Dear Jacob,
Why are you venting your ire and frustration solely at the FDA? Other regulators, including European regulators appear to be just as culpable.
Just to give you an example, at this very moment, NHS healthcare commissioners in England are struggling with a large number of funding requests for Pirfenidone for idiopathic pulmonary fibrosis (IPF).
The European regulator European Medicines Agency (EMA) approved the drug for European licensing in March 2011, after giving a positive opinion to the drug in December 2010.
However, look at what happened when the same drug went before the FDA:
In March 2010, the FDA's Pulmonary-Allergy Drugs Advisory Panel voted 9-3 to approve Pirfenidone.
However, the FDA had such major concerns about Pirfenidone, that it overruled its own Advisory Panel and in May 2010, sent a Complete Response Letter (CRL) to the manufacturers, requesting a further study to support the efficacy of Perfenidone in IPF patients, and declined to give Pirfenidone a US license.
In January 2011, Pirfenidone's manufacturer InterMune announced a further Phase III study, with enrolment to start in the first half of 2011.
In July 2011, the first patient was enrolled in the Phase III ASCEND study. Results of the trial will be submitted to FDA in the 2nd half of 2013, with the FDA expected to take a licensing decision in the first half of 2014.
In another parallel development, recently on 15th December 2011, The German Institute for Quality and Efficiency in Healthcare (IQWiG) [the German equivalent of UK's NICE], published a devastating report on Pirfenidone which clearly states that the therapy offers little benefit to patients:
Pirfenidone: extent of added benefit assessed
“No proven added benefit”/ Indication of benefit, but also proof of harm
You can access the full German report at:
and
This publication by The Institute for Quality and Efficiency in Health Care (IQWiG), an independent scientific institute that provides recommendations to Germany's drug reimbursement authority, that treatment with Esbriet, also known as pirfenidone, showed no "additional benefit" or effect on the mortality rate or quality of life", has had a devastating effect on InterMune's share price which has plummeted dramatically on the stock market by over 30% in the past fortnight.
Regards,
Ash