Two items for your consideration:
EC Does It
BioCentury reminds us that the House Energy and Commerce Committee is expected to vote this week on a bill that would allow FDA to collect newly enacted generic drug user fees, a committee spokesperson told BioCentury. The bill does not include a provision that would allow FDA to collect new biosimilar user fees.
Last week, the House of Representatives passed a continuing resolution that would extend funding at current levels for government operations but omitted technical language that would have allowed FDA to benefit from an increase in drug and medical device user fees and to spend the newly enacted user fees for biosimilars and generics.
FDA had planned to use $299 million from new generic drug user fees in FY13 to reduce huge application backlogs, increase postmarket safety oversight, and ramp up inspections of generic drug manufacturers outside the U.S.
I was pleased to offer a guest op-ed on Ed Silverman’s Pharmalot blog. Here’s a link. Of particular interest is the comments section. Have a look and see how the other 47% lives.