A new proposal tied to President Obama’s deficit reduction plan
released this week would reduce the market exclusivity period for
brand-name biologic drugs to seven years, from the 12-year period passed
as part of last year’s US healthcare reform bill. The White House had
pushed for the seven-year period initially, but ultimately, the
healthcare law incorporated the 12 years favored by industry. According
to Obama administration estimates, the shorter period would save the
federal government $3.5 billion over 10 years by increasing competition.
Industry has argued that the shorter exclusivity period will create a
disincentive for innovation and is expected to strongly oppose the
President’s proposal.
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