The US elections on November 5 surprised plenty of observers, even those who closely follow such matters, says Carl Feldbaum, president of the Biotechnology Industry Organization (BIO; Washington, DC). Republican majorities in both branches of Congress give new impetus to the Bush agenda, and could boost momentum behind several federal initiatives or ongoing programs affecting the biotechnology industry, including tax incentives to the industry for investing heavily in research and development, reforms of Medicare and prescription drug benefits, reorganizational efforts within the US Food and Drug Administration (FDA; Rockville, MD), and modest reforms within the Patent and Trademark Office (PTO; Crystal City, VA).

The Bush administration and Republican control over Congress is considered “business friendly,” but this political line-up leads to worries over the potential resumption of “ideological warfare” over stem cell research, cloning, and other similar developments, Feldbaum warns. “Big battles [against banning human cloning, even for research purposes] were won in 1998 and again last year, but they were bloody. We hope there is little taste in Congress to renew those battles, but we just don't know.”

Meanwhile, engagement with some of the newer administration officials is markedly amicable. For example, soon after Mark B. McClellan was appointed FDA Commissioner, he began meeting with biotechnology industry representatives and listening to their recent concerns, including worries over hints that the agency might soon be considering some biologics as generics, according to Feldbaum. Commissioner McClellan assures BIO that he sees no ready-made administrative pathway for considering or approving generic versions of biologics and indicated that such a pathway “would have to be legislated,” Feldbaum says. Although some Democrats in Congress might seek such legislation, Republican majorities in both houses render that approach all but impossible.

BIO is also urging McClellan to make sure that critical user fees continue to go for “right uses” amid the current turmoil within FDA, Feldbaum says. Key parts of the agency are being reorganized following a surprise announcement in September that reviews of therapeutic biotech products will be moved from their customary center into the Center for Drug Evaluation and Research within the agency (Nat. Biotechnol. 20, 1065, 2002). “This is a three-ring circus of sorts, and an important one,” he says.

PTO relatively recently developed a user-fee scheme, meaning biotech companies are paying “dramatically higher fees” to have their patent applications processed, Feldbaum notes. BIO is hoping that the new political climate will prove helpful in persuading top PTO officials to channel those extra revenues directly into expediting patent reviews rather than allowing them to be spent for “unspecified purposes.”

In the aftermath of the November elections, BIO will be focusing considerable attention on the federal Centers for Medicare and Medicaid Services (CMS; Baltimore, MD), formerly the Health Care Finance Administration, including decision making within the agency and legislative reforms regarding CMS that are likely to come before Congress, according to Feldbaum. For instance, the Bush policy team will likely move quickly with members of Congress to enact a prescription drug benefit under Medicare, he says.

Before the election, officials at CMS began “making significant but arbitrary decisions on drug reimbursement, citing [a new doctrine of] 'functional equivalence,' even though no one knows what it means and how it will affect biotech drugs,” Feldbaum says (see page 1182). With that new doctrine, “CMS threw a 'knuckleball' that applies to only a couple of drugs now....But it affects the whole industry, including some of our small companies who need to explain to investors how they will be reimbursed under Medicare for their products, and is a danger to future drug development.”