggressive engagement of USDA and USAID [Agency for International Development] with developing countries in Africa and other parts of the world, using agriculture as a means of engagement," he says. Unlike the Bush administration, for which such programs were, at best, "an adjunct to security, this [Obama] administration could see agricultural biotechnology as a constructive tool." Of course, "there will be obstacles to overcome, but a lot of opposition to biotechnology could melt with a prolonged recession."

"We're spending about $22 billion per year for the region [Africa], and candidate Obama called for doubling resources, and to put agricultural resources among the top ten," says Robert Paarlberg of Wellesley College (Wellesley, MA, USA), and author of Starved for Science: How Biotechnology is Being Kept out of Africa. "Science-based assistance does seem to have a voice." However, biotech will not soon make inroads into African agriculture because so many countries there remain dominated by Europe through custom and because Europe provides them much more assistance than does the United States, he adds. Thus, although USAID "has tried to throw its weight around, that doesn't work in Africa."

"The EU approach has helped keep African countries from adopting GM [genetically modified] crops," agrees De Greef of EuropaBio. "We hope if the EU and US become less adversarial, it could remove pressure from Africa, which feels forced to choose between US or EU regulations."

In terms of global agbiotech disputes, there are "tricky dossiers" to be faced, De Greef says. Even though the US won a round against the EU in a long-standing World Trade Organization (Geneva) case about genetically modified organism imports, "no official appeal" from the EU has been filed yet, he says. "If EU does not appeal or comply, the US, Argentina and Canada can take unilateral measures, but the US probably will prefer to negotiate, which seems more Obama's style. I'd like to see agreements rather than litigation, and a real victory would be to have science-based regulations."