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FDA Failing to Deliver On Generics

In an article this week in the Seatle Post-Intelligencer reporter Joseph Tartakoff has put a worthy spotlight on the FDA and its failure to implement a new, simpler process for certifying generic drugs.  It's worth a read, though, as with anything from the Bush Administration having to do with health care, it's a bit depressing. 

The gist of the article is that where the FDA is, by law, supposed to be making the approval path for generic drugs simple and speedy, it is, at the least, going slow but at the worst it is actually holding particular drugs up.

This is an important issue for anyone who needs prescription medicines, of course, but it has particular impact on lupus patients because lupus therapies are all old.  Old therapies use old drugs that are aging out of their patents. As their patents expire these old drugs become eligible to be made and sold as generics.  And when that happens it means a huge cost drop for the end-user patients.

We need the process for certifying generics to be quick and efficient. It is the FDAs duty to see to this and it also their law-based legal mandate.

As an example of the problem Tartakoff sites the case of "Calcitonin", a generic drug proposed for approval almost three years ago by Nastech Pharmaceutical has been bogged down in a process that the FDA has been ordered by Congress to simplify and speed up. 

This particular case has some strange undertones of corruption but the issue is clearly systemic at FDA.  The product -- Calcitonin -- would provide patients who have postmenopausal osteoporosis with a generic alternative to Miacalcin, a nasal spray treatment with nearly $145 million in sales last year.

It could also produce a much-needed boost for the drug company, Nastech, which was forced to lay off more than half its staff while waiting for approvals from the FDA.

The Food and Drug Administration agreed to review Nastech's Calcitonin for approval in February 2004, three months after Nastech submitted its application.  (It takes three monts just to get a date with these guys?  What are they doing with our tax dollars?)

But, and this is where the whiff of corruption begins to appear, it seems that the Nastech application is being held up because of letters challenging the application (get this) written for an unnamed pharmaceutical company by an attorney who used to work for the FDA. Huh???

This is more than a little strange and disturbing.  Check out the article and post on the boards what you know about such things.  I know that we are expecting and waiting for some drugs to make it through to the generic pipeline.  Come on FDA; it's us that you should be working for. 


Posted April 16, 2008 Permalink