Whose Fox Will Guard the Generic Drug Hen House?

In large type, The New York Times made a page 1 announcement of a "Deal in Place For Inspecting Foreign Drugs."  The article details that generics producers would pay yearly fees of $299 million to finance inspection of non-U.S. based manufacturing plants every 2 years.

This announcement gives me no comfort. The major pharmaceutical company payers control too much of the offshore inspection budget of the FDA and that power of control raises too high a risk of corruption of the system. If Congress approved a fee structure with dollars flowing into the U.S. general fund, rather than being earmarked specifically for FDA offshore inspections, and reasonable appropriations were made by Congress to support the FDA offshore inspection program, there would be a healthy separation between the payers and the FDA/Inspectors. As the proposal now stands, it sounds as if the pharmaceutical industry has strengthened its stranglehold on the FDA, offshore inspections, control of generics, and perhaps on Congressional campaign budgets and solicitations. Keep your eye on that hen house and remember that the foxes are only interested in taking care of themselves.