In
a report originally published by the American Enterprise Institute for Public
Policy Research (AEI) late last year, the nonpartisan public policy group advocated
for a 12 to 14-year exclusivity period, concluding that "the social losses
from providing for fairly long exclusivity periods (twelve to fourteen years)
would be small compared to what are likely to be substantial social gains from
exclusivity." The report,
which was authored by AEI Resident Scholar Dr. John Calfee,
was one of 58 past articles that the AEI collected as part of its Health Policy
Outlook series (see "AEI Believes Advantages of
Longer Data Exclusivity Period Outweigh Disadvantages"). Today, we focus on another article in
that series, "Facing Reality on Follow-On Biologics,"
which was also written by Dr. Calfee.
For
those suggesting that significant health care cost savings can be obtained through
the implementation of a follow-on biologics regulatory pathway, Dr. Calfee (at left) counters
that "[t]here is no reason to expect a reasonable follow-on biologic law
to bring dramatic cuts in health-care spending as claimed," and warns that
if Congress is not careful, "it will interrupt long-term drug research
programs and reduce incentives to develop new biologics." Dr. Calfee explains that the factor
that allowed generic small molecule drugs to go from less than 20% of the prescription
market in 1984, when the Hatch-Waxman Act was passed, to more than 50% by 2000,
does not apply to biologic drugs. That
factor is "interchangeability based on bioequivalence." Because biologics are more complex than
small molecule therapeutics, "the 'generic' that comes from a new biologic
manufacturing facility may not work the same way as drugs that patients have
been using for years." As a
result, a follow-on biologic "will have to be supported by far more data
than is required for small-molecule generics."
The American Enterprise Institute?
LOL.
Home to great minds like Newt Gingrich, Lynn Cheney, and Paul Wolfovitz. And this toad.
What does the Heritage Foundation say about the 12 year exclusivity period? I'm sure they have a scholar that could be paid to write something pleasing to the industry.
Posted by: Keep It Real | August 24, 2009 at 11:43 PM
Keep It Real:
The AEI is also home to economist Alex Brill, who has authored a white paper supporting a 7-year data exclusivity period.
Still laughing?
Don
Posted by: Donald Zuhn | August 24, 2009 at 11:48 PM