i tried to get into this....was rejected. too bad. pirfenidone is proving to be an effective medication for mild to moderate IPF. it is in use in most of the world. the EU has approved it some years ago. Japan and most of the asian world approved it. all of the scandinavian countries have approved it. Canada, central america, south america, most of the micornesia nations, quite a few countries in the Caribbean, and several countries in Africa have approved it. it is not only in use in India and surrounding countries, India produces a generic form. Seems that one of the few countries that does not allow it's use is the good ol' USA.

Instead, the FDA insists on more tests, more trials to judge its effectiveness and safety. it has been tested in this country for over ten years. in fact, the first human trial was in Washington.....

"The initial human data supporting a role for pirfenidone in the treatment of IPF was published by Raghu et al in 1999.66 In this phase II study, 54 patients with severe IPF, many of whom were actively taking immunosuppressive medications such as prednisone, Imuran, or Cytoxan, were recruited from the University of Washington Interstitial Lung Disease Program and treated with open-label pirfenidone at a divided dose of 3600 mg/day over a 25-month period." http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3039013/

so my question to the world or at least to these readers is why? why does the FDA drag it's feet? what can we as patients do to catch up to the rest of the world? just how long does it take to make a decision that this drug is ok? when i compare it to so many other drugs that entered the market to combat some form of illness, Pirfenidone lags.....Polio vaccine...less than ten years.....or how about some other drugs such as birth control, cancer vaccines, medications to control behaviour issues? yet something that has shown success in trial after trial, country after country, is still in the lab instead of helping to improve lives in our country. and not only improving them, but reducing the peripheral costs associated with the disease....hmmm....maybe that is why.....god knows we really don't want to reduce costs to the consumer, or reduce the deficit, or implement any other programs or policies that might affect the bottom line for the board room....

Barney,
I hear ya. I don't know too much about the inner workings of the FDA although my impression is it's yet another bloated government bureaucracy. You would think with such worldwide acceptance the FDA would fast-track this.
PF is a relatively unknown disease although it's kills as many as breast cancer.
Perhaps something could be done? Petition the parent agency?
Congress? The President?

i wonder how many hundreds of thousand signatures it would take to shake the FDA?