You’d think that if someone seriously wanted to reduce health care costs in the U.S., he would want to streamline the approval process for generic drugs.
Just the opposite seems to have occurred.
Whereas five years ago the FDA typically approved a new generic drug within 16 months of the manufacturer’s application, the typical delay is now more than 26 months. The budget for the FDA’s generics office is only $51 million for 2010: up from 2009, but still clearly insufficient to meet the need. It’s hard to think of many ways that an additional $30 million or so could be invested with better near-term payoff on the nation’s collective medical bill.
Executives at a generics meeting joked that the government spends less on reviewing applications for new generic drugs than the New York Yankees spend on the payroll for the left side of their infield.