FDA and User Fee Act (for 2012)

Most of us know FDA is government body that regulates and monitors food and drug produced for commercial purpose. Its prime job is to evaluate safety of therapeutic products, be it food or medicine or cosmetic products. A question must have arisen in your mind, except those who are privy of internal matter, about where such a large agency gets fund to keep running. FDA is funded by two ways; one, money from tax payers; second, 'user fee' a fee paid by applicants.

There are two federal laws according to which FDA can take fee from manufacturers of drug or medical device. Every manufacturer has to acquire approval from FDA for their respective product. Producer can not bring their product in market without FDA approval.

PDUFA (Prescription Drug User Fee Act) and MDUFA (Medical Device User Fee Act) are the two laws which authorize FDA to take fee. The fee is only for use in CDER and CBER i.e. Center for drug evaluation research and Center for biologic evaluation research. FDA has to propose amendment if it wants increment in fee. Last time PDUFA was amended in 2007. Reauthorization for the year 2012 is being contemplated and final bill is likely be tabled in January for vote by Congress.

The law set a sort of benchmark for FDA. At the time of New Drug Application (NDA), FDA should ensure speedy approval of the 90% their new applications in 6 to 10 months. FDA has to meet this benchmark if it wants to continue fee collection. This condition is matter of concern for a part of community. Some people believe that while fullfiling the assurity, safety might get compromised.

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