Government
Obama favors shorter protections for original biologics
NEWS IN BRIEF — Posted July 13, 2009
The White House on June 24 announced it supports a seven-year exclusive marketing period for original biologic drugs as part of creating an approval process for generic biopharmaceuticals.
The White House position lines up with both a June 10 Federal Trade Commission report and a bill sponsored by House Energy and Commerce Committee Chair Henry Waxman (D, Calif.). Industry groups such as the Biotechnology Industry Organization favor 12 to 14 years of marketing protections in addition to existing patent laws because they say a shorter period would not allow original biologic drugmakers to recover their research costs.
A bill sponsored by Rep. Anna Eshoo (D, Calif.) would provide this longer exclusive marketing period. The FTC, however, concluded that such a policy could be harmful.
The FTC "found that giving such lengthy periods of exclusivity will harm patients by diminishing innovation and unnecessarily delaying access to affordable drugs," wrote White House Office of Health Reform Director Nancy-Ann DeParle and White House Office of Management and Budget Director Peter Orszag, PhD, in a June 24 letter to Waxman.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2009/07/13/gvbf0713.htm.
