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FDA to seek answer to pipeline blockage
18-Mar-2004
Related topics: Regulatory & Safety
The US Food and Drug Administration is to develop a blueprint for speeding up the approval of new medical products to counteract the slowdown in R&D productivity in the pharmaceutical industry.
Among the areas identified as being fundamental to improving the 'Critical Path' to improvement are a number aimed at modernising the manufacturing tools necessary for the mass production of therapies, as well as safety and efficacy assessments.
Announcing the White Paper - entitled Innovation or Stagnation? - FDA Commissioner Mark McClellan said: "Today, as never before, we face a tremendous potential for new medicines to prevent and cure diseases, but fewer new products are actually reaching the FDA."
On the manufacturing side, the report notes that many product failures during development are ultimately attributable to problems relating to the transition from laboratory prototype to industrial product.
As a result it is crucial that technical standards (e.g. assays, procedures, or reference standards) and improved methods for the design, characterisation, and mass manufacture of products are available to improve predictability in this area.
"The pharmaceutical industry generally has been hesitant to introduce state-of-the-art science and technology into its manufacturing processes, in part due to concern about regulatory impact,"notes the report. This led to high in-process inventories, low factory utilisation rates, significant product wastage and compliance problems, driving up costs and decreasing productivity, it adds.
Among the recommendations are an increasing emphasis on process analytical technologies - automated sensors that monitor and control processes - and other technologies that can improve efficiency.
The agency also said that it intends to look critically at areas where FDA regulation may have slowed adoption of technological improvements, in a process which led to internal changes and new collaborations with industry, academia etc.
"Not enough applied scientific work has been done in creating new tools to get fundamentally better answers about how the safety and effectiveness of new products can be demonstrated, in faster time frames, with more certainty, and at lower costs," the report suggests.
The next steps in this initiative include a series of workshops and meetings, to start development of the National Critical Path Opportunities list and to identify the key priorities, said the agency.
R&D costs for new drugs have soared in recent years. In 2000, it cost $802 million (€654m) to make a new drug compared with $318 million in 1987, according to the US trade group Pharmaceutical Research and Manufacturers of America (PhRMA).
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