Biotech Values

[DewDiligence]

Re: The generic-drug backlog at the FDA

The agency’s office of generic drugs has a budget of $51 million for fiscal year 2010, up from $41 million in fiscal 2009. Executives at the [GPhMA] meeting joked that government was spending less per year on reviewing applications for new generic drugs than the New York Yankees spend on the payroll of the left side of their infield. (Alex Rodriguez and Derek Jeter between them earned $54.6 million last year, according to ESPN).

Maybe A-rod and Jeter should be the ones to rule on generic-drug applications :- )

Dr. Hamburg also proposed a priority-setting system in which the agency could identify “the most critical [generic] drugs in terms of public health and patient access and move those more quickly.” …Mr. Buehler of the F.D.A. said the generic office was looking for ways to streamline its application queue so that staff members could identify and process simple applications faster, for example, or by giving less priority to generic applications for branded drugs still subject to several more years of patent protection.

These ideas were purportedly adopted by OGD a few years ago. They evidently haven’t been put into practice.