"Every five years, lawmakers, lobbyists, patient groups and agency regulators line up to take their shot at changing how things get done at the Food and Drug Administration.
The occasion is the reauthorization of the FDA’s authority to collect user fees from drug and device companies to help fund the agency’s review of their products.
Strictly speaking, it’s all about renegotiating the fees and the agency’s “performance goals and procedures.”
In fact, it can become a wide-ranging free-for-all in which the numerous interest groups in the field and members of the relevant committees on the Hill attempt to convert their agendas into the FDA’s agenda — a mini health care debate, minus the ill will, drama and suspense.
. . .
'The user fees are an essential component of FDA’s funding for reviews of drugs and medical devices,' said Allan Coukell, director of medical programs at the Pew Health Group.
He added that the measure 'has become an important point every five years to really address some of the shortcomings of FDA law or agency operations.'"
- Date added:
- Apr 28, 2012
- Project:
- Pew Prescription Project
- Topic:
- Drugs and Devices at the FDA
- Related Expert:
- Allan Coukell
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