The US Food and Drug Administration (FDA) has deferred its plan to impose a generic drug user fee programme for the time being, it is learnt. The move was considered as a way to address the delays in generic drugs review and as an effort to support the Office of Generic Drugs in FDA with adequate funds.
The proposal to implement a fee structure for generic drugs which will be used for hiring review staff and supporting review information systems for generic products is not under active consideration at present, according to an US FDA source.
"We have discussed the proposal with the Generic Pharmaceutical Association (GPhA), but currently nothing like that is under consideration," said the source.
The plan was to raise adequate funds for the strengthening of FDA's generic drug review operations is intended to hasten the disposal of Abbreviated New Drug Applications which will help a majority of Indian drug majors who are waiting for approval from the FDA for their operations in US. According to reports in 2007, the US FDA has a backlog of nearly 1200 ANDA proposals in which 38 per cent were from Indian companies.
Even as the US generic market is expected to expand tremendously with more than US $50 billion drugs are going off patent in the next three years and the number of ANDA filings are increasing every year, the FDA has a minimum work force to process the applications, remarks US generic drug industry.
There were allegations that the FDA has been under-funding the Office of Generic Drugs for years and is allowing branded products manufacturers to use procedural foul plays to block final approval of generic products. As per FDA's 2008 budget of US $ 2.1 billion, almost $444 million in user fees should have been collected from the industries regulated by the agency, with first fees from generic pharmaceutical companies estimated as $15.7 million.
"For the Indian companies with their market in US, the user fee for generic drugs which would come around US $5000 is not a matter to consider big. But if the user fee would help the FDA's process of ANDA files disposal, the Indian companies can open their market in US much faster," said a source from domestic industry.
The sources said that the US FDA's plan was to introduce generic drug user fee in lines with its existing user fee programme for generic veterinary drugs.