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Generic Approvals Taking Longer

I attended the Annual GPhA meeting this past week.  This event is attended by the CEO’s and other top brass of most of the major generic pharmaceutical companies. This year was highlighted by a presentation from the FDA Commissioner, Dr. Margaret Hamburg.  In her remarks, Dr. Hamburg admitted to a need for FDA to step up in food and drugs, to be less reactive and more proactive.  In the area of generic drugs she admitted to the poor record of approvals (see below) and said that only better science and more resources would help.  She didn’t elaborate on what ‘better science’ is needed, but she specifically pointed out that the President’s 2011 budget included additional money for the Office of Generic Drugs – all from proposed user fees.  Dr. Hamburg pledged to work with GPhA to enact user fees this fiscal year.  She offered no details on what this would look like.

The poor record of approvals that Dr. Hamburg addresssed  was discussed in an earlier closed session by OGD Director Gary Buehler.  He indicated that the median approval time had increased to 26 months.

During a panel session with the presidents of Mylan, Actavis, Watson, Par and Teva, it was pointed out that the 2010 budget for OGD, $55 million, is the same as the left side of the field for the NY Yankees.  Given the  billions of dollars saved by the government when generics are used, the increase of US government funds would be warranted.  A generic user fee could tilt the generic business to larger producers and reduce the number of generics in the small volume markets favored by small generic producers.