After a bitter and divisive re-election campaign, George W. Bush is set to lead the US for the next four years — and that includes directing its science policy. For life science researchers, this means you shouldn’t expect any major flip-flops on issues such as drug reimportation, funding for controversial biological research involving embryos, or major shifts in funding priorities.
On the other hand, there are a few harbingers of small changes to come that may affect biologists and the resources you have to do your work. At the top of this list is the 2005 federal budget. With the House and Senate approving omnibus spending bills at the end of November, clearing the way for President Bush to sign them into law, this much is clear: NIH will receive a modest two percent increase in its annual budget, boosting that number to $28.4 billion, and CDC will have $4.5 billion at its disposal in FY 2005, a three percent increase from last year’s appropriation. Neither of these increases keeps up with the biomedical research and development price index, projected at 3.5 percent, but in contrast to the NSF’s budget, which received a two percent cut, the numbers are relatively good.
Less clear is how the Bush administration will respond to the recent uproar over FDA’s handling of safety concerns regarding Merck’s Vioxx drug for arthritis, which the company pulled from the market last September after acknowledging problems with its reporting of the drug’s effects on heart disease risk. While the Bush administration has traditionally taken a relatively non-confrontational approach to regulating the drug industry, it is facing pressure to tighten FDA’s scrutiny of pharmaceuticals both in the process of being approved and those already on the market. At a time when pharma and biotech are ever more anxious to rapidly launch new products, a more cautious FDA could stymie the industry’s efforts to boost profits in the near term.
Changes in the administration of Medicare could also trickle down into the labs and boardrooms of pharma and biotech. When Mark McClellan took over the Centers for Medicare and Medicaid Services in early 2004 after serving a stint as FDA commissioner, he began instituting a policy that allowed CMS to pay for new FDA-approved treatments and diagnostic tests under the condition that the manufacturers or other groups pay for studies evaluating whether these new and potentially expensive procedures are truly effective. That policy could make it easier for biotech and pharma to get reimbursed by CMS for such products as new molecular diagnostic tests or drugs that target specific patient subpopulations, but how the policy will play out in practice is still to be determined.
In other changes in and around Washington, James Greenwood, a Republican Congressman from Pennsylvania, will replace Carl Feldbaum as president of the Biotechnology Industry Organization in early January. Greenwood, a congressman since 1992, will be charged with representing the best interests of biotech in the ongoing battle over whether the US should allow drug reimportation, and with advocating for greater funding for stem cell research. That cause was lent further credibility when California voters approved an initiative in November to provide $3 billion in state funding over 10 years for certain forms of stem cell research.
Lastly, Secretary of Health and Human Services Tommy Thompson has resigned from his post, lending speculation that McClellan could leave CMS to take his position. In that role, McClellan would have oversight over both FDA and CMS, consolidating his control over US healthcare policy.
John S. MacNeil, a senior editor at Genome Technology, can be reached at [email protected] His Sense/Antisense column, which covers government research policy and regulatory issues, appears bi-monthly.