Follow-On Biologics Bill’s Prospects Are Uncertain, Waxman Staffer Says

Busy House committee schedule and “fractured” Senate will make reaching consensus a challenge, Ann Witt says, but potential inclusion of FOBs into health reform bill is “wildcard.”

Rep. Henry Waxman's Health Counsel, Ann Witt, is offering a subdued prognosis about the chances that follow-on biologic legislation will be enacted in the near term.

"I don't know what's going to happen with these bills," Witt said April 21 during a policy forum sponsored by the Jefferson School of Population Health. "Although this is a very high priority of Mr. Waxman's, there are some other high priorities right now in the Energy & Commerce committee - mainly healthcare reform and climate change - and finding time to get this bill through is challenging."

Waxman, D-Calif., has long been one of the Hill's most vigorous advocates of a pathway for follow-on biologics, and his rise to chairman of the Energy and Commerce Committee this session seemed to give him more leverage to help enact one. But even as he has gained more command of the schedule, a firm consensus has eluded him.

Waxman has forged a deal with the ranking member of the Health Subcommittee, Nathan Deal, R-Ga., for a bill (¹ H.R. 1427) that would provide up to six years of exclusivity for brand biologics. But a rival bill from fellow California Democrat Anna Eshoo (² H.R. 1548) that would offer up to 14.5 years of exclusivity has the support of Joe Barton, R-Texas, ranking member of the full committee (³ (Also see "Follow-On Grudge Match: The Round One Scorecard In Waxman vs. Eshoo" - Pink Sheet, 23 Mar, 2009.), p. 29).

More importantly, the Eshoo/Barton bill currently has 59 cosponsors - more than seven times as many as Waxman's legislation, which has eight. It is perhaps this logistical hurdle rather than the committee's busy schedule - Witt says "just finding a hearing room on any given date for the next three months is challenging" - that has prevented more movement on the legislation.

Witt's discussion of healthcare reform as a separate agenda item is also telling. Follow-on biologics has been seen, in the Obama administration's budget and elsewhere, as a building block that would help achieve the savings necessary for broader healthcare reform.

But Witt downplayed the prospects of folding FOBs into a reform plan, calling it a "wildcard." If that "were to happen, I think the regular way a bill moves through the House or Senate would certainly be changed," she said.

Last session, an FOB pathway had also been floated as a potential attachment for the FDA reform legislation that passed in 2007. If a pathway is not included in any eventual health reform bill either, FOB advocates could be forgiven for being disheartened to see two trains leave the station without their precious cargo. But standing on the platform has its advantages too, if follow-on biologics can wait for a more amenable passenger.

Many big pharma firms are working follow-on biologics into their business plans as an opportunity, not a threat, and realizing those sales will require a pathway. This pro-FOB approach may have already manifested itself as a division in the brand trade association about what the criteria for the products should be (⁴ (Also see "Senate Biosimilars Bill May Create Exclusivity For Pediatrics And Extra Indications, PhRMA Says" - Pink Sheet, 24 Mar, 2009.)). So if the generic industry and their allies can wait, they may find a more amenable negotiation partner emerge, one who wants to capitalize on FOBs or one who wants to craft some vital exclusivity extensions for key products.

A "Fractured" Senate

The sense that the current landscape may not be the best one for the generic camp to strike a deal may be most manifest in the Senate. The Senate passed compromise legislation out of HELP Committee last year with 12 years of exclusivity, but with Hillary Clinton now running the State Department, the coalition that created needs to be rebuilt.

Sen. Sharron Brown, D-Ohio, had emerged as Clinton's replacement in the group, which also included committee Chairman Edward Kennedy, D-Mass., Ranking Member Michael Enzi, R-Wyo., and Orrin Hatch, R-Utah.

However, Brown is "unhappy" with the bill and has left the group, Witt said, "so it's not exactly clear what the remainder of the consensus group is going to do." Brown and Sen. Charles Schumer, D-N.Y., who is in not on the HELP but is key player in the FOB debate, have introduced a version of Waxman's bill in the Senate.

"In any case, the Senate is somewhat more fractured this time then it was before, and they too are going to have to reach some kind of consensus," she said.

Kennedy appears committed to trying to fix the "evergreening" issue, which had been the major stumbling block to reintroduction, but he would also like to find another Democratic co-sponsor at this point. One HELP committee member with a long-standing interest in pharmaceutical issues is Chris Dodd, D-Conn., who spearheaded the creation of the pediatric exclusivity program. To get his support, Kennedy would presumably have to add that extra six months incentive to the bill (⁵ (Also see "Kennedy's Follow-On Biologics Revisions Add Anti-"Evergreening" Language" - Pink Sheet, 15 Apr, 2009.)).

-M. Nielsen Hobbs ([email protected])