CBO: Biogenerics Would Save Government $6.6 Billion Over Decade
The Congressional Budget Office (CBO) has released a cost analysis finding that the creation of an abbreviated pathway for follow-on biologics -- or biogenerics -- would save the federal government $6.6 billion over 10 years and lower total expenditures for biologics by $25 billion over the same time period, according to an announcement of the analysis released by an association representing America's pharmacy benefit managers (PBMs), who administer prescription drug plans for morethan 210 million Americans.
"For a quarter century, generic versions of chemical drugs have saved consumers and payors billions of dollars. Now, CBO has confirmed that giving FDA additional authority to approve generic versions of biologics will save billions more," says Mark Merritt, president and CEO of the Pharmaceutical Care Management Association (PCMA). "Even greater savings would be available if Congress simply applied to biologics the Hatch-Waxman standards that are currently used to approve generics for chemical compounds. It would be helpful if some provisions in the bill -- such as 'evergreening' -- which unnecessarily delay the entry of biogenerics were reconsidered. CBO acknowledges that the 'evergreening' issue will present significant problems beyond the ten-year scoring window."
According to the PCMA announcement, CBO estimates that:
-- Enacting S. 1695 would reduce total expenditures on biologics in the United States Hidden List by $25 billion over the 2009-2018 period.
-- Enacting the bill would reduce budget deficits (or increase surpluses) by a total of $6.6 billion over the 2009-2018 period.
Unlike conventional drugs, there is no clear regulatory process where biogenerics can be approved by the FDA. PCMA was joined by a number of influential consumer, employer, and insurer groups who endorsed the "Access to Life Saving Medicine Act of 2007," bipartisan legislation that seeks to create a clear regulatory pathway for biogenerics.
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"For a quarter century, generic versions of chemical drugs have saved consumers and payors billions of dollars. Now, CBO has confirmed that giving FDA additional authority to approve generic versions of biologics will save billions more," says Mark Merritt, president and CEO of the Pharmaceutical Care Management Association (PCMA). "Even greater savings would be available if Congress simply applied to biologics the Hatch-Waxman standards that are currently used to approve generics for chemical compounds. It would be helpful if some provisions in the bill -- such as 'evergreening' -- which unnecessarily delay the entry of biogenerics were reconsidered. CBO acknowledges that the 'evergreening' issue will present significant problems beyond the ten-year scoring window."
According to the PCMA announcement, CBO estimates that:
-- Enacting S. 1695 would reduce total expenditures on biologics in the United States Hidden List by $25 billion over the 2009-2018 period.
-- Enacting the bill would reduce budget deficits (or increase surpluses) by a total of $6.6 billion over the 2009-2018 period.
Unlike conventional drugs, there is no clear regulatory process where biogenerics can be approved by the FDA. PCMA was joined by a number of influential consumer, employer, and insurer groups who endorsed the "Access to Life Saving Medicine Act of 2007," bipartisan legislation that seeks to create a clear regulatory pathway for biogenerics.
Watch more breaking news now on our video feed:
Bookmark http://onthehillblog.blogspot.com/ and drop back in for more news from the nation's capital.
Labels: Access to Life Saving Medicine Act of 2007, biogenerics, cbo, congressional budget office, Medicare, medications, s 1695
posted by Scott Nance at
6:04 AM
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