WSJ: FDA may have more generic applications than it can approve under current budgetary constraints

NEW YORK — The Food and Drug Administration may have more generic drug applications than it does personnel to process them, according to a Wall Street Journal report published Tuesday. 

 

According to industry expert Robert Pollack, a former acting deputy director of the FDA Office of Generic Drugs who now works at Lachman Consultants, the number of generic drugs approved by the FDA has been relatively stable over the past few years — reaching 517 in fiscal 2012 and 440 in fiscal 2013. 

 

The corresponding number of applicants significantly exceeds approvals. The FDA received 1,003 generic applications in fiscal 2012 and 958 in fiscal 2013. Year-to-date, the FDA has so far received 1,440 applications, including 600 last month, the Wall Street Journal reported, citing an agency spokeswoman.