Electoral campaign delays resolution of biotech issues
Jeffrey L. Fox
Washington
Except for debates over ES cells, biotech has not been at the heart of the US presidential election campaign. Candidate Kerry (pictured here) offers slightly more explicit, albeit limited, views on biotech than his opponent.
Getty/Mark Wilson
Presidential candidates, pundits, and others on the US political scene are telling voters that the election this November will be crucial. But except for the highly charged issue of funding embryonic stem (ES) cell research, neither Republican President George W. Bush nor Democratic Senator John Kerry has said much to either rouse or repel representatives of the biotech industry or those who closely follow it.
Not surprisingly, few observers are comfortable discussing such matters before the election is decided, and those who do speak the language of diplomacy insist on anonymity. In the former category, representatives of the Biotechnology Industry Organization (BIO) in Washington, DC, say that they steadfastly endeavor to avoid party politics while voicing industry issues.
Indeed, BIO considers most if not all biotech-related issues "bipartisan...and we strenuously keep both feet in both camps," says its soon-to-retire President Carl Feldbaum, alluding to forthcoming presidential and congressional contests. "Many issues are quite centrist, even though a few, like stem cell research, have become polarized." BIO plans to maintain this bipartisan stance after its next president, congressman James Greenwood of Pennsylvania, whom Feldbaum calls a "moderate" Republican, takes charge next January (Nat. Biotechnol.22, 1067, 2004).
Of the two presidential candidates, Kerry offers more in the way of explicit, albeit limited biotech views. Besides taking a forceful stance favoring federal support for biotech research and development efforts in human health, including his specific promise of expanded access to human ES cell lines, and in other areas such as agriculture, Kerry also favors "government regulation that assures strong science-based decision making." In campaign documents, he further states that biotech research efforts have "already produced dramatic breakthroughs in human health, and offer promise in food, agriculture and industrial products."
Even so, BIO's Feldbaum describes Kerry as "distanced" from the national biotech community and also that of his home state of Massachusetts, where the industry and its academic counterparts enjoy a high profile. Feldbaum says that Kerry's posture "may be out of deference" to fellow Massachusetts Senator Edward Kennedy Jr., who is particularly involved with medical and research issues, including many that encompass biotech. "We've not had traffic with Kerry like we've had with Kennedy or other senators, so [Kerry] is not a well-known quantity," Feldbaum says, while also noting that the industry does not agree with Kerry's positions favoring efforts to lower drug pricing in part by allowing cheaper drugs to be imported from Canada.
"On the surface, Bush has seemed more an ally [to the biotech industry], but [there are] differences," Feldbaum continues. However, he speculates that a reelected Bush might budge over one of those differences, namely approving new lines for ES cell research—for instance, if a promising health breakthrough occurs.
No matter the result of the presidential vote, the US Food and Drug Administration (FDA) is an important focal point for BIO and others as they anticipate the November election. Feldbaum emphasizes the importance of having a Senate-confirmed commissioner at the agency. Although he and others praise Acting Commissioner Lester Crawford, they also allude to key policy proposals that seem stalled in part because this agency has so often been without a presidentially appointed boss—earlier during part of Clinton's tenure and both early and now again during Bush's tenure since Mark McClellan was shifted last March to direct the Centers for Medicare and Medicaid Services (Nat. Biotechnol.22, 366, 2004).
Meanwhile, several observers assert that Bush appointees at the FDA are dragging their feet on important biotech-related policies, particularly guidelines addressing safety of foods from cloned or transgenic animals. They have been suspected of interpreting the law so narrowly that they refuse to issue regulations, attributing their inertia to the lack of authority to do so. Along such lines, however, another comprehensive review effort of biotech regulations within the US Department of Agriculture is said to be progressing well (Nat. Biotechnol.22, 791, 2004).
Feldbaum discounts that explanation regarding delays at FDA in favor of one involving an instinct among officials there or at any federal agency to postpone dealing with potentially controversial policy recommendations, such as one saying that meat from cloned animals is safe to eat, until after elections and wait until things simmer down. Meanwhile, such delays are a source of uncertainty for companies working in this area, making it harder for them to procure investments.
Finally, the looming election "casts a pall" over politically charged deliberations at FDA regarding follow-on biologics. "Rightly or wrongly...people take a wait-and-see attitude until a boss is in place," Feldbaum says. "It would be good to get the election behind us and get rolling on many of these fronts."
