Spend Less? Congress May Like Biosimilars
1 CommentBy Ed Silverman // April 1st, 2008 // 2:05 pm
Think that biosimilar legislation will go nowhere this year? Think again. The potential for biosimilars to lower Medicare and Medicaid drug spending could spark support for a follow-on biologics bill this year, if lowered expenditures could offset higher spending elsewhere, FDA Legislative Watch reports.
Under rules that the House applies to pending legislation, any new spending under a bill must be matched by a cut elsewhere or by a tax increase, the newsletter notes. But legislators eyeing new projects at FDA or NIH, for example, could “look to a bill like this and have a five-year savings that matches the five-year spending,” David Schmickel of the Senate Health, Education, Labor and Pensions committee told an industry conference. “That’s motivation for a lot of members to get these things done.”
Any proposal that might decrease spending “is big news in Congress,” Lisa Layman, a former Senate staffer who now lobbies for the Generic Pharmaceutical Association, told the crowd. “There are a lot of people for whom the savings are important - legislators who are struggling with the deficit and federal health programs, as well as patients.”
One bill was introduced last month that would create a so-called pathway for FDA approval while offering brand-name companies 12 years of exclusivity, plus an extra two years for a medically significant innovation. The BIO trade group was effusive in its support; the generic trade group called it a “step backwards.”
Jack2
I think some sort of bill will pass this year. Biotech companies want a bill under the current administration, rather than risking getting a much less favorable bill under a future administration. Companies that want to pursue biosimilars want a bill ASAP, and don’t want to risk the possibility of not getting a bill. So, while we might see haggling over the details, I also predict it will get done, since all groups really just want a bill.