Sen. David Vitter's strange bedfellows might help Democrats pick up his seat in 2010, but for now, they are hoping that his unusual alliances will help them advance healthcare reform.

The first-term Republican senator from Louisiana, who was implicated in the D.C. Madam scandal in 2007, has now signed on to follow-on biologics legislation developed by Rep. Henry Waxman, D-Calif.

Waxman introduced his bill, H.R. ¹ H.R. 1427, on March 11. Companion legislation is expected to be introduced in the Senate next week by Sens. Charles Schumer, D-N.Y.; Sherrod Brown, D-Ohio; Susan Collins, R-Maine; and Vitter.

On the House side, the generic industry's stalwart Republican, Jo Anne Emmerson, Mo., is a co-sponsor, as is Frank Pallone, D-N.J., and Nathan Deal, R-Ga., the Commerce Health Subcommittee's chairman and ranking member, respectively.

The addition of Deal, Collins and Vitter gives Waxman the broadest coalition he has yet had to advance a pathway for follow-on biologics.

Deal has clashed with Waxman on FDA regulation of tobacco (² Also see "Is Tobacco Oversight Bad For FDA’s Health?" - Pink Sheet, 9 March, 2009., p. 40) but appears to have found common ground on follow-on biologics.

The ³ modified bill that the Republicans have signed on to includes modest changes, most notably an exclusivity period for brand biologics very similar to what small molecule drugs receive now.

Competing Bills About Creating Competing Products

As Waxman forges alliances across the aisle, the opponents within his own caucus are consolidating their position. Waxman's bill will soon be joined by legislation from Rep. Anna Eshoo, D-Calif. Commerce Committee Ranking Republican Joe Barton, Texas, is reprising his role as a sponsor of Eshoo's bill, which will be the same as last year's H.R. 5629, except for technical amendments (⁴ Also see "Biosimilars Bill From Reps. Eshoo, Barton Gathers Steam In House Cmte." - Pink Sheet, 24 March, 2008., p. 17). The target date for introduction is next week, according to staff.

The Eshoo/Barton bill will give the House two biosimilars measures to consider, one less than in the 110 Congress. Rep. Jay Inslee, D-Wash., who introduced the third bill last time around, is expected to co-sponsor Eshoo's proposal this year.

Eshoo's bill, which picked up a formal endorsement from the Biotechnology Industry Organization last year, offers up to 14.5 years of exclusivity, more than twice the maximum six years available to brands under Waxman's new bill.

Slowdown In The Senate

The most advanced legislation on the topic, the Senate bill that cleared the Health Committee last year, does not seem likely to be reintroduced shortly, and the collation that created it essentially no longer exists.

Last year's S. 1695, sponsored by Sens. Edward Kennedy, D-Mass., Hillary Clinton, D-N.Y., Michael Enzi, R-Wy., and Orrin Hatch, R-Utah, would have given brands 12 years of exclusivity.

But with Kennedy now slowed by illness and Clinton heading the State Department, it's unclear how strong a benchmark the bill remains for future Senate action.

Hatch lamented to reporters on March 12 that Kennedy's reduced schedule will significantly complicate developing consensus on healthcare reform.

Kennedy "admits that he needs to take multiple naps during the day," Hatch said. "But if he was up there full time working on this, I have no doubt that that would be a great help because he does actually have the ability to bring together all of the funding groups of the Democratic party - from the unions to the trial lawyers to the feminists to the environmentalists to the gays and lesbians who are for the most part very intelligent people who work and don't particularly pay tithing to churches but get involved in politics - and he can bring all those groups together."

At a Finance Committee hearing the day before, Hatch accused the administration of trying to undermine the Senate's compromise bill by supporting seven years of brand exclusivity instead.

"I don't think we can do it on seven-year data exclusivity, and I don't know anyone who does and you will never get a bill through if that's where the administration sticks," Hatch said.

Money Is In The Driver's Seat

Although Obama's budget does not specify a length of brand exclusivity, at the Finance hearing White House Office of Management & Budget Director Peter Orszag said that the administration was assuming seven years of exclusivity.

However, the budget's estimate of $9.2 billion in savings from FOBs over ten years - a figure that Hatch cited in his remarks - appears the same as the Congressional Budget Office score of the bill Hatch co-sponsored last session which included 12 years of exclusivity (⁵ Also see "Follow The Follow-On Money: Obama’s Budget Has Modest Biogeneric Savings" - Pink Sheet, 2 March, 2009., p. 6).

Any potential CBO scoring of Waxman's bill would not likely come until after it's marked up, but given its shorter exclusivity, it seems probable it would result in more potential savings then last year's Senate bill would.

Adding savings would appeal to Democratic leadership as it develops health reform legislation, since it would create a larger budgetary offset to pay for expanded coverage. Indeed, Waxman's push on the follow-on biologics legislation may be timed so that it can be bolted onto a broader health bill that leadership hopes can advance early this summer.

- M. Nielsen Hobbs (n.hobbs@elsevier.com)

Follow-On Biologics Debate Creates Strange Bedfellows As Bills Emerge

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