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FDA Plans to Accelerate Generic Drug Review
The FDA has revealed a new program designed to speed up the approval process of generic drugs. The new drug review program called Generic Initiative for Value and Efficacy (GIVE) aims to significantly increase the number of generic drugs approved each year. In 2007, the FDA tentatively approved 682 generic drugs, which is a 30% increase over 2006. The FDA plans to expedite certain drug applications (including those for which there are no exclusivity protections and those that involve low-risk manufacturing changes), and also plans to hire more staff to review generic drug applications.
Generic medications represent 63% of total prescriptions dispensed in the U.S., but only 20% of all dollars spent on prescription drugs. Generic Pharmaceutical Association President and CEO Kathleen Jaeger indicated, “For years, the Agency has tinkered around the edges with programs 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. The generic industry stands ready to work with the Agency in tackling these issues to increase consumer access. That’s why we have entered into good faith efforts with the FDA to create a meaningful user fee program that truly results in timely generic access.
“A significant investment in the generic approval process must ensure that the investment produces a meaningful program with measurable results. A successful user fee program must include robust performance measures; certainty in the review and approval process, including an Agency commitment of resources and recruitment and retention of reviewers; and the closure of barriers to access. 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.”
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