FDA generics initiative waste of money?

By Katrina Megget

- Last updated on GMT

Related tags: Generic drug

The Generic Pharmaceutical Association has questioned a new US Food
and Drug Administration (FDA) initiative as possibly "throwing
money down the drain".

The regulatory agency outlined a new programme last week, the Generic Initiative for Value and Efficiency (GIVE), which is to be implemented in a bid to streamline the generic drug approval process, increase efficiency and clear a backlog of some thousand generic drug applications. Over the last three or four years the Office of Generic Drugs (OGD) has seen an increase in the number of abbreviated new drug applications (ANDAs), and despite approving 682 generic drug products in fiscal year 2007 - 30 per cent more than the previous year - the office still has a backlog of more than 1000 applications. While seen by the FDA as a way to maximise resources to increase the number and variety of generic drug products available, the Generic Pharmaceutical Association (GPhA) released a statement which was less than glowing. "While we share the goal of increasing efficiency in the generic approval system, another initiative in name only, simply will not get the job done,"​ GPhA president and chief executive Kathleen Jaeger said. "For years the Agency has tinkered around the edges with programmes and initiatives designed to increase efficiency but have proven to yield little in the way of significant results. There are serious legislative and regulatory issues that must be addressed to yield a true increase in the number of affordable generics brought to market." ​ Under the initiative, the FDA will revise the review order for certain applications, including first generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, which will be identified at the time of submission for expedited review. The FDA will also use a new review process for the chemistry, manufacturing and controls (CMC) information in the ANDA called "Question-based Review" which will use the principles of quality-by-design. An increase in staff numbers for generic drug review is also expected, as is an enhanced use of electronic programmes for handling drug submissions and internal documents, and when possible, resources from other FDA departments will be engaged in the effort as well. Meanwhile, the FDA will also look to increase its communications with generic drug manufacturers and provide training on proper application submissions. While the GPhA would work with the FDA to tackle issues, Jaeger said it was the core issues of citizen petition process, scientific consults, enhanced communication, more inspection resources, accountability and structure of the OGD that needed to be addressed. "If we do not address these long-existing, core fundamental issues, we will simply be throwing money down the drain and be doing little to help consumers get the affordable medicines they need,"​ she said. The FDA already has a user fee programme with generic manufacturers. Generics represent 63 per cent of total prescriptions dispensed in the US, which are 30 to 80 per cent lower in price than their brand name equivalents.

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