Follow-on Biologics Go Back To The Future: Senate Cmte. Endorses 12 Years of Brand Exclusivity

Hatch/Enzi/Hagan amendment retains the number from last year's bill, but a fight on floor seems possible.

Senate proponents of shorter exclusivity for brand biologics now face a difficult choice: Do they pitch a floor fight on follow-on biologics after being defeated in the Health Committee?

At the moment, the answers appears to be no, but the wounds are still fresh from the July 13 vote in the Health Committee endorsing 12 years of exclusivity from brand biologics. An amendment from Republicans Michael Enzi of Wyoming and Orrin Hatch of Utah, and North Carolina Democrat Kay Hagan, was adopted 16-7 after nearly two hours of debate.

Hatch, whose work on the 1984 legislation that created the ANDA process has made him in many ways the congressional embodiment of brand industry, lead the argument for the amendment. The proposal offered the highest guaranteed exclusivity of the proposals on the table, but Hatch framed it as preserving the compromise bill that the committee had endorsed unanimously last year.

The timing of the vote, which occurred at the end of the committee's evening session, was somewhat unexpected. The follow-on biologic proposals had not been scored, and Sen. Sherrod Brown, D-Ohio, expressed concern that the potential savings from a pathway should be factored into the debate. Brown's amendment would have offered a maximum of eight years.

Hatch acknowledged that shorter exclusivity would produce more savings, but argued that it would come at that the expense of products that would go undeveloped. A vote was needed that evening, Hatch argued, because "this is the only time I have to do this." Hatch sits on the Judiciary Committee, which is in the midst of confirmation hearings for Supreme Court nominee Sonia Sotomayor.

The Health Committee vote was a resounding defeat for the generic industry. Indeed, the panel was poised to add six months of possible pediatric exclusivity before Brown's rhetorical vehemence -- noting that it was not part of last year's bill, as the backers had positioned their proposal --prompted Enzi to withdraw it.

"I'm sure I can add it later," Enzi said.

For generic firms, none of their arguments and white papers over the past year, or even the larger Democratic majority, appeared to have changed the dynamics of the debate.

The most prominent argument for shorter exclusivity, the Federal Trade Commission's report, was dismissed by Hatch. "I don't believe that FTC has made a strong case" that patents alone offer sufficient protection or incentives for product development, he said.

Even several of Hatch's rivals ended endorsing the 12 years. Chairman Edward Kennedy, D-Mass., and Sen. Barbara Mikulski, D-Md., each had proposals will lower initial exclusivity, but ended up voting (by proxy in Kennedy's case) for the Hatch/Enzi/Hagan amendment.

The question for generic firms and their allies is where next to press their case. Last session during the debate on the FDA Amendments Act, opponents of restrictions on drug advertising lost in the Health Committee, but were able to get what they saw as unfavorable language removed on the floor.

That could be one possible model for the generic firms' efforts this year on FOBs, but a high-risk one. If generic firms are defeated on the floor, it becomes harder to reshape the bill in conference committee.

The Generic Pharmaceutical Association seems to be looking to conference committee as the next front. GPhA's post-vote release notes, "the White House already has the FDA working on creating a pathway and it has firmly stated that seven years of exclusivity is a good compromise."

GPhA also acknowledges that the issue will be taken up in the House, but its statement about that arena could be seen to have a hint of desperation. "We hope that when the House Energy and Commerce Committee acts it follows the lead of its chairman in approving a market exclusivity period that puts patients first," the release states.

Chairman Henry Waxman, D-Calif., is sponsoring a bill that would offer up to six years of exclusivity, but Rep. Anna Eshoo, D-Calif., appears to have the votes to pass her bill that offers as many as 14.5 years (Also see "Follow-on Biologics Vote Time: Eshoo Plans Challenge Of Waxman At House Mark-up" - Pink Sheet, 10 Jul, 2009.).

-M. Nielsen Hobbs ([email protected])