Sen. Brown Vows Floor Fight On Follow-on Biologics

But he'll need to find a length of brand exclusivity that attracts enough senators while continuing to satisfy generic firms and their allies.

Sen. Sherrod Brown, D-Ohio, is assessing what length of brand exclusivity to offer as he prepares for a floor fight on follow-on biologics.

Brown is keenly aware of the tactical difficultly for generic camp following the adoption of 12 years of exclusivity in the Health Committee on the evening of July 13 during mark-up of health reform legislation (Also see "Follow-on Biologics Go Back To The Future: Senate Cmte. Endorses 12 Years of Brand Exclusivity" - Pink Sheet, 13 Jul, 2009.).

"I'd be thrilled to get to the seven-three-one at this point," Brown acknowledged on a July 14 conference call with reporters. Seven-three-one refers to years of exclusivity in Brown's amendment, which was defeated in committee immediately before the amendment for a fixed 12 years was adopted. Under Brown's proposal, brands would have gotten a seven-year base, plus up to another year with six month extensions for additional indications and pediatric studies; the three refers to products with already approved substances, such as new dosage forms.

Finding The Right Number

That amount of exclusivity was not enough for the Health Committee, and it remains unclear whether it would be enough for the whole Senate. "I don't know yet what we'll offer on the floor that will have the best chance to win," he said. Finding a number won't be easy, since none of the compromise ideas have gained much traction.

Brown's preferred piece of follow-on biologics legislation, a companion to the bill from Rep. Henry Waxman. D-Calif., contains a maximum of six years of brand exclusivity - half the length of what is now in the health care reform bill. In committee, Brown's compromise proposal was soundly defeated, 5-17, and other compromise amendments from Sens. John McCain, R-Ariz., and Barbara Mikulski, D-Md., were not even voted on. During mark up, acting Health Committee Chair Chris Dodd, D-Conn., noted that the "committee proposal" - Sen. Ted Kennedy's new plan offering between 9 and 13.5 years of exclusivity - "had not received one second of support" during debate.

Brown's compromise effort may not just be a hard sell; it may be a risky one. If the whole body votes against shorter exclusivity, it would give conferees less wiggle room, and Brown's effort might even invite a counter amendment for longer exclusivity. In mark-up, he barely beat back Enzi's efforts to add six months of pediatric exclusivity to the 12 years.

Holding Out For The Best Deal

If Brown can't find the votes on the floor, he does have another option to try to shape the bill - withholding support for it altogether. However, "I'm not willing to say that," Brown said. "I've got to look at the bill. ...I very much want to vote for a health care bill. This is very disappointing and discouraging."

AARP Executive VP Nancy LeaMond echoed Brown's ambivalence. "We obviously are deeply disappointed that the provision will be in the HELP bill," she said on the call. "We'll look at the bill as it is reported out. ...and obviously we have a number of concerns. This is a very major concern for us."

Despite the HELP committee's rebuke on exclusivity, the Senate may be the more favorable chamber for the generic camp on follow-on biologics. The Senate version of the Waxman bill, S. 726, which is lead sponsored by Sen. Charles Schumer, D-N.Y., has nearly as many co-sponsors (seven, including Brown) as Waxman's bill itself, H.R. 1427, has in the House (13 co-sponsors). And the brand friendly amendment that seems poised to pass in committee in the House, from Rep. Anna Eshoo, D-Calif., offers a total of 14.5 years of exclusivity (Also see "Follow-on Biologics Vote Time: Eshoo Plans Challenge Of Waxman At House Mark-up" - Pink Sheet, 10 Jul, 2009.).

On the other hand, the House leadership appears more aligned with the generic viewpoint than leadership on the Senate side, a fact that will prove critical during floor debate and any eventual conference committee.

-M. Nielsen Hobbs ([email protected])