Should FDA split safety ops from CDER?

This is a topic that comes up early in my GCP class at UC Santa Cruz Extension, when we do an overview of the FDA's operations and PDUFA as they pertain to good clinical practice.  PDUFA has over the years enabled a a more efficient and predictable pathway through the US regulatory review process.  Improvements are not without cost, and the consequences here have been felt on the continuing review of the safety of marketed medicines as budget has shifted to meet the Congressionally mandated trigger for user fees, and one option long under study has been to move safety evaluations altogether away from the evaluation of new drugs.


Bloomberg today has looked at the data since 1995 (PDUFA was first enacted in 1992) and reports that over half of the 21 drugs approved since 1995 have since been withdrawn from the market behind cardiovascular problems.  Armed with these findings, Sen Chuck Grassley (R-Iowa) is developing a bill with Rep. Rosa DeLauro (D-CT) to create a new Office of Surveillance and Epidemiology whose function - and one presumes budget - would be completely separate from CDER and its budgetary constraints, and its heavy reliance on voluntary post-marketing adverse event reporting.  FiercePharma has it all here, along with an interesting link to a story about Sen Grassley's plans to move from the Senate Finance Committee to Judicial.  You read it here second.


Next week I will be attending and speaking at this meeting, Managing Relationships with CROs in London, and then a couple of days off.