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FDA announces generics plan

The FDA reveals plans for a programme designed to make low-cost generic drugs more easily and widely available to doctors and consumers in the US

The FDA has released plans for a programme designed to make low-cost generic drugs more easily and widely available to doctors and consumers in the US.

The goal is one that the generic drug industry supports, but nonetheless, the proposal has been met with scepticism from the Generic Pharmaceutical Association (GPhA), the trade group for generic drug manufacturers and distributors.

The FDAís plan, called The Generic Initiative for Value and Efficiency (GIVE), is designed to streamline the process by which generic drugs are approved for marketing.  The agency intends to hire and train new generic drug reviewers, expanding its current fulltime staff of 215 employees.  Additional manpower will be secured by making use of resources from other departments.

GIVE also calls for the FDA to speed the generic drug review process by shifting from paper to electronic handling of materials such as drug submissions and internal review documents, as well as to provide the industry with additional training on generic drug application submission procedures though seminars and webcasts.

Other aspects of the plan include identifying low-risk manufacturing changes that could be approved using an abbreviated review process and expediting the review of applications for products that are the first generic versions of a drug.

GPhA President and CEO Kathleen Jaeger released a statement in response to the FDAís announcement arguing that GIVE does not go far enough: ìWhat consumers need is for the FDA to address the core fundamental issues that are blocking timely consumer access to affordable generics. 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.î

Near to the top of this list of issues for the GPhA is the question of citizen petitions, which are often filed by brand-name drug companies in an effort to delay generics from coming to market. GPhA claims that the FDA is not required by law to hold off on approving a generic application until a citizen petition has been resolved, but that it almost always does so.

Other key issues for the group include scientific consults, enhanced communication, more inspection resources, and problems related to the accountability and structure of the Office of Generic Drugs.

ìIf 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,î Jaeger maintained.

A similar position was taken by The Coalition for a Competitive Pharmaceutical Market, a group that represents generic drug manufacturers as well as interested parties concerned about the cost of prescription drugs, such as large national employers, health plans, pharmacy benefit managers and chain pharmacies.

The Coalition acknowledged that the announcement of GIVE was a small step in the right direction but stressed that ìreal work remains on important issuesî. Specifically, the group cited ìthe lack of a workable approval pathway for biogenerics, increased funding for the Office of Generic Drugs and stopping brand-name pharmaceutical companies from unfairly extending brand drug patents.î

30th September 2008


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