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News & Analysis | REG•WATCH Blog | Press Room
Monday, June 25, 2007
House Moves on FDA Reform, PDUFA Renewal
Last week, the House Energy and Commerce Committee approved a bill to reform certain drug regulation practices at FDA and renew the Prescription Drug User Fee Act (PDUFA). The full Senate approved a similar bill in May. (For a detailed analysis of the Senate version, click here.
The Pharmalot blog has a good summary of some of the drug safety provisions in the House bill which go beyond what the Senate approved.
The user fee program, the other half of the bill, is a double-edged sword. While it is an important source of funding for the agency, it comes with strings attached and allows drug companies to call the shots during the approval process.
A provision in the House bill demonstrates this dichotomy. The bill would reduce the amount of fees paid by industry if federal appropriations increase. This is encouraging, because many public health and safety advocates believe the federal government, not the drug industry, should be responsible for ensuring FDA has enough resources to perform its regulatory duties.
However, there is a danger this may lead to lower funding for FDA in the long-run. If this appropriations process turns into a zero-sum game where both sides are jockeying to see who can pay less, it would ultimately force FDA to do its job for less money.
FDA is already under-funded. The House should take this provision but also force a steady rise in the drug safety budget. That would allow appropriators and the drug industry to haggle over their respective responsibility in a more productive way. It would be in industry's best interest to lobby for increased funding. Republicans would be in favor of giving industry a break, and Democrats (if they understood the problems with user fees, which they appear not to) could get behind no-strings-attached funding and a bigger role for government.
Posted by Matt Madia
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