Replies to post #90854 on 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.

[turtlepower]

So are you asking for a bigger government or a more efficient one? :)

http://www.nytimes.com/2010/02/20/business/20generics.html

[hmpa]

Except for "politically sensitive" situations (Lovenox/m-Enoxaparin being the prime example, and we are not talking lack of budget here), FDA almost never delays first few ANDAs for a particular drug - whose launch results in a major price drop. For many popular drugs, as many as 10 or more ANDAs are eventually filed. One could argue that the system benefit of yet increased competition (between the generics) is marginal, while FDA's resources have to be spent not only on the initial approval (including inspections, etc.) but on the continued support of the marginal producers, too. In particular, extreme level of competition between the generics companies encourages them to go to the cheapest API suppliers (while with the approved DMF, but still the least FDA-inspected outfits in India and China). To me, once the initial generic launch(es) occur, there is no reason to be upset about the follow-up ANDA fate (unless you are heavily invested in the company that submitted them).